(16 days)
K042863, K04102
Not Found
No
The description focuses on automated analysis and quantification based on comparison to a normal database and standard anatomical locations, which is a rule-based or statistical approach, not explicitly AI/ML. There is no mention of AI, DNN, or ML in the provided text.
No
This device is for aiding clinicians in the assessment and quantification of pathologies from PET and PET-CT brain scans, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as aiding clinicians in the assessment and quantification of pathologies from PET and PET-CT brain scans, quantifying comparisons of local peak activity values to normal data, and presenting results that may be from brain function alterations by neurodegenerative processes. It also mentions tools that "may aid the physician in the rule out process" for structural abnormalities, which are characteristics of a diagnostic device.
Yes
The device description explicitly states "The Vantage package includes automated analysis and review of PET and PET-CT brain scans" and describes its function as software for quantification and comparison of scan data. There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software is designed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. It specifically mentions comparing local peak activity values to a reference normal database of age-stratified control subjects. This comparison to a reference standard for diagnostic purposes is a key characteristic of IVDs.
- Device Description: The description reinforces the comparison to an "age stratified normal database (or asymptomatic control subjects as defined)" and the display of results as Z-scores, which indicate deviation from the normal mean. This further supports its use in a diagnostic context.
- Predicate Devices: The listed predicate devices, K04102 (NeuroQ) and K042863 (Scenium), are known to be software devices used for the analysis of medical images, often in a diagnostic context for neurological conditions. This suggests that similar devices in this category are regulated as IVDs.
While the information doesn't explicitly state "in vitro," the core function of analyzing data derived from patient samples (PET and PET-CT scans, which reflect metabolic activity) and comparing it to a reference standard for diagnostic assessment aligns with the definition and purpose of an IVD. The software is providing information about the patient's condition based on the analysis of biological signals captured by the imaging modalities.
N/A
Intended Use / Indications for Use
The GE Vantage PET Neuro Software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workflows steps, which are specific to use with particular drug and disease combination.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects. The resulting quantification is presented to the user through 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG metabolic activity between a subjects images and age stratified controls, which may be resulting from brain function alterations by neurodegenerative processes.
CT fusion to PET offers visualization of structural abnormalities, which may result from brain injury, trauma, disorder, disease or dysfunction, such as subdural hematoma tumor, stroke (or cerebrovascular disease) etc. Such tools may aid the physician in the rule out process.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The Vantage package includes automated analysis and review of PET and PET-CT brain scans. It has been developed to aid in assessment of human brain scans hrough quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified normal database (or asymptomatic control subjects as defined). It rage a basic review of any PET brain scan, realignment of the PET volume to a standard attas and comparison to brain scans derived from control subjects or prior PET and/or MR scans. Results are displayed in user-friendly graphical format as Z-score, where Zscore is the scale of the deviation from the normal mean, relative to corresponding standard deviation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, PET-CT
Anatomical Site
human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians, physician
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.
K042863, K04102
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
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness (in accordance to 21
SEP - 1 200
CFR 807.87(h))
Device Name Proprietary Device Name: Date prepared:
GE Vantage PET Neuro Software May 26, 2006
| Establishment Name and Registration Number of Submitter | |
|---|---|
| Name: | GE Healthcare (Formerly GE Medical Systems) |
| Registration Number: | 2126677 |
| Corresponding Official: | D. Duersteler |
| GE Healthcare | |
| P.O. Box 414 | |
| Milwaukee, WI 53201 | |
| Phone: 262-312-7029 | |
| FAX: 262-312-7144 | |
| Email: david.duersteler@med.ge.com | |
| Device Classification | |
| Classification Code: | 90 KPS |
| Panel Identification: | Radiology |
| Classification Name: | Emission Computed Tomography Syst |
| (Per 21CFR 892.1200) |
Common Name: Classification Class: Reason for 510(k) Submission:
em (Per 21CFR 892.1200) PET/CT Imaging Software Class II Product New device
Device Description
The Vantage package includes automated analysis and review of PET and PET-CT brain scans. It has been developed to aid in assessment of human brain scans hrough quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified normal database (or asymptomatic control subjects as defined). It rage a basic review of any PET brain scan, realignment of the PET volume to a standard attas and comparison to brain scans derived from control subjects or prior PET and/or MR scans. Results are displayed in user-friendly graphical format as Z-score, where Zscore is the scale of the deviation from the normal mean, relative to corresponding standard deviation.
Identification of Legally Marketed Equivalent Devices
| NeuroQ | Syntermed, Inc. | K04102 |
|---|---|---|
| Scenium | Mirada Solutions, Ltd. | K042863 |
General Electric Company
Image /page/0/Picture/14 description: The image shows a black and white logo. The logo appears to be a stylized design, possibly representing a company or brand. The design is circular and contains intricate patterns and shapes within it. The image is somewhat pixelated, suggesting it may be a low-resolution or scanned image.
1
Image /page/1/Picture/0 description: The image contains the word "Gammailhouse". The text is in a simple, sans-serif font. The image is a simple black and white picture.
Image /page/1/Picture/1 description: The image shows a logo with the letters 'GE' in a stylized font inside a circle. To the left of the circle are the letters 'P' and 'M' stacked vertically. To the right of the circle is the number '53201'. The logo appears to be a company or brand identifier, with the number possibly representing a product code or identifier.
510(k) Summary of Safety and Effectiveness May 26, 2006 Page 2
Comparison with Predicate Devices
Vantage as compared with the above predicate devices provides a clinically focused software solution for brain analysis with PET and PET/CT imaging. Similar to Scenium and Neuro Q, Vantage™ is a post processing tool that assists in regional assessment of human brain scans by providing comparison between a patient brain scan to a brain scan derived from FDG-PET studies of a defined group of control subjects, where the asymptomatic control group is as defined and age stratified by a neurologist with medical expertise. The algorithms used in Vantage™ to calculate quantitative measures compares local peak activity values instead of average peak activity values used by predicate devices; at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects.
Indications for Use of Device
The GE Vantage PET Neuro Software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workflows steps, which are specific to use with particular drug and disease combination.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects. The resulting quantification is presented to the user through 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG metabolic activity between a subjects images and age stratified controls, which may be resulting from brain function alterations by neurodegenerative processes.
CT fusion to PET offers visualization of structural abnormalities, which may result from brain injury, trauma, disorder, disease or dysfunction, such as subdural hematoma tumor, stroke (or cerebrovascular disease) etc. Such tools may aid the physician in the rule out process.
Conclusion
In the opinion of General Electric Medical Systems, the GE Vantage PET Neuro Software is substantially the same in design, materials, energy sources, and technology, does not introduce new safety concerns, performs as well as currently marketed devices, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Syntermed NeuroQ (K041022) and Miraga Solutions Scenium (K042863) products.
2
General Electric Company
P.O. Box 414
Milwaukee, WI 53201
:
、
・
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP - 1 2006
GE Healthcare % Mr. Tamas Borsai Responsible Third Party Official TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K062393
Trade/Device Name: Vantage Regulation Number: 21 CFR 8892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 11, 2006 Received: August 16, 2006
Dear Mr. Borsai:
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 or seal. The text "1906 - 2006" is at the top of the logo. The letters "FDA" are in a bold, stylized font in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are below the word "Centennial".
Promoting Public Hoalth
4
Page 2 -
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 proctice 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 logal|| 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 yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): _ Ob23393 Device Name: Vantage Indications for Use:
The Vantage software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workflows steps, which are specific to use with particular drug and disease combination.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects. The resulting quantification is presented to the user through 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG metabolic activity between a subjects images and age stratified controls, which may be resulting from brain function alterations by neurodegenerative processes.
CT fusion to PET offers visualization of structural abnormalities, which may result from brain injury, trauma, disease or dysfunction, such as subdural heratom tumor, stroke (or cerebrovascular disease) etc. Such tools may aid the physician in the rule out process.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801-109)
OR Over-The-Counter Use_
David E. Lyon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K062393 510(k) Number