The angiographic X-ray systems are indicated for use for patients 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 Cathlab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution.

The Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing:

(1) communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices,
(2) communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface,
(3) interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.

Device Description

The basis for this 510(k) submission is a modification of the family of legally marketed GE angiographic, fluoroscopic X-ray systems devices to expand their indications for use regarding the generic integration interfaces for other imaging / data medical devices used in interventional and surgical cathlab environments and cleared/approved for commercial distribution.

Same time with the intended use/indications for use expansion we introduce the Integrated Vivid E9 solution. The Vivid E9 (BT12 version) integrates with Innova IGS 520, Innova IGS 530, and Innova IGS 540 systems, integration consisting in displaying the Vivid E9 system screen on Innova IGS Large Display Monitor solution.

For the Innova IGS Vivid E9 integration we apply the specific qualifications criteria and processes described in the section "Determination of Substantial Equivalence" below.

AI/ML Overview

This document describes the 510(k) summary for the GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers solutions.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on integration capabilities and does not present a typical table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or image quality scores for a diagnostic AI device. Instead, the "acceptance criteria" are related to the safety and functionality of integrating the system with other medical devices.

Acceptance Criteria (from "Determination of Substantial Equivalence" section)	Reported Device Performance/Compliance
Integration of 3rd party systems:	Evaluated for electrical and electromagnetic safety.
- Shall be "FDA cleared/approved device"	The integration relies on the fact that integrated devices are already FDA cleared/approved.
- Shall comply with one or more generic integration interfaces offered by the GE angiographic, fluoroscopic X-ray systems.	Demonstrated compliance through internal testing (see "Quality Assurance Measures").
- Integration of devices shall be safe and effective and shall not raise different questions of safety and effectiveness than the predicate device(s).	Quality Assurance Measures Applied to Development: - Risk Analysis - Requirements Reviews - Design Reviews - Testing on unit level (Module verification) - Integration testing (System verification) - Performance testing (Verification) - Safety testing (Verification) - Simulated use testing (Validation) The device and its applications/accessories comply with voluntary standards and applicable performance standards for radiation-emitting products.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "testing" described is primarily system integration and safety verification. The document does not specify a number of integrated devices or test scenarios.
Data Provenance: Not applicable. The testing described is internal engineering verification and validation, not based on patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Number of Experts: Not applicable. Ground truth as typically understood for diagnostic AI devices (e.g., disease presence) is not established in this submission. The "ground truth" here is compliance with safety, performance, and integration standards, which is assessed through engineering tests and regulatory requirements.
Qualifications of Experts: Not specified, but implied to be qualified GE Healthcare engineers and regulatory personnel involved in the design, development, and testing of the system.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no mention of human reader adjudication for this device, as it is related to system integration and functional performance rather than diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
Effect Size of Human Readers with/without AI assistance: Not applicable, as this submission is not about the diagnostic accuracy of AI in interpreting images or the impact on human reader performance. It concerns the integration of existing cleared/approved devices and the X-ray system.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The "Cathlab Frontiers solutions" are described as communication protocols and interfaces that simplify workflow and integrate imaging/data devices. The "performance" described pertains to the system's ability to integrate safely and effectively, not to a standalone diagnostic algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" used for this submission is compliance with regulatory standards, engineering specifications, and safety requirements. It's established through internal testing (risk analysis, requirements reviews, design reviews, various levels of verification, and validation) and confirmation that integrated third-party devices are already FDA-cleared/approved.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This submission does not involve a machine learning algorithm that requires a training set in the typical sense. The "Cathlab Frontiers solutions" are integration functionalities based on defined communication protocols and interfaces.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a machine learning algorithm mentioned in this submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2016

Ms. Dorai Subramaniam Regulatory Affairs Leader 283, RUE DE LA MINIERE BUC. 78530 FRANCE

Re:K122457

Trade/Device Name: GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: December 12, 2012 Received: December 19, 2012

Dear Ms. Dorai Subramaniam:

This letter corrects our substantially equivalent letter of January 2, 2013.

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. 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oaks

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122457

Device Name: GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers Solutions

Indications for Use:

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 Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing:

(1) communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices,
(2) communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface,
(3) interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.

Prescription Use X AND/OR Over-The-Counter Use. (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janine M. Morris -S 2013.01.02 17:38:37 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K122457 510(k)

Page 1 of .

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Section 5: 510(k) Summary

GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers solutions

5.1 510(k) Summary

5-2

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	10 August 2012
Submitter:	GE HealthcareGE Medical Systems, SCS283 rue de la MiniereBuc, FRANCE, 78530T: +33-01-30-70-42-07
Primary Contact Person:	Dorai SubramaniamRegulatory Affairs LeaderGE Healthcare, (GE Medical Systems, SCS)T: +91-80-4088-3769Email: dorai.subramaniam@ge.com
Secondary Contact Person:	Carol AlloianRegulatory Affairs LeaderGE Healthcare -Americas,9900 W innovation driveWauwatosa, WI, USA, 53226-4856T: (847) 244-8327F: (847) 589-8524Email: carol.alloian@ge.com
Device:Trade Name:	GE Innova/Innova IGS/Discovery IGS/Optima angiographic,fluoroscopic X-ray systems with Cathlab Frontiers solutionsInnova 4100-IQ, Innova 3100-IQ, Innova 2100-IQ, Innova 2121-IQ, Innova 3131-IQ, Innova IGS 540, Innova IGS 530, InnovaIGS 520, Innova IGS 620, Innova IGS 630, Discovery IGS 730,Optima CL320i, Optima CL323i.
Common/Usual Name:	Interventional fluoroscopic x-ray system, angiographic x-ray system
Regulation Description:	Image-intensified fluoroscopic x-ray system
Regulation number:	892.1650
Product Code:	OWB, JAA and IZI
Class:	II
Predicate Device(s):	K113034 : GE Innova Solid State X-ray Imager Fluoroscopic X-ray SystemK111209 : Integrated Innova - S5i System OptionK113403 : GE Discovery IGS angiographic, fluoroscopic X-RaySystem
Device Description:	The basis for this 510(k) submission is a modification of thefamily of legally marketed GE angiographic, fluoroscopic X-raysystems devices to expand their indications for use regarding thegeneric integration interfaces for other imaging / data medicaldevices used in interventional and surgical cathlab environmentsand cleared/approved for commercial distribution.
	Same time with the intended use/indications for use expansion weintroduce the Integrated Vivid E9 solution. The Vivid E9 (BT12version) integrates with Innova IGS 520, Innova IGS 530, andInnova IGS 540 systems, integration consisting in displaying theVivid E9 system screen on Innova IGS Large Display Monitorsolution.
	For the Innova IGS Vivid E9 integration we apply the specificqualifications criteria and processes described in the section"Determination of Substantial Equivalence" below.
Intended Use:	The angiographic X-ray systems are indicated for use for patientsfrom newborn to geriatric in generating fluoroscopic androtational images of human anatomy for cardiovascular, vascularand non-vascular, diagnostic and interventional procedures.
	Additionally, with the OR table, the angiographic X-ray systemsare indicated for use in generating fluoroscopic and rotationalimages of human anatomy for image-guided surgical procedures.
	The OR table is suitable for interventional and surgicalprocedures.
	The Cathlab Frontiers solutions are indicated for use inconjunction with single plane and biplane GE angiographic X-raysystems and imaging / data medical devices used in interventionaland surgical Cathlab environments and cleared for commercialdistribution.
	The Cathlab Frontiers solutions are integrated GE angiographicX-ray and imaging / data medical devices that simplify the end-
	to-end clinical workflow in the Cathlab by implementing:
	(1) communication protocols for exchanging and automaticallysynchronizing patient, exam, system, and image informationbetween the angiographic X-ray systems and the imaging / datamedical devices,
	(2) communication protocols for the control of imaging / datamedical device functions from the angiographic X-ray systemsuser interface,
	(3) interfaces for displaying the imaging / data medical deviceoutput on the monitor display solutions of the GE angiographicX-ray systems.
Technology:	The GE Angiographic, Fluoroscopic X-ray Systems employs thesame Solid State X-ray Imaging and Digital Flat-Panel Detectortechnology as its predicate devices.
Determination of	Summary of Non-Clinical Tests:
Substantial Equivalence:	The Integration has been evaluated for electrical andelectromagnetic safety. The GE Angiographic, Fluoroscopic X-ray Systems and its applications and accessories comply withvoluntary standards and applicable performance standards forradiation emitting products of this premarket submission. Thefollowing quality assurance measures were applied to thedevelopment of the system:• Risk Analysis• Requirements Reviews• Design Reviews• Testing on unit level (Module verification)• Integration testing (System verification)• Performance testing (Verification)
	• Safety testing (Verification)• Simulated use testing (Validation)
	Summary of specific qualification of 3rd party systemsintegrations:The criteria to qualify the integration of 3rd party imaging/datamedical devices are based on the following aspects:• Shall be "FDA cleared/approved device"• Shall comply with one or more generic integrationinterfaces offered by the GE angiographic, fluoroscopicX-ray systems.
	Integration of devices shall be safe and effective and shall not raise different questions of safety and effectiveness than the predicate device(s).
	Summary of Clinical Tests:
	The subject of this premarket submission, Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions, did not require clinical studies to support substantial equivalence as one of the criteria for integration rely on the fact that they are already cleared /approved devices by FDA. Integration does not introduce any new clinical information and the clinical information is pre-existing on the cleared or approved devices.
Conclusion:	GE Healthcare considers the GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers solutions to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

Section 5

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GE Healthcare 510(k) Premarket Notification Submission

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Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.