(17 days)
The Gallini BIOSYSTEM Needle is used for bone biopsy and aspiration procedures.
Not Found
The provided text is a 510(k) premarket notification approval letter for the Gallini BIOSYSTEM® Bone Marrow Aspiration/Biopsy Needle. This document determines substantial equivalence to a predicate device based on its indications for use, but it does not contain any information regarding acceptance criteria or the results of a study demonstrating device performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a detailed technical performance study.
§ 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.