(14 days)
The Cook Zilver® 635™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Zilver® 635™ Biliary Stent is a self-expanding, nitinol stent designed for excellent radial strength and optimal longitudinal flexibility. Constructed from a series of interconnected Z-shaped segments, the stent conforms to the shape of the biliary system and provides circumferential scaffolding throughout the stent's length. Gold radiopaque markers on each end of the Zilver® 635™ Biliary Stent, along with one radiopaque marker at the distal end of the delivery system, allow precise positioning of the stent. The stent's interconnected Z-shaped segments also keep foreshortening to a minimum. The Zilver® 635" Biliary Stent comes preloaded in a 6 French delivery system. The stent is deployed with the use of a simple hand held device. The stent is available in unrestrained outer diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 20, 30, 40, 50, 60 mm. The 80 mm length stent is an addition to this product line.
This is a
510(k) premarket notification for a medical device, not an AI/ML device. The provided text is a summary of the device, its predicate devices, and the tests performed to assure its design and performance. There is no mention of acceptance criteria related to AI/ML performance metrics, studies involving human readers, or ground truth establishment for AI model training. Therefore, I cannot generate the requested information about acceptance criteria and study details for an AI/ML device.
The document discusses "Test Data" for the Zilver® 635™ Biliary Stent, which includes:
- Deployment
- Profile
- Deployment Accuracy
- Stent length and Change due to Deployment
- Stent Diameter
- Uniformity of Expansion
- Stent Integrity
However, these are performance tests for a physical medical device (a biliary stent), not a study assessing the performance of an AI/ML algorithm.
§ 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.