(67 days)
The Ranfac Single Action Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.
Ranfac Single Action Biopsy Needle
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or how ground truth was established for a medical device.
The document is a 510(k) clearance letter from the FDA for a "Ranfac Single Action Biopsy Needle." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
It primarily focuses on:
- Device Name: Ranfac Single Action Biopsy Needle
- Regulation Number: 876.1075
- Regulatory Class: II
- Product Code: KNW, FCG
- Date: August 22, 2001
- Indications For Use: Obtaining a percutaneous soft tissue biopsy.
- Regulatory process: Confirmation of substantial equivalence based on the 510(k) submission.
Therefore, I cannot provide the requested table or answer the specific questions based on this input.
§ 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.