(29 days)
The SenoRx Biopsy Device II is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue samples where there is partial or complete removal of the imaged abnormality.
Not Found
The provided text is an FDA 510(k) clearance letter for the SenoRx Biopsy Device II. It primarily discusses the regulatory approval, substantial equivalence, and general controls applicable to the device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the detailed study parameters requested in the prompt.
Therefore, I cannot fulfill the request using only the provided text. The document is a regulatory communication, not a performance study report.
§ 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.