(29 days)
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.
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.
The provided material, K012775, describes the GE Positrace/Discovery VI PET/CT Dual Mode Oncology Scanner. This submission is a 510(k) premarket notification for a new version of an existing device, the Positrace Dual Mode PET/CT Oncology System (K001681).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for K012775 does not include explicit acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a clinical study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a previously cleared predicate device (Positrace Dual Mode PET/CT Oncology System, K001681).
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device must be of a comparable type, substantially equivalent to the currently marketed predicate device (Positrace scanner K001681), have the same technological characteristics, be comparable in key safety and effectiveness features, use the same basic design, and have the same intended uses. | "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." "The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards." "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." |
| Clinical Performance | No specific clinical performance metrics (e.g., diagnostic accuracy) were required or provided for this 510(k) submission. | "Clinical Tests: None required." |
2. Sample Size Used for the Test Set and Data Provenance
Since "Clinical Tests: None required" is explicitly stated, there was no specific clinical test set used with a defined sample size. The submission relies on the established safety and effectiveness of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that no clinical tests were required, no experts were used to establish ground truth for a test set.
4. Adjudication Method for the Test Set
As no clinical test set was used, no adjudication method was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done or reported. The submission explicitly states "Clinical Tests: None required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware imaging system (PET/CT scanner), not an AI algorithm. Therefore, the concept of a "standalone performance" for an algorithm is not applicable in this context. The evaluation focuses on the safety and performance of the hardware and its output, not an automated diagnostic algorithm.
7. The Type of Ground Truth Used
No ground truth derived from clinical data (e.g., pathology, outcomes data, expert consensus) was used for this K012775 submission, as clinical tests were not required. The "ground truth" for the submission's acceptance was the demonstration of substantial equivalence to the predicate device, relying on the predicate's established performance and the new device's compliance with safety standards and manufacturing quality systems.
8. The Sample Size for the Training Set
There is no mention of a training set in the context of an AI/algorithm. This device is a physical diagnostic imaging system.
9. How the Ground Truth for the Training Set Was Established
As there was no training set for an AI/algorithm, this question is not applicable.
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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 - SMV8380 Darrow RoadTwinsburg, OH 44087 |
|---|---|
| Contact Person: | Geoff CochraneManager, EngineeringTelephone: 330-487-6638; Fax: 330-405-7684 |
| Date Prepared: | 09-Aug-2001 |
| Device Name: | Positrace / Discovery VI Dual Mode PET/CT Oncology SystemEmission Computed Tomography System, 21 CFR 892.1200, 90-KPS |
| Marketed Device: | Positrace Dual Mode PET/CT Oncology System, 510(k) Number K001681, currently incommercial distribution. |
| Device Description: | The Positrace / Discovery VI PET/CT scanner is a whole-body scanner primarilyintended for oncology applications. It consists of a patient table, PET scanner, CTscanner, UNIX workstation, monitor, keyboard, mouse, modem, and networkinterface. |
| Indications for Use: | Combination of whole-body positron emission tomography (PET) scanning with adiagnostic quality computed tomography scanner. Intended for use as a diagnosticimaging 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.
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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.
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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
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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
§ 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.