Disposable ureteral access sheath

The Disposable Ureteral Access Sheath is a single-use, sterile medical device used to establish a continuous conduit during urological endoscopic procedures, allowing endoscopes and instruments to pass in and out of the urinary tract. It comes in five types with different joint configurations (Z, Y, W, T, and C types) and is available in multiple sizes (10Fr to 14Fr inner diameter, 35–50 cm lengths).

The proposed device differs from the predicate in sheath inner diameter options (10–14Fr versus 12Fr only) and available lengths (35–50cm versus 35–45cm). The predicate has three integrated instrument channels (image, irrigation, equipment); the proposed device uses a simpler access sheath plus separate dilator tube design. Both use identical materials (PEBAX, stainless steel, PTFE for sheath; polyethylene for dilator), EO sterilization, and meet identical performance specifications (friction coefficient ≤0.03, tensile strength ≥15N, 3-year shelf life).

Performance testing per ISO 11135:2014 (sterilization validation), ISO 11737-1:2018 and ISO 11737-2:2019 (sterility assurance), ASTM F1980-2016 (shelf-life validation), and ASTM F88/F88M-15 (burst strength). Biocompatibility evaluated per FDA guidance on ISO 10993-1 with cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogenicity testing.

The proposed device has identical intended use, regulatory classification (Class II, FED code), sterilization method, and shelf life as the predicate. Although the proposed device offers additional size options and uses a simpler two-component design without integrated channels, performance testing demonstrates equivalent safety and effectiveness across all critical parameters. The predicate's three channels merely increase operational complexity for physicians; the simpler design does not compromise function. Biocompatibility and mechanical performance (friction, tensile strength, bending resistance) are equivalent or identical.