Advanced Vessel Analysis II is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.

Advanced Vessel Analysis II (AVA II) is a post processing application option for the Advantage Workstation (AW) platform, CT Scanner or PACS stations, which can be used in the analysis of 2D and 3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.

AVA II automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure area's of abnormalities within a vessel.

Device Description

CT Advanced vessel analysis (AVA II / AVA 2) is a post processing analysis software package designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of vascular anatomy.

Advanced vessel analysis is a software post-processing package for the Advantage Workstation (AW) platform, CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis, thrombus, pre/post stent planning procedures and directional vessel tortuosity visualization.

AI/ML Overview

This 510(k) submission for the GE Healthcare Advanced Vessel Analysis II (AVA II) does not contain a detailed study with acceptance criteria and device performance results in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's indications for use and general safety considerations.

Here's a breakdown of the available information and what is missing:

1. A table of acceptance criteria and the reported device performance

Not provided. The submission states that the device "performs as well as devices currently on the market" and that potential hazards are controlled by "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements." However, specific acceptance criteria for performance metrics (e.g., accuracy in stenosis measurement, plaque analysis) and the quantitative results validating these are not included in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. There is no mention of a specific test set, its size, or the provenance of any data used for validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. Since no specific test set or ground truth establishment process is described, this information is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not provided. The document does not describe any MRMC study or any results quantifying human reader improvement with AVA II. The device is described as a "post processing analysis software package designed to assist Radiologists, Cardiologists, and other clinicians," implying a human-in-the-loop system, but no comparative effectiveness study is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not provided. The device is described as an "application to analyze vascular anatomy and pathology and aid in determining treatment paths," suggesting it's intended to assist human interpretation rather than act as a standalone diagnostic tool. No standalone performance results are discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided.

8. The sample size for the training set

Not provided. This submission does not include information on a training set as would be relevant for a machine learning or AI-driven device undergoing typical validation studies. The AVA II is described more as a "post processing analysis software package" with "automatic visualization tools," suggesting it might be based on established image processing algorithms rather than a learning-based model in the modern AI sense.

9. How the ground truth for the training set was established

Not provided.

Summary of what is available:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to previously cleared devices (Smart Vessel Analysis, CardIQ Analysis III, Auto Bone). The mechanism for ensuring safety and effectiveness is stated as adherence to:

Software Development, Validation, and Verification Processes
Federal Regulations
User Requirements
Industry and International Standards

Without the full details of these validation processes, specific performance metrics against defined acceptance criteria cannot be extracted from this summary. The submission indicates that a risk management summary (hazard analysis) was performed, and the controls mentioned above address those risks. However, quantitative performance data is not made public in this summary document.

Summary

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K06079

Image /page/0/Picture/1 description: The image contains a lowercase letter 'g' with a horizontal line running through the middle of the letter. The 'g' is in a bold font and is black. The horizontal line is also black and appears to be slightly thicker than the lines that make up the letter 'g'.

5 2006 APR

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

Larry A. Kroger, Ph.D. Submitter Senior Regulatory Programs Manager Tel: (262) 544-3894 Fax: (262) 544-4768 GE Healthcare W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: March 15, 2006.

PRODUCT IDENTIFICATION

Name:	Advanced Vessel Analysis II
Classification Name:	Accessory to Computed Tomography System per 21 CFR 892-1750
Manufacturer :	General Electric Medical Systems283, rue de la Minière78533 Buc Cedex, FRANCE
Distributor:	GE Healthcare, P.O. Box 414, Milwaukee, WI 53210
Marketed Deviceslisted below:	The Advanced Vessel Analysis II is substantially equivalent to the devices
Model: Model:	Smart Vessel Analysis Option, 510(k) # K993792 CardIQ Analysis III, 510(k) # K041267

Auto Bone, 510(k) # K031871 Model: ●
General Electric Medical Systems, Buc, France . Manufacturer:

Device Description:

Advanced vessel analysis is a software post-processing package for the Advantage . . Workstation (AW) platform, CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic images/data providing a number

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of display, measurements and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis, thrombus, pre/post stent planning procedures and directional vessel tortuosity visualization.

Indications for Use:

Comparison with Predicate:

Device Name	FDA Clearance Number
Smart Vessel Analysis	K993792
CardIQ Analysis III	K041267
Auto Bone	K031871

AVA II is substantially equivalent to the predicate devices listed above :

Adverse Effects on Health:

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

· Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
· Adherence to industry and international standards.

Conclusions:

Advanced Vessel Analysis II does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Advanced Vessel Analysis II to be equivalent to those of CardIO Analysis III (K041267), Auto Bone (K031871), Smart Vessel Analysis (K993792).

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized bird with three wing-like shapes, suggesting movement or flight. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'. The text is arranged along the perimeter of the circle, with the bird emblem positioned in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Healthcare % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K060779

Trade/Device Name: Advanced Vessel Analysis II Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 20, 2006 Received: March 22, 2006

Dear Mr. Devine:

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 (Premarket Approval), it may be subject to such 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); 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.

5 2006 APR

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. brigdon

Nanev C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ バイム △ フフ9

Device Name: Advanced Vessel Analysis II

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Hogdon

510(k) Num

Page 1 of 1

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.