(70 days)
The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
The intact™ BLES is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the intact™ BLES may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. 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.
Common or Usual Name: Electrosurgical Generator
Trade or Proprietary Name: intact™ Breast Lesion Excision System (BLES)
Classification Name: Electrosurgical Cutting & Coagulation Device & Accessories (21 C.F.R. § 878.4400) Biopsy Instrument (21 C.F.R. § 876.1075)
This document does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a 510(k) summary for the intact™ Breast Lesion Excision System (BLES), detailing its name, submitter, predicates, and intended use. It also includes an FDA letter confirming substantial equivalence. There is no performance study data or acceptance criteria outlined.
§ 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.