(30 days)
The Xpert Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant strictures in the biliary tree.
The Abbott Vascular Devices Xpert™ Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Xpert Self-Expanding Transhepatic Biliary Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding Xpert Biliary Stent to the biliary tree.
This is a 510(k) summary for a medical device and does not contain information about studies with acceptance criteria or performance metrics in the way that an AI/ML device submission would. The document describes a traditional medical device (a stent system) and relies on substantial equivalence to a predicate device rather than performance determined through clinical studies with specific acceptance criteria.
As such, I cannot provide the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) because it is not present in the provided text. The submission focuses on device description, intended use, and a claim of substantial equivalence based on non-clinical testing.
§ 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.