(66 days)
This device is to be used for taking histological and cytological biopsies of soft tissue.
IBI® Needle
The provided document is a 510(k) clearance letter from the FDA for a device named "IBI® Needle". This letter confirms substantial equivalence to a predicate device and outlines regulatory information. However, the document does not contain information about specific acceptance criteria for device performance, a study proving the device meets these criteria, or any details related to AI performance, sample sizes for testing or training, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based on the given text.
The document only states the "Indications for Use: This device is to be used for taking histological and cytological biopsies of soft tissue." It does not delve into the performance metrics of the device itself.
§ 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.