(32 days)
The intended use of the Worldwide Medical Technologies Bone Marrow Biopsy Needle is to obtain a sample of bone marrow for histological examination in the diagnosis and treatment of various diseases. The sample is typically taken by percutaneous puncture of the posterior iliac creast of the pelvis.
Worldwide Medical Technologies Bone Marrow Biopsy Needle
The provided documents do not contain information about acceptance criteria or a study that proves a device meets such criteria. This is a 510(k) clearance letter for a medical device (Bone Marrow Biopsy Needle), which primarily focuses on substantial equivalence to a predicate device, rather than detailed performance study results or acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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.