November 5, 2024

Imaxeon Pty Ltd

℅ Dr. Gopal Abbineni
Director, Regulatory Affairs, Radiology Medical Devices
Bayer Medical Care, Inc.
1 Bayer Drive
Indianola, Pennsylvania 15051

Re: K241849
Trade/Device Name: MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set;
MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike;
MEDRAD ISI2 Module (ISI2)
Regulation Number: 21 CFR 870.1650
Regulation Name: Angiographic Injector And Syringe
Regulatory Class: Class II
Product Code: IZQ
Dated: October 2, 2024
Received: October 3, 2024

Dear Dr. Gopal Abbineni:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above
and have determined the device is substantially equivalent (for the indications for use stated in the enclosure)
to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment
date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the
provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general controls
provisions of the Act. Although this letter refers to your product as a device, please be aware that some
cleared products may instead be combination products. The 510(k) Premarket Notification Database
available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.07.04
Silver Spring, MD 20993
www.fda.gov
K241849 - Dr. Gopal Abbineni Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software

Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for
devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent
parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule").
The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label
and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the
dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR
830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device
Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these
requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-
comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
K241849 - Dr. Gopal Abbineni Page 3

Sincerely,

Shruti N. Mistry -S
Shruti Mistry
Assistant Director
DHT3C: Division of Drug Delivery and General
Hospital Devices, and Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

510(k) Summary
Imaxeon Pty Ltd. MEDRAD® Centargo CT Injection System
The Summary is prepared in conformance with 21CFR 807.92

I. SUBMITTER
Imaxeon Pty Ltd.
Unit 1 38-46 South Street Rydalmere
NSW 2116 Australia
Contact: Mr. Anhua Hu
Email: Anhua.hu@bayer.com
Phone: +61 439078849

US Correspondent Contact: Dr. Gopal Abbineni

Bayer Medical Care Inc.
1 Bayer Drive Indianola PA 15051 United States
Email: gopal.abbineni@bayer.com
Phone: +1 202-657 8090

US Alternative Contact: Ms. Hortense Allison

Bayer Medical Care Inc.
1 Bayer Drive Indianola PA 15051 United States
Email: hortense.allison@bayer.com
Phone: +1 412-935 7777

Date Prepared: October 4, 2024

II. DEVICE
Trade Name: MEDRAD® Centargo CT Injection System
MEDRAD® Centargo Day Set
MEDRAD® Centargo Patient Line
MEDRAD® Centargo Replacement Spike
MEDRAD® ISI2 Module
Common Name: Automatic injector for contrast media
Classification Name: Injector, Contrast Medium, Automatic
Classification Regulation: 21 CFR 870.1650
Regulatory Class: Class II
Product Code: IZQ

III. PREDICATE DEVICE

Trade Name: CT ExprèsTM 3D Contrast Media Delivery System

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 MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

510(k) Number: K151048

Common Name: Automatic injector for contrast media
Classification Name: Injector, Contrast Medium, Automatic
Classification Regulation: 21 CFR 870.1650
Regulatory Class: Class II
Product Code: IZQ
This predicate has not been subject to a design-related recall.

IV. REFERENCE DEVICE

Trade Name: MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
Number: K192370
Common Name: Injector and Syringe, Angiographic
Classification Name: Injector and Syringe, Angiographic
Classification Regulation: 21 CFR 870.1650
Regulatory Class: Class II
Product Code: DXT

V. DEVICE DESCRIPTION
The MEDRAD® Centargo CT Injection System (Centargo) is an automated contrast injection system intended
to be used to inject intravenous contrast media and saline into humans for diagnostic studies in CT
applications. Centargo is intended for use with the following approved contrast media in an Imaging Bulk
Package (IBP):
• ULTRAVIST® (Iopromide) NDA 021425/S-034
• ISOVUE® (Iopamidol) NDA 020327/S-023
• OPTIRAY® (Ioversol) IBP NDA 020923/S-026
• OMNIPAQUE™ (Iohexol) NDA 020608/S-045

Centargo is based on well-established technologies for injection, using a piston-based electromechanical

device. The system is designed to protect the patient against air injection by incorporating multiple sensors
to detect air within the fluid pathway. The system is comprised of two main modules:
• Scan Room Unit – responsible for handling the contrast/saline and delivering injections
• Control Room Unit - controls, monitors, and communicates with the Scan Room Unit through wired
or wireless connection

The Scan Room Unit is located within the scan room whereas the Control Room Unit is not. When
communicating via wired or wireless connection, the Control Room Unit can remotely control the Scan
Room Unit and initiate and execute injections. However, the Scan Room Unit can operate independently
without the use of the Control Room Unit via the Scan Room Unit’s graphical user interface (GUI).

The Scan Room Unit is available in two different configurations:

• Pedestal with battery and AC power

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

• Overhead mount with AC power only

The fluids are delivered from a multi-patient disposable set (Day Set) through a single use patient line
(Patient Line). The Day Set is labeled for 24 hours or for a maximum of 25 bottles of contrast media,
whichever comes first. Fluid source spikes (Replacement Spike) are for single container use.

The system is intended to be used in a CT suite. It is intended to be operated by personnel with training and
experience in CT procedures and use of CT injection systems. Operators will consist of radiological
technologists trained in the use of the equipment. This system is intended for use on the general patient
population, including adults and pediatrics.

Options and Accessories

All optional set-ups and accessories for Centargo are related to software-based features. They are either
software license enabled or require a hardware accessory to be connected (the ISI2 Module).
The following types of options are available for Centargo:
• Scanner connectivity related options – enables injectors and scanners to communicate
• Smart Protocols related options -- computes individualized contrast injection protocols
• Automated documentation related options – transfers data with external systems

Scanner connectivity related options

These options enable injectors and scanners to communicate, enhancing clinical capability by synchronizing
scan timing and simplifying operator workflow. There are three different options for connecting a Centargo
to a scanner:
• ISI-700 (accessory ISI2 Module required) – Proprietary interface
• ISI-900 (accessory ISI2 Module required) – CiA-425 standard based, Class IV
• Connect.CT (software only) – Proprietary interface

Smart Protocols related options

Injection protocols may be either fixed standard protocols with fixed volumes and rates for all patients (i.e.,
one size fits all), or they can be personalized for each patient (e.g., be weight based). Protocols can also be
adapted for the iodine concentration in use as well as the scanner tube voltage. Finally, protocols can also
be adapted for the particulars of some study types and the specific CT scanner capabilities being used. The
three kinds of Smart Protocols available on Centargo are:
• Personalized Patient Protocol Technology (P3T)
• Iodine Load/Dose Based Protocols, Iodine Delivery Rate Based Protocols
• Tube Voltage Based Protocols

Automated documentation related options

Centargo by default is a standalone injection system that operates in accordance with its intended use
without any network connections being required. If a customer prefers to have injection information
transmitted to their hospital system (e.g., Radiology Information System (RIS)), they may purchase one or

PAGE 3 OF 17
 MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

more automated documentation options. These options are for customer convenience and are not
themselves considered medical devices as their sole function is to transfer data.

VI. INDICATIONS FOR USE

MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the
controlled, automatic administration, on the venous side, of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol),
OPTIRAY® (Ioversol), or OMNIPAQUE™ (Iohexol) contrast media as supplied in an approved Imaging Bulk
Package (IBP) presentation and 0.9% Sodium Chloride Injection USP (saline) to human subjects undergoing
examinations in computed tomography (CT). The system is to be used by and under quasi-continuous
supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room
designated for radiological procedures that involve intravascular administration of contrast agent.

The Day Set is used for a maximum time of twenty-four (24) hours, or for a maximum of 25 bottles of
contrast media, whichever comes first. The Patient Line must be discarded after each patient procedure. The
Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast
media containers are to be discarded after their respective use times have expired or the Day Set use life has
expired, whichever occurs first.

Saline should only be used to deliver multiple single doses to multiple patients when used with the
MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is
punctured, it should not be removed from the work area during the entire period of use. Saline containers
are to be discarded with the Day Set.

The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging
scanner.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A table comparing key features of the subject device (Centargo) and predicate device (CT Exprès) is provided
below.

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

Table 1 – Key Feature Comparison

Item Predicate Device (K151048): Subject Device (K241849): Comparison
CT Exprès™ 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System
System
Class II II Same
FDA Regulation 21 CFR 870.1650 21 CFR 870.1650 Same
Number
Classification IZQ IZQ Same
Product Code
Intended Use/ The CT ExprèsTM 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System is an Same Intended Use
Indications for Use System is indicated for controlled automatic automated contrast injection system that is
administration, on the venous side, of contrast indicated for the controlled, automatic
media and saline, to human subjects while administration, on the venous side, of
undergoing examination by means of a ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol),
computed tomography (CT) scanner. OPTIRAY® (Ioversol), or OMNIPAQUE™ (Iohexol)
contrast media as supplied in an approved
The CT ExprèsTM 3D Contrast Media Delivery Imaging Bulk Package (IBP) presentation and
System is specifically indicated for use in CT 0.9% Sodium Chloride Injection USP (saline) to
procedures for the delivery of Isovue human subjects undergoing examinations in
(Iopamidol Injection) contrast media as computed tomography (CT). The system is to be
supplied in Imaging Bulk Package (IBP), for a used by and under quasi-continuous supervision
maximum of 20 bottles of contrast media or a of trained healthcare professionals in an
maximum of ten (10) hours, whichever comes appropriate licensed healthcare facility, in a
first, per Day Set III HP disposable. The Bottle room designated for radiological procedures that
Spike disposable is for single-bottle use only involve intravascular administration of contrast
and must be discarded with the contrast agent.
media bottle. The Patient Set disposable must
be discarded after each patient procedure. The Day Set is used for a maximum time of
twenty-four (24) hours, or for a maximum of 25
The CT ExprèsTM 3D is to be used only by and bottles of contrast media, whichever comes first.
under quasi-continuous supervision of trained The Patient Line must be discarded after each
health care professionals in an appropriate patient procedure. The Replacement Spike is for
licensed health care facility, in a room single-container use only and must be discarded
designated for radiological procedures that with the fluid container. Contrast media

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

Item Predicate Device (K151048): Subject Device (K241849): Comparison

CT Exprès™ 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System
System
involve intravascular administration of a containers are to be discarded after their
contrast agent. respective use times have expired or the Day Set
use life has expired, whichever occurs first.

Saline should only be used to deliver multiple

single doses to multiple patients when used with
the MEDRAD® Centargo CT Injection System and
the provided Saline Tag. Once the port of the
saline container is punctured, it should not be
removed from the work area during the entire
period of use. Saline containers are to be
discarded with the Day Set.

The ISI2 Module is indicated for the specific

purpose of allowing an injector to interface with
an imaging scanner.
System Components
System CT Exprès Injector Unit Centargo Scan Room Unit Same
CT Exprès Control Panel Centargo Control Room Unit
Accessories CT Exprès Hand Switch ISI2 Module Different and
CT Exprès Stand Substantially Equivalent

Heat Maintainer CT Exprès Bottle Insulator Heat maintainer is integral to the device Different and
Substantially Equivalent

Disposables CT Exprès Day Set III HP Centargo Day Set Same

CT Exprès Patient Set Centargo Patient Line
CT Exprès Bottle Spike Type B (25mm) Centargo Replacement Spike
Physical Design

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

Item Predicate Device (K151048): Subject Device (K241849): Comparison

CT Exprès™ 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System
System
Weight Injector: Approx. 10 kg Injector (Scan Room Unit): Approx. 75 kg Different and
Console: Approx. 2.1 kg Control Room Unit: Approx. 7 kg Substantially Equivalent

Dimensions Injector: 44 x 32 x 16 cm Injector (Scan Room Unit): 168 x 76 x 69 cm Different and

Console: 30 x 20 x 22 cm Control Room Unit (W3CZ): 27 x 38 x 20 cm Substantially Equivalent
Control Room Unit (Workflow Hub): 27 x 36
x 19 cm
Power Requirement Different and
Rated Voltage: 110 to 240 V AC 100 to 240 V AC Substantially Equivalent
Rated Current: 1.6 A 336-377 VA
Rated Frequency: 50/60Hz 50/60Hz
Display Type Color LCD with touch screen Color LCD with touch screen Same
Characteristics
Remote Operation Yes Yes Same
Single Patient Use Patient Set Patient Line Same
Disposable
Operating Principle Rotary peristaltic pump Servo driven piston Different and
Substantially Equivalent
Used to administer Yes Yes Same
contrast media and
saline
Operational Characteristics
Programmable Yes, 8 bar (ca. 120 psi) Yes, 20.68 bar (300 psi). User programmable Different and
Pressure Limit Substantially Equivalent
Injection Up to 24 phases per patient Up to 60 phases per patient (6 phases per Different and
Capabilities (8 phases per injection; up to 3 injections injection: up to 10 injections per patient) Substantially Equivalent
per patient)
Injection Rates for 0.5-9.0 mL/s 0.1 to 10 mL/s Different and
Contrast Media Substantially Equivalent

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

Item Predicate Device (K151048): Subject Device (K241849): Comparison

CT Exprès™ 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System
System
Injection Rates for 0.1-9.0 mL/s 0.1 to 10 mL/s Different and
Saline Substantially Equivalent
Injection Volume 10-200 mL per injection 1-400 mL per injection Different and
per Injection Substantially Equivalent –
1 mL to 200 mL for contrast and flush
phases, 1 mL to 400 mL for Dual Flow
phases, in 1 mL increments.

A total of 400 mL of contrast can be

delivered in the same injection if both
contrast reservoirs contain the same type
and concentration.
Flow Rate Accuracy ± 10% for a programmed injection volume ±(5% + 0.1) mL/s when averaged over 2 Different and
between 10 mL and 59 mL seconds for flow rates >5 mL/s or averaged Substantially Equivalent –
± 6% for a programmed injection volume over 10 mL for flow rates ≤5 mL/s
between 60 mL and 200 mL
Volume Accuracy ± 10% for a programmed injection volume Contrast or saline phase: Different and
between 10 mL and 59 mL • ±(2% + 1) mL Substantially Equivalent –
± 6% for a programmed injection volume
between 60 mL and 200 mL Simultaneous (DualFlow) phase:
For ratio <80%, or that occurs following a
contrast phase of ≥20 mL:
• Combined fluid volume: ±(4% +2) mL
• Contrast: ±(4% +2) mL
• Saline: ±(4% +2) mL

For ratio ≥80% without preceding contrast

phase of 20 mL or greater:

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

Item Predicate Device (K151048): Subject Device (K241849): Comparison

CT Exprès™ 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System
System
• Combined fluid volume: +(4% + 7) mL /-
(4% +2) mL
• Contrast: ±(4% +2) mL
• Saline: +(4% + 7) mL /- (4% +2) mL

Contrast Media 200 & 500 mL (IBPs) 200 & 500 mL (IBPs) Same
Container Volume
Saline Flush Yes Yes Same
Needle Size 16-24 G 18-24 G Different and
Substantially Equivalent –
Injection Pause 0-400 seconds 0-900 seconds Different and
Substantially Equivalent –
Injection Protocol Yes Yes Same
Storage
Priming/Filling Rate 1.5 mL/s (manual) 2.0 mL/s (manual) Different and
6.0 mL/s (automatic) 6.0 mL/s (automatic) Substantially Equivalent
Air Detection Outlet: Ultrasound Inlet: Optical Different and
Principle Outlet: Ultrasonic Substantially Equivalent
In reservoir: Software
Technical Detection 0.04 mL 0.001 mL Different and
Limit of air in tubing Substantially Equivalent

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

Item Predicate Device (K151048): Subject Device (K241849): Comparison

CT Exprès™ 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System
System
Air Detector Alert For programmed injection volume < 35 mL In reservoir: 1 mL Different and
Limit CM, 1.25 mL Outlet: 1 mL or greater Substantially Equivalent
For programmed injection volume > 35 mL
CM, 1.25 mL if fragment air bubble, Note: The volume of the Patient Line after
otherwise an additional air volume of 0.75 the air detector is approximately 11 mL
mL is tolerated.

Note: The volume of the Patient Set (after

the air detector) is 8 mL
Occlusion Detection Fail safe piezo-resistive pressure sensor Software control via motor current Different and
Principle monitoring Substantially Equivalent

Occlusion Detection 132 PSI ± 17.4 PSI (9.1 bar ± 1.2 bar) Settable to 300 psi. Maximum over pressure Different and
Alert Limit is programmed value +50 psi Substantially Equivalent
Injector Software Features (Optional features)
Smart Protocols: No Yes. P3T Cardiac is indicated for use with CT Different and
Personalized Angiography of the cardiac structures, Substantially Equivalent
Patient Protocol coronary arteries, chambers of the heart,
Technology (P3T) pulmonary vasculature, thoracic, and
Cardiac abdominal aorta.
Smart Protocols: No Yes. P3T PA is indicated for use with CT Different and
Personalized Angiography of the cardiac structures, Substantially Equivalent
Patient Protocol coronary arteries, chambers of the heart,
Technology (P3T) pulmonary vasculature, thoracic, and
PA abdominal aorta.
Smart Protocols: No Yes. P3T Abdomen is indicated for use with Different and
Personalized CT imaging of abdominal organs (i.e., liver, Substantially Equivalent
Patient Protocol pancreas, kidneys).

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

Item Predicate Device (K151048): Subject Device (K241849): Comparison

CT Exprès™ 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System
System
Technology (P3T)
Abdomen
Smart Protocols: No Yes. Iodine Load/Dose Based, Iodine Different and
Iodine Load/Dose Delivery Rate Based, and Tube Voltage Substantially Equivalent
Based, Iodine Based Protocols
Delivery Rate
Based, and Tube
Voltage Based
Protocols
Informatics No Yes - This feature offers the user the ability Different and
to associate patient/exam information with Substantially Equivalent
injection details and send the output to one
or more hospital systems (e.g. Radiology
Information System)
Connectivity Accessory
Imaging System No Yes. The ISI2 Module is indicated for the Different and
Interface (ISI2) specific purpose of allowing an injector to Substantially Equivalent
Accessory interface with a scanner.
Connect.CT No Yes. The Connect.CT application is indicated Different and
for the specific purpose of allowing the Substantially Equivalent
injector to interface with a CT scanner.
Disposables
Patient Tubing
Components Patient Set Cassette Patient Line Tube Different and
Patient Set Tubing 2X check valves Substantially Equivalent
Pinch Clamp Patient Line Connector
Patient Connector with Safety Cap
Safety Feature Break away pin designed to break on Via software controls Different and
Against Re-use insertion Substantially Equivalent

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

Item Predicate Device (K151048): Subject Device (K241849): Comparison

CT Exprès™ 3D Contrast Media Delivery MEDRAD® Centargo CT Injection System
System
Day Set
Components T-connector Reservoir x3 Different and
Contrast media line x2 Manifold Substantially Equivalent
Spike for saline line Plunger x3
Saline line Inlet tubing x3
Filter x2 Air detector tubing
Reservoir x2 Spike adapter x3
Tubing guide x2 Replaceable spike with dust cap x3
Stopcock x3
Contrast Media Line PVC tubing PVC Tubing Same
Tubing Material
Saline Line Tubing PVC tubing PVC Tubing Same
Material
Spike
Spike Size 25 mm 28 mm Different and
Substantially Equivalent
Safety Feature Spike tip designed to break off into bottle Spike is removable with the bottle, labeling Different and
Against Re-Use on removal instructions on workflow Substantially Equivalent

Biocompatibility
Biocompatibility Yes Yes Same
Testing

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 MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

VIII. INTENDED USE/INDICATIONS FOR USE COMPARISON

Intended Use/Indications for Use comparison discussion:

The Intended Use of Centargo is the same as the CT Exprès 3D Contrast Media Delivery
System as both devices are intended for the controlled, automatic administration of
contrast media and saline on the venous side to human subjects while undergoing
examination by means of a computed tomography (CT) scanner. The differences in allowing
the use of different contrast agents do not change the intended use of the device. All of the
contrast agents are iodinated agents, Centargo has been tested to demonstrate the
compatibility with the listed contrast agents, and the differences in contrast agents do not
raise different questions of safety and effectiveness when compared to the predicate
device. The substantial equivalence of the MEDRAD® Centargo CT Injection System has been
confirmed through chemical compatibility testing, biocompatibility and EMC testing.
The ISI2 is included in the indications for use statement to specify the scanner connectivity
via cables. While there are differences between the subject device and predicate in terms of
scanner connectivity, our successful software testing confirmed there are no new or
different questions of safety or effectiveness.
The additional of the saline tag in the indications for use statement adds clarity for users
and based on our usability studies, mention of it does not raise new or different questions
of safety and effectiveness when compared to the predicate device.

IX. TECHNOLOGICAL COMPARISON

Technological comparison discussion:

Both systems aim to deliver fluids consistently and reliably according to user programmed
protocols. Although there are differences in the technology used to deliver fluids
(Plunger/barrel-based vs peristaltic pump), the Centargo system fluid delivery performance
has been demonstrated to be as safe and effective as the predicate device. Likewise, while
there are differences in physical design and operational characteristics, Centargo has
demonstrated device performance against established acceptance criteria and testing did
not raise new questions of safety and effectiveness.

Software features and connectivity accessories are available on Centargo and were verified
and validated using the same test methods as the reference device (MEDRAD® Stellant FLEX
CT Injection System, (K192370). Testing with Centargo did not raise new questions of safety
and effectiveness when compared to the predicate device.

Both the predicate (CT Exprès) and subject (Centargo) devices are used in conjunction with
disposables that create a fluid pathway from the bottles of contrast media and the saline

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 MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

container to the patient. While there are differences in design, the disposables have
demonstrated device performance against established acceptance criteria and testing did
not raise new questions of safety and effectiveness when compared to the predicate
device.

While there are differences in design and technology, these differences do not raise new questions of safety
and effectiveness when compared to the predicate device. Centargo has demonstrated its ability to perform
within its specified parameters and operate as intended by users of the device. As a result, the device is
deemed as safe and effective as the predicate device.

X. PERFORMANCE DATA

A. Performance Testing
• Device performance testing included verification of the system injection volume and flow rate
accuracy, pressure accuracy, air detection, heat maintenance, battery performance, occlusion
detection, and protocol management. Testing also verified that the device was not affected by
environmental conditions such as atmospheric conditions and handling. All testing passed and
the demonstrated product performance met all prior established acceptance criteria.
• The Centargo device is a Class II device and is classified by the FDA per 21 CFR 870.1650
(Angiographic Injector and Syringe). There are no special controls for the injector itself. However,
as the system also includes disposables, the device testing included verification and validation in
accordance with the Guidance for Industry and FDA Staff, Intravascular Administration Sets
Premarket Notification Submissions [510(k)]: July 11, 2008. Testing addressed the risks and
recommended mitigation measures identified in the guidance.
• The MEDRAD® Centargo CT Injection System disposables were tested for performance and
verified in accordance with the following standard:
• ISO 8536-4:2010, Infusion equipment for medical use-Part 4: Infusion sets for single use.
Only applicable requirements from ISO 8536-4 were tested. The results indicate the
disposable conforms to its pre-determined specifications.

B. Software Verification and Validation Testing

Software verification and validation was performed in accordance with the following standards:
• IEC 62304 Edition 1.1 2015-06 Consolidated Version: Medical device Software-Software life cycle
processes FDA Guidance for the Content of Premarket Submissions for Device Software
Functions Contained in Medical Devices: Guidance for Industry and FDA Staff, June 14, 2023,
and Guidance for Industry and Food and Drug Administration Staff - Off-The-Shelf Software Use
in Medical Devices, August 11, 2023. Test results were evaluated against established acceptance
criteria; all test results were acceptable.
• Cybersecurity testing was conducted according to Cybersecurity in Medical Devices: Quality
System Considerations and Content of Premarket Submissions Final Guidance for Industry and
Food and Drug Administration Staff, September 27, 2023. Testing provides a reasonable
assurance that the device and related systems are cybersecure.

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

C. Biocompatibility Testing
The MEDRAD® Centargo CT Injection System disposables have both direct and indirect patient
contacting materials which were verified in accordance with the following standard:
• ISO 10993-1 Fifth Edition:2018, Biological evaluation of medical devices- Part 1: Evaluation and
testing within a risk management process.

The following endpoints were evaluated to characterize the biocompatibility profile based on the
classification of the devices (externally communicating, indirect blood path, limited contact (<= 24 h)):
• Cytotoxicity
• Hemocompatibility (Hemolysis only)
• Sensitization
• Irritation / Intracutaneous Reactivity
• Acute Systemic Toxicity
• Materials Mediated Pyrogenicity

Particulate testing was completed according to methodology described in USP <788> Particulate Matter
in Injections. The Centargo sterile disposables met all acceptance criteria and have been determined to
be compatible for their intended use.

D. Chemical Compatibility Testing

Chemical Integrity testing was performed to support the material compatibility of the MEDRAD®
Centargo CT Injection System Disposable sets with the following contrast media:
• ULTRAVIST® (Iopromide) Image Bulk Presentation
• ISOVUE® (Iopamidol) Image Bulk Presentation
• OPTIRAY® (Ioversol) Image Bulk Presentation
• OMNIPAQUE™ (Iohexol) Image Bulk Presentation

E. Cleaning and Disinfection Validation Testing

Cleaning/disinfection validation was performed, and testing results demonstrated the efficacy of the
cleaning and disinfection procedures.

F. Sterility, Packaging, and Shelf-Life Testing

The MEDRAD® Centargo CT Injection System disposable sets are Radiation sterilized and are validated to
a SAL of 10-6. The testing was performed as per the following standards.
• ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products-
Microbiological methods-Part 1: Determination of a population of microorganisms on products.
• ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods -
Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization
process.

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MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

• ISO 11137-1 First edition 2006-04-15- Sterilization of health care products-Radiation-Part1:

requirements for development validation and routine control of a sterilization process for
medical devices.
• ISO 11137-2 Third edition 2013-06-01 [Including AMD1:2022]: Sterilization of health care
products- Radiation Part 2: Establishing the sterilization dose.
• IS0 11607-1 Second edition 2019-02: Packaging for terminally sterilized medical devices-part 1:
Requirements for materials sterile barrier systems and packaging systems.
• The sterilization testing passed, and the product performance met all prior established
acceptance criteria.
• Disposables functional testing was performed on accelerated aged samples and results
confirmed the performance for the labeled shelf-life.
• Package stability testing was demonstrated via verification of aged product that had been pre-
conditioned. Testing was acceptable to satisfy the package testing requirements. Additionally,
product testing was successfully completed after exposure to shipping and handling conditions.

G. Contamination Control Testing

Bayer performed the following contamination control studies:

• Microbial ingress study and

• Cross contamination study

Based on the results obtained, it has been concluded that MEDRAD® Centargo CT Injection System has
the ability to maintain sterile fluid path and resist the ingress of microorganisms when used as intended.

H. Human Factors/ Usability Testing

Human Factors/Usability testing were performed in a simulated use environment to optimize the device
design and support the safe use of the MEDRAD® Centargo CT injection System. The summative
evaluation is conducted as per the following standard and FDA Guidance.
• IEC 62366-1 Edition 1.1 2020-06 Consolidated version. Medical devices-Part 1: Application of
Usability engineering to medical devices.
• Applying Human Factors and Usability Engineering to Medical Devices (Guidance for Industry
and FDA Staff) February 3, 2016.
The results demonstrated that the overall residual risk is low, and users can operate the system as
safely and effectively as the predicate device.

I. Reliability Testing
Reliability testing was performed using statistical methods to demonstrate the capability to meet system
performance requirements sequentially and repeatedly. All testing passed and the demonstrated
performance met all prior established acceptance criteria.

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 MEDRAD® CENTARGO CT INJECTION SYSTEM- 510(K) SUMMARY

J. Electromagnetic Compatibility (EMC) and Electrical Safety Testing

Electromagnetic compatibility and electrical safety testing were performed in accordance with the
following standards:
• ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons.
Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
• ANSI AAMI IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests

Testing included verification of both configurations, including in conjunction with the ISI2 Module
accessory. All testing passed and the demonstrated performance met all prior established acceptance
criteria.

K. Animal Studies: Not Applicable

L. Clinical Testing: Not Applicable

Summary
In summary, the conclusions drawn from the nonclinical and other tests (discussed above) demonstrate that
the device is as safe, as effective, and performs as well as or better than the predicate device (K151048).

XI. CONCLUSION
Bayer considers the MEDRAD® Centargo CT Injection System (Centargo) to be substantially equivalent to the
predicate device, CT ExprèsTM 3D Contrast Media Delivery System (K151048). This conclusion is based upon
the devices having the same intended use and comparable technological characteristics. While there are
differences in design and technology, these differences do not raise new questions of safety or
effectiveness when compared to the predicate device. Centargo has demonstrated its ability to perform
within its specified parameters and operate as intended by the users of the device. As a result, its
performance is deemed acceptable and substantially equivalent to the predicate device.

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