(60 days)
Prostate Biopsy Needles shall be single use only and are to be used by a urologist in a healthcare setting to obtain needle biopsies of the prostate.
Not Found
This is not a standalone AI device, therefore, the information requested is not applicable. The provided text is a 510(k) clearance letter for a Prostate Biopsy Needle, which is a medical device and not an AI algorithm. The document discusses regulatory clearance for marketing the device, not its performance based on AI algorithms or clinical studies in the context of AI.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.