(240 days)
The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device.
The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device includes adding hardware and software to a gamma camera system.
The provided text is a 510(k) notice for the PCD Option to the Prism Dual Head System. It describes the device's intended use and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics that would allow me to populate the requested table and answer the detailed questions about the study proving the device meets those criteria.
The document states:
- "Laboratory tests have shown that the PCD option has improved image quality and sensitivity compared to a standard gamma camera."
- "The product will perform in accordance with the development specifications."
- "A matrix was enclosed comparing the PCD option to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device."
These are general statements, not quantifiable acceptance criteria or detailed study results. Therefore, I cannot extract the specific information requested in your prompt based solely on the provided text.
To answer your questions, I would need a section of the document that outlines:
- Specific, measurable acceptance criteria (e.g., "sensitivity > X%", "spatial resolution < Y mm").
- Detailed results from a study that directly addresses these criteria, including methodology, sample sizes, ground truth establishment, expert qualifications, etc.
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Image /page/0/Picture/0 description: The image shows the text "SEP 12" followed by a solid black rectangle and the text "K960192". The text is in bold, black font and is slightly blurred. The "SEP 12" text is smaller than the "K960192" text.
PICKER INTERNATIONAL 510(k) NOTICE
PCD OPTION TO THE PRISM DUAL HEAD SYSTEM
E: SUMMARY OF SAFETY AND EFFECTIVENESS
This is a summary of the information submitted by Picker International, Inc. To the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 807.92(c) for the Positron Coincidence Option (PCD).
The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device. This device includes adding hardware and software to a gamma camera system.
Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units.
The PCD option to the Prism Dual Head system is substantially equivalent to legally marketed devices. The PCD option will be operated by trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations. The PCD option will be certified to electrical safety standards (IEC-601) by a third party organization prior to use on human patients. Labeling (Product Bulletin and Operator's Manual) will be provided to the user of the equipment.
Laboratory tests have shown that the PCD option has improved image quality and sensitivity compared to a standard gamma camera. The product will perform in accordance with the development specifications. A matrix was enclosed comparing the PCD option to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device.
Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the PCD option. In addition, all information contained in this 510(k) Notice is accurate and complete.
§ 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.