Ureteral Access Sheath

The Ureteral Access Sheath is a single-use sterile device used to establish a working channel during endoscopic urological procedures, allowing passage of endoscopes and instruments into the urinary tract. It is intended for adult patients only and consists of an outer sheath, a tapered dilator, and sockets with hydrophilic coating. The device is available in two models (FS and GS) with inner diameters from 9–15 French and lengths from 20–55 cm.

The proposed device and predicate share the same intended use, indications, and similar dimensions and technical characteristics. Both consist of an outer sheath and tapered dilator with hydrophilic coating. The differences between predicate and proposed device are the intended population, material used, sheath socket, and sheath tip.

ISO 11135:2014 (sterilization validation), ISO 10993-7:2008 (EO residual evaluation), ISO 10993-1:2018 (biocompatibility), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (irritation), ISO 10993-11:2017 (acute systemic toxicity), ASTM D4169:2023 (shipping container performance), ASTM F1886/F1886M-16 (seal integrity), ASTM F88/88M-23 (sealing strength), ASTM F1929-23 (seal leak detection), and USP-NF General Chapter 151 (pyrogen test).

The device is substantially equivalent because it shares the same intended use and indications as the predicate Flexor® Ureteral Access Sheath, and both devices have similar dimensions and technical characteristics including the same basic design (outer sheath with tapered dilator and hydrophilic coating). Non-clinical testing—including tensile strength, flexing resistance, smoothness, surface friction, guide wire passage, negative pressure, flexural properties, and X-ray detectability—all qualified successfully. Biocompatibility testing demonstrated safety across cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogen evaluations, and sterilization and stability were validated to accepted standards.