Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

The Niti-S Biliary Stent and Niti-S Biliary Slim M Stent are self-expanding metallic stents made of Nitinol wire woven in a hook-type design, delivered via a disposable stent delivery system. Both devices are indicated for palliation of malignant strictures in the biliary tree using endoscopic or percutaneous approaches.

The subject devices feature co-axial tube delivery systems with delivery lengths of 180 cm (endoscopic) and 50 cm (percutaneous) for the Biliary Stent and 180 cm (endoscopic) for the Slim M Stent. Delivery system profiles are 8 Fr (2.7 mm) and 6 Fr (2 mm) respectively, using 0.035 in and 0.025 in guidewires. The stent design is identical to the predicate K073667, but the delivery systems align with the Esophageal TTS Stent design (K240522) with slight component modifications and material changes.

Not stated in this summary.

The Niti-S Biliary Stent and Slim M Stent are substantially equivalent because their indications for use and stent materials are identical to previously cleared predicates (K073667 and K221071), and the updated delivery systems use materials and design principles identical to the cleared Esophageal TTS Stent (K240522). Performance testing including packaging strength, sterility, deployment force, accuracy, and radiopacity demonstrates equivalent performance to the predicate devices.