(155 days)
The Remington CenterFire is Intended for use in obtaining biopsies from soft tissue such as liver, kidney, prostate, breast, spleen and various soft tissue turnors. It is not intended for use in the bone.
Remington CentreFire Biopsy Instrument
The provided text is a 510(k) clearance letter from the FDA for the Remington CentreFire Biopsy Instrument. It does not contain information about the acceptance criteria for a device's performance, nor does it describe any study that proves a device meets such criteria. Instead, it states that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the provided text. The document is a regulatory approval letter, not a technical report detailing performance studies.
§ 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.