(121 days)
The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the FlexStent® Biliary Self Expanding Stent System. It approves the device as substantially equivalent to legally marketed predicate devices for the palliation of malignant strictures in the biliary tree.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is an approval based on a substantial equivalence determination, not a detailed report of clinical study results.
Therefore, I cannot fulfill your request for the specific information laid out in your prompt based on the provided text. The document confirms the regulatory approval for marketing, but it does not detail the technical performance and study design data that would typically be found in a clinical study report or a more comprehensive FDA submission summary.
§ 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.