(23 days)
The Xpert™ Biliary Stent 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™ Biliary Stent 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 stent to the biliary tree.
I'm sorry, but this document does not contain the information required to answer your request. The provided text is a 510(k) summary and FDA letter for the Xpert™ Biliary Stent, which is a medical device, not an AI/ML device. Therefore, it does not include data on acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, which are relevant to AI/ML device evaluations.
§ 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.