(104 days)
Siemens/CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.
ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner.
Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged. Attenuation correction is utilized to enable quantitative interpretation of the acquired emission data.
Software version 7.1 and Single Photon Detection Transmission Scan System for ECAT PET Scanners. ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner. Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged.
The provided text, primarily a 510(k) clearance letter and an "Indications For Use" statement, does not contain the specific details about acceptance criteria, device performance results, or a detailed description of a clinical study as requested.
The document indicates that the device (ECAT Pet Scanner System and Software Version 7.1) was found substantially equivalent to a predicate device, allowing it to be marketed. However, it does not provide the technical performance data that would typically be included in a study report.
Therefore, I cannot fulfill the request to build the table and answer the specific questions about the study based on the provided text.
To provide the requested information, a document containing the technical specifications, performance claims, and the study report (or summary of the study results) would be necessary.
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Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three stylized lines that form the head, body, and tail of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 25 1998
William Skremsky Regulatory Affairs Specialist CTI, Inc. 810 Innovation Drive Knoxville, Tennessee 37932 Re:
K974256 ECAT Pet Scanner System and Software Version 7.1 Dated: January 23, 1998 Received: January 26, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Skremsky:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate -commerce prior to May 28, 1976, the eastment date of the Medical Device Americans, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Prematicer Approval), it inay be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Resulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes complisace with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning vour device in the Federal Register. Thease note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and ---Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): 774256
Device Name: Software version 7.1 and Single Photon Detection Transmission Scan System for ECAT PET Scanners
Indications For Use:
Siemens/CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human bodv.
ECAT software is used in conjunction with ECAT tomographs for acquisition, reconstruction, archiving, display and the processing of data acquired from ECAT PET scanners. In addition, the ECAT software controls of the patient handling system, transmission sources and septa associated with the ECAT scanner.
Single photon detection transmission scanning is a proposed alternative to the currently used coincidence detection transmission method for measuring the attenuation effect of the body on the tracer radiation being detected and imaged. Attenuation correction is utilized to enable quantifative interpretation of the acquired emission data.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974256
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.