(11 days)
The SenoRx EnCor Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It 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 a 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 procedures.
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The provided text is a 510(k) premarket notification letter from the FDA to SenoRx Inc. regarding their EnCor Biopsy Device 7 Gauge. It confirms substantial equivalence and outlines regulatory requirements. However, this document does not contain the detailed acceptance criteria for device performance or the study data proving it meets those criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not include the specifics of performance testing that would normally be found in the 510(k) summary or a clinical study report.
Therefore, I cannot provide the requested information from this document. The information typically required to answer your questions (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not present in this regulatory clearance letter.
§ 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.