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 Description

The AW VolumeShare 5 is a stand-alone workstation with its own image database residing on its dedicated computer. The AW VolumeShare 5 workstation supports functions for image display, manipulation, and selective recording (either on film or on disk).

The AW VolumeShare 5 is intended to be used to create and review diagnostic evidence related to radiology procedures by trained and licensed physicians and/or qualified clinical/medical personnel. The device is not intended for diagnosis of mammography images

AW VolumeShare 5 workstation, like its predicate Advantage Workstation 4.3, provides a platform for a variety of other GE software medical devices to operate, all of which are cleared by FDA in their own names.

AngioViz is an option offered on AW Volume Share 5. It is an integrated post processing image analysis software dedicated to the application of vascular imaging on body vessels.

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

AI/ML Overview

The provided 510(k) premarket notification for the GE Healthcare AW VolumeShare 5 with AngioViz Option does not contain acceptance criteria or a study proving that the device meets specific performance criteria.

Here's a breakdown of the information that is present and absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Absent. The document explicitly states: "The subject of this premarket submission, AW VolumeShare 5 with AngioViz, did not require clinical studies to support substantial equivalence." This means there were no performance metrics defined or measured for this specific submission to demonstrate equivalence to a predicate device. The submission focuses on the technological equivalence and safety, not on specific performance claims measured against acceptance criteria.

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

Absent. Since no clinical studies were performed, there is no test set or associated sample size discussed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Absent. As no clinical studies were performed, there was no test set requiring expert-established ground truth.

4. Adjudication Method:

Absent. No clinical studies, no adjudication method.

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

Absent. The document explicitly states no clinical studies were required or performed. Therefore, no MRMC study was conducted or reported.

6. Standalone Performance Study:

Absent. No standalone performance study was conducted or reported for the AngioViz option. The submission focuses on the AW VolumeShare 5 as a review workstation and the technological similarity of AngioViz to the predicate device's underlying technology.

7. Type of Ground Truth Used:

Absent. Ground truth is not relevant in the context of this submission, which relies on technological equivalence rather than performance evaluation against a gold standard for specific diagnostic claims.

8. Sample Size for the Training Set:

Absent. This submission does not describe any machine learning or AI models that would require a 'training set.' The AngioViz application is described as generating "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." This implies image processing and visualization techniques, not necessarily a trained AI model with a training set in the typical sense.

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

Absent. As there is no training set mentioned, there is no discussion of how ground truth would be established for it.

In summary:

This 510(k) submission for the GE Healthcare AW VolumeShare 5 with AngioViz Option received FDA clearance based on substantial equivalence to a predicate device (Advantage Workstation 4.3 (K052995)). The justification for substantial equivalence primarily relies on:

Technological Equivalence: Stating that "AW VolumeShare 5 with AngioViz option employs the same Technology as that of its predicate device."
Compliance with Voluntary Standards: (as detailed in Sections 9, 11, and 16 of the submission, though these sections are not provided in the snippet).
Quality Assurance Measures: Including Risk Analysis, Requirements Reviews, Design Reviews, Performance testing (Verification), Safety testing (Verification), and Final acceptance testing (Validation). However, the results of these tests and their specific acceptance criteria are not detailed in the provided pages.

No clinical studies were performed or deemed necessary to support this substantial equivalence determination. Therefore, the document does not contain the specific performance metrics, test sets, expert ground truth establishment, or comparative studies you requested.

Summary

{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 SCS283, rue de la Minière BP3478533 Buc Cedex - FRANCE
Primary Contact Person:	Helen Peng, RACRegulatory Affairs LeaderGE HealthcareTEL: 262-548-5091FAX: 262-548-3844
Secondary Contact Person:	Stephen G. Slavens, RACRegulatory Affairs DirectorGE HealthcareTEL: (262) 548-4992FAX: (262) 548-3884
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 ownimage database residing on its dedicated computer. The AWVolumeShare 5 workstation supports functions for image display,manipulation, and selective recording (either on film or on disk).
	The AW VolumeShare 5 is intended to be used to create and reviewdiagnostic evidence related to radiology procedures by trained andlicensed physicians and/or qualified clinical/medical personnel. Thedevice is not intended for diagnosis of mammography images
	AW VolumeShare 5 workstation, like its predicate AdvantageWorkstation 4.3, provides a platform for a variety of other GEsoftware medical devices to operate , all of which are cleared byFDA in their own names.
	AngioViz is an option offered on AW Volume Share 5. It is anintegrated post processing image analysis software dedicated to theapplication 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 (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/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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).