(54 days)
The VIABIL™ Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures.
The predicate VIABIL "" Biliary Endoprosthesis is a flexible, self-expanding stent with an inner tubular lining that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL " Biliary Endoprosthesis at the target site in the biliary tract. There are two principle components of the device: the endoprosthesis and the delivery catheter. Two catheter lengths are available: a 40 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 195-cm working length catheter for endoscopic delivery. The endoprosthesis is available in two diameters (8 mm and 10 mm), and four lengths (4 cm, 6 cm, 8 cm, and 10 cm).
The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for a medical device (VIABIL™ Biliary Endoprosthesis) and primarily focuses on establishing substantial equivalence to a predicate device.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document states: "A variety of tests, assessments, and comparisons demonstrate that the VIABIL™ Biliary Endoprosthesis is substantially equivalent to its predicate in terms of composition, design, intended use, and performance attributes." However, it does not provide the details of these tests, assessments, or comparisons, nor does it quantify any performance metrics against pre-defined acceptance criteria.
§ 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.