(18 days)
The Resound EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
The Resound Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.
The provided text describes a medical device, the Resound™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA), and its 510(k) submission for substantial equivalence. However, the document does not contain information related to specific acceptance criteria, studies proving the device meets those criteria, or details regarding performance data in the structured format requested (e.g., sample sizes, expert qualifications, MRMC studies, ground truth establishment methods).
The "Performance Data" section explicitly states:
- "Bench Testing has been performed on the finished Resound EUS-FNA device to demonstrate that the proposed device is substantially equivalent to the predicate devices."
This indicates that the main type of study conducted was bench testing (physical and/or mechanical testing), not clinical performance studies involving human subjects or AI algorithms, which are typically where the detailed performance metrics, sample sizes, and expert adjudications mentioned in your request would originate.
The submission focuses on demonstrating substantial equivalence to predicate devices (Wilson-Cook EchoTip Ultrasound Needle and Olympus Single-Use Aspiration Needle) based on technological characteristics and bench testing, rather than establishing specific clinical performance metrics against a defined set of acceptance criteria.
Therefore, I cannot provide the requested information from the given text because it is not present. The document focuses on regulatory approval through substantial equivalence, which often relies on non-clinical data for devices of this type (biopsy needles used for aspiration).
§ 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.