Ureteral Access Sheath

The Ureteral Access Sheath is a single-use medical device that establishes a conduit during endoscopic urological procedures, allowing passage of endoscopes and other instruments into the urinary tract. It is designed to facilitate treatment of urinary stones and other urinary diseases during minimally invasive endoscopic procedures.

The subject device differs from the predicate in three main ways: (1) material composition—uses PTFE+PEBAX+304 stainless steel with LDPE dilator versus predicate's PTFE+PA+stainless steel with PE dilator; (2) sheath length ranges 28–50 cm versus predicate's 13–55 cm; (3) structure—offers both tip-unbendable and tip-bendable variants with suction capability, versus predicate's simpler single-design approach. Both share the same ID range (10–14 Fr), hydrophilic coating, and EO sterilization.

Biocompatibility testing per ISO 10993 series (cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogenicity); performance testing covering dimension, compatibility, fracture force, bending resistance, liquid leakage, and friction; sterilization validation per ISO 11135 and ISO 11737; shelf-life validation per ISO 11607, DIN 58953-6, and ASTM F2096, F88, F1886, F1929, D4169.

Although the subject device differs in materials, length specifications, and structural design from the predicate, these differences do not raise new safety or effectiveness questions because: (1) both devices share identical regulatory classification, product code, and intended use for establishing ureteral access conduits; (2) all material differences have been validated through comprehensive biocompatibility and performance testing demonstrating safety; (3) the technological variations represent only design choices within established parameters and do not fundamentally alter the device's mechanism of action or clinical function.