Optilume® High Pressure Urological Balloon Dilation Catheter

The Optilume® High Pressure Urological Balloon Dilation Catheter is a single-use, sterile catheter designed to dilate narrow segments (strictures) in the urinary tract. It features a 0.038-inch guidewire-compatible over-the-wire design with a non-compliant inflatable balloon at its distal end, supplied in five diameter and length combinations, and is intended for transient use (less than 1 hour) by trained physicians.

Both the Optilume and predicate (Uromax Ultra) devices have dual lumens for 0.038-inch guidewire passage and balloon inflation, identical rated burst inflation pressure of 20 atm, matching 75 cm length, sterile single-use design, and nearly identical balloon size ranges (Optilume: 4–10 mm diameter, 20–80 mm long; predicate: 4–10 mm diameter, 40–100 mm long). No significant technological differences exist between the two devices.

ISO 10993-1 for biocompatibility evaluation, ISO 11135:2014 for ethylene oxide sterilization validation per the overkill approach, and FDA guidance on biological evaluation of medical devices. The submission referenced ISO 11135-1:2014 Annex B for sterilization process qualification.

Substantial equivalence is supported by identical intended use (urinary tract dilation), matching design and materials (dual-lumen over-the-wire catheter with noncompliant balloon), equivalent performance specifications (20 atm burst pressure, same working length and guidewire compatibility), successful biocompatibility testing per ISO 10993-1 for limited-duration breached-surface contact, and comprehensive performance testing (balloon behavior, dimensional tolerances, radiopacity, tensile strength, cystoscope compatibility) all meeting requirements equivalent to the predicate. The balloon diameter and length ranges of the subject device fall within the predicate's envelope, confirming technological and functional equivalence.