Regulatory Submission of a Medical Device Design Project

BIOE 5250 – Fall 2018

Professor Kent

December 4, 2018

Parth Patel, Christina Pothier, and Kevin Swift

Heart Buddy
Wireless VAD Device

KCP Heart Solutions

Boston MA, USA
Table of Contents
Executive Summary....................................................................................................................................... 5
Device Description ........................................................................................................................................ 5
Intended Use ................................................................................................................................................. 5
Competitive Products/Predicates ................................................................................................................. 5
Resource Guidelines...................................................................................................................................... 6
Key Component or Development Partners ................................................................................................... 6
Description of Design and Manufacturing Sites ........................................................................................... 6
Overall Timeline ............................................................................................................................................ 6
Target Countries............................................................................................................................................ 6
Design and Development Plan ...................................................................................................................... 7
1. Introduction .......................................................................................................................................... 7
1.1. Purpose of the Document ................................................................................................................. 7
1.2. Intended Audience ............................................................................................................................ 7
1.3. Scope of the Document .................................................................................................................... 7
2. Goals and Objectives............................................................................................................................. 7
2.1. Background and Effect Goal .............................................................................................................. 7
2.2. Project Objectives ............................................................................................................................. 8
2.3. Project Objectives Priority ................................................................................................................ 8
3. Scope Baseline ...................................................................................................................................... 8
3.1. Product Scope Description ................................................................................................................ 8
3.2. Product Acceptance Criteria ............................................................................................................. 9
3.3. Major Deliverables ............................................................................................................................ 9
3.4. Work Breakdown Structure .............................................................................................................. 9
3.5. Exclusions ........................................................................................................................................ 11
3.6. Constraints ...................................................................................................................................... 11
3.7. Assumptions .................................................................................................................................... 11
3.8. Requirements Documentation ....................................................................................................... 11
4. Schedule .............................................................................................................................................. 12
4.1. Phases and Reviews ........................................................................................................................ 13
5. Project Organization Plan ................................................................................................................... 14
5.1. Project Organizational Structure .................................................................................................... 14
5.2. Resources ........................................................................................................................................ 14
5.3. Responsibilities and Authorities ..................................................................................................... 15
6. Design and Development Documentation.......................................................................................... 15
7. Change History .................................................................................................................................... 16
Business Strategy Overview ........................................................................................................................ 17
Ventricular Assist Device (VAD) Market Overview ..................................................................................... 17
Technology .................................................................................................................................................. 17
Strategy ....................................................................................................................................................... 17
Regulatory Strategy .................................................................................................................................... 18
Major Milestones ........................................................................................................................................ 18
Competitive Advantage .............................................................................................................................. 18
Financial Outlook ........................................................................................................................................ 19
Clinical Study Outline .................................................................................................................................. 22
Design Input Specifications ......................................................................................................................... 23
Quality System Procedure.............................................................................. Error! Bookmark not defined.
Essential Requirements Checklist ............................................................................................................... 29
Standards Checklist ..................................................................................................................................... 51
Verification Testing for Design History File ................................................................................................. 53
Introduction................................................................................................................................................ 53
Purpose ................................................................................................................................................... 53
Terminology ............................................................................................................................................ 53
Scope ......................................................................................................................................................... 54
References ................................................................................................................................................ 54
Test Procedures ....................................................................................................................................... 54
Design Outputs........................................................................................................................................ 54
Sample size.............................................................................................................................................. 54
Test equipment and tools ....................................................................................................................... 54
Documentation and Recording* ............................................................................................................. 57
Revision History........................................................................................................................................ 57
Appendix A ................................................................................................................................................ 58
Appendix B ................................................................................................................................................ 58
Conclusion ................................................................................................................................................... 61
References .................................................................................................................................................. 61
Executive Summary
This report provides a detailed design summary of KCP Heart Solution’s Heart Buddy, a wireless
ventricular assist device (wireless VAD) for use in patients with cardiac insufficiency. This document
outlines: the functionality of the device, the process used to develop, test and verify the design of the
device, the intended target markets for sale, the regulatory strategy for gaining clearance in those
markets and the anticipated financial impact upon commercialization of the device.

Device Description
KCP Heart Solutions’ Heart Buddy – henceforth referred to as Heart Buddy or “the device” is a wireless
ventricular assist device. The device is a centrifugal pump system that assists in blood flow from the left
ventricle (the primary pumping chamber of the heart) to the aorta. The device contains an inlet cannula
attached to the left ventricle from which blood will be drawn into the system through the use of a
centrifugal pump which subsequently ejects the blood to the rest of the body via an outlet cannula
attached to the aorta. The device is powered through the use of a battery pack incorporated into a vest
worn by the patient through a wireless connection. Additionally, the device is controlled by a small
bedside table top monitoring system unit that also wirelessly communicates to the device. This device
will provide support to patients whose circulatory system cannot sustain a normal blood flow rate until a
permanent treatment solution can be administered.

Intended Use
The device will be indicated for providing short-term hemodynamic support (e.g. bridge to transplant or
bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure.

Competitive Products/Predicates
There are three types of competitive products already available on the market:

Traditional Wired VADs:

- HeartMate 3 Left Ventricular Assist Device manufactured by St. Jude Medical (Thoratec
Laboratories)
- Jarvik 2000 Heart System by Jarvik Heart, Inc.
- HeartWare VAS by HeartWare
- CentriMag by Thoratec Corporation.

Catheter Based Devices:

Minimally invasive, catheter-based cardiac assist device designed to partially unload the left ventricle
thus reducing the heart’s workload and oxygen consumption.
- Impella 5.0 by AbioMed.

Extracorporeal membrane oxygenation (ECMO):

ECMO is a mechanical circulatory system therapy that provides both respiratory and cardiac
functionality. While ECMO is not classified as a VAD, it can be used to treat hemodynamically
compromised patients.

Advantages:
The transcutaneous power system will reduce infection rates (one of the most prevalent complications
for this type of device), reduce pain and provide a better quality of life as it eliminates an access site into
the body required for a wired powered system providing a significant advantage over the tradition VAD
and catheter-based systems.

The system will also be much less complex and require fewer resources compared to an ECMO system.

Resource Guidelines
KCP Heart Solutions resources will be primarily dedicated to designing and developing the wireless
powering system (including power supply), monitoring system and software required to run and control
the device. KCP Heart Solutions will manufacture, package and label both the wireless charging system
and the final product in house.

The remaining items will be either sourced or contracted as shown below:

- Centrifugal pump will be an off the shelf pump sourced from Terumo Medical Corporation
- Cannula extrusions will be contracted, developed and manufactured by Putnam Plastics
- Vest will be contracted, developed and manufactured by MediVest

Key Component or Development Partners

The key component and development partners are Terumo Medical Corporation (centrifugal pump),
Putnam Plastics (cannula extrusions) and TBD (vest).

Description of Design and Manufacturing Sites

The device was designed at KCP Corporate Headquarters in Boston, MA. The product will be
manufactured, packaged and labeled at the company manufacturing site in Nashua, NH.

Overall Timeline
The design and development process (including verification and validation) will take two years which will
then initiate the start of the clinical study. The clinical study will take two years with a 6-month
enrollment period with subsequent 6-month and 24-month end points. The point of first sale is
estimated for Q4 of year 5 with the goal for profitability in Q1 of year 7. The timeline will be discussed
further in the report, with incorporating the considerations of a successful clinical trial and navigating
the regulatory pathways in the device’s target markets.

Target Countries
The device’s initial target markets will be in the European Union (EU), the United States of America
(USA), Canada, Australia and Saudi Arabia. Strategies specific to gaining regulatory clearance in each
region will be detailed later in the report.
Design and Development Plan
Heart Buddy – Wireless VAD Project

1. Introduction
1.1. Purpose of the Document
The purpose of this document is to define the goals, strategies, roles, responsibilities and methods for
performing for the development of the Heart Buddy product within the Wireless VAD project.

1.2. Intended Audience

The intended audience(s) of this document is/are:

-Engineering Team Members (Christina Pothier, Parth Patel, and Kevin Swift)

- Instructor Joel Kent

- Management and Senior Leadership

- Regulatory Bodies:
European Medicines Agency (EMA) – European Union
Food and Drug Administration (FDA) - USA
Health Canada (HC) – Canada
Therapeutic Goods Administration (TGA) – Australia
Saudi Food and Drug Authority SFDA – Saudi Arabia

1.3. Scope of the Document

This Design and Development plan covers the design and development of the Heart Buddy product
within the Wireless VAD project.

2. Goals and Objectives

2.1. Background and Effect Goal
The purpose of the project is to meet the increasing competition in the VAD market from current
competitors such as St. Jude and Abiomed but also potential new competitors such as Leviticus Cardio
(cleared in the EU) or other potentially emerging wireless VADs. The increasing rate of new products
from above listed companies has made some of our older products less attractive to the customers. As a
result, the market share has dropped from 30% to 20%. If we do not act on this threat, the market share
is believed to plummet to 3% in 5 years forcing the Nashua, NH factory to shut down.

However, successful completion of this project would meet the current threat and provide the company
with a superior technology and a clear advantage to regain market share while maintaining current
profit margins both domestically and internationally. Domestically, the Heart Buddy would be the only
FDA cleared wireless VAD that would lead to a 30% growth, resulting in a projected 50% market share.
Internationally, the system would be one of a limited group of competitors that would result in the
following increases in market share:

Canada – Market share increase 25%

EU –Market share increase25%

Australia –Market share increase20%

Saudi Arabia – competitors Market share increase 15%

2.2. Project Objectives

The project has the following objectives:

1. Develop a system according to the scope baseline of this project plan

2. Completed according to the Baseline budget specified in this plan

3. Complete the project no later than the following dates to deliver product that may be exhibited at
the following trade shows:

American College of Cardiology Scientific Expo (USA) December, 2023

Canadian Cardiovascular Congress (Canada) August, 2024

European Society of Cardiology Congress (EU) December, 2024

Saudi Heart Association Conference (Saudi Arabia) December, 2024

Cardiovascular and Thoracic Surgery Conference (Australia) March, 2024

2.3. Project Objectives Priority

The following priority should apply:

1. Result (Safety for people, property and environment and regulatory compliance)

2. Time (Exhibitions are secondary to project completion time if in conflict)

3. Budget and resources

4. Result (customer satisfaction)

3. Scope Baseline
3.1. Product Scope Description
The product shall consist of a sterile (pump, inflow and outflow cannula) and non-sterile hardware
(portable powering vest and monitor unit) units and has the following intended use:

The device is indicated for providing short-term hemodynamic support (e.g. bridge to transplant or
bridge to myocardial recovery) in patients with advanced refractory left ventricular heart failure.
The system will have the following key features:

- Centrifugal Pump

- Wireless Powering Unit & Battery

- Blood Transport Circuit (inflow and outflow cannula tubing)

-System Monitor and Control Unit

-Sterile Packaging

3.2. Product Acceptance Criteria

Project deliverables shall be approved according to the product development procedure.

Product shall be developed in accordance with the regulatory requirements that applies for target
markets as specified in project charter and the requirement documentation as set out in the
requirement specifications.

3.3. Major Deliverables

The project has the following major deliverables:

- A first prototype of working hardware and disposable

- A serialized production of 100 hardware units and 100 disposables that are verified and
validated and ready for clinical trials or CE-marking

- DHRs for the products above

- A complete DMR for the products above

- A complete DHF/Technical file for the design

3.4. Work Breakdown Structure

0 Heart Buddy Work Breakdown Structure
1 Project Pitch
1.1 Create Project Pitch and Presentation
1.2 Present to Management team
1.3 Gain Project Approval
2 Project Initiation
2.1 Define WBS for Project Management Implementation Activities
2.2 Define WBS for Device Development Implementation Activities
2.3 Establish Initial Regulatory Strategy
2.4 Establish Project Controls
2.5 Allocate Project Resources and Personnel
2.6 Approve Project Timeline
2.7 Approve Design and Development Plan
3 Design Inputs and Feasibility
3.1 Obtain Voice of the Customer
3.2 Create Market Impact Assessment
3.3 Create Financial Projections
3.4 Create Market and Product Specifications
3.5 Create Risk Management Workbook
3.6 Create Product Drawings
3.7 Perform Tolerance Analysis
3.8 Create Hazard Analysis
3.9 Define Manufacturing Sites
3.10 Identify applicable standards
3.11 Create Initial Prototypes
3.12 Perform Initial Bench/Lab Testing
4 Design Output
4.1 Source Materials
4.2 Create Initial Manufacturing Documents and Routings
4.3 Perform IQ's on Tooling
4.4 Build Product for Verification Activities
4.5 Perform Design Verification Testing (T=0)
4.6 Perform Sterilization Testing
4.7 Perform Biocompatibility Testing
4.8 Perform Package Testing
4.9 Create DFU, Labels and Translations
4.10 Prepare PMA application
4.11 Perform FDA Pre-Submission Meeting
4.12 Adjust PMA application
4.13 Obtain IDE for Clinical Study
5 Clinical Study
5.1 Create Clinical Study Protocol
5.2 Enroll Patients in Clinical Study
5.3 Perform Clinical Study
5.4 Approve Results of Study / Close Out Study
5.5 Obtain PMA acceptance
6 Additional Design Output (Concurrent with Clinical Study)
6.1 Perform AA testing (confident in trail results & completed by trial end)
7 Design Transfer (Concurrent with Clinical Study)
7.1 Create Master Validation Plan
7.2 Perform Operational Qualification on Equipment
7.3 Perform Process Qualification on Equipment
7.4 Perform Process Qualification
8 Regulatory Submissions
8.1 Perform Post Market Surveillance (U.S.)
8.2 Obtain ISO Certification
8.3 Obtain Design Dossier Certification
8.4 Obtain CE mark
 8.5 Obtain Health Canada Clearance
8.6 Obtain SFDA Clearance
8.7 Obtain TGA Clearance
8.8 Perform Post Market Surveillance (Int.)
9 Project Close Out
9.1 Project Acceptance
9.2 Host Close Out Review
9.3 Project Completed

3.5. Exclusions
The following parts/deliverables are not a part of the project:

- Development of the centrifugal pump (off the shelf) to Terumo

- Development of the tubing will be outsourced to Putnam Plastics

- Development of the external carrying vest will be outsourced to MediVest

3.6. Constraints
The following constraints apply to the project:

- The required flow rates required for a successful procedure must be attainable with the pump.

- The wireless charging system must not be detrimental to the patient.

- The wireless charging system must be negatively impacted by typical surgical suite and hospital
equipment

3.7. Assumptions
The following assumptions are considered to be true for planning purposes:

- The quality management system will be approved by notified body throughout the duration of
the project

- No significant changes to the QMS with regards to design and development will be done
throughout the duration of the project

- Key researchers will provide information in timely manner during the course of the project

- No supply issues will be realized with outsourced or off the shelf components

- Patent application US9859480A is assumed to become an approved patent

3.8. Requirements Documentation

The requirements for the product and processes can be found in the following documents:
 - User needs specification

- Requirement traceability matrix

- Market and Product Specifications

- Risk Management Workbook (DFMEA, UFMEA, PFMEA, Hazard Analysis)

- Tolerance Analysis and Product Drawings

- Manufacturing and Incoming Inspection Documentation

-Quality System Documentation

-Regulatory Strategy

-Clinical Study Results

4. Schedule
Baseline target dates are:

Phase Date

Project Pitch 12/2018

Project Initiation 12/2018

Design Inputs / Feasibility 04/2019

Design Output 11/2020

Clinical Study Completion 12/2022

PMA Clearance 12/2023

HC Approval 08/2024

CE Approval 12/2024

SFDA Approval 12/2024

TGA Approval 03/2025

See detailed schedule information in the Gantt Chart Below.

Timeline Assumptions:

- 30-day IDE Review

- 6-month enrollment
- 180-day PMA Review
- 6-month ISO certification approval
- 75-day review for Canada
- 12-month Design Dossier approval

4.1. Phases and Reviews

The development is done according to the phases defined in SOP-002 Design and development.

Design reviews will be performed according to SOP-002 Design and development and the table below:

Design reviews/Decision points Date Review team

At the end of the “Design Inputs and 04/2019 Parth Patel, Christina Pothier, Kevin
Feasibility” stage gate prior to “Design Swift and Project Team
Output” stage
 At the end of the “Design Output” stage gate 11/2020 Parth Patel, Christina Pothier, Kevin
prior to “Clinical Study” stage Swift and Project Team

At the end of the “Design Transfer” stage 06/2023 Parth Patel, Christina Pothier, Kevin
Swift and Project Team

At the end of the “Clinical Study” stage prior 12/2023 Parth Patel, Christina Pothier, Kevin
to U.S. product release Swift and Project Team

After HC approval for International product 08/2024 Parth Patel, Christina Pothier, Kevin
release Swift and Project Team

After CE and SFDA approval for International 12/2024 Parth Patel, Christina Pothier, Kevin
product release Swift and Project Team

After TGA approval for International product 03/2025 Parth Patel, Christina Pothier, Kevin
release Swift and Project Team

5. Project Organization Plan

5.1. Project Organizational Structure
Below is the organization chart of the project:

The organization chart above also defines the organizational interfaces between various functions in the
project.

5.2. Resources
The following personnel are working in the project:

Core Team Representatives Specific Team Member Name

Project Manager N/A
R&D Manager N/A
R&D Electrical Engineer Parth Patel
R&D Biomedical / Mechanical Engineer Christina Pothier
R&D Software Engineer Kevin Swift
Biology / Sterility Representative N/A
R&D Technician N/A
Manufacturing / Plant Manager N/A
Marketing Representative N/A
Advanced Engineering N/A
Manufacturing Engineer N/A
Quality Engineer N/A
Regulatory N/A
Supply Chain / Purchasing N/A

The following material resources will be used in the project:

Components and raw materials required for prototyping

Components required for verification testing and clinical study samples

Test equipment and fixturing

5.3. Responsibilities and Authorities

Responsibilities and authorities shall be according to SOP-004 with the addition of the following
positions:

- Parth Patel – R&D Electrical Engineer

- Christina Pothier – R&D Bio/Mechanical Engineer

- Kevin Swift – R&D Software Engineer

The associated responsibilities and authorities can be found in appendix SOP-004.

6. Design and Development Documentation

Documentation will be controlled according to the following SOPs:

- SOP-001 Document control

- SOP-002 Control of records

- SOP-003 Device master record

-SOP-004 Design and Development

7. Change History

Revision Ref Description

A N/A Initial release

Business Strategy Overview
This section of the report will focus on the VAD market and the impact the wireless VAD will have for the
company.

Ventricular Assist Device (VAD) Market Overview

Heart disease is a serious issue in the Unites States, estimated by the CDC to result in 610,000 deaths
annually, accounting for 1 in every 4 deathsi. It is the leading cause of death in both men and women
and over half of the annual deaths in men can be attributed to heart diseasei. There are many different
contributing factors for heart disease such as diabetes, obesity, lack of diet and exercise and excessive
alcohol usei.

Internationally, heart disease resulted in 3.9 million deaths in Europe (45% of all deaths), with 1.8 million
occurring within the EU (37% of all deaths) in 2017ii. It was the main cause of death in all but 12
countries in Europe for men and the main cause of death in women in all but 2 countriesii. It was
estimated that there were 11.3 million new cases of heart disease reported in 2015 aloneii. Canada
reported that 2.4 million (8.5% of Canadians) people are currently living with heart disease with about
158,700 (6.1 per 1000) new cases diagnosed every yeariii. In Australia cardio vascular disease caused
43,477 deaths in 2017 and is stated as one of Australia’s largest health problemsiv. It was estimated that
it kills one Australian every 12 minutes and affects every 1 in 6 residents in the countryiv. Finally, in Saudi
Arabia the prevalence of heart disease was reported to be at 5.5% of the populationv.

The Left Ventricular Assist Device (LVAD) market is primarily focused on these types of patients with
advanced or end stage heart failure that can no longer be treated with conventional therapies or
management strategies. These patients have a reduction in heart function and can no longer maintain a
normal blood circulation level required to sustain normal bodily function. The long-term treatment for
these patients is a heart transplant. However, due to the limited number of donor hearts and treatment
sites available, the wait periods can be very long. The LVAD device is a bridge solution used to
supplement the normal function of the heart in these patients until they can receive a donor heart.

The LVAD market is expect to exceed $2 billion dollars by 2024vi, with a growth rate of 10.5%vii.
Additionally, the number of patients requiring a heart transplant has double in the last 15 years, 30% of
which required an LVAD. The procedure is becoming (both domestically and internationally) more
recognized for its efficacy and it is becoming more prevalent in a growing market, leading to a strong
global growth opportunity for KCP Heart Solutions.

Technology
The Heart Buddy wireless LVAD will be a technically superior device with a unique patented wireless
charging system that transcutaneously powers the pump. This technology will remove the necessity of a
percutaneous power line connecting the implanted pump to an external power supply thus providing an
advantage over the competition.

Strategy
The business strategy will be specialized for each of the following regions:

US and Canada:
After clearance from the FDA and Health Canada, KCP Heart Solutions will implore a large-scale direct
sales team to maximize the exposure and usage of our product providing the highest likelihood for
improved patient outcomes and stronger sales. Being based in the USA with headquarters in Boston,
MA, and the geographically close proximity of Canada warrants this expense and will drive the main
growth of the product.

Europe:
Europe is being viewed by the company as the second largest market for the Heart Buddy product. A
small satellite office (sales and marketing only, no manufacturing) will be opened in Europe, after
successful results from the clinical study are being realized and confidence can be gained in the product,
to train and provide a smaller scale direct sales force in Europe.

Australia and Saudi Arabia:

Australia and Saudi Arabia are being viewed by the country as a strong but tertiary market for the
device. While the company believes the device will be successful in these regions, it will partner with
sponsors and distributors to distribute and sell the Heart Buddy system.

Regulatory Strategy
KCP Heart Solutions will first gain regulatory clearance in the United States through the PMA submission
process. After clearance, KCP Heart Solutions will file for ISO certification and Design Dossier
certification approval required for CE mark and clearance in the EU. It is anticipated that the ISO
certification will be granted in 6 months, while the Design Dossier will take 12 months at which point a
CE mark will be granted for sale in the EU. After receipt of the ISO certification, KCP Heart Solutions will
apply for clearance in both Canada and Saudi Arabia. It is estimated that after receipt of the ISO
certification, it will take 75 days to receive a clearance in Canada, while it will take 6 months to receive
clearance in Saudi Arabia. Finally, KCP Heart Solutions is expected to receive clearance in Australia 3
months after receiving CE clearance, at a total of 15 months past clearance in the US.

Major Milestones
The following major milestones are expected during the execution of this project:
- Patent Application submitted in December, 2018
- Successful Bench Tested Prototypes in November, 2020
- FDA granted IDE for the Heart Buddy system in December, 2020
- Clinical Study Initiation in December, 2020
- Patent Granted in December, 2021
- Clinical Study Completion in December, 2022
- PMA Clearance in December, 2023
- HC Approval in August, 2024
- CE Approval in December, 2024
- SFDA Approval in December, 2024
- TGA Approval in March, 2025
- Profitable in February, 2025

Competitive Advantage
The wireless transcutaneous powering system provides the following key competitive advantages:
- Increased Patient Safety
o Reduction in infection rates
 ▪ 19% of patients currently get infection at driveline site
o Reduction in bleeding due to removal of wire
- Increased Quality of Life
o Increased mobility due to removal of percutaneous wire
o Less pain due to removal of percutaneous wire and reduced rates of infection
o Increased comfort during normal daily activity

Financial Outlook
The estimated project cost will be $20 million dollars on average for the first five years consisting of the
two years of product development, 2.5-year clinical trial and 6-month FDA approval process. The first
sale will be in Q1 of year 5 (2024). It is estimated that the break-even point will be in February, 2025,
corresponding to year 6 after the initiation of the project.

The financial breakdown in terms of sales and net profit can be seen in the table below.

Heart Buddy - Annual Sales & Net Profit

300,000,000

250,000,000

200,000,000
USD ($)

150,000,000

100,000,000

50,000,000

0
1 2 3 4 5 6 7 8 9
Year Post Project Initiation

Sales Net Profit

The estimated post-approval yearly revenue is estimated to be $150,000,000 the first year after FDA
clearance with a yearly operating cost $25,000,000 resulting in a net profit of $125,000,000 annually.

This number is expected to grow after additional regulatory clearances are realized. We expect the
operating cost to remain stable but with an increase in overall sales and net profit on an annual basis
per the table below:

Year Project Year Registration Received Market Share Total Revenue ($)
2024 6 FDA 40% 125,000,000
2025 7 FDA, HC (5 months) 40%, 25%, 150,000,000
2026 8 FDA, HC, CE & SFDA 40%, 25%, 25%, 15% 185,000,000
2027 9 FDA, HC, CE, SFDA & TGA 40%, 25%, 25%, 15%, 20% 250,000,000

We believe that the KCP Heart Buddy system while involving a lengthy investment time frame, will have
significant profitability in the future.
EU Regulatory Pathway
Heart Buddy is likely to be a Class III device, according to Annex 9 the European Union’s Medical Device
Directive 93/42/EEC. The reasons for this classification are that the device is implantable, long-term, and
surgically invasive. Additionally, it is intended to be in direct contact with the heart and central
circulatory system.

An EU Authorized Representative will have to be appointed as KCP Heart Solutions has no physical
locations within the EU. This Authorized Representative will serve the company as a liaison to the
Competent Authorities (health administrations) in regulatory communication matters.

Clinical data will be necessary for the approval of the Heart Buddy device. To run a clinical study, pre-
approval must be obtained from a European Competent Authority.

A design dossier will be compiled. This shall include an Essential Requirements checklist, in which all
pertinent and applicable international and local standards will be listed. Compliance with each relevant
standard will be stated and for any standards which are not applicable an explanation of why they do
not apply will be included. A Declaration of Conformity will be submitted as well.

A Notified Body, approved by the Competent Authorities, must be appointed to review the device
submission and audit the company’s development pathway. They will then decide whether or not to
approve the CE marking. If they decided to approve it, the CE marking will be appropriately added to all
device packaging.

US Regulatory Pathway
In the United States the Heart Buddy device will be classified as a Class III device. Justification for this
classification is because the device is intended to “support or sustain human life” and it is considered to
be “of substantial importance in preventing impairment of human health”.

For Class III devices in the United States, a Pre-Market Approval (PMA) is required. Nonclinical and
clinical study data must be submitted as part of the PMA. Before the Heart Buddy device can be used in
human clinical trials an Investigational Device Exemption (IDE) must be obtained.

KCP Solutions plans to take advantage of the FDA Pre-Submission program. Before the PMA is submitted
the FDA will meet with representatives of the company to provide guidance pertaining to the PMA
submission package.

After the PMA has been filed and the submission fee of $310,764 has been paid, the FDA will
communicate their decision within 180 days.

Canada Regulatory Pathway

The Canadian classification of the Heart Buddy device is likely to be Class IV. Any “surgically invasive
device intended to … correct a defect of the central cardiovascular system” is automatically considered a
Class IV device.

To distribute medical devices in Canada, KCP Heart Solutions must first apply for and receive a Medical
Device Establishment License (MDEL) which certifies the company as a legal medical device supplier.

The Heart Buddy device will require a Medical Device License (MDL). An application for the MDL shall be
prepared and submitted to Health Canada for review. The application package for a Class IV device must
include pre-clinical and clinical studies, process validation studies, software validation studies, and
literature studies.

The fee to submit an application for an MDL will be $10,164 (USD). A decision is anticipated 75 days
after the application has been filed.

Australia Regulatory Pathway

The classification of Heart Buddy in Australia will be Class AIMD (Active Implantable Medical Device).
The Heart Buddy meets the criteria for this class because it is both an active device, meaning that the
device relies on electrical power to function, and it is an implantable device which invades the body
cavity through a surgical operation.

Heart Buddy must be approved by the Therapeutic Goods Administration, a division of the Australian
Government Department of Health, to be placed on the Australian Register of Therapeutic Goods
(ARTG). Once the device has been put on the ARTG it can be legally sold and distributed in Australia. The
company legally responsible for supplying the device in Australia is known as the sponsor. Only a
sponsor from Australia can apply to get a device put on the ARTG. For this reason, KCP Heart Solutions
must distribute Heart Buddy devices through an Australian medical device company.

The Therapeutic Goods Administration (TGA) will review the device information. They may or may not
decide to audit the application. If the TGA decides to approve the application, the sponsor company will
receive a Certificate of Inclusion as proof that the device has been officially included in the ARTG.

Saudi Arabia Regulatory Pathway

For a medical device to gain marketing authorization in the Kingdom of Saudi Arabia (KSA) it must first
gain market approval in one of the following markets: the European Union, the United States, Japan,
Canada, or Australia. KCP Heart Solutions anticipates market approval of Heart Buddy in the EU, US,
Canada, and Australia.

An Authorized Representative (AR), licensed by the Saudi Food and Drug Authority (SFDA), must be
appointed to handle regulatory communications regarding the application of Heart Buddy.
A Medical Device Marketing Authorization (MDMA) application must be submitted to the SFDA for
review. It will then be reviewed by a third party Conformity Assessment Body (CAB) for technical
accuracy.

The SFDA will make a decision based on advice from the CAB. If they decide to approve the application,
an MDMA will be issued. It will remain valid for as long as the validity of the device approval is
maintained in the previously-marketed countries.

The SFDA decision is anticipated 6 months after the submission of the MDMA application.

Clinical Study Outline

This study will be based on endpoints of previously conducted studies of similar devicesviii.

Study Type: Interventional (Clinical Trial)

Enrollment: 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heart Buddy Clinical Investigation
Study Start Date: December 2020
Estimated Study Completion Date: December 2022

Outcome Measures:
Primary Outcome
o Survival at both the 6-month and 24-month end points
o Comparison to currently marketed traditional wired LVAD devices

Secondary Outcomes
o Quality of Life
▪ EQ-5D-5L standardized measurement developed by the EuroQol Group
▪ Patients describe their perceived health status
▪ 1 month, 6-month, 1 year and 2-year time points
o Functional Status
▪ 6-minute walk test – measures the distance a patient can walk in 6 minutes
▪ Assesses the patient’s functional status
▪ 1 month, 6-month, 1 year and 2-year time points
o New York Heart Association Classification Functional test
▪ NYHA classification relates symptoms to every day activities and quality of life
▪ 1 month, 6-month, 1 year and 2-year time points
o All Adverse Events
▪ Frequency of pre-defined anticipated adverse events
▪ 6-month and 24-month
o Device Malfunctions
▪ Frequency and incidence of device malfunctions
▪ 6-month and 24-month
o Reoperations
▪ Frequency of all reoperations required
 ▪ 6-month and 24-month
o Rehospitalizations
▪ Frequency and incidence of rehospitalizations
▪ 6-month and 24-month
o Stroke Free Survival
▪ Percentage of participants free of debilitating stroke
▪ 6-month and 24-month

Eligibility Criteria:
Ages Eligible for Study: 18 Years and older (Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria
- Informed Consent
- BSA ≥ 1.2m2
- NYHA IIIB or IV or ACC/AHA Stage D
- LVEF ≤ 25%
- CI ≤ 2.2 L/min/m2

Exclusion Criteria:
- Etiology of HF
- Technical obstacles which pose an inordinate high surgical risk
- Pregnancy
- Existence of ongoing mechanical circulatory support

Sites:
- New York
- Chicago
- Minneapolis

Sponsor:
- KCP Heart Solutions

Design Input Specifications

MEDICAL DEVICE SPECIFICATION

i Version No. 1

ii Date of initial version 14 November 2018

iii Date of last modification 14 November 2018

 iv Date of publication 4 December 2018

v Completed / submitted by KCP Heart Solutions

NAME, CATEGORY AND CODING

1 Proprietary Name(s) Heart Buddy

2 Generic name Left ventricular assist (bypass) device

3 Specific type or variation Wirelessly powered

(optional)

4 GMDN name Heart Buddy

5 GMDN code 47533

6 GMDN Definition/description Implantable Ventricular Circulatory Assist System

7 Part numbers KCP0001

8 Legal manufacturer KCP Heart Solutions

9 Target countries United States, Canada, EU, Australia, Saudi Arabia

10 Legal manufacturer KCP Heart Solutions

11 manufacturing site(s) Nashua, NH

12 country of origin United States

PURPOSE OF USE

13 Clinical or other purpose Designed for use in a clinical setting to supplement a patient’s and
maintain circulatory blood flow

14 Level of use (if relevant) Health center / Hospital

15 Clinical department/ward(if Operating Room / Intensive Care Unit

relevant)

16 Indications for Use To aid the left ventricle in providing circulatory blood flow
17 Overview of functional Device is to remain in its packaging until intended use. Unit must be
requirements implanted by a qualified surgeon.

TECHNICAL CHARACTERISTICS

18 Detailed requirements Device must be received in its packaging with no visible damage. Device
is stored within its packaging at room temperature, with no exposure
to direct sunlight.

19 Displayed parameters N/A

20 User adjustable settings N/A

PHYSICAL/CHEMICAL CHARACTERISTICS

21 Components(if relevant) Left ventricular assistive pump, blood transportation tubing, wireless
powering unit and battery

22 Mobility, portability(if Portable, battery portion is worn externally on the patient using a
relevant) strapped vest.

23 Raw Materials(if relevant) Polyethylene

UTILITY REQUIREMENTS

24 Electrical, water and/or gas Rechargeable battery

supply (if relevant)

ACCESSORIES, CONSUMABLES, SPARE PARTS, OTHER COMPONENTS

25 Accessories (if relevant) Strapped vest to hold external battery unit

26 Sterilization process for Device arrives sterilized

accessories (if relevant)

27 Consumables / reagents (if N/A

relevant)

28 Spare parts (if relevant) N/A

29 Other components (if relevant) N/A

PACKAGING

30 Sterility status on delivery (if Device within packaging will be sterile upon receipt.
relevant)

31 Shelf life (if relevant) 2 year shelf life for disposable and hardware units

32 Transportation and storage (if Units shall remain within protective and sterile packaging. Excessive
relevant) agitation during shipping is to be avoided.

33 Labelling (if relevant) Product will be appropriately labelled detailing relevant product,
manufacturing, and sterilization information

ENVIRONMENTAL REQUIREMENTS

34 Context-dependent N/A
requirements

TRAINING, INSTALLATION AND UTILISATION

35 Pre-installation Keep device in packaging until use. Sterile barriers must be maintained
requirements(if relevant) prior to implantation

36 Requirements for N/A

commissioning (if relevant)

37 Training of user/s (if relevant) Training will be provided to medical staff.

38 User care(if relevant) N/A

WARRANTY AND MAINTENANCE

39 Warranty N/A

40 Maintenance tasks N/A

41 Type of service contract N/A

42 Spare parts availability post- Spare parts can be purchased by directly contacting KCP Heart
warranty Solutions.
43 Software / Hardware upgrade KCP Heart Solutions will notify all clients of any upgrades as they are
availability released.

DOCUMENTATION

44 Documentation requirements User, technical and maintenance manuals to be supplied in the English
language.

Information on equipment and procedures will be supplied.

Contact details of manufacturer, supplier and local service agent will be

provided.

DECOMMISSIONING

45 Estimated Life Span 5 years

SAFETY AND STANDARDS

46 Risk Classification Class III

47 Regulatory Approval / FDA Pre-Market Approval (USA), CE Mark (EU and Australia)
Certification
48 International standards ISO 14971: Application of risk management to medical devices

ISO 13485: Quality management systems requirements for regulatory

purposes

ISO 14155: Clinical investigation of medical devices for human subjects

ISO/TC 194: Biological and clinical evaluation of medical devices

ISO 10993: Biological evaluation of medical devices

ISO 11607: Packaging for terminally sterilized medical devices

ISO 11135: Sterilization of health-care products

ISO 14644: Cleanrooms and associated controlled environments

ISO 15223: Symbols used in medical device labelling

ISO 80369: Small-bore connectors

ISO 7189: Cardiovascular implants and extracorporeal systems

ISO 5840: Cardiovascular implants; heart valve substitutes

ISO 5198: Centrifugal, mixed-flow, and axial pumps

ISO 14117: Electromagnetic compatibility of active medical devices

IEC 60601: Electrical standards for medical equipment

49 Regional / Local Standards ANSI/AAMI EQ89-2015: Guidance for the use of medical equipment,
maintenance strategies, and procedures (US)

ANSI/AAMI ES1-1993: Safe current limits for electromedical apparatus

(US)

CAN/CSA-C22.2: Electrical testing and certification for medical devices

(Canada)

CAN/CSA-ISO 13485: QMS requirements for regulatory purposes

(Canada)

50 Regulations 21 CFR part 820 (US)

Council Directive 93/42/EEC (EU)

Directive 93/68/EEC (EU)

Directive 2001/104/EC (EU)

Directive 2007/47/EC (EU)

SOR-98/282 Medical Devices Regulations (Canada)

 Quality System Document
KCP Heart Soultions Quality System Procedure
QSP 001
Nonconforming Material (NCR) Subject: Control of Nonconforming
Procedure Product
Revision A
Issue Date: 12/3/2018
Reference ISO 9001:2000 Element: 8.3 Page 29 of 3
Control of Nonconforming Product

1.0 Purpose

1.1 To establish a procedure for the control and disposition of nonconforming

products and materials, to prevent unintentional use or shipment in the Heart
Buddy system.
2.0 Scope

2.1 This procedure applies to all nonconforming products and materials detected
within KCP Heart Solutions, whether obtained from vendors, produced in-house,
or in company stock.

This procedure applies to all employees, specifically the following:

- Incoming inspection operators
- Supplier Quality Engineers & Managers
- Purchasing and Supply Chain

3.0 Responsibility and Authority

3.1 The Learning and Development department is responsible for verifying that all
employees are trained on QSP 001. They will keep detailed records of employee
training records including dates of training and procedure revision levels.
3.2 Incoming inspection operators are to be thoroughly versed in this procedure and
have the knowledge to alert a Supplier Quality Manager when product is received
or manufactured outside of the approved specification.
3.3 The Quality Manager has responsibility and authority to ensure this procedure is
followed. He/She may delegate tasks to qualified personnel as needed. They are
responsible for filling out and providing the warehouse with appropriate
paperwork (NCR) to ensure that the nonconforming materials are removed from
the production available component storage.
3.4 Warehouse personnel are responsible for moving the nonconforming
components to the QA quarantine area.
 3.5 Purchasing is responsible for providing the supplier with a Supplier Corrective
Action Request (SCAR) to inform the supplier of the issue for components not
manufactured at KCP Heart Solutions.

4.0 Procedure

4.1 Nonconforming product detected at KCP Heart Solutions

4.1.1 Nonconforming product can be detected in many ways, by any person, at

any time.
4.1.2 When nonconforming material is detected, it is immediately removed from
the normal process flow and the Supplier Quality Manager is to be
notified.
4.1.3 The product or material is removed from the normal process flow by being
placed on the designated “QC Hold Quarantine Area”. This are will be a
locked area that segregates the nonconforming product from the
production accepted product.
4.1.4 Nonconforming material is identified with a HOLD tag, which is filled out
and attached to the affected item(s). The HOLD tag contains part
number, quantity, description, reason for being on hold, name of the
person who detected the problem, and the date.
4.1.5 Disposition of nonconforming products can be determined by any of the
above the Supplier Quality Manager. The SQ Manager will periodically
go through all the items on the hold shelf to dispose of the products. No
nonconforming material shall be removed from the hold shelf except by
the SQ Manager.
4.1.6 After parts are properly disposed of, the disposition is noted on the HOLD
tag. Completed HOLD tags are given to the Quality Manager and kept on
file to assist with measurements of quality objectives.
4.1.7 Depending on the source of the nonconforming materials, it may be
necessary to notify the Accounting department of a product’s disposal, for
example if the part is returned to a vendor for credit.
4.1.8 Also depending on the nature of the nonconformance, it may be
necessary to generate a Corrective Action Request, and possibly a
notation in the Vendor Tracking Log.

4.2 Nonconforming product detected after delivery or use.

4.2 1 When nonconforming product is detected after delivery or use, corrective

action is taken appropriate to the nonconformance. Appropriate action may be in
the form of parts and/or information sent to customers, a recall of the product, or
other action deemed necessary by top management to correct the
nonconformance and prevent its recurrence.
5.0 Related and Support Documentation

Hold tags
Company layout depicting the Supplier QC Hold area
6.0 Revision History

Date: Revision Description of Revision:

level:
12/3/2018 A Initial release
Essential Requirements Checklist

Essential Requirement Applicable to If Not Applicable Method of Conformity Identity of Specific Documents
Device? Explain Why Not (General and Product Specific and the location
Harmonized standards must be listed
or justified why not – include non
applicability of standard sections with
justification

I. GENERAL REQUIREMENTS

1. The devices must be designed and manufactured in such a way that, when YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
used under the conditions and for the purposes intended, they will not manufactured under a full Quality 001111
compromise the clinical condition or the safety of the patients, or the safety Management System in accordance 2. Proactive Surveillance Report
and health of users or, where applicable, other persons, provided that any with ISO 13485 and presently certified. PSR01
risks which may be associated with their intended use constitute acceptable 2. Risk analysis has been performed in 3. Risk Analysis Report RAR01
risks when weighed against the benefits to the patient and are compatible accordance with ISO 14971. Studies 4. IEC 60601 Certificate IEC
with a high level of protection of health and safety. show that risks associated with this 0011
This shall include: device are acceptable when weighed 5. ISO 14155 Certificate 00022
against the benefits with a high level of
· reducing as far as possible, the risk of use error due to the ergonomic
protection of health and safety.
features of the device and the environment in which the device is intended
to be used (design for patient safety), and 3. The device is tested for electromagnetic
compatibility for Safety and Electrical
· consideration of the technical knowledge, experience, education and
performance in accordance with IEC
training and where applicable the medical and physical conditions of
60601.
intended users (design for lay, professional, disabled or other users).
4. The implanted device has been clinically
evaluated in compliance with ISO 14155
clinical investigation of medical devices
for human subjects in accordance with
Annex X

2. The solutions adopted by the manufacturer for the design and construction YES N/A Same as above Same as above
of the devices must conform to safety principles, taking account of the
generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer must apply
the following principles in the following order:
 · eliminate or reduce risks as far as possible (inherently safe design and
construction),
· where appropriate take adequate protection measures including
alarms if necessary, in relation to risks that cannot be eliminated,
· inform users of the residual risks due to any shortcomings of the
protection measures adopted.

3. The devices must achieve the performances intended by the manufacturer YES N/A Same as above Same as above
and be designed, manufactured and packaged in such a way that they are
suitable for one or more of the functions referred to in Article 1 (2) (a), as
specified by the manufacturer.

4. The characteristics and performances referred to in Sections 1, 2 and 3 must YES N/A Same as above Same as above
not be adversely affected to such a degree that the clinical conditions and
safety of the patients and, where applicable, of other persons are
compromised during the lifetime of the device as indicated by the
manufacturer, when the device is subjected to the stresses which can occur
during normal conditions of use.

5. The devices must be designed, manufactured and packed in such a way that YES N/A Same as above Same as above
their characteristics and performances during their intended use will not be
adversely affected during transport and storage taking account of the
instructions and information provided by the manufacturer.

6. Any undesirable side-effect must constitute an acceptable risk when YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
weighed against the performances intended. manufactured under a full Quality 001111
Management System in accordance 2. Proactive Surveillance Report
with ISO 13485 and presently certified. PSR01
2. Risk analysis has been performed in 3. Risk Analysis Report RAR01
accordance with ISO 14971. Studies 4. ISO 14155 Certificate 00022
show that risks associated with this
device are acceptable when weighed
against the benefits with a high level of
protection of health and safety.
3. The implanted device has been clinically
evaluated in compliance with ISO 14155
clinical investigation of medical devices
for human subjects

6a. Demonstration of conformity with the essential requirements must include a YES N/A Same as above Same as above
clinical evaluation in accordance with Annex X.
 II.

7. Chemical, physical and biological properties

7.1 The devices must be designed and manufactured in such a way as to YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
guarantee the characteristics and performances referred to in Section I on manufactured under a full Quality 001111
the ‘General requirements’. Particular attention must be paid to: Management System in accordance 2. Risk Analysis Report RAR01
with ISO 13485 and presently certified. 3. Biological Evaluation Test
· the choice of materials used, particularly as regards toxicity and, where
2. Risk analysis has been performed in report 00033
appropriate, flammability,
accordance with ISO 14971.
· the compatibility between the materials used and biological tissues,
3. The materials used to manufacture the
cells and body fluids, taking account of the intended purpose of the device,
device have been tested and subjected
· where appropriate, the results of biophysical or modeling research to biological evaluation in accordance
whose validity has been demonstrated beforehand. with ISO 10993 standards.

7.2. The devices must be designed, manufactured and packed in such a way as to YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
minimize the risks posed by contaminants and residues to the persons manufactured under a full Quality 001111
involved in the transport, storage and use of the devices and to the patients, Management System in accordance 2. Risk Analysis Report RAR01
taking account of the intended purpose of the product. Particular attention with ISO 13485 and presently certified. 3. Biological Evaluation Test
must be paid to the tissues exposed and to the duration and frequency of 2. Risk analysis has been performed in report 00033
exposure. accordance with ISO 14971. 4. ISO 11607 Certificate No
3. Materials used to manufacture the 00044
device have been tested and subjected
to biological evaluation in accordance
with ISO 10993 standards.
4. The device is packed in accordance with
a system of compliance with ISO 11607.

7.3. The devices must be designed and manufactured in such a way that they can YES N/A Same as above Same as above
be used safely with the materials, substances and gases with which they
enter into contact during their normal use or during routine procedures; if
the devices are intended to administer medicinal products they must be
designed and manufactured in such a way as to be compatible with the
medicinal products concerned according to the provisions and restrictions
governing these products and that their performance is maintained in
accordance with the intended use.
7.4. Where a device incorporates, as an integral part, a substance which, if used NO The device does not N/A N/A
separately, may be considered to be a medicinal product as defined in consider a medicinal
Article 1 of Directive 2001/83/EC and which is liable to act upon the body product.
with action ancillary to that of the device, the safety, quality and usefulness
of the substance must be verified by analogy with the methods specified in
Annex I to Directive 2001/83/EC.
For the substances referred to in the first paragraph, the notified body shall,
having verified the usefulness of the substance as part of the medical device
and taking account of the intended purpose of the device, seek a scientific
opinion from one of the competent authorities designated by the Member
States or the European Medicines Agency (EMEA) acting particularly through
its committee in accordance with Regulation (EC) No 726/2004 on the
quality and safety of the substance including the clinical benefit/risk profile
of the incorporation of the substance into the device. When issuing its
opinion, the competent authority or the EMEA shall take into account the
manufacturing process and the data related to the usefulness of
incorporation of the substance into the device as determined by the notified
body.
Where a device incorporates, as an integral part, a human blood derivative,
the notified body shall, having verified the usefulness of the substance as
part of the medical device and taking into account the intended purpose of
the device, seek a scientific opinion from the EMEA, acting particularly
through its committee, on the quality and safety of the substance including
the clinical benefit/risk profile of the incorporation of the human blood
derivative into the device. When issuing its opinion, the EMEA shall take into
account the manufacturing process and the data related to the usefulness of
incorporation of the substance into the device as determined by the notified
body.
Where changes are made to the ancillary substance incorporated in a
device, in particular related to its manufacturing process, the notified body
shall be informed of the changes and shall consult the relevant medicines
competent authority (i.e. the one involved in the initial consultation), in
order to confirm that the quality and safety of the ancillary substance are
maintained. The competent authority shall take into account the data
related to the usefulness of incorporation of the substance into the device
as determined by the notified body, in order to ensure that changes have no
negative impact on the established benefit/risk profile of the addition of the
substance in the medical device.
When the relevant medicines competent authority (i.e. the one involved in
the initial consultation) has obtained information on the ancillary substance,
which could have an impact on the established benefit/risk profile of the
addition of the substance in the medical device, it shall provide the notified
body with advice, whether this information has an impact on the established
benefit/risk profile of the addition of the substance in the medical device or
not. The notified body shall take the updated scientific opinion into account
in reconsidering its assessment of the conformity assessment procedure.
7.5. The devices must be designed and manufactured in such a way as to reduce YES (applicable N/A 1. Materials used to manufacture the 1. Biological Evaluation Test
to a minimum the risks posed by substances leaking from the device. Special to tubing and device have been tested and subjected report 00033
attention shall be given to substances which are carcinogenic, mutagenic or centrifugal to biological evaluation in accordance 2. Risk Analysis Report RAR01
toxic to reproduction, in accordance with Annex I to Council Directive pump) with ISO 10993 standards. 3. ISO 11607 Certificate No
67/548/EEC of 27 June 1967 on the approximation of laws, regulations and 2. Risk analysis has been performed in 00044
administrative provisions relating to the classification, packaging and accordance with ISO 14971 4. IEC 60601 Certificate IEC
labeling of dangerous substances. 3. The device is packed in accordance with 0011
If parts of a device (or a device itself) intended to administer and/or remove a system of compliance with ISO 11607.
medicines, body liquids or other substances to or from the body, or devices 4. The device is tested for electromagnetic
intended for transport and storage of such body fluids or substances, compatibility for Safety and Electrical
contain phthalates which are classified as carcinogenic, mutagenic or toxic performance in accordance with IEC
to reproduction, of category 1 or 2, in accordance to Directive 67/548/EEC, 60601
these devices must be labeled on the device itself and/or on the packaging
as a device containing phthalates.
If the intended use of such devices includes treatment of children or
treatment of pregnant or nursing women, the manufacturer must provide a
specific justification for the use of these substances with regard to
compliance with the essential requirements, in particular of this paragraph,
within the technical documentation and, within the instructions for use,
information on residual risks for these patient groups and, if applicable, on
appropriate precautionary measures.

7.6. Devices must be designed and manufactured in such a way as to reduce, as YES N/A 1. Materials used to manufacture the 1. Biological Evaluation Test
much as possible, risks posed by the unintentional ingress of substances into device have been tested and subjected report 00033
the device taking into account the device and the nature of the environment to biological evaluation in accordance 2. Risk Analysis Report RAR01
in which it is intended to be used. with ISO 10993 standards.
2. Risk analysis has been performed in
accordance with ISO 14971

8. Infection and microbial contamination

8.1. The devices and manufacturing processes must be designed in such a way as YES N/A 1. The device is produced under strictly 1. ISO 11135 Certificate
to eliminate or reduce as far as possible the risk of infection to the patient, controlled conditions to minimize STER0077
user and third parties. The design must allow easy handling and, where contamination. The device is sterilized 2. ISO 15499:2016 certificate
necessary, minimize contamination of the device by the patient or vice versa using ethylene oxide. The methods of No. 076531
during use. sterilization and process control of 3. ISO 11607 Certificate No
sterilization are in conformance with 00044
ISO 11135:2014. 4. Risk Analysis Report RAR01
2. The device is design under the guidance 5. ISO 13485 Certificate No.
on the conduct of biological evaluation 001111
within a risk management process in
conformance with ISO/TR 15499:2016.
3. A validated post- sterilization aeration
process assures amount of ethylene
 oxide and ethylene chlorohydrin which
is in conformance with ISO 10993-
7:2008.
4. The device is packed in accordance with
a system of compliance with ISO 11607.
5. Risk analysis has been performed in
accordance with ISO 14971
6. The device is designed and
manufactured under a full Quality
Management System in accordance
with ISO 13485 and presently certified.

8.2. Tissues of animal origin must originate from animals that have been subject NO This device does not utilize N/A N/A
to veterinary controls and surveillance adapted to the intended use of the any tissues of animal
tissues. origin.
Notified Bodies shall retain information on the geographical origin of the
animals.
Processing, preservation, testing and handling of tissues, cells and
substances of animal origin must be carried out so as to provide optimal
security. In particular safety with regards to viruses and other transmissible
agents must be addressed by implementation of validated methods of
elimination or viral inactivation in the course of the manufacturing process.

8.3. Devices delivered in a sterile state must be designed, manufactured and YES (only N/A 1. The device is produced under strictly 1. ISO 11135 Certificate
packed in a non-reusable pack and/or according to appropriate procedures applicable to controlled conditions to minimize STER0077
to ensure that they are sterile when placed on the market and remain sterilized contamination. The device is sterilized 2. ISO 11607 Certificate No
sterile, under the storage and transport conditions laid down, until the components using ethylene oxide. The methods of 00044
protective packaging is damaged or opened. mentioned sterilization and process control of 3. Risk Analysis Report RAR01
before) sterilization are in conformance with 4. ISO 13485 Certificate No.
ISO 11135:2014. 001111
2. A validated post- sterilization aeration
process assures amount of ethylene
oxide and ethylene chlorohydrin which
is in conformance with ISO 10993-
7:2008.
3. The device is packed in accordance with
a system of compliance with ISO 11607.
4. Risk analysis has been performed in
accordance with ISO 14971
5. The device is designed and
manufactured under a full Quality
Management System in accordance
with ISO 13485 and presently certified.
8.4. Devices delivered in a sterile state must have been manufactured and YES N/A Same as above Same as above
sterilized by an appropriate, validated method.

8.5. Devices intended to be sterilized must be manufactured in appropriately YES N/A 1. The device is produced under strictly 1. ISO 11135 Certificate
controlled (e.g. environmental) conditions. controlled conditions to minimize STER0077
contamination. The device is sterilized 2. ISO 11607 Certificate No
using ethylene oxide. The methods of 00044
sterilization and process control of 3. Risk Analysis Report RAR01
sterilization are in conformance with 4. Clean Room Certificate No.
ISO 11135:2014. 000993
2. A validated post- sterilization aeration
process assures amount of ethylene
oxide and ethylene chlorohydrin which
is in conformance with ISO 10993-
7:2008.
3. The device is packed in accordance with
a system of compliance with ISO 11607.
4. Risk analysis has been performed in
accordance with ISO 14971
5. The device is sterilized in condition
tightly controlled under the Quality
Management System that governs the
entire manufacturing process. The
environments are in compliance with
ISO 14644 standard.

8.6. Packaging system for non-sterile devices must keep the product without YES N/A Same as above Same as above
deterioration at the level of cleanliness stipulated and, if the devices are to
be sterilized prior to use, minimize the risk of microbial contamination; the
packaging system must be suitable taking account of the method of
sterilization indicated by the manufacturer.

8.7. The packaging and/or label of the device must distinguish between identical YES N/A 1. The label of the device includes all 1. ISO 15223 certificate LAB003
or similar products sold in both sterile and non-sterile condition. information to distinguish between
sterile and non-sterile for safety
purpose in accordance with ISO 15223

9. Construction and environmental properties

9.1. If the device is intended for use in combination with other devices or YES N/A 1. The device is tested for electromagnetic 1. IEC 60601 Certificate IEC
equipment, the whole combination, including the connection system must compatibility for Safety and Electrical 0011
be safe and must not impair the specified performances of the devices. Any performance in accordance with IEC 2. IEC 60950 Certificate No. IEC
restrictions on use must be indicated on the label or in the instructions for 60601. 0123
use. 2. The battery pack is tested in accordance 3. ISO 80369 test report
with IEC 60950 BORE01
3. Small bore connectors are tested for 4. ISO 7198 test report TUBE01
this device and are in accordance with 5. ISO 5840 test report VALV01
ISO 80369 6. ISO 5198 test report PUMP01
4. Vascular Prostheses such as tubular
vascular grafts and vascular patches are
tested in accordance with ISO 7198
5. Cardiac valve prostheses are in
accordance with ISO 5840
6. The centrifugal pump for this device is
tested in accordance with ISO 5198

9.2 Devices must be designed and manufactured in such a way as to remove or YES N/A 1. Risk analysis has been performed in 1. Risk Analysis Report RAR01
minimize as far as is possible: accordance with ISO 14971 2. IEC 60601 Certificate IEC
2. The device is tested for electromagnetic 0011
· the risk of injury, in connection with their physical features, including
compatibility for Safety and Electrical 3. ISO 14117 test report no.
the volume/pressure ratio, dimensional and where appropriate ergonomic
performance in accordance with IEC 004325
features;
60601.
· risks connected with reasonably foreseeable environmental conditions,
3. The device is tested according to the
such as magnetic fields, external electrical influences, electrostatic
method comply ISO 14117
discharge, pressure, temperature or variations in pressure and acceleration;
· the risks of reciprocal interference with other devices normally used in
the investigations or for the treatment given;
· risks arising where maintenance or calibration are not possible (as with
implants), from ageing of materials used or loss of accuracy of any
measuring or control mechanism.

9.3. Devices must be designed and manufactured in such a way as to minimize YES N/A 1. Risk analysis has been performed in 1. Risk Analysis Report RAR01
the risks of fire or explosion during normal use and in single fault condition. accordance with ISO 14971 2. IEC 60601 Certificate IEC
Particular attention must be paid to devices whose intended use includes 2. The device is tested for electromagnetic 0011
exposure to flammable substances or to substances which could cause compatibility for Safety and Electrical
combustion. performance in accordance with IEC
60601

10. Devices with a measuring function

10.1. Devices with a measuring function must be designed and manufactured in NO Device is not intended to N/A N/A
such a way as to provide sufficient accuracy and stability within appropriate measure/ not have a
limits of accuracy and taking account of the intended purpose of the device. measuring function.
The limits of accuracy must be indicated by the manufacturer.

10.2. The measurement, monitoring and display scale must be designed in line NO Same as above N/A N/A
with ergonomic principles, taking account of the intended purpose of the
device.

10.3. The measurements made by devices with a measuring function must be NO Same as above N/A N/A
expressed in legal units conforming to the provisions of Council Directive
80/181/EEC.

11. Protection against radiation

11.1. General

11.1. Devices shall be designed and manufactured in such a way that exposure of YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
1. patients, users and other persons to radiation shall be reduced as far as manufactured under a full Quality 001111
possible compatible with the intended purpose, whilst not restricting the Management System in accordance 2. Risk Analysis Report RAR01
application of appropriate specified levels for therapeutic and diagnostic with ISO 13485 and presently certified. 3. IEC 60601 Certificate IEC
purposes. 2. Risk analysis has been performed in 0011
accordance with ISO 14971. 4. IEC 60950 Certificate No. IEC
3. The device is tested for electromagnetic 0123
compatibility for Safety and Electrical 5. CISPR 11 Certificate number
performance in accordance with IEC CSV448
60601.
4. The battery pack is tested in accordance
with IEC 60950
5. The transmitter and receiver is tested in
accordance with CISPR
11:2015+AMD1:2016 CSV Consolidated
version and certified.

11.2. Intended radiation

11.2. Where devices are designed to emit hazardous levels of radiation necessary YES N/A Same as above Same as above
1. for a specific medical purpose the benefit of which is considered to outweigh
the risks inherent in the emission, it must be possible for the user to control
the emissions. Such devices shall be designed and manufactured to ensure
reproducibility and tolerance of relevant variable parameters.

11.2. Where devices are intended to emit potentially hazardous, visible and/or YES N/A Same as above Same as above
2. invisible radiation, they must be fitted, where practicable, with visual
displays and/or audible warnings of such emissions.

11.3. Unintended radiation

11.3. Devices shall be designed and manufactured in such a way that exposure of NO There is no such N/A N/A
1. patients, users and other persons to emission of unintended, stray or unintended radiation.
scattered radiation is reduced as far as possible.

11.4. Instructions

11.4. The operating instructions for devices emitting radiation must give detailed YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
1. information as to the nature of the emitted radiation, means of protecting manufactured under a full Quality 001111
the patient and the user and on ways of avoiding misuse and of eliminating Management System in accordance 2. Risk Analysis Report RAR01
the risk inherent in installation. with ISO 13485 and presently certified. 3. IEC 60601 Certificate IEC
2. Risk analysis has been performed in 0011
accordance with ISO 14971. Studies
show that risks associated with this
device are acceptable when weighed
against the benefits with a high level of
protection of health and safety.
3. The device is tested for electromagnetic
compatibility for Safety and Electrical
performance in accordance with IEC
60601.

11.5. Ionizing radiation

11.5. Devices intended to emit ionizing radiation must be designed and NO This device does not emit N/A N/A
1. manufactured in such a way as to ensure that, where practicable, the ionized radiation.
quantity, geometry and quality of radiation emitted can be varied and
controlled taking into account the intended use.

11.5. Devices emitting ionizing radiation intended for diagnostic radiology shall be NO Same as above N/A N/A
2. designed and manufactured in such a way as to achieve appropriate image
and/or output quality for the intended medical purpose whilst minimizing
radiation exposure of the patient and user.

11.5. Devices emitting ionizing radiation, intended for therapeutic radiology, shall NO Same as above N/A N/A
3. be designed and manufactured in such a way as to enable reliable
monitoring and control of the delivered dose, the beam type and energy and
where appropriate the quality of radiation.

12. Requirements for medical devices connected to or equipped with

an energy source

12.1. Devices incorporating electronic programmable systems must be designed YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
to ensure the repeatability, reliability and performance of these systems manufactured under a full Quality 001111
according to the intended use. In the event of a single fault condition (in the Management System in accordance 2. Risk Analysis Report RAR01
system) appropriate means should be adopted to eliminate or reduce as far with ISO 13485 and presently certified. 3. IEC 60601 Certificate IEC
as possible consequent risks. 2. Risk analysis has been performed in 0011
accordance with ISO 14971. 4. IEC 60950 Certificate No. IEC
3. The device is tested for electromagnetic 0123
compatibility for Safety and Electrical 5. ISO 14155 Certificate 00022
performance in accordance with IEC
60601.
4. The battery pack is tested in accordance
with IEC 60950
5. The implanted device has been clinically
evaluated in compliance with ISO 14155
clinical investigation of medical devices
for human subjects.

12.1a For devices which incorporate software or which are medical software in YES N/A 1. The medical device’s software life cycle 1. IEC 62304 Software life cycle
themselves, the software must be validated according to the state of the art is designed in accordance to comply certificate No 003458
taking into account the principles of development lifecycle, risk with IEC 62304 2. ISO 13485 Certificate No.
management, validation and verification. 2. The device is designed and 001111
manufactured under a full Quality 3. Risk Analysis Report RAR01
Management System in accordance 4. IEC 60601 Certificate IEC
with ISO 13485 and presently certified. 0011
 3. Risk analysis has been performed in
accordance with ISO 14971.
4. The device is tested for electromagnetic
compatibility for Safety and Electrical
performance in accordance with IEC
60601.

12.2. Devices where the safety of the patients depends on an internal power YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
supply must be equipped with a means of determining the state of the manufactured under a full Quality 001111
power supply. Management System in accordance 2. Risk Analysis Report RAR01
with ISO 13485 and presently certified. 3. IEC 60601 Certificate IEC
2. Risk analysis has been performed in 0011
accordance with ISO 14971. 4. CISPR 11 Certificate number
3. The device is tested for electromagnetic CSV448
compatibility for Safety and Electrical
performance in accordance with IEC
60601.
4. The transmitter and receiver is tested in
accordance with CISPR
11:2015+AMD1:2016 CSV Consolidated
version and certified.

12.3. Devices where the safety of the patients depends on an external power NO The device does not N/A N/A
supply must include an alarm system to signal any power failure. connect to an external
power supply.

12.4. Devices intended to monitor one or more clinical parameters of a patient NO The device is not intended N/A N/A
must be equipped with appropriate alarm system to alert the user of to monitor clinical
situations which could lead to death or severe deterioration of the patient’s parameters.
state of health.

12.5. Devices must be designed and manufactured in such a way as to minimize YES N/A 1. The device is tested according to the 1. ISO 14117 test report no.
the risks of creating electromagnetic fields which could impair the operation method comply ISO 14117 004325
of other devices or equipment in the usual environment. 2. The device is designed and 2. ISO 13485 Certificate No.
manufactured under a full Quality 001111
Management System in accordance 3. Risk Analysis Report RAR01
with ISO 13485 and presently certified. 4. IEC 60601 Certificate IEC
3. Risk analysis has been performed in 0011
accordance with ISO 14971. 5. CISPR 11 Certificate number
4. The device is tested for electromagnetic CSV448
compatibility for Safety and Electrical
performance in accordance with IEC
60601.
5. The transmitter and receiver is tested in
accordance with CISPR
 11:2015+AMD1:2016 CSV Consolidated
version and certified.

12.6. Protection against electrical risks

12.6. Devices must be designed and manufactured in such a way as to avoid, as far YES N/A Same as above Same as above
1. as possible, the risk of accidental electric shocks during normal use and in
single fault condition, provided the devices are installed correctly.

12.7. Protection against mechanical and thermal risks

12.7. Devices must be designed and manufactured in such a way as to protect the YES N/A 1. The device is tested according to the 1. ISO 14117 test report no.
1. patient and user against mechanical risks connected with, for example, method comply ISO 14117 004325
resistance, stability and moving parts. 2. The device is designed and 2. ISO 13485 Certificate No.
manufactured under a full Quality 001111
Management System in accordance 3. Risk Analysis Report RAR01
with ISO 13485 and presently certified. 4. IEC 60601 Certificate IEC
3. Risk analysis has been performed in 0011
accordance with ISO 14971.
4. The device is tested for electromagnetic
compatibility for Safety and Electrical
performance in accordance with IEC
60601.

12.7. Devices must be designed and manufactured in such a way as to reduce to YES N/A Same as above Same as above
2. the lowest possible level the risks arising from vibration generated by the
devices, taking account of technical progress and of the means available for
limiting vibrations, particularly at source, unless the vibrations are part of
the specified performance.

12.7. Devices must be designed and manufactured in such a way as to reduce to YES N/A Same as above Same as above
3. the lowest possible level the risks arising from the noise emitted, taking
account of technical progress and of the means available to reduce noise,
particularly at source, unless the noise emitted is part of the specified
performance.
12.7. Terminals and connectors to the electricity, gas or hydraulic and pneumatic YES N/A Same as above Same as above
4. energy supplies which the user has to handle must be designed and
constructed in such a way as to minimize all possible risks.

12.7. Accessible parts of the devices (excluding the parts or areas intended to YES N/A Same as above Same as above
5. supply heat or reach given temperatures) and their surroundings must not
attain potentially dangerous temperatures under normal use.

12.8. Protection against the risks posed to the patient by energy supplies
or substances

12.8. Devices for supplying the patient with energy or substances must be YES N/A 1. The device is designed and 1. ISO 13485 Certificate No.
1. designed and constructed in such a way that the flow-rate can be set and manufactured under a full Quality 001111
maintained accurately enough to guarantee the safety of the patient and of Management System in accordance 2. Risk Analysis Report RAR01
the user. with ISO 13485 and presently certified. 3. IEC 60601 Certificate IEC
2. Risk analysis has been performed in 0011
accordance with ISO 14971.
3. The device is tested for electromagnetic
compatibility for Safety and Electrical
performance in accordance with IEC
60601.

12.8. Devices must be fitted with the means of preventing and/or indicating any YES N/A Same as above Same as above
2. inadequacies in the flow-rate which could pose a danger.
Devices must incorporate suitable means to prevent, as far as possible, the
accidental release of dangerous levels of energy from an energy and/or
substance source.

12.9. The function of the controls and indicators must be clearly specified
on the devices

12.9. Where a device bears instructions required for its operation or indicates YES N/A 1. The label of the device includes all 1. ISO 15223 certificate LAB003
1. operating or adjustment parameters by means of a visual system, such information to distinguish between
information must be understandable to the user and, as appropriate, the sterile and non-sterile for safety
patient. purpose in accordance with ISO 15223

13. Information supplied by the manufacturer

13.1. Each device must be accompanied by the information needed to use it safely YES N/A 1. The device is accompanied by all 1. EN 1041 Certificate No
and properly, taking account of the training and knowledge of the potential necessary information required to be 001090
users, and to identify the manufacturer. supplied by the manufacturer.
Packaging for the device is labelled with
This information compromises the details on the label and the data in the
this information. This information is
instructions for use.
provided in conformance with EN 1041.
As far as practicable and appropriate, the information needed to use the
device safely must be set out on the device itself and/or on the packaging
for each unit or, where appropriate, on the sales packaging. If individual
packaging of each unit is not practicable, the information must be set out in
the leaflet supplied with one or more devices.
Instructions for use must be included in the packaging for every device. By
way of exemption, no such instructions for use are needed for devices in
Class 1 or 11a if they can be used safely without any such instructions.

13.2. Where appropriate, this information should take the form of symbols. Any YES N/A Same as above Same as above
symbol or identification color used must conform to the harmonized
standards. In areas for which no standards exist, the symbols and colors
must be described in the documentation supplied with the device.

13.3. The label must bear the following particulars:

(a) the name or trade name and address of the manufacturer. For YES N/A 1. The label of the device bears all 1. EN 1041 Certificate No
devices imported into the Community, in view of their distribution in the appropriate informations required to be 001090
Community, the label, or the outer packaging, or instructions for use, shall supplied by the manufacturer. This
contain in addition the name and address of the authorized representative information is printed on the label in
where the manufacturer does not have a registered place of business in the conformance with EN 1041.
Community;

(b) the details strictly necessary to identify the device and the YES N/A Same as above Same as above
contents of packaging especially for the users;

(c) where appropriate, the word ‘STERILE’; YES N/A Same as above Same as above

(d) where appropriate, the batch code, preceded by the word YES N/A Same as above Same as above
‘LOT’, or the serial number;
(e) where appropriate, an indication of the date by which the YES N/A Same as above Same as above
device should be used, in safety, expressed as the year and month;

(f) where appropriate, an indication that the device is for single YES N/A Same as above Same as above
use. A manufacturer’s indication of single use must be consistent across the
Community;

(g) if the device is custom-made, the words ‘custom-made device’; NO This device is not a custom N/A N/A
made except for two
different sizes (Small/
Medium).

(h) if the device is intended for clinical investigations, the words YES N/A 1. The label of the device bears all 1. EN 1041 Certificate No
‘exclusively for clinical investigations’; appropriate informations required to be 001090
supplied by the manufacturer. This
information is printed on the label in
conformance with EN 1041.

(i) any special storage and/or handling conditions; YES N/A Same as above Same as above

(j) any special operating instructions; YES N/A Same as above Same as above

(k) any warnings and/or precautions to take; YES N/A Same as above Same as above

(l) year of manufacture for active devices other than those YES N/A Same as above Same as above
covered by (e). This indication may be included in the batch or serial
number;

(m) where applicable, method of sterilization. YES N/A Same as above Same as above

(n) in the case of a device within the meaning of Article 1(4a), an NO The device does not use a N/A N/A
indication that the device contains a human blood derivative human blood derivative.
13.4. If the intended purpose of the device is not obvious to the user, the YES N/A 1. The intended purpose of the device is 1. EN 1041 Certificate No
manufacturer must clearly state it on the label and in the instructions for clearly stated on the label and 001090
use. instructed for use. The information is
provided in accordance with EN 1041

13.5. Wherever reasonable and practicable, the devices and detachable NO The device has no N/A N/A
components must be identified, where appropriate in terms of batches, to detachable part. (only
allow all appropriate action to detect any potential risk posed by the devices wearable vest which
and detachable components. comes under accessories)

13.6. Where appropriate, the instructions for use must contain the following
particulars:

(a) the details referred to in Section 13.3, with the exception of (d) YES N/A 1. The label of the device bears all 1. EN 1041 Certificate No
and (e); appropriate informations required to be 001090
supplied by the manufacturer. This
information is printed on the label in
conformance with EN 1041.

(b) The performances referred to in Section 3 and any undesirable YES N/A Same as above Same as above
side-effects;

(c) if the device must be installed with or connected to other YES N/A Same as above Same as above
medical devices or equipment in order to operate as required for its
intended purpose, sufficient details of its characteristics to identify the
correct devices or equipment to use in order to obtain a safe combination;

(d) all the information needed to verify whether the device is YES N/A Same as above Same as above
properly installed and can operate correctly and safely, plus details of the
nature and frequency of the maintenance and calibration needed to ensure
that the devices operate properly and safely at all times;

(e) where appropriate, information to avoid certain risks in YES N/A Same as above Same as above
connection with implantation of the device;

(f) information regarding the risks of reciprocal interference posed YES N/A Same as above Same as above
by the presence of the device during specific investigations or treatment;
(g) the necessary instructions in the event of damage to the sterile YES N/A Same as above Same as above
packaging and, where appropriate, details of appropriate methods of re-
sterilization;

(h) if the device is reusable, information on the appropriate NO This device cannot be N/A N/A
processes to allow reuse, including cleaning, disinfection, packaging and, reused.
where appropriate, the method of sterilization of the device to be
resterilized, and any restriction on the number of reuses.
Where devices are supplied with the intention that they be sterilized before
use, the instructions for cleaning and sterilization must be such that, if
correctly followed, the device will still comply with the requirements in
Section 1;
If the device bears an indication that the device is for single use, information
on known characteristics and technical factors known to the manufacturer
that could pose a risk if the device were to be re-used. If in accordance with
Section 13.1 no instructions for use are needed, the information must be
made available to the user upon request;

(i) details of any further treatment or handling needed before the YES N/A 1. The instructions for use of this device 1. EN 1041 Certificate No
device can be used (e.g. sterilization, final assembly, etc.); include all necessary particulars for safe 001090
use. The information is provided in
accordance with EN 1041

(j) in the case of devices emitting radiation for medical purposes, YES N/A Same as above Same as above
details of the nature, type, intensity and distribution of this radiation.

The instructions for use must also include details allowing medical staff to
brief the patient on any contra-indications and any precautions to be taken.
These details should cover in particular:

(k) precautions to be taken in the event of changes in the YES N/A 1. The instructions for use of this device 1. EN 1041 Certificate No
performance of the device; include all necessary particulars for safe 001090
use including all details for medical
staffs to brief patients on contradictions
and precautions to be taken. The
information is provided in accordance
with EN 1041
(l) precautions to be taken as regards exposure, in reasonably YES N/A Same as above Same as above
foreseeable environmental conditions, to magnetic fields, external electrical
influences, electrostatic discharge, pressure or variations in pressure,
acceleration, thermal ignition sources, etc.;

(m) adequate information regarding the medicinal product or YES N/A Same as above Same as above
products which the device in question is designed to administer, including
any limitations in the choice of substances to be delivered;

(n) precautions to be taken against any special, unusual risks YES N/A Same as above Same as above
related to the disposal of the device;

(o) medicinal substances, or human blood derivatives incorporated NO The device does not N/A N/A
into the device as an integral part in accordance with Section 7.4; consider a medicinal
product.

(p) degree of accuracy claimed for devices with a measuring NO This device is not intended N/A N/A
function. for the measuring
function.

(q) date of issue or the latest revision of the instructions for use. YES N/A 1. The instructions for use of this device 1. EN 1041 Certificate No
include all details for medical staffs to 001090
brief patients on contradictions and
precautions to be taken for the safe
use. The information is provided in
accordance with EN 1041
Standards Checklist
ISO 14117:2012 Active implantable medical devices -- Electromagnetic compatibility -- EMC test
protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac
resynchronization devices

ISO 5840-1:2015 Cardiovascular implants -- Cardiac valve prostheses -- Part 1: General requirements

ISO 7198:2016 Cardiovascular implants and extracorporeal systems -- Vascular prostheses -- Tubular
vascular grafts and vascular patches

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Consolidated version: Information technology

equipment - Safety - Part 1: General requirements

ISO 80369 Small-bore connectors for liquids and gases in healthcare applications

ISO 80369-7:2016 Part 7: Connectors for intravascular or hypodermic applications

ISO 80369-20:2015 Part 20: Common test methods

ISO 5198:1987 Centrifugal, mixed flow and axial pumps -- Code for hydraulic performance tests --
Precision grade

IEC 60601

IEC 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-6:2010 +AMD1:2013 CSV Consolidated version

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability

IEC 60601-1-9:2007+AMD1:2013 CSV Consolidated version

Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance
- Collateral Standard: Requirements for environmentally conscious design

CISPR 11:2015+AMD1:2016 CSV Consolidated version

Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and
methods of measurement (applicable to transmitter)

ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory
purposes

ISO 14971:2007 Medical devices -- Application of risk management to medical devices

ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice
ISO 10993

ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk
management process

ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with
blood

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after
implantation

ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization
residuals

ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin
sensitization

ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity

ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference
materials

ISO 10993-15:2000 Biological evaluation of medical devices Part 15: Identification and quantification of
degradation products from metals and alloys

ISO/TR 15499:2012 Biological evaluation of medical devices—Guidance on the conduct of biological

evaluation within a risk management process

ISO 14644

ISO 14644-1:2015 Cleanrooms and associated controlled environments -- Part 1: Classification of air
cleanliness by particle concentration

ISO 14644-10:2015 Cleanrooms and associated controlled environments -- Part 10: Classification of
Surface Cleanliness by Chemical Concentration

ISO 11607

ISO 11607-1:2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for
materials, sterile barrier systems and packaging systems

ISO 11607-2:2006 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements
for forming, sealing and assembly processes

ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the
development, validation and routine control of a sterilization process for medical devices

ISO 15223
ISO 15223 Medical devices -- Symbols to be used with medical device labels, labelling and information to
be supplied

ISO 15223-1:2016 Part 1: General requirements

ISO 15223-2:2010 Part 2: Symbol development, selection and validation

ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the
development, validation and routine control of a sterilization process for medical devices

IEC 62304:2006/Amd 1:2015 Medical device software -- Software life cycle processes

EN 1041:2008 - Information supplied by the manufacturer of medical devices - Commission

communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June
1993 concerning medical devices - OJ C 389 of 2008

Verification Testing for Design History File

Title Release Date

Design Verification Test Procedure 11 1 2019

Project name Project No.

Heart Buddy 1

Author
Parth P., Christina P., Kevin S.

Reviewer(s) and approver(s)

Kent Joel

Introduction

Purpose
The Purpose of this document is intended to meet the need for specifications of the Heart
Buddy performance parameters and their tolerances.

Terminology
Product specific terminology.

Term Comment

LVAD Left Ventricular Assisting Device

ANSI American National Standard Institute

ISO International Standards Organization
 dB Decibel

DIR Design Input Requirement

IEC International Electro Technical Commission

N/A Not Applicable

SAL Sterility Assurance Level

Scope
This document describes certain measurements and parameters that are deemed useful in
determining the performance. Some of these lend themselves to setting of tolerances for
maintaining product uniformity and for compliance with the performance specified for a model.
Included in the scope is only the design verification test procedure for testing and determining
the design input.

References
Ref. ID Document Name Document
Number(s)
1 Design Input Specification DIS001

ISO 10993-1-2018: Biological Evaluation of Medical N/A

2 Devices Part 1: Evaluation and Testing

3 Defect Management Log DML001

Test Procedures

Design Outputs
The design output would satisfy the requirements specified in ref ID 1.

Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Acute Systemic Toxicity

Material-Mediated Pyrogenicity Subacute/Subchronic Toxicity Genotoxicity Implantation
Hemocompatibility Chronic Toxicity Carcinogenicity Reproductive/Developmental Toxicity#
Degradation

Sample size
The Sample size is 10 of the product to get uniform testing and data produced.

Test equipment and tools

Essential hand tools, electrical equipment, Digital Pressure Meters, Electrical Safety Analyzers,
Incubator Radiant Warmer Analyzers, Patient Monitor Simulators, and Portable Oscilloscopes;
and simulation software.
Test Instructions
The primary material of construction in the Heart Buddy device is a titanium alloy, Ti6Al4V. The
outflow graft is constructed of polyester vascular graft prostheses sealed with gelatin.
Toxicology and biocompatibility evaluations and testing for the device were conducted in
accordance with ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and
Testing. Summaries of the test results are provided in Table.

Sr Test Purpose/ Method Result

No

1 Cytotoxicity To determine if test article The test article was

extracts cause cytotoxic noncytotoxic with
effects and cell lysis equivalent results to
the negative control.

2 Sensitization – Guinea To evaluate the potential of a The test article

pig maximization material or product to cause extracts did not elicit
a sensitizing effect or a sensitization
allergenic reaction over an response following an
extended period of exposure induction phase.
3 Irritation/intracutaneous To determine if the test The injected test and
reactivity – rabbit article extracts would cause control sites did not
intracutaneous reactivity local irritation in the dermal show significant
tissues of the test animals. dermal reactions over
the observation
periods.

4 Acute systemic toxicity To determine if the test The respective test

article extracts would cause article extracts did not
acute systemic toxicity cause abnormal
clinical signs
indicative of toxicity

5 Pyrogenicity - material To determine if the test The rise in

mediated pyrogen test article extracts causes a temperature was <
febrile response 0.5 ˚C and the test
(temperature rise) in article was
intravenously injected rabbits considered non-
pyrogenic.

6 Chronic toxicity To determine if the test The test article

article extracts would cause extracts did not show
systemic toxicity due to a significantly greater
potential leachable biological reaction on
components, when the test animals as
compared to the
 intravenously injected over animals treated with
90 days in rats. the control article.

7 Chemical characterization To identify and assess The risks estimated

extractables utilizing from each route of
exhaustive extraction exposure and
conditions. toxicological effects
were deemed low for
the Heart Buddy.

8 Genotoxicity; Ames Test To determine the potential of Test article extract did
(mouse micronucleus) the test article to induce not show a significant
micronuclei formation in increase in the
immature polychromatic number of
erythrocytes (PCE) present micronucleate
in the bone marrow of adult
CD-1 mice

9 Implantation To verify the in vivo safety of There was no

the device when implanted in evidence of
an animal model over a compromised
specified period of time. hemodynamics,
hemocompatibility,
biocompatibility,
hepatic function, or
renal function, and no
infection, or
pathologic effects
associated with the
device over the tested
period of time.
Documentation and Recording*
Document Calibrated tools used in testing of system
* Print out this page as Needed to Record Multiple Data and Attach to Appendix A

Tools Used Tag Number Calibration/ Qualification

due date if applicable
ABX Digital Thermometer 4468/2 N/A

IO654765 Humidity Master 6365 10 10 2020

AFG1022 Tektronix Arbitrary 5674 N/A

Waveform Generator

Sr Pass Fail Not Comments / Observation Defect Tracking Date and ID

No ID (Ref ID 3] of performer
Tested

1. X Ambient Temperature Recorded: 1x 12 3 2017

69-degree Fahrenheit Parth Patel

2. X Ambient Humidity Recorded: 3x 12 3 2017

40% RH Parth Patel

3. X Body Temperature Recorded: 7x 12 3 2017

72-degree Fahrenheit Parth Patel

4. X Body Humidity Recorded: 2x 12 3 2017

38% RH Parth Patel

5. X Frequency Recorded: 4x 12 3 2017

40 Hz Parth Patel

6. X Other Disturbance Recorded: N/A 12 3 2017

N/A Parth Patel

Revision History
Revision 1
Version 1
 Revision Reason/changes
1 Initial Release

Appendix A
Attachments from Results are to be placed in Appendix A

Appendix B
Attachment and plots from Results are to be placed in Appendix B.
Verification testing:
Heart Buddy (the whole device)

Test Purpose Result

Hydrodynamic performance To verify flow-pressure capacity, flow Passed

estimation, power requirements, vibration
resistance, mechanical shock resistance.
Computational fluid dynamics (CFD) To assess the hydraulic performance of the Passed
analysis pump design and pump hemolytic and
thrombotic potentials.
Torque strength To verify the torque strength of the inflow Passed
cannula to the pump attachment.
Shock and vibration To verify that the device maintains essential Passed
performance after being subjected to shock
and vibration.
Leak test To verify that there are no leaks at the joints. Passed
Start-up, speed control and voltage test To demonstrate that that the device Passed
maintains set speed and voltage and starts
on command.
Particulate release To demonstrate that the average count of Passed
particles from samples is acceptable.
Pump physicals To verify the pump size. Passed

Outflow Graft

Kink resistance To demonstrate that the outflow graft can Passed

articulate without kinking.
Bend relief engagement To demonstrate that the installation and Passed
removal force of the outflow graft bend relief
and the pull-off force of the bend relief to the
bend relief clip is acceptable.
Outflow graft length and diameter To verify that the minimum length and the Passed
inner diameter of the outflow graft are
acceptable.
Bend relief removal torque To demonstrate that outflow graft bend relief Passed
torque required to disconnect the bend relief
from the graft is acceptable.
Shock and vibration To demonstrate that there is no leak at the Passed
joints after the graft is subjected to shock
and vibration loads.
System Controller , transmitter, and receiver
Drop resistance, shock resistance and To verify that the System Controller and Passed
vibration Modular Cable satisfy the mechanical drop,
shock and vibration requirements.
Performance testing and functionality To verify that System Controller satisfies Passed
testing performance requirements such as thermal
management, motor power, operating
voltage, Controller electronics power and
Controller power, and to verify Controller
functionality such as Controller mating
characteristics, Controller case
requirements, power cable requirements,
user interface.
Pump power display To demonstrate that Controller has the Passed
capability to measure and display device
power.
Overcurrent protection test To verify that Controller is capable of Passed
restoring power to the device within 100 ms.
Water and material ingress To verify that System Controller connected Passed
with Modular Cable satisfies requirements
such as water and material ingress, Modular
Cable-Controller connector durability.
Insertion and extraction forces To demonstrate that the System Controller Passed
and Modular Cable comply with the insertion
and extraction forces specified in the design
requirements.
Electrical safety and electromagnetic To demonstrate that the device complies Passed
compatibility testing with IEC 60601-1 and its collateral
standards, including the requirements for
electromagnetic compatibility (IEC 60601-1-
2); to validate the use of the device in
ambulances and aircraft; to demonstrate the
device compatibility with security and
logistical systems (SLS), electrosurgical unit
(ESU), electrocardiogram (EKG/ECG),
defibrillators, ultrasound, and pacemaker
and implantable cardioverter defibrillators
(ICD).
Software Validation
The Device and the System Controller are software driven components of the system. The
software development process complies with AAMI ANSI IEC 62304:2006, AAMI ANSI ES
60601-1:2005/(R)2012.

Sterilization
The following system components are provided sterile:
The Pump,
Outflow Graft,
Transmitter
small diameter bore connectors
The sterilization method is 100% ethylene oxide (EO) and the sterilization process has been
validated to provide a minimum sterility assurance level (SAL) of 10-6 in accordance with
AAMI/ANSI/ISO 11135:2014.
A validated post-sterilization aeration process assures that residual levels of EO and ethylene
chlorohydrin (ECH) are within acceptable limits specified by ANSI/AAMI/ISO 10993-7:2008.

Packaging and Shelf Life

Packaging integrity and shelf life testing was completed for each component per ASTM D4169-
09 and AAMI ANSI ISO 11607-1: 2006. Shelf life has been established at 3 years for the
everything except at 5 years for the Sealed Outflow Graft.

Conclusion
KCP Heart Solutions views the Heart Buddy system as a product with significant potential to reshape the
VAD market, offering patients a higher level of care that will result in higher quality of life. The company
believes this document thoroughly describes the benefits of our product, the business pan and the
regulatory strategy to successfully bring this product to market.

References

i
https://www.cdc.gov/heartdisease/facts.htm
ii
http://www.ehnheart.org/cvd-statistics.html
iii
https://www.canada.ca/en/public-health/services/publications/diseases-conditions/heart-disease-canada-fact-
sheet.html
iv
https://www.heartfoundation.org.au/about-us/what-we-do/heart-disease-in-australia
v
https://www.hindawi.com/journals/aph/2015/235101/
vi
Energias Market Research. “Advancements in Medical Devices Contributing to the Growth of Left Ventricular
Assist Device Market to Grow at a CAGR of 10.5% during 2018-2024 : Energias Market Research Pvt. Ltd.”
GlobeNewswire, 19 Mar. 2018.
vii
Wood, Laura. “Global Left Ventricular Assist Device (LVAD) Market Outlook to 2023: Profiles for Thoratec,
Terumo, Transonic, Berlin Heart, HeartWare International, and Many More.. - ResearchAndMarkets.com.” Business
Wire, 5 Oct. 2018.
viii
https://clinicaltrials.gov/ct2/show/NCT02170363