(77 days)
The ExtractorRX is indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
The Microvasive ExtractorRX is a triple lumen retrieval balloon catheter. The ExtractorRX is capable of accepting an .035" guidewire in one open channel while simultaneously injecting and/or inflating the balloon in the other two lumens. An open channel allows for the quick exchange of a guidewire completely isolated from injection agents and balloon inflation. No stylet is necessary for scope passage. The ExtractorRX may be placed with or without the aid of a guidewire.
This document describes a 510(k) premarket notification for a medical device, the Microvasive ExtractorRX. It is not an AI/ML device, and therefore the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance does not apply.
The provided text focuses on demonstrating substantial equivalence to a predicate device (Microvasive Extractor XL) for a traditional medical device (biliary stone retrieval balloon catheter). The "performance characteristics" referred to are laboratory tests to verify safety and performance, and a biocompatibility assessment, not clinical performance metrics typically associated with AI/ML systems.
Therefore, I cannot provide the requested table and information, as it is not relevant to the type of device and submission described in the input.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.