(111 days)
The Beacon EUS Access System is used to access the following areas of the gastrointestinal tract: the intra- or extrahepatic bile ducts, pancreatic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.
The Beacon™ EUS Access System is a sterile, single-use, endoscopic ultrasound device which consists of the Beacon Endoscopic Ultrasound (EUS) Delivery System and a Beacon EUS Access Needle. The Beacon EUS Delivery System with Beacon EUS Access Needle is inserted through the accessory channel of an ultrasound endoscope. The Beacon EUS Access Needle is intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
The provided text is a 510(k) summary for the Beacon EUS Access System. It describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain specific details about the acceptance criteria or a study proving the device meets those criteria, nor does it include the types of information requested in points 1-9 of your prompt.
The document broadly states: "Performance testing for the Beacon™ EUS Access System consisted of in-vitro functional testing, biocompatibility testing, sterilization validation, packaging validation, and shelf life testing. Testing performed demonstrates that the subject device is substantially equivalent to the predicate devices for the proposed intended use."
Without access to the actual performance testing report from the 510(k) submission, it is impossible to provide the detailed information requested in your prompt. The summary provided in the FDA document is generic and does not include specific quantitative acceptance criteria or results.
§ 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.