(30 days)
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.
A disposable single use Biopsy Needle
I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for the BONETRAP Bone Marrow Biopsy Needle. The document is a 510(k) summary and an FDA approval letter, which primarily focus on the device's substantial equivalence to a predicate device and its indications for use, not on a detailed performance study with specific metrics and methodologies.
§ 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.