(64 days)
The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
The Intact® Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
The Intact Excision XL 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 System 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.
Not Found
This 510(k) summary for the Intact Excision XL device does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document is a standard 510(k) submission, primarily focusing on:
- Identifying the device and its manufacturer.
- Stating its intended use.
- Establishing substantial equivalence to predicate devices (Intact BLES and Intact® Advance).
- Providing the FDA's formal letter of clearance for marketing.
Therefore, I cannot provide the requested information from the provided text. The submission for this device did not include a new clinical study to demonstrate performance against specific acceptance criteria. Instead, it relies on substantial equivalence to existing legally marketed devices.
To answer your request, I would need a document detailing a clinical performance study with acceptance criteria.
§ 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.