(90 days)
This device is used to access or sample submucosal and extramural lesions of the gastrointestinal tract, access of the following: the intra- or extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.
The EchoTip® Ultra High Definition Ultrasound Access Needle is a 19 gauge endoscopic ultrasound needle with a stylet and a needle. The needle is dimpled for improved ultrasonic visualization and is advanced through the accessory channel of an ultrasound endoscope to the target site. The preloaded stylet is used to puncture the target site and aid in inserting the needle. The stylet is withdrawn from the needle. Fine needle injection (FNI), fine needle aspiration (FNA) or access to the target site can then be performed.
The provided text describes a 510(k) summary for the Cook Ireland EchoTip Ultra High Definition Ultrasound Access Needle. It focuses on device description, indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain a detailed study with acceptance criteria and device performance metrics in the way typically found in clinical trials or performance studies for AI-driven devices.
The document is a 510(k) premarket notification for a medical device (a biopsy needle), not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment (which are common for AI/ML device evaluations) are not applicable to this document.
The "Performance Data" section in the original document simply states:
"Non-clinical testing was carried out on the device to determine the equivalence of the EchoTip® Ultra High Definition Ultrasound Access Needle to the predicate devices and to provide assurance of safety and effectiveness."
This phrasing indicates that the performance evaluation was based on non-clinical (e.g., bench or lab) testing to demonstrate equivalence to a previously approved device, rather than a clinical study evaluating diagnostic or prognostic performance against specific metrics.
Therefore, I cannot provide the requested table or details because the provided text does not contain that 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.