INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP

K092639 · GE Medical Systems SCS · LLZ · Dec 2, 2009 · Radiology

Device Facts

• Record ID: K092639
• Device Name: INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
• Applicant: GE Medical Systems SCS
• Product Code: LLZ · Radiology
• Decision Date: Dec 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Innova Vision Applications software is intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures.

Device Story

Software application (Innova Vision, TrackVision, EP Vision) running on Advantage Workstation (AW); inputs include segmented DICOM 3D datasets (XA, CT, MR) and live fluoroscopic images from Innova X-ray systems. Device performs real-time 3D-2D fusion/registration of anatomical data; overlays planning data (landmarks, ablation lines, needle paths) onto live images. Used in interventional suites by physicians; controlled via tableside touch screen or AW console. Provides visual guidance for catheter/needle placement; enhances procedural workflow; enables ECG-gated display/motion tracking for EP procedures. Benefits include improved precision and efficiency during minimally invasive interventions.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing, including software unit, integration, and system verification, and final acceptance validation.

Technological Characteristics

Software application executing on Advantage Workstation (AW) hardware; interfaces with Innova Digital Fluoroscopic Imaging System via dedicated link. Supports DICOM 3D datasets. Features include 3D-2D fusion, ECG-gated display, and motion tracking. Complies with IEC 60601-1-4 and IEC 62304 standards.

Indications for Use

Indicated for patients undergoing interventional procedures requiring catheter or device guidance, including neuroradiology, interventional radiology (needle-based), and interventional cardiology (electro-physiology).

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• DG 200/300 Digital Angiographic System (K852353)
• Innova 4100lo, 3100lo, 2100lo with StentViz (K092004)
• Advantage Workstation (K052995)
• Volume Viewer plus (K041521)
• EP-Navigator (K062650)

Submission Summary (Full Text)

{0}------------------------------------------------

## : 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: 2009-August-25

> DEC - 2 2009 GE Healthcare, GE Medical Systems, SCS Submitter: 283 rue de la Miniere - BP34 Buc Cedex, FRANCE, 78533

Primary Contact Person: Nicole Landreville USA Premarket Regulatory Affairs Leader GE Healthcare, QARA Regions - Americas T: [phone] F: [phone]

Secondary Contact Eric Fivel-Demoret Regulatory Affairs Leader Person: GE Healthcare, GE Healthcare, GE Medical Systems, SCS 283 rue de la Miniere - BP34 Buc Cedex, FRANCE, 78533 T: [phone] F: [phone]

Innova Vision Applications Device: Trade Name:

Common/Usual Name: Innova Vision, Innova TrackVision and Innova EP Vision

Classification Names: Picture archiving and communications system

Product Code: LLZ 21CFR 892.2050 Manufactured by GE Medical Systems: Predicate Devices:

- . K852353 DG 200/300 Diaital Anaioaraphic System
- K092004 Innova 4100 lo, 3100lo, 2100lo with StentViz .
- K052995 Advantage Workstation .
- K041521 Volume Viewer plus t

Manufactured by Philips:

- K062650 EP-Navigator

{1}------------------------------------------------

Device Description:

Innova Vision Applications image processing alaorithms are executed on a commercially available hardware platform called AW (Advantage Workstation), which can perform the followina functions:

> - Superimpose the seamented DICOM 3D XA, CT, MR dataset on radioscopic or radioaraphic image of the same anatomy, obtained on an Innova Fluoroscopic Xrav svstem

> - Register the segmented DICOM 3D XA, CT, MR data with radioscopic or radiographic images obtained on an Innova Fluoroscopic X-ray system for interventional procedures.

The Innova Vision Applications software will be available as three different options (Innova Vision, TrackVision and EP Vision) that tarqet different clinical indications: catheter-based interventions for interventional procedures such as neuroradiology or interventional radiology; needle-based interventions for interventional radiology; and interventional cardiology procedures such as electro-physiology procedures, respectively.

Each option contains specific functions and settings and supports 3D datasets from specific modalities.

Innova EP Vision provides image stabilization features such as ECG gated display or motion tracking in the image.

To enhance quidance capabilities, the Innova Vision Applications software can load planning data, deposited on the 3D model in Volume Viewer, such as 3D landmarks, ablations lines or traiectories for needle path, and display them on the 3D-2D fused image to support the physician during procedures. The application also allows marking points of interest such as ablation points during the procedures.

To provide efficient workflow during the interventional procedures, the most frequently used functions can be controlled from tableside.

{2}------------------------------------------------

- Innova Vision Applications software is intended to enable users Intended Use: to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device quidance during interventional procedures.
Technology: Innova Vision Applications software is a software application that executes on the Advantage Workstation (AW) review station. The live Innova fluoroscopic images, as well as the necessary exam data, are transmitted from the Innova Digital Fluoroscopic Imaging System to the Advantage Workstation (AW) through a dedicated link. The 3D datasets are loaded from the AW database. The application saves fused photos or video clips in this database.

> The 3D-2D fusion and the user interface of the application are displayed on the AW main screen, which is distributed in Control Room and in Exam Room by a video splitter.

The most frequently used functions are available from exam room on the Innova Central Touch Screen. This user interface is controlled by the application through the Innova Ethernet network.

The Innova Vision Applications employs the same fundamental scientific technology as its predicate devices.

#### Summary of Non-Clinical Tests: Test Summarv

The Innova Vision Applications Software comply with voluntary standards IEC60601-1-4 (2000): Medical electrical equipment -Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1. (General) and IEC62304 edition 1 (2006): Medical device software - Software life cycle processes.

The following quality assurance measures were applied to the development of the system:

- Risk Management .
- Requirements Reviews .
- Design Reviews
- Software Unit Testing (Unit Test Verification) .
- Software Integration Testina (Intearation Verification) ●
- System Testing (System Verification) ●
- Final acceptance testing (Validation)

## Summary of Clinical Tests:

The subject of this premarket submission, Innova Vision Applications, did not require clinical studies to support substantial equivalence.

{3}------------------------------------------------

# Determination of Substantial Equivalence:

GE Healthcare believes that the Innova Vision Applications software is as safe and effective, and performs in a substantially equivalent manner to the predicate devices. This conclusion is based on:

- Innova Vision applications do not introduce new . indications for use.
- Innova Vision applications do not raise new issues of . safety and effectiveness.
- . Innova Vision applications do not introduce new technology. .

### Conclusion:

GE Healthcare considers the Innova Vision Applications to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is in black and white.

#### 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 Medical Systems, SCS % Ms. Nicole Landreville GE Healthcare, QARA Regions - Americas 3000 North Grandview Boulevard #W450 WAUKESHA WI 53188

DEC - 2 2009

Re: K092639

Trade/Device Name: Innova Vision Applications Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 18, 2009 Received: November 19, 2009

Dear Ms. Landreville:

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 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 801); medical device reporting (reporting of medical

{5}------------------------------------------------

Page 2 -

Enclosure

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The logo is black and white.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): KO92639

Device Name: Innova Vision Applications

Indications for Use:

Innova Vision Applications software is intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic irnages of the same anatomy in order to support catheter/device guidance during interventional procedures.

Prescription Use_ X __ AND/OR (Part 21 CFR 801 Subpart D)

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)

Tom Mothy

(Division (Division of Reproductive, Abdomina and Radiological Devic 510(k) Number