INTEGRATED INNOVA - S5I SYSTEM OPTION

K111209 · GE Healthcare · IZI · Jul 26, 2011 · Radiology

Device Facts

• Record ID: K111209
• Device Name: INTEGRATED INNOVA - S5I SYSTEM OPTION
• Applicant: GE Healthcare
• Product Code: IZI · Radiology
• Decision Date: Jul 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

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. The Integrated Innova - s5i system option is indicated for use in conjunction with single plane and biplane angiographic X-ray systems. The Integrated Innova - s5i system option simplifies the clinical workflow associated with the use of Volcano s5i systems by: (1) automatically synchronizing the patient demographic and medical exam information (patient name, date of birth, etc.) from angiographic X-ray systems with Volcano s5i systems, (2) providing a remote access to commonly used Volcano s5i system functions from the angiographic X-ray systems user interface, (3) displaying the Volcano s5i systems output on the monitor display solutions of the angiographic X-ray systems.

Device Story

Integrated Innova-s5i system option provides connectivity between GE angiographic X-ray systems and Volcano s5i intravascular imaging/pressure systems. Device functions as a workflow integration tool in clinical settings (e.g., cath labs) operated by physicians and clinical staff. It synchronizes patient demographic/exam data between systems, enables remote control of Volcano s5i functions via the X-ray system interface, and routes Volcano s5i output to X-ray system monitors. By centralizing control and display, it reduces workflow complexity, allowing clinicians to manage intravascular imaging and X-ray data from a single interface, potentially improving procedural efficiency.

Clinical Evidence

No clinical data; substantial equivalence supported by bench testing, including software verification, system integration testing, and simulated use validation.

Technological Characteristics

Software-based integration system for angiographic X-ray and intravascular imaging platforms. Connectivity-focused architecture enabling data synchronization, remote function access, and display routing. Complies with voluntary standards and internal quality assurance measures including risk analysis and software design specifications.

Indications for Use

Indicated for patients undergoing cardiovascular, vascular, or non-vascular diagnostic and interventional procedures requiring fluoroscopic or rotational imaging using single or biplane angiographic X-ray systems in conjunction with Volcano s5i intravascular imaging/pressure systems.

Regulatory Classification

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.

Predicate Devices

• INNOVA x1x1 & X100 systems with IVUS option (K061163)

Submission Summary (Full Text)

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K111209
P. 1 of 2

JUL 26 2011

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GE Healthcare

Integrated Innova - s5i system option - 510(k) Premarket Notification

## 510(k) Summary

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

| Date: April 27th, 2011 | |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE HEALTHCARE<br>GE Medical Systems SCS<br>283, rue de la minière<br>78530 BUC<br>FRANCE |
| Primary Contact Person: | Fayçal KHERRA<br>Regulatory Affairs Leader<br>GE Medical Systems SCS<br>283, rue de la minière<br>78530 BUC<br>FRANCE<br>T: [phone]<br>Email: [e-mail] |
| Secondary Contact Person: | Carol Alloian<br>Regulatory Affairs Leader<br>GE Healthcare, QARA Regions - Americas<br>9900 W innovation drive<br>Wauwatosa, WI, USA, 53226-4856<br>T: [phone]<br>F: [phone]<br>Email: [e-mail] |
| Device/Trade Name: | Integrated Innova - s5i system option (Formerly known as Innova<br>System with IVUS Option) |
| Common/Usual Name: | Integrated Innova - s5i system option (Formerly known as Innova<br>System with IVUS Option) |
| Classification Names:<br>Product Code: | IZI : SYSTEM, X-RAY, ANGIOGRAPHIC<br>MQB : SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) |
| Predicate Device(s): | K061163 : INNOVA x1x1¹⁰ & X100¹⁰ systems with IVUS option |
| Device Description: | The integrated INNOVA - s5i system option provides enhanced<br>connectivity with Volcano's intravascular imaging and pressure system. |
| Intended Use: | The angiographic X-ray systems are indicated for use in generating<br>fluoroscopic and rotational images of human anatomy for<br>cardiovascular, vascular and non-vascular, diagnostic and interventional<br>procedures. |
| | The Integrated Innova - s5i system option is indicated for use in<br>conjunction with single plane and biplane angiographic X-ray systems. |
| | The Integrated Innova - s5i system option simplifies the clinical workflow<br>associated with the use of Volcano s5i systems by:<br>(1) automatically synchronizing the patient demographic and<br>medical exam information (patient name, date of birth, etc.) from<br>angiographic X-ray systems with Volcano s5i systems,<br>(2) providing a remote access to commonly used Volcano s5i system<br>functions from the angiographic X-ray systems user interface,<br>(3) displaying the Volcano s5i systems output on the monitor display<br>solutions of the angiographic X-ray systems. |
| Technology: | The integrated Innova - s5i system option employs the same<br>fundamental scientific technology as its predicate devices. |
| Determination of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>The integrated Innova - s5i system option complies with voluntary<br>standards as detailed in Section 9 of this premarket submission. The<br>following quality assurance measures were applied to the development<br>of the system:<br>• Risk Analysis |
| | • Software Requirements Specifications<br>• Requirements Reviews<br>• Software design specification document. |
| | • Design Reviews<br>• Traceability between requirements & hazards towards their associated<br>mitigations as appropriate and V&V |
| | • Testing on unit level (Module verification)<br>• Integration testing (System verification)<br>• Performance testing (Verification)<br>• Safety testing (Verification) Simulated use testing (Validation) |
| | Summary of Clinical Tests:<br>The subject of this premarket submission, integrated Innova - s5i system<br>option, did not require clinical studies to support substantial equivalence. |
| Conclusion: | GE Healthcare considers the integrated Innova - s5i system option to be<br>as safe and as effective as the predicate devices, and its performance is<br>substantially equivalent to the predicate devices. |

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KIII 209
P. 2 of Z

GE Healthcare

Integrated Innova - s5i system option - 510(k) Premarket Notification

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.

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

Mr. Faycal Kherra Regulatory Affairs Leader GE Healthcare - GE Medical Systems SCS 283, rue de la minière BUC, 78530 FRANCE

JUL 2 6 2311

Re: K111209

Trade/Device Name: Integrated Innova-s5i system option Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: April 27, 2011 Received: April 29, 2011

## Dear Mr. Kherra:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becales on and 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 conimores that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have boon roomstiled in assee approval of a premarket approval application (PMA). and Cosmetic (110.) that to hovice, subject to the general controls provisions of the Act. The I ou mayy are sprovisions 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 11 your device to to to stime major regulations affecting your device can be found in Title 21, accitional corners 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 I least be advised hit i Dri i issualite our device complies with other requirements of the Act that I Dri has intate a and regulations administered by other Federal agencies. You must or any I caeral statutes and regencients, 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 [phone]. 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

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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KI11209

- 510(k) Number (if known): K || | 20 9
- · Device Name: Integrated Innova s5i system option

## • Indications for Use:

The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular and non-vascular, diagnostic and interventional procedures.

The Integrated Innova - s5i system option is indicated for use in conjunction with single plane and biplane angiographic X-ray systems.

The Integroted Innova - 55i system option simplifies the clinical workflow associated with the use of Volcano s5i systems by:

(1) automatically synchronizing the patient demographic and medical exam information lpatient name, date of birth, etc.) from angiographic X-ray systems with Volcano s5i systems,

(2) providing a remote access to commonly used Volcano s5i system functions from the angiographic X-ray systems user interface,

(3) displaying the Volcano s5i systems output on the monitor display solutions of the angiographic X-ray systems.

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)

Mancy S. Patil

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K11209

Prescription Use (Per 21 CFR 801.109)