(27 days)
The Cordis PALMAZ® BLUE™ .014 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.
The Palmaz Blue Transhepatic Biliary Stent is a balloon expandable Cobalt Chromium Biliary stent. The stent is provided premounted on a balloon catheter, i.e., the Cordis Aviator 0.14" Delivery System. The stent and delivery system are advanced over a guidewire through a sheath lumen, via the use of a stainless steel introducer tube accessory, (which is provided together with the Palmaz Blue .014 Transhepatic Biliary Stent System) to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and subsequently the delivery system is removed.
The Palmaz Blue .014 Transhepatic Biliary Stent System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.
Please note: The provided document is a 510(k) summary for a medical device (biliary stent) and does not describe acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML device. The information requested (e.g., sample sizes for test/training sets, expert qualifications, ground truth, MRMC studies) is directly applicable to AI/ML device evaluations. This document describes the "substantial equivalence" of a physical medical device to predicate devices based on non-clinical (in-vitro bench testing and animal testing) performance data.
Therefore, I cannot fulfill your request for information related to AI/ML device evaluation criteria using the provided text. The document focuses on the lack of performance standards for this device type under section 514 and instead relies on demonstrating equivalence through non-clinical studies specified in FDA guidance for metal expandable biliary stents.
If you can provide a different document that describes an AI/ML device and its validation study, I would be happy to analyze it according to your requested format.
§ 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.