(73 days)
The WallFlex™ Biliary RX Stents are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
The WallFlexTM Biliary RX Stent System is an implantable biliary self-expanding metal stent that is pre-loaded onto a Delivery System with a working length of 194mm, which allows delivery of the stent into the Biliary system endoscopically. 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. The WallFlex "M Biliary RX Stent is available uncovered, partially covered, or fully covered with a Permalume 199 covering.
The provided text describes a 510(k) submission for an expanded indication for the WallFlex™ Biliary RX Stent System, not a study involving acceptance criteria and device performance metrics in the context of an AI/ML medical device.
Therefore, the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, training set details, and ground truth establishment) cannot be extracted from the provided text as it does not pertain to the evaluation of an AI/ML device.
The submission is for a medical device (a stent system) seeking an expanded indication for use, specifically for "relief of malignant biliary obstruction prior to surgery." The document explicitly states:
- "No performance data was required for this submission."
- "Boston Scientific used published clinical results of stents used for pre-operative biliary drainage. The conclusion from this review demonstrates that the WallFlex Biliary Stent System can be safely and effectively used as a relief of biliary obstruction prior to surgery."
This indicates that the submission relied on a review of existing literature and the technological equivalence to a predicate device (K122072), rather than new, primary performance data or a clinical study designed to meet specific acceptance criteria of the device itself.
§ 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.