(35 days)
The Daum BiopsyNeedle is intended for use in percutaneous or open surgical biopsies, including but not limited to, b10psy of breast, lung, kidney, liver, lymph nodes, and prostate.
The Daum BiopeyNeedle is a standard soft-tissue biopsy needle.
This 510(k) summary for the Daum BiopsyNeedle (K961185) does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm-based device evaluations. The document is concerned with demonstrating substantial equivalence to already marketed biopsy needles based on design, function, intended use, and material composition (titanium vs. stainless steel).
Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory submission for a medical device that does not involve AI or complex performance metrics beyond basic functional equivalence for a biopsy needle.
§ 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.