(196 days)
The WallFlex Biliary RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.
The Epic Biliary Endoscopic Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
The WallFlex™ Biliary RX Stent System is available in the following stent configurations: Uncovered, Fully Covered. The WallFlex Bliary RX Stent System consists of a self-expanding metal stent and a delivery system. The self-expanding metal stent consists of Platinum cored Nitinol wires wound together to form a cylinder including flares on both the proximal end and distal end.
WallFlex Fully Covered (FC) and Partially Covered (PC) Stents have a Permalume™ Coating, which is a translucent silicone polymer. The coating is used to reduce the potential for tumor in growth through the stent. The coating is used to reduce the potential for tumor in growth through the stent. The FC and PC stents have a retrieval loop for removal during the initial stent placement procedure, to be used in the event of incorrect placement.
The WallFlex Biliary RX Fully Covered Stent System RMV consist of a flexible delivery system preloaded with a self-expanding billiary metal stent. The stents are available in a fully covered configuration only, and have a Permalume™ Covering, which consists of a translucent silicone polymer, to reduce potential for tumor in growth through the stents also have a retrieval loop for removal during the initial stent placement procedure where the retrieval loop is used in the event of incorrect placement, or for removal following indwell up to 12 months.
The Epic "Billary Stent is a sterile laser cut sent composed of a nickel titanium alloy. The stents are available uncovered.
On both the proximal and distal ends of the stent, radiopaque markers increase visibility of the stent to aid in placement.
Since the provided text is a 510(k) summary for medical devices (biliary stents), it does not contain any information about acceptance criteria or a study proving that an AI/device meets acceptance criteria. This type of document is about demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics, rather than through clinical studies with specific performance metrics and acceptance criteria for a novel algorithm's clinical performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence for physical medical devices, not on the performance of a diagnostic or assistive AI system.
§ 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.