GE Healthcare November 2, 2018
Michel Genuer
Senior Regulatory Affairs Program Manager
283 Rue De La Miniere
78530 Buc, France
Re: K181403
Trade/Device Name: Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Codes: OWB, JAA, IZI, OXO
Dated: May 17, 2018
Received: May 29, 2018
Dear Michel Genuer:
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 (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
located 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.
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
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.03.01
Silver Spring, MD 20993
www.fda.gov
K181403 - Michel Genuer Page 2
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
For
Robert A. Ochs, Ph.D.
Director
Division of Radiological Health
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health
Enclosure
,
Page 4 - 2
GE Healthcare
510(k) Premarket Notification Submission- GE Healthcare IGS interventional x-ray
systems
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: 31-October-2018
Submitter: GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE
78530 BUC, FRANCE
Primary Contact Person: Michel GENUER
Senior Regulatory Affairs Program Manager
GE Healthcare, (GE MEDICAL SYSTEMS SCS)
Tel: (+33)-1-3070-4741
Email: michel.genuer@ge.com
Secondary Contact Persons: GE Healthcare, (GE MEDICAL SYSTEMS SCS)
Philip Malca
Regulatory Affairs Director
Tel: (+33)-6 4637 3852
Email: philip.malca@ge.com
Maxime CORNIERE
Regulatory Affairs Leader
Tel: (+33)-1-3070-4153
Email: maxime.corniere@ge.com
Device Trade Name: Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7, Discovery™
IGS 7 OR
Common/Usual Name: interventional fluoroscopic x-ray system, angiographic x-ray system
Regulation description: Image-intensified fluoroscopic x-ray system
Regulation Number: 21CFR 892.1650
Product Code: OWB
Subsequent Product Codes JAA, IZI and OXO for Discovery™ IGS 7 and Discovery™ IGS 7 OR.
Classification: Class II
Page 1 of 7
GE Healthcare
510(k) Premarket Notification Submission- GE Healthcare IGS interventional x-ray
systems
Trade Name: GE Innova/Innova IGS/Discovery
Predicate Device(s):
IGS/Optima angiographic, fluoroscopic
X-ray systems with Cathlab Frontiers
solutions.
510(k) Clearance: K122457
Regulation Name: Image-Intensified fluoroscopic x-ray
system
Regulation Number: 21CFR 892.1650
Classification: Class II
Product Code: Primary product code: OWB
Secondary Product codes: IZI, JAA
Trade Name: Discovery IGSTM 740
510(k) Clearance: K133278
Regulation Name: Image-Intensified fluoroscopic x-ray
system
Regulation Number: 21CFR 892.1650
Classification: Class II
Product Code: Primary product code: OWB
Secondary Product codes: JAA, OXO
GE Healthcare IGS interventional x-ray systems are designed to
Device Description:
perform monoplane, biplane fluoroscopic x-ray examinations to
provide the imaging information needed to perform minimally
invasive interventional X-Ray imaging procedures (standard
configuration). Additionally, in the OR configuration (with an OR
Table), these systems allow to perform surgery and X-Ray image
guided surgical procedures in a hybrid Operating Room.
Discovery™ IGS 7 OR, Discovery™ IGS 7, Innova™ IGS 6, Innova™ IGS
5 are the GE Healthcare IGS interventional X-Ray system product
models.
Each product model is designed with a set of components that are
combined into different configurations for providing specialized
interventional x-ray systems. GE Healthcare IGS interventional x-ray
system consists of a C-arm positioner (monoplane or biplane), an x-
ray imaging table or the interface to the radiologic table, an x-ray
tube assembly (per plane), an x-ray power unit with its exposure
control unit (per plane), an x-ray imaging chain (including a digital
detector and an image processing unit, per plane).
Discovery™ IGS 7 is a monoplane system (C-arm with mobile AGV
gantry) and is proposed in IGS 740 configuration with a square 41cm
digital detector or in IGS 730 configuration with a square 31cm
digital detector. These product configurations are declined in sub
configurations: Standard or OR configuration. The Innova-IQ table in
the OR configuration is the GE OR table.
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GE Healthcare
510(k) Premarket Notification Submission- GE Healthcare IGS interventional x-ray
systems
Discovery™ IGS 7 OR is a monoplane system (C-arm positioner with
mobile AGV gantry) and is proposed with a square 41cm digital
detector or with a square 31cm digital detector configuration. This
is the product model compatible with a qualified configuration of
the Maquet Magnus OR table system. This product model is
provided with a table integration kit. The Magnus OR table
configuration compatible with Discovery™ IGS 7 OR includes a flat
table top configuration for Interventional X-Ray imaging and surgery
procedures, an optional universal table top (table top with
articulated joints) to enable expansion to surgical procedures
requiring advanced patient positioning and with X-Ray imaging
capabilities. A set of Magnus OR table accessories is included in the
compatible configuration.
Innova™ IGS 6 is a biplane system (a dual C-arm positioner, LC and
LP gantry) and is provided with an Omega V table. Innova™ IGS 6 is
proposed in IGS 630 configuration with a square 31cm digital
detector per plane or in IGS 620 configuration with a square 20.5cm
digital detector per plane. These product configurations are
available in Standard configuration.
Innova™ IGS 5 is a monoplane system (C-arm positioner with LC
gantry) and is proposed with a square digital detector of 41cm or
31cm or 20.5cm. These product configurations are available in
Standard configuration with Innova-IQ or Omega V table or Omega
IV table (IGS 520 configuration only); or in OR configuration with GE
OR table.
The purpose of this Premarket Notification is for 2 changes:
First, a change of the collision management of Discovery™ IGS 7 OR
to enable the use of a Neurosurgical head holder (skull clamp).
During trauma neck surgery and stereotactic navigation, a gantry
collision with the skull clamp could result in patient harm, delayed
or halted surgical procedures. The subject of this submission is to
introduce a functionality for adapting the collision avoidance model
to the geometrical characteristic of the skull clamp and patient
position with a guard volume defined and validated by the operator
during the procedure preparation phase. During the procedure, the
collision avoidance software will slow down and stop gantry and/or
table axis to minimize risk of collision of a motorized moving part
with the patient head or the skull clamp. In this configuration, the
OR table, the Neurosurgical head holder and its support are from
third party Medical device manufacturers. As a consequence, there
is no mechanical interfaces between these devices and the
Discovery™ 7 OR. Those devices are registered and cleared in the
US. The Neurosurgical head holder is from Pro Med Instrument
manufacturer (K063494). The OR table is the registered Magnus OR
table system from Maquet manufacturer.
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GE Healthcare
510(k) Premarket Notification Submission- GE Healthcare IGS interventional x-ray
systems
The second change is for a primary technology change, adding an
optional wireless footswitch in the examination room to Innova™
IGS 5, Innova™ IGS 6, Discovery™ IGS 7 and Discovery™ IGS 7 OR. It
provides identical functionalities as the wired footswitch for the
control of X-ray on and off, and for the control of the table top brake
release.
Labelling is updated for the enhanced collision management for the
use with Neurosurgical head holder and for the wireless footswitch.
The angiographic X-ray systems are indicated for use for patients
Intended Use:
from newborn to geriatric in generating fluoroscopic and rotational
images of human anatomy for cardiovascular, vascular and non-
vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are
indicated for use in generating fluoroscopic and rotational images
of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures.
The angiographic X-ray systems are indicated for use for patients
Indication for Use:
from newborn to geriatric in generating fluoroscopic and rotational
images of human anatomy for cardiovascular, vascular and non-
vascular, diagnostic and interventional procedures.
Additionally, with the OR table, the angiographic X-ray systems are
indicated for use in generating fluoroscopic and rotational images
of human anatomy for image-guided surgical procedures.
The OR table is suitable for interventional and surgical procedures.
The modified GE Healthcare IGS Interventional X-Ray systems
Technology:
employ the same fundamental scientific technology as the
unmodified predicate devices.
The change to enable the dynamic adaptation of the collision
avoidance model with a model fitted to the needs of the operator
and of the procedure, is a software change. The collision avoidance
software is the same as with the predicate devices. The change is
the dynamic adaptation of the collision avoidance model. All causes
of hazard relative to the use of a Neurosurgical head holder in
combination with the Discovery™ IGS 7 OR have been identified and
mitigated.
The optional wireless footswitch consists of a footswitch containing
a transmitter system, a receiver that is installed near the connection
plug of the wired footswitch (at the table base of the Innova-IQ
table, of the Omega table or at the Discovery Control Center table
side cart), and a charger. The introduction of this wireless footswitch
does not change existing electrical or software interface of the
predicate devices. The new option is equivalent to the wired
footswitch on the predicate in that the functionalities are identical.
The communication between the footswitch emitter and the
Page 4 of 7
GE Healthcare
510(k) Premarket Notification Submission- GE Healthcare IGS interventional x-ray
systems
receiver is performed via a proprietary protocol using 2.4 GHz radio
frequency technology.
The wireless option provides placement flexibility and reduces cable
clutter.
Both changes have no impact on x-ray imaging performance.
The intended use and indications for use remain unchanged from
those of the predicate devices. The expansion to x-ray
interventional, minimally invasive surgery and conventional open
surgery procedures requiring the use of a neurosurgical holder in
combination with Discovery™ IGS 7 OR is included in Discovery IGS
7 OR’s indications for use of interventional, image-guided surgical
and surgical procedures.
Determination of Substantial The modifications to Discovery™ IGS 7 OR collision management
Equivalence: software and to IGS interventional x-ray systems for the wireless
footswitch were developed under the GE Healthcare’s design
controls processes and overall quality management system.
IGS interventional x-ray systems conform to 21CFR 1020.30 and 32,
and with voluntary standards IEC 60601-2-43:2010, IEC 62304
(2006) and IEC 62366 (2007).
Risk management activities using risk analysis to identify any
potential issues incorporating the wireless footswitch and the use of
a skull clamp were performed. These issues were assessed and
mitigated.
The following testing was used to assess safety and effectiveness
and, thus, to establish the substantial equivalence with the
predicate devices.
Summary of Non-Clinical Tests:
The following quality management measures were applied to the
development of these modifications:
• Simulated Use Testing ensured the system conforms to user
needs and intended uses through simulated clinical
workflow using step-by step procedures that would be
performed for representative clinical applications.
• Usability validation testing was conducted to confirm that
the product can be used safely and effectively. Participants
were representatives of actual users, with knowledge of the
customer needs and clinical applications.
• Product verification ensured the system conforms to its
requirements including hazard mitigations risk
management requirements. The verification tests
confirmed that design output meet design input
requirements. Tests were executed at component, software
subsystems and system levels.
Page 5 of 7
GE Healthcare
510(k) Premarket Notification Submission- GE Healthcare IGS interventional x-ray
systems
• Safety testing were performed to confirm that the product
meets the requirements of the aforementioned standards.
It includes the EMC and coexistence testing per the “Radio
Frequency Wireless Technology in Medical Devices”
Guidance for Industry and Food and Drug Administration
Staff issued on August 14, 2013 (Wireless Guidance).
Summary of Clinical Tests:
The subject of this premarket submission, change to Discovery™ IGS
7 OR collision management to enable the use of a neurosurgical
head holder and the change to add an optional wireless footswitch
in the examination room to GE Healthcare interventional x-ray
systems did not require clinical studies to support substantial
equivalence. The expansion to x-ray and surgical procedures
requiring the use of a neurosurgical holder in combination with
Discovery™ IGS 7 OR is included in Discovery IGS 7 OR’s indications
for use of image-guided surgical and surgical procedures. It does not
introduce new indications for use. Substantial equivalence relies on
clinical information that is pre-existing on the cleared predicate
devices.
Design verification and validation testing were performed to
confirm that the safety and effectiveness of the devices has not
been affected. The test plans and results have been executed with
acceptable results.
GE Healthcare considers that the Discovery™ IGS 7 OR incorporating
Conclusion:
the enhanced collision management for the use of a skull clamp or
that a GE Healthcare IGS interventional x-ray system incorporating
the optional wireless footswitch to be as safe and as effective and
substantially equivalent to the predicate devices.
This conclusion is based on the fact that Discovery™ IGS 7 OR
incorporating the collision management optimization for the use in
combination with the Neurosurgical head holder and that GE
Healthcare interventional x-ray systems incorporating the optional
wireless footswitch have:
• the same indications for use as their predicate devices.
• The modified devices have the same technological
characteristics as their predicate devices.
• Verification and Validation testing has demonstrated that
the design inputs, user requirements, and risk mitigations
have been met.
• Engineering bench testing per the FDA guidance Radio
frequency wireless technology in medical devices as well as
conformance to IEC standards and guidance documents
were provided.
Page 6 of 7
GE Healthcare
510(k) Premarket Notification Submission- GE Healthcare IGS interventional x-ray
systems
• The successful completion of the above testing was
sufficient to assess safety and effectiveness and, thus, to
establish the substantial equivalence.
Page 7 of 7
