(27 days)
The Boston Scientific Express™ Biliary LD Stent is indicated for the palliation of malignant neoplasms in the biliary tree.
The 5 mm Express Biliary LD Stent (Premounted Stent System and Unmounted Stent) are identical to the currently marketed Express Biliary LD Premounted Stent Systems (K021630 and K024048) and to the currently marketed Express Biliary LD Unmounted Stents (K030645), with the exception of size. The Express Biliary LD Stent is a balloon expandable 316L surgical grade stainless steel stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs.
The provided text describes a 510(k) summary for the Boston Scientific Express Biliary LD Stent and explicitly states the device's substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about acceptance criteria, device performance via a clinical study, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance. The information focuses on design, manufacturing, and intended use equivalence, referencing existing 510(k) applications for a detailed device description.
Therefore, I cannot fulfill your request for information regarding clinical study setup and results from the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence through non-clinical means.
§ 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.