(14 days)
Not Found
No
The document describes image processing and analysis tools but does not mention AI, ML, or related terms like deep learning or neural networks. The functionality described appears to be based on traditional image processing algorithms.
No
The device is described as a post-processing application that analyzes CT angiographic images to aid in determining treatment paths and assessing vascular disease, stenosis, and plaque. It assists physicians in diagnosis and planning but does not directly deliver therapy or treat a condition.
Yes
The device is intended to analyze vascular anatomy and pathology to aid in determining treatment paths, assess cardiovascular and vascular disease, and support a physician in assessment of stenosis analysis, pre/post stent planning, and visualization, all of which fall under diagnostic purposes.
Yes
The device is described as a "software post-processing package" and "application option" for existing hardware platforms (Advantage Workstation, CT Scanner, PACS stations). It processes images derived from these hardware sources and does not include any hardware components itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that Advanced Vessel Analysis II is a post-processing software application that analyzes Computed Tomography (CT) Angiographic images. It works with images derived from a medical imaging modality, not with biological samples.
- Intended Use: The intended use is to analyze vascular anatomy and pathology from images to aid in determining treatment paths. This is a diagnostic aid based on imaging data, not a test performed on a biological sample.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) Angiographic images/data derived from DICOM 3.0 compliant CT scans
Anatomical Site
vascular anatomy, cardiovascular and vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, Cardiologists, and other clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Systems |
| 283, rue de la Minière | |
| 78533 Buc Cedex, FRANCE | |
| Distributor: | GE Healthcare, P.O. Box 414, Milwaukee, WI 53210 |
| Marketed Devices | |
| listed 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:
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
1
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:
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.
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).
2
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
3
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
4
Indications for Use
510(k) Number (if known): __ バイム △ フフ9
Device Name: Advanced Vessel Analysis II
Indications for Use:
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.
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