(53 days)
For the percutaneous punture of the abdomen or pelvis for the purpose of removing tissue of the soft tissue organs for microscopic examination, for the purpose of diagnosis of disease. The needle is to be used with the automatic biopsy devices marketed by C.R. Bard and Manan Medical Products.
Automatic Cutting Needle
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Automatic Cutting Biopsy Needle" does not contain specific acceptance criteria, device performance data, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods), or information about ground truth establishment.
This document is a regulatory clearance letter, primarily stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It does not typically include the detailed technical and scientific data from performance studies.
To answer your request, I would need a document specifically detailing the performance study, often found in an appendix to the 510(k) submission or a separate technical report.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely 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.