ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

The ClearEVAC Ureteral Aspirating Access Sheath is a single-use, sterile, EO-sterilized medical device designed to establish a conduit during endoscopic urological procedures. It facilitates the passage of endoscopes and other instruments into the urinary tract by being inserted through the natural urethra in adult patients undergoing urological procedures in hospitals or qualified medical institutions.

The device consists of a guide sheath with a Y-type joint and dilator, available in inner diameters of 10Fr and 12Fr and lengths of 40cm and 50cm. Key differences from the predicate include variations in sheath ID (predicate offers 10Fr, 11Fr, 12Fr, 13Fr, 14Fr), sheath length (predicate offers 35cm, 40cm, 45cm, 50cm), and a 2-year shelf life versus the predicate's 3-year shelf life. Materials include copolyester polyether block polyamide with PTFE coating, differing somewhat from the predicate's PEBAX composition but both demonstrating biocompatibility.

ISO 13485 (quality management), ISO 10993-1:2018 (biocompatibility testing including cytotoxicity, irritation, sensitization, and acute system toxicity), and FDA guidance on international standards. Bench testing includes dimensions, surface inspection, compatibility and trafficability, deformation resistance, leakage, bending fatigue, friction coefficient, component tensile force, Luer connectors, shelf life study, and sterilization validation.