(43 days)
The ATEC® Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The ATEC® Breast Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device (Vacuum Assisted Core Biopsy Device, Trade/Device Name: SUROS Surgical Systems, Inc. - ATEC® Breast Biopsy System). This type of document primarily confirms substantial equivalence to a predicate device for market clearance. It does not contain the details of a study with acceptance criteria and reported device performance in the format requested.
The document states:
- Device Name: SUROS Surgical Systems, Inc. - ATEC® Breast Biopsy System
- Indications For Use: To provide breast tissue samples for diagnostic sampling of breast abnormalities, and intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
To answer your request, a detailed study report (e.g., a clinical trial report or a performance validation study report) would be needed, which is not part of this 510(k) clearance letter. The FDA clearance confirms that SUROS demonstrated substantial equivalence to a legally marketed predicate device, implying that its performance is comparable to the predicate. However, specific acceptance criteria and performance metrics from a dedicated study are not detailed in this document.
Therefore, I cannot populate the table or provide the specific study details you requested based solely on the information provided in this 510(k) clearance letter. This document is a regulatory approval notice, not a 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.