(46 days)
Not Found
No
The summary describes a standard PET scanner and its components, focusing on hardware and basic image acquisition. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies.
No
The device is a PET scanner, which is an imaging system used for diagnosis by measuring the distribution of radiopharmaceuticals, not for treating a condition.
Yes
The device "image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body," which is a diagnostic purpose.
No
The device description clearly outlines hardware components (partial-ring PET scanner, lutetium-containing gamma-ray detectors) that are integral to its function of collecting gamma rays and generating images. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device, the PEM 2400 PET Scanner, is used to image and measure the distribution of radiopharmaceuticals within the human body. It's an imaging device that works directly on the patient, not on a sample taken from the patient.
- The intended use clearly states it's for imaging and measuring within human beings. This is an in-vivo application, not in-vitro.
The description and intended use clearly define it as an imaging system used directly on patients for diagnostic purposes, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The PEM 2400 PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
Product codes
90 KPS
Device Description
The PEM 2400 PET Scanner is a high spatial resolution small field-of-view PET imaging system specifically developed for close-range spot imaging. The PEM 2400 PET Scanner is a partial-ring PET scanner, equipped with lutetium-containing gamma-ray detectors, which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. The PEM 2400 PET scanner is designed to collect gamma rays from a patient's body part with high efficiency. In order to achieve this high efficiency, the detectors should be positioned as close as possible to the body part under examination. The PEM 2400 PET Scanner can display images obtained from a digital imaging modality for correlative purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET
Anatomical Site
Not Found
Indicated Patient Age Range
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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
In-vitro and in-vivo performance testing were conducted in accordance with the "Guidance for Industry - Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems," issued by FDA on December 3, 1998. The result of the performance testing (included in this 510(k) submission) demonstrates substantial equivalence, which is the primary basis for 510(k) concurrence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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AUG 1 8 2003
510(k) Summary
PEM 2400 PET Scanner
Classification Name: PET Scanner 21 CFR 892.1200
PEM Technologies, Inc. 7617 Standish Place Rockville, MD 20855
Phone: (301) 315-2007 Fax: (301) 564-5386
Contact: Irving Weinberg MD PhD Prepared: June 30, 2003
LEGALLY MARKETED PREDICATE DEVICES A.
The intended use of the PEM 2400 PET Scanner device is equivalent to the predicate PET scanner devices listed below, all of which are classified as Emission Computed Tomography devices under 21 CFR 992.1200.
| Device | Manufacturing | 510(k) Number |
|---|---|---|
| GE 2048 PET Scanner | GE Medical Systems | K914267 |
| ECAT ART-LSO PET Scanner | CTI PET Systems, Inc. | K003241 |
| ECAT PET/CT PET Scanner | CTI PET Systems, Inc. | K002715 |
B. DEVICE DESCRIPTION
The PEM 2400 PET Scanner is a high spatial resolution small field-of-view PET imaging system specifically developed for close-range spot imaging. The PEM 2400 PET Scanner is a partial-ring PET scanner, equipped with lutetiumcontaining gamma-ray detectors, which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. The PEM 2400 PET scanner is designed to collect gamma rays from a patient's body part with high efficiency. In order to achieve this high efficiency, the detectors should be positioned as close as possible to the body part under examination. The PEM 2400 PET Scanner can display images obtained from a digital imaging modality for correlative purposes.
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C. INTENDED USE
The PEM 2400 PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The predicate GE 2048 PET Scanner (K914267) is unable to image the entire body, and is designed to place gamma-ray detectors in close proximity to a body part (e.g., the patient's head). The PEM 2400 PET Scanner is substantially equivalent to the GE 2048 PET Scanner in these two aspects (limitation and proximity to a single body part). The predicate ECAT PET/CT PET Scanner (K002715) provides correlative data from a device previously cleared for marketing solely for x-ray imaging (K991764). The PEM 2400 PET Scanner is similarly enabled for correlation with images from x-ray imaging devices. The predicate ECAT ART-LSO PET Scanner (K003241) contains only two detector heads (each of which uses fast scintillator materials), as does the PEM 2400 PET Scanner.
The PEM 2400 PET Scanner is a medical device and has the same indications-foruse statement as the predicate devices. The device also has the same technological characteristics as the predicate devices. Since a comparison of the descriptive characteristics of the proposed and predicate devices may not be sufficiently precise to assure equivalence, performance data are provided. The result of the performance testing (included in this 510(k) submission) demonstrates substantial equivalence, which is the primary basis for 510(k) concurrence.
E. TESTING
In-vitro and in-vivo performance testing were conducted in accordance with the "Guidance for Industry - Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems," issued by FDA on December 3, 1998.
F. CONCLUSIONS
This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2003
Irving Weinberg, MD, Ph.D. President PEM Technologies 7617 Standish Place ROCKVILLE MD 20855
Re: K032063
Trade/Device Name: PEM 2400 PET Scanner Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system
Regulatory Class: II Product Code: 90 KPS Dated: June 30, 2003 Received: July 9, 2003
Dear Dr. Weinberg:
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 (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 Patt 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K032063
Device Name: PEM 2400 PET Scanner
Indications for Use: The PEM 2400 PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
Daniel R. Lyman
OR
(Division Signand Radiolog 510(k) Nur
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