MPOWER, MODEL 712 SERIES

K022001 · Positron Corp. · KPS · Jul 12, 2002 · Radiology

Device Facts

• Record ID: K022001
• Device Name: MPOWER, MODEL 712 SERIES
• Applicant: Positron Corp.
• Product Code: KPS · Radiology
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended 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.

Device Story

POSICAM HZ™, POSICAM HZL™, and mPower™ are PET scanners for whole-body, multislice diagnostic imaging. Devices operate in controlled medical environments (hospitals, medical centers, mobile units) under physician supervision. Systems acquire positron emission data to generate diagnostic images for clinical evaluation. Output assists healthcare providers in visualizing metabolic activity for diagnostic decision-making. Benefits include non-invasive assessment of physiological processes.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Emission computed tomography system (21 CFR 892.1200). Multislice PET imaging capability. Designed for whole-body diagnostic imaging. Operates in controlled clinical or mobile environments.

Indications for Use

Indicated for whole body, multislice, positron emission tomography (PET) diagnostic imaging in patients within controlled medical facilities, including hospitals, medical centers, or mobile medical units.

Regulatory Classification

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.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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