(76 days)
Disposable needle for obtaining biopsies from soft tissues such as kidney, lisposable needie 101 obtains, spleen and various soft tissue tumors.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Light Saber™ Core Tissue Biopsy Needle." It states that the device is substantially equivalent to a legally marketed predicate device.
However, this document does NOT contain any information regarding acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The letter is a regulatory approval document and does not detail the technical performance or validation studies of the device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study that proves the device meets them based solely on the provided text. This information would typically be found in the 510(k) submission itself, not in the 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.