(23 days)
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Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related concepts in the intended use, device description, or performance study sections. The focus is on the core PET imaging technology.
No
The device is described as a "positron emission tomography diagnostic imaging" scanner, indicating its use for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "intended to be used for whole body, multislice, positron emission tomography diagnostic imaging."
No
The summary describes PET scanners, which are hardware devices used for diagnostic imaging. There is no mention of software being the primary or sole component of the device.
Based on the provided information, the Positron Corporation POSICAM HZ™, POSICAM HZL™, mPower™ PET scanners are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is for "whole body, multislice, positron emission tomography diagnostic imaging." This describes an imaging device that visualizes processes within the body, not a device that tests samples (like blood, urine, or tissue) outside the body.
- IVD Definition: IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This PET scanner does not fit this definition.
- Input Modality: Positron emission tomography is an in-vivo imaging technique, meaning it's performed on a living organism.
Therefore, the information clearly indicates this is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Positron Corporation POSICAM HZ™, POSICAM HZL™, mPower™ PET scanners are intended to be used for whole body, multislice, positron emission tomography diagnostic imaging.
Product codes
90 KPS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Positron Emission Tomography (PET)
Anatomical Site
whole body
Indicated Patient Age Range
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Intended User / Care Setting
to be used to image individual patients in a controlled medical facility, such as a hospital, medical center, or mobile medical unit environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUL 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ·
Ms. Irene C. Albright Manager, Documentation Services and Ouality Systems Positron Corporation 1304 Langham Creek #300 HOUSTON TX 77084
Re: K022001
Trade/Device Name: POSICAM HZ™, POSICAM HZL™, mPower™ PET Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: June 18, 2002 Received: June19, 2002
Dear Ms. Albright:
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. Iisting 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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Page 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/dsmaldsmamain.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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Attachment 3 -- Indications for Use Enclosure
510(k) Number: 022001
Device Name: POSICAM HZ™, POSICAM HZL™, mPower™ PET scanners Intended Use / Indications for Use:
The Positron Corporation POSICAM HZ™, POSICAM HZL™, mPower™ PET scanners are intended to be used for whole body, multislice, positron emission tomography diagnostic imaging.
Environment of Use / Patient Population:
The PET scanner is intended to be used to image individual patients in a controlled medical facility, such as a hospital, medical center, or mobile medical unit environment.
(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Regner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
Prescription Use √
(per 21 CFR 801.109)
OR
Over the Counter Use Optional Format 1-2-96