(83 days)
To DETECT AND IMAGE THE DISTRIBUTION of THE GAMMA EMITTING RADIONUCLIDE IN THE PATIENT 'S BREAST AND THE SURROUNDING AREA AND TO STORE THE IMAGES WHEN THE RADIONUCLIPE IS ADMINISTERED INTO THE PATIENT 'S Bo Dy-THE
The BCC nuclear imaging system has two rectangular fields of view detector heads.
The provided text is a 510(k) summary for the BCC Planar Scintillation Camera, indicating it is a device for detecting gamma ray emitting radionuclides in the body. The submission aims to demonstrate substantial equivalence to a predicate device, the NuCamma Bi90 camera, rather than presenting a de novo study with acceptance criteria and performance data.
Therefore, the document does not contain information about:
- Specific acceptance criteria and reported device performance in a table.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance studies.
- The type of ground truth used.
- Sample size for training sets or how ground truth for training sets was established.
Instead, the submission focuses on proving the substantial equivalence of the BCC device to the predicate device, NuCamma Bi90. The key arguments for substantial equivalence are:
- Intended Use: The BCC performs a reduced range of studies compared to the NuCamma Bi90, but the studies it does perform are identical to those the NuCamma Bi90 can perform. The specific intended use mentioned is "to detect the location and distribution of gamma ray emitting radionuclides in the body and store the data for analysis," with a focus on imaging the breast and surrounding area when a radionuclide is administered.
- Hardware and Software: The detector heads are described as identical in both hardware and software.
- Safety and Effectiveness: The BCC is stated to have been "deemed safe and effective and is certified to the same electrical safety standards as the predicate device by a third party organization prior to use on patients."
- Gantry Optimization: The gantry of the BCC is optimized for clinical study of the breast, which means it does not have the same range of automatic motions as the NuCamma Bi90, implying a specialized, rather than less capable, design for its specific intended use.
The submission concludes that a matrix comparing the features and intended use of the BCC with the predicate device led to the conclusion that the BCC is substantially equivalent and raises no new safety or effectiveness concerns.
§ 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.