Single Use Suction-Evacuation Ureteral Access Sheath

The Single Use Suction-Evacuation Ureteral Access Sheath is a single-use medical device that creates a conduit during endoscopic urological procedures to facilitate passage of endoscopes and instruments into the urinary tract. It is specifically designed for treatment of urinary stones during endoscopic procedures and features injection and vacuum pressure capabilities to aid stone cleaning.

The device consists of a dilator, sheath, sheath hub, sealing cap, dilator hub, and pressure control vent. Both dilator and sheath have hydrophilic coatings for lubrication, a soft distal end (10cm) that can bend with endoscopes, and radiopaque properties visible under X-ray fluoroscopy. Available in sizes 10–12 Fr (3.33–4mm) with lengths from 13–55cm, using materials including PVP, Pebax, SUS304, PTFE, and PE.

ISO 10993-1 (biocompatibility), ISO 11135 (sterilization validation), USP 71 (sterilization), ASTM D4169 (transportation simulation), ASTM F1980 (shelf-life).

The subject device has the same intended use, mechanism of action, patient population, sterilization method (EO), single-use design, and biocompatibility standards as the predicate ClearPetra device. Although the subject device has minor differences in manufacturer, component configuration (includes pressure control vent), and size range (10–12 Fr vs. 10–22 Fr), performance testing demonstrated equivalence in device functionality, radiodetectability, connector performance, transportation, biocompatibility, sterilization, coating, and shelf-life.