Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent

The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent are self-expanding nitinol mesh stents used for palliative treatment of malignant obstructions in the duodenum and colon. The duodenal stent (22 mm diameter) treats pyloric or duodenal obstructions from cancer, while the colonic stent (22-24 mm diameters) treats colorectal strictures and relieves large bowel obstruction prior to surgery. Both are delivered endoscopically over a guidewire using a co-axial tube delivery system.

The subject device stent material (nitinol) is identical to the cleared predicate K223067. The delivery system design is based on the Esophageal TTS Stent (K240522) reference device, with the same co-axial tube type, EO sterilization, and 0.035-inch guidewire accommodation. Minor differences include delivery system length of 220 cm (versus 180-220 cm for reference) and delivery system profile of 10 Fr/3.3 mm (versus 10.5 Fr/3.5 mm for reference).

Not stated in this summary.

The stent material composition, formulation, processing, and sterilization are identical to the previously cleared K223067 predicate with no new chemicals introduced. The delivery system is based directly on the K240522 Esophageal TTS cleared design with only minor component modifications and material changes that do not alter the principle of operation. Performance testing including deployment accuracy, dimensional, tensile strength, trackability, and sterility verification demonstrated the device meets design requirements and performs as intended, supporting that it is as safe and effective as the predicates.