(25 days)
Used for endoscopic removal of stones in the biliary system and for contrast injection.
The subject extraction balloon represents modifications made to existing extraction balloons currently marketed by Cook Endoscopy. The Fusion Quattro Extraction Balloon XL is supplied sterile and intended for single use only.
This document is a 510(k) summary for the Cook Endoscopy Fusion Quattro Extraction Balloon XL. It describes a medical device, and the information provided does not include details about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment.
Based on the provided text, I am unable to answer your request as the document does not contain the necessary information about acceptance criteria, study details, or performance data for a device in the manner you've described. The document is a regulatory submission for a medical device (a balloon catheter for stone extraction), and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
The "Performance Data" section explicitly states: "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process. We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility." This indicates that the submission relies on design control and equivalence to a predicate device, not on a new, detailed performance study with specific acceptance criteria that would typically be described in the format you provided.
§ 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.