(29 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No.
The intended use clearly states that it is a "diagnostic imaging device" and produces images to "depict the anatomical distribution of radioisotopes". It is not described as treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Intended for use as a diagnostic imaging device."
No
The device description explicitly lists hardware components such as a patient table, PET scanner, CT scanner, UNIX workstation, monitor, keyboard, mouse, modem, and network interface.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic imaging device" that produces images depicting the "anatomical distribution of radioisotopes within the human body." This describes an in-vivo (within the living body) diagnostic process, not an in-vitro (outside the living body) diagnostic process.
- Device Description: The description details a scanner system (patient table, PET scanner, CT scanner, workstation, etc.) used to acquire images from a patient. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or using reagents, which are hallmarks of IVD devices.
Therefore, this device falls under the category of an in-vivo diagnostic imaging device.
N/A
Intended Use / Indications for Use
Combination of whole-body positron emission tomography (PET) scanning with a diagnostic quality computed tomography scanner. Intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images which depict the anatomical distribution of radioisotopes within the human body. The integrated il produced in intended to provide an enhancement to the emission images by compensating for the attenuation of byothing intended to provide registration of anatomical and physiological images to localize the radioisotope activity in the patient anatomy. The CT or PET scanner may be used independently.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS, 90 JAK
Device Description
The Positrace / Discovery VI PET/CT scanner is a whole-body scanner primarily intended for oncology applications. It consists of a patient table, PET scanner, CT scanner, UNIX workstation, monitor, keyboard, mouse, modem, and network interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron emission tomography (PET), Computed Tomography (CT)
Anatomical Site
whole-body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards. Clinical Tests: None required.
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.
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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
SEP 1 8 2001
Attachment B Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c).
GE Medical Systems
General Electric Company 8380 Darrow Road, Twinsburg, OH 44087
| Submitter: | GE Medical Systems - SMV
8380 Darrow Road
Twinsburg, OH 44087 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Geoff Cochrane
Manager, Engineering
Telephone: 330-487-6638; Fax: 330-405-7684 |
| Date Prepared: | 09-Aug-2001 |
| Device Name: | Positrace / Discovery VI Dual Mode PET/CT Oncology System
Emission Computed Tomography System, 21 CFR 892.1200, 90-KPS |
| Marketed Device: | Positrace Dual Mode PET/CT Oncology System, 510(k) Number K001681, currently in
commercial distribution. |
| Device Description: | The Positrace / Discovery VI PET/CT scanner is a whole-body scanner primarily
intended for oncology applications. It consists of a patient table, PET scanner, CT
scanner, UNIX workstation, monitor, keyboard, mouse, modem, and network
interface. |
| Indications for Use: | Combination of whole-body positron emission tomography (PET) scanning with a
diagnostic quality computed tomography scanner. Intended for use as a diagnostic
imaging device. |
Comparison with Predicate Device: The Positrace / Discovery VI is of a comparable type and substantially equivalent to the currently marketed Positrace scanner. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, and has the same intended uses as the predicate device.
Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed Positrace scanner. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems that the Positrace / Discovery VI scanner is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Geoffrey Cochrane Engineering Manager GE Medical Systems General Electric Company 8380 Darrow Road TWINSBURG OH 44087 SEP 1 8 2001
Re: K012775
Trade/Device Name: GE Positrace/Discovery VI PET/CT Dual Mode Oncology Scanner Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Product Code: 90 KPS Regulation Number: 21CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Product Code: 90 JAK Regulatory Class: II Dated: August 9, 2001 Received: August 20, 2001
Dear Mr. Cochrane:
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 10 more carrer 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 (PMA), it may be subject to 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.
2
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
3
Special 510(k) Premarket Notification GE Medical Systems - Positrace / Discovery VI Oncology Scanner 09-Aug-2001
STATEMENT OF INTENDED USE
510(k) Number (if known):
Device Name: Discovery VI Dual Mode PET / CT Oncology System
Indications for Use
Combination of whole-body positron emission tomography (PET) scanning with a diagnostic quality computed tomography scanner. Intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images which depict the anatomical distribution of radioisotopes within the human body. The integrated il produced in intended to provide an enhancement to the emission images by compensating for the attenuation of byothing intended to provide registration of anatomical and physiological images to localize the radioisotope activity in the patient anatomy. The CT or PET scanner may be used independently.
(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_
Nancy L. Broadrick