Single-use Ureteral Access Sheath

The Single-use Ureteral Access Sheath is a sterile, disposable medical device used during endoscopic urological procedures to create a passage for endoscopes and surgical instruments into the urinary tract. It consists of an access sheath (sheath tube and connector) and a dilator (dilator tube and dilator base), sterilized by ethylene oxide gas with a 3-year shelf life.

The device is available in four inner diameters (9Fr, 10Fr, 11Fr, 12Fr) and two lengths (40cm, 50cm), compared to the predicate's wider range (10–16Fr with lengths up to 55cm). Material differences include the subject device's use of polycarbonate, ABS, and POM in connectors and dilator bases, versus the predicate's polyamide and silica gel. Both devices share the same primary structure, bending resistance, friction force performance (≤0.5 N), and peak tensile force specifications (≥20 N).

ISO 10993-1 (biocompatibility evaluation), ISO 11135:2014 and ISO 11737 (sterilization validation), ISO 10993-7:2008 (EO/ECH residual testing), ASTM F1980-21 (accelerated aging), ASTM F1140/F1140M-13, F1886/F1886M-16, F88/F88M-23, and F1929-23 (package validation).

The subject device has identical indications for use, regulatory classification, and product code as the predicate. Although the subject device offers a narrower range of sizes (9–12Fr versus 10–16Fr), the performance characteristics—including bending resistance, friction force, peak tensile force, and biocompatibility testing—are equivalent or meet the same specifications. The material differences in connectors and dilator components do not raise safety or effectiveness concerns because biocompatibility was evaluated per ISO 10993-1, and all bench performance tests demonstrate equivalent functionality. Physicians will select appropriate sizes based on patient anatomy, so the size difference does not impact safety or effectiveness.