The angiographic X-ray systems are indicated for use 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.

Device Description

The basis for this submission is a modification of the common platform of a family of legally marketed devices to expand its indications for use to include image-guided surgical procedures and open surgery procedures. The currently cleared devices are indicated for use for interventional and minimally invasive procedures. The subject modification is intended to introduce a new configuration (OR configuration) that will enable the Innova Systems to be additionally indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The modifications mainly consist of introduction of new configuration called OR configuration. The OR configuration of the product is designed in accordance with the operating table standard (IEC 60601-2-46) with deviation for clause 36.101*, it corresponds to the Innova 4100-IQ, 3100-IQ, 2100- IQ product equipped with • OR table (OR table is the Innova-IQ table with specific covers with an "OR" branding) • IPX4Table side user interface • Mandatory UPS • Mandatory surgical accessories • Dedicated surgery protocols *Electromagnetic Compatibility tested to cover high power surgical tool up to 300W and as per the Requirements of the IEC 60601-2-46 Edition 2, refer details in section 9.3.1 standards data forms 3654. To maintain compliance with the operating table safety standard, not all controls are allowed to be mounted on the table rails. The following controls only are allowed: • IPX4 Table Side Status Control (TSSC) • IPX4 Smart Box (Smart Box) • IPX4 Table Panning Device (TPD) • IPX4 Innova Central touch screen • IVUS PIM A table side cart is provided to place any other control (3D mouse, IVUS console and joystick) Table mounted injectors are not allowed with the OR configuration.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for GE Healthcare's Innova Systems - OR configuration. This document outlines the modifications made to an existing device family to expand its indications for use to include image-guided surgical procedures. As such, this submission focuses on the safety and effectiveness of the modified system in its new configuration and does not involve a study of a medical device's performance against specific acceptance criteria in the way an AI/ML algorithm or diagnostic device typically would.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable to this S10(k) submission.

This submission asserts substantial equivalence to predicate devices based on:

Non-Clinical Tests: The document states that the Innova Systems-OR configuration complies with voluntary standards and lists quality assurance measures such as Risk Analysis, Requirements Reviews, Design Reviews, unit-level testing, integration testing, performance testing, safety testing, and simulated use testing.
Clinical Tests: The submission explicitly states: "The subject of this premarket submission, Innova Systems -OR configuration, did not require clinical studies to support substantial equivalence."

In summary, the document does not contain the information requested because the device in question is an angiographic X-ray system being modified for expanded use, and its substantial equivalence was determined through non-clinical testing and comparison to predicate devices, rather than a performance study against specific acceptance criteria for a diagnostic output.

Summary

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DEC 1 3 2011

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:	October 5, 2011
Submitter:	GE HealthcareGE Medical Systems, SCS283 rue de la MiniereBuc, FRANCE, 78530T: +33-01-30-70-42-07
Primary Contact Person:	Dorai.SubramaniamRegulatory Affairs Leader,GE Medical Systems,John F. Welch Technology Centre,Plot #122, EPIP, Phase 5,Whitefield Road, Bangalore, Karnataka 560066, IndiaT: +91-80-4088-3769Email: Dorai.Subramaniam@ge.com
Secondary Contact Person:	Carol AlloianRegulatory Affairs Leader,GE Healthcare- Americas9900 W innovation driveWauwatosa, WI, USA, 53226-4856T: (847) 244-8327F: (847) 589-8524Email: carol.alloian@ge.com
Device/Trade Name:	Innova Systems (Innova 4100-IQ, 3100-IQ, 2100-IQ)
Common/Usual Name:	Innova Systems (Innova 4100-IQ, 3100-IQ, 2100-IQ)
Classification Names:	Angiographic x-ray system
Product Code:	IZI, 892.1600.
Predicate Device(s):	K111209: INTEGRATED INNOVA - S5I SYSTEM OPTION,K090745 : Siemens Artis zee
Device Description:	The basis for this submission is a modification of the commonplatform of a family of legally marketed devices to expand itsindications for use to include image-guided surgical procedures andopen surgery procedures. The currently cleared devices areindicated for use for interventional and minimally invasiveprocedures. The subject modification is intended to introduce a newconfiguration (OR configuration) that will enable the Innova Systems
	to be additionally indicated for use in generating fluoroscopic androtational images of human anatomy for image-guided surgicalprocedures.The modifications mainly consist of introduction of newconfiguration called OR configuration.The OR configuration of the product is designed in accordance withthe operating table standard (IEC 60601-2-46) with deviation forclause 36.101, it corresponds to the Innova 4100-IQ, 3100-IQ, 2100-IQ product equipped with• OR table (OR table is the Innova-IQ table with specific coverswith an "OR" branding)• IPX4Table side user interface• Mandatory UPS• Mandatory surgical accessories• Dedicated surgery protocolsElectromagnetic Compatibility tested to cover high power surgicaltool up to 300W and as per the Requirements of the IEC 60601-2-46Edition 2, refer details in section 9.3.1 standards data forms 3654.To maintain compliance with the operating table safety standard,not all controls are allowed to be mounted on the table rails. Thefollowing controls only are allowed:• IPX4 Table Side Status Control (TSSC)• IPX4 Smart Box (Smart Box)• IPX4 Table Panning Device (TPD)• IPX4 Innova Central touch screen• IVUS PIMA table side cart is provided to place any other control (3D mouse,IVUS console and joystick)Table mounted injectors are not allowed with the OR configuration.
Intended Use:	The angiographic X-ray systems are indicated for use in generatingfluoroscopic and rotational images of human anatomy forcardiovascular, vascular and non-vascular, diagnostic andinterventional procedures.Additionally, with the OR table, the angiographic X-ray systems areindicated for use in generating fluoroscopic and rotational images ofhuman anatomy for image-guided surgical procedures. The ORtable is suitable for interventional and surgical procedures.
Technology:	The Innova Systems employs the same fundamental scientifictechnology as its predicate devices.
Determination of SubstantialEquivalence:	Summary of Non-Clinical Tests:The Innova Systems -OR configuration complies with voluntarystandards as detailed in Section 9 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 Clinical Tests:The subject of this premarket submission, Innova Systems -ORconfiguration, did not require clinical studies to support substantialequivalence.
Conclusion:	GE Healthcare considers the Innova Systems -OR configuration tobe as safe, as effective as its predicates devices, and itsperformances substantially equivalent to the predicate devices.

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GE Healthcare

510(k) Premarket Notification Submission

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GE Healthcare

510(k) Premarket Notification Submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

GE Healthcare Americas Division % Ms. Carol Alloian Regulatory Affairs Leader 9900 W. Innovation Drive WAUWATOSA WI 53226-4856

DEC 1 3 2011

Re: K113034

Trade/Device Name: Innova Systems- OR configuration (Innova 4100-IQ, 3100-IQ, 2100-

IO) Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: October 5. 2011 Received: October 11, 2011

Dear Ms. Alloian:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S. Patil

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Name: Innova Systems- OR configuration (Innova 4100-IQ, 3100-IQ)

Indications for Use

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Badiologi Office of In Vitro Diagnostic De vice Evaluation and Safety

510K K113034

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.