(140 days)
Not Found
No
The description focuses on automated highlighting, bookmarking, measurement (SUV, volume), and data management based on user-defined thresholds and standard DICOM formats, without mentioning AI or ML algorithms or training/test data.
No.
The device assists clinicians in diagnosis, staging, treatment planning, and monitoring treatment response, but it does not directly perform or provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be used by the clinician to assist in diagnosis".
Yes
The device description explicitly states it is a "PET/CT software package" and details its functionalities as software tools for analysis and visualization of existing image data. It also specifies compatibility with a workstation and external systems via data import/export standards, further indicating its nature as a software application operating on existing hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of PET VCAR clearly states it is a software package that processes PET/CT images. PET/CT images are generated from the patient's body using imaging equipment, not from a specimen taken from the body.
- The intended use focuses on image analysis and visualization. The software assists clinicians in analyzing and visualizing PET/CT images for diagnosis, staging, treatment planning, and monitoring. This is distinct from the analysis of biological samples.
- There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or substance. The input is image data (DICOM files), not biological samples.
Therefore, PET VCAR falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. The PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiexam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.
Product codes (comma separated list FDA assigned to the subject device)
JAK, KPS
Device Description
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. The PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiexam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.
The GE PET VCAR has to ensure relations with the following external systems:
Data Import
Image, exam and patient data can be imported in accordance with the DICOM Standard.
Data Export
Finding, exam and patient information can be exported in the Secondary Capture format of the DICOM standard that enables its storage on PACS systems.
Finding, exam and patient information can be exported in the Structured Report format of the DICOM standard that enables its display with DICOM SR compatible viewers.
Finding, exam and patient information can be exported in standard formats like HTML, XML, PDF, CSV, that enables its display with viewers compatible with the mentioned formats.
Configuration Requirements
PET VCAR is compatible with Advantage Windows WorkstationTM 4.4 or higher
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET/CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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
GE Healthcare
PET VCAR
MAR 2 3 2007
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)
1. Identification of submitter: Larry A. Kroger, Ph.D. Senior Regulatory Program Manager 3000 N. Grandview Blvd Waukesha, 53188 USA Telephone: 262-544-3894 Fax: 262-548-4768 Date Prepared: August 23, 2006
2. Identification of Product:
| Device name | PET VCAR. |
|---|---|
| Classification name | Computed tomography x-ray system per |
| 21 CFR 892.1750 |
Emission computed tomography system
per 21 CFR 892.1200 |
| Manufacturer/
Distributor | General Electric Medical Systems SAS
283, Rue de la Minière
78533 BUC Cedex France |
3. Marketed Devices
PET VCAR is substantially equivalent to the devices listed below:
| Model: | Volume Viewer Plus |
|---|---|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K041521 |
| Model: | Advanced Lung Analysis II |
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K042694 |
| Model: | Advantage Fusion |
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K983256 |
1
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized with curved lines and serifs, and the circle has decorative swirls around its perimeter.
4. Device Description :
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. The PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiexam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.
The GE PET VCAR has to ensure relations with the following external systems:
Data Import
Image, exam and patient data can be imported in accordance with the DICOM Standard.
Data Export
Finding, exam and patient information can be exported in the Secondary Capture format of the DICOM standard that enables its storage on PACS systems.
Finding, exam and patient information can be exported in the Structured Report format of the DICOM standard that enables its display with DICOM SR compatible viewers.
Finding, exam and patient information can be exported in standard formats like HTML, XML, PDF, CSV, that enables its display with viewers compatible with the mentioned formats.
Configuration Requirements
PET VCAR is compatible with Advantage Windows Workstation™ 4.4 or higher
2
Image /page/2/Picture/1 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.
5. Indications for Use
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. The PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiexam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.
6. Comparison with Predicate Device
The functional features of PET VCAR software package are substantially equivalent to that of the following devices:
| Device Name | FDA Clearance Number |
|---|---|
| Volume Viewer Plus | K041521 |
| Advantage Lung Analysis II | K042694 |
| Advantage Fusion | K983256 |
7. 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. .
8. Conclusions
The PET VCAR does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the PET VCAR to be equivalent to those of Volume Viewer Plus (K041521), Advanced Lung Analysis II (K042694) and Advantage Fusion (K983256).
3
Image /page/3/Picture/0 description: The image shows a circular seal with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The central graphic consists of three curved lines that resemble a stylized human figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
GE Healthcare % Mr. Neil E. Devine, Jr. Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
MAR 2 3 2007
Re: K063324
Trade/Device Name: PET VCAR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: JAK and KPS Dated: March 7, 2007 Received: March 8, 2007
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.
Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in the center, with the word "Centennial" underneath. Above the letters "FDA" are the numbers "1906-1906". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
4
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.
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.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _长0633 at
Device Name: PET VCAR
Indications for Use:
PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. The PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiexam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.
Prescription Use Over-The-Counter Use X ANDIOR (Part 21 CFR 801 Subpart D) (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)
Page __ 1_ of __ 1
David A. Sygman
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510/k) Number