(15 days)
The intended use of the Worldwide Medical Technologies " I " Type Bone Marrow Aspiration Needle is for the percutaneous puncture of the sternum to obtain a sample of the bone marrow for pathological examination in the diagnosis and treatment of various diseases.
Not Found
The provided document is an FDA 510(k) clearance letter for the "Worldwide Medical Technologies 'I' Type Bone Marrow Aspiration Biopsy Needle." This document grants market clearance based on substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.
Therefore, I cannot provide the requested information from this document. The questions posed are typically relevant to the performance evaluation of AI/ML-driven medical devices, which this document does not describe.
§ 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.