AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION

K110834 · GE Healthcare · LLZ · Apr 26, 2011 · Radiology

Device Facts

• Record ID: K110834
• Device Name: AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
• Applicant: GE Healthcare
• Product Code: LLZ · Radiology
• Decision Date: Apr 26, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. AngioViz is an application which produces from a DSA series parametric images representing maximum opacification, time to peak and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow. The AngioViz application can be used to process DSA image data from any location in the human body for which DSA imaging is used.

Device Story

AW VolumeShare 5 is a standalone workstation for multi-modality DICOM image review, processing, and filming. It functions as a platform for various GE software medical devices. The AngioViz option processes Digital Subtraction Angiography (DSA) series data to generate parametric images, including maximum opacification and time-to-peak maps. These outputs assist clinicians in visualizing vascular flow characteristics. The device is operated by trained physicians or qualified clinical personnel in a clinical setting. Clinicians use the displayed images as a basis for diagnosis. The device benefits patients by providing enhanced visualization of vascular flow from existing DSA data, aiding in clinical decision-making.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Standalone workstation; DICOM-compliant; software-based image processing; AngioViz application for parametric vascular flow mapping. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for use by trained physicians and qualified clinical personnel to select, review, process, and film multi-modality DICOM images for diagnostic purposes, excluding mammography. AngioViz option is indicated for processing DSA image data from any body location to visualize vascular flow characteristics.

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

• Advantage Workstation 4.3 (K052995)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K110834'. The characters are written in a simple, handwritten style. The image appears to be a close-up of the characters.

# GE Healthcare AW VolumeShare 5 with AngioViz Option 510(k) Premarket Notification

APR 2 6 2011

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

| Date: | March 24th, 2011 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems SCS<br>283, rue de la Minière BP34<br>78533 Buc Cedex - FRANCE |
| Primary Contact Person: | Helen Peng, RAC<br>Regulatory Affairs Leader<br>GE Healthcare<br>TEL: [phone]<br>FAX: [phone] |
| Secondary Contact Person: | Stephen G. Slavens, RAC<br>Regulatory Affairs Director<br>GE Healthcare<br>TEL: [phone]<br>FAX: [phone] |
| Device: Trade Name: | AW VolumeShare 5 with AngioViz Option |
| Common/Usual Name: | AW VolumeShare 5 with AngioViz Option |
| Classification Name: | 21CFR 892.2050 Picture archiving and communications system |
| Product Code: | LLZ |
| Predicate Devices: | Advantage Workstation 4.3 (K052995) |
| Device Description: | The AW VolumeShare 5 is a stand-alone workstation with its own<br>image database residing on its dedicated computer. The AW<br>VolumeShare 5 workstation supports functions for image display,<br>manipulation, and selective recording (either on film or on disk). |
| | The AW VolumeShare 5 is intended to be used to create and review<br>diagnostic evidence related to radiology procedures by trained and<br>licensed physicians and/or qualified clinical/medical personnel. The<br>device is not intended for diagnosis of mammography images |
| | AW VolumeShare 5 workstation, like its predicate Advantage<br>Workstation 4.3, provides a platform for a variety of other GE<br>software medical devices to operate , all of which are cleared by<br>FDA in their own names. |
| | AngioViz is an option offered on AW Volume Share 5. It is an<br>integrated post processing image analysis software dedicated to the<br>application of vascular imaging on body vessels. |
| | AngioViz is an application which produces from a DSA series |

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, giving the logo a classic and recognizable appearance.

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

Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, while the background is white.

GE Healthcare AW VolumeShare 5 with AngioViz Option 510(k) Premarket Notification

parametric images representing maximum opacification, time to peak and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow.

The AngioViz application can be used to process DSA image data from any location in the human body for which DSA imaging is used.

#### AW VolumeShare 5 is a review workstation, which allows easy Intended Use: selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images.

AW VolumeShare 5 with AngioViz option employs the same Technology: technology as that of its predicate device.

#### Determination of Substantial Summary of Non-Clinical Tests:

Equivalence:

AW VolumeShare 5 with AngioViz complies with voluntary standards as detailed in Section 9, 11 and 16 of this premarket submission. The following quality assurance measures were applied to the development of the system;

- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- Performance testing (Verification) .
- Safety testing (Verification) .
- Final acceptance testing (Validation) .

#### Summary of Clinical Tests:

The subject of this premarket submission, AW VolumeShare 5 with AngioViz, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the AW VolumeShare 5 with AngioViz Software application to be as safe, as effective, and its performance is substantially equivalent to the predicate device.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is written in all capital letters.

### 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

Helen Peng. RAC Regulatory Affairs Leader GE Healthcare 3000 North Grandview Blvd., #W1140 WAUKESHA WI 53188

APR 2 6 2011

Re: K110834

Trade/Device Name: AW VolumeShare 5 with AngioViz Option Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 24, 2011 Received: March 25, 2011

Dear Ms. Peng:

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

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

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 Pastel

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

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

Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and border are depicted in black, creating a strong contrast against the white background.

AW VolumeShare 5 ، 510(k) Pre

## Indications for Use Statement

510(k) Number (if known):

Device Name: AW VolumeShare 5 with AngioViz Option

Indications for Use:

AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images.

AngioViz is an application which produces from a DSA series parametric images representing maximum opacification, time to peak and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow.

The AngioViz application can be used to process DSA image data from any location in the human body for which DSA imaging is used.

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 In Vitro Diagnostic Devices (OIVD)

Mary S. Patel

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

**510(k) Number** K110834