(140 days)
The instrument is designed to be used for high-speed histological biopsy.
ABS® Device
This document is a 510(k) premarket notification letter from the FDA to Gallini U.S., L.L.C. for their "Gallini ABS Device" (K973152). It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The letter is a notification of substantial equivalence, which primarily means the FDA believes the device is as safe and effective as a legally marketed device and can be cleared for market. It does not typically include detailed performance study results or acceptance criteria within the letter itself. Such information would usually be found in the 510(k) submission document, which is not provided here.
Therefore, I cannot provide the requested information based on the given 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.