Single-use Ureteral Access Sheath

The Single-use Ureteral Access Sheath is a prescription medical device used to establish a pathway during endoscopic urological procedures, allowing endoscopes and instruments to pass into the urinary tract. It consists of an inner semi-rigid dilator and outer semi-rigid sheath, both with hydrophilic coatings, and is supplied sterile for single use only.

The device is offered in five French size combinations (10Fr/12Fr through 14Fr/16Fr) and four lengths (35–55 cm), with an inner diameter accommodating 0.038-inch guidewires. Key materials include stainless steel (inner layer), TPU and LDPE (outer layers), and polyvinylpyrrolidone hydrophilic coating. The sheath has a locking mechanism connecting to the dilator's luer lock hub, and both components are radiopaque for fluoroscopic visualization.

ISO 10993-1:2018 (biocompatibility), ISO 11607 (sterile barrier systems), ISO 11135 (sterilization process validation). Functional and mechanical testing included appearance, patency, breaking force, flexural properties, bending reliability, corrosion resistance, and coating uniformity.

The subject device matches the primary predicate (K240167) in indications for use, regulatory class, product code, and sterility/sterilization method. It uses identical materials (TPU, LDPE, PET, SUS304) and the same hydrophilic coating (PVP), with comparable biocompatibility and performance characteristics. The subject device expands available lengths (50–55 cm) beyond the predicate's 45 cm maximum, supported by the secondary predicate (K203165), which demonstrates that longer models are substantially equivalent. Comprehensive performance testing shows the subject device is as safe and effective as its predicates.