(30 days)
The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Abbott Vascular Devices Xceed Nitinol 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 stent to the biliary tree.
This document does not contain the information required to populate the fields in the request. The provided text is a 510(k) summary for a medical device (Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System) and a letter from the FDA regarding its clearance.
The content focuses on:
- Device Identification: Name, regulation, classification, product code.
- Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Device Description: Delivery system and self-expanding stent.
- Substantial Equivalence Claim: To a predicate device (K031331) based on non-clinical testing.
- FDA Clearance Letter: Confirming substantial equivalence, specifying labeling limitations (e.g., safety and effectiveness for vascular use not established), and outlining general regulatory requirements.
It does not include:
- A table of acceptance criteria or performance results.
- Details of any clinical or non-clinical study design, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
§ 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.