(108 days)
This instrument has been designed to be used with an Olympus ultrasonically guided fine needle aspiration(FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
The subject devices are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).
The subject devices consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G are available. The subject devices are sterilized and packaged in a sterilization package. The Syringe (VACLOK Syringe and Stopcock), which is supplied by Merit Medical System and packaged in an individual sterilization package, is bundled. The subject devices and the Syringe are put in one carton. When users use the device, the syringe is attached to the aspiration port on the handle section of the subject devices.
This document describes the premarket notification (510(k)) for the Olympus Single Use Aspiration Needle NA-U200H. It does not contain information about an AI/ML device or its performance criteria. The performance data provided are for a medical device (a biopsy needle) based on sterility, biocompatibility, and bench/animal/clinical performance evaluations, not AI/ML model metrics.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as the provided text pertains to a traditional medical device premarket notification.
If you have a document describing an AI/ML device, please provide it, and I will do my best to extract the relevant information.
§ 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.