LumenaTM Ureteral Access Sheath

The Lumena™ Ureteral Access Sheath is a single-use, sterile endoscopic device designed to establish a conduit during urological procedures, allowing endoscopes and surgical instruments to pass into the urinary tract. It is available in multiple sizes (9.5–13 French diameter, 35–45 cm length) with either a straight or bendable tip, and includes a sheath tube and dilator.

The proposed device shares the same indications, regulatory classification (Class II, 21 CFR 876.1500), and fundamental design as the predicate. Both are EtO-sterilized, single-use devices composed of PEBAX, stainless steel, and PTFE sheath tubes with polycarbonate or polyamide connectors, polyethylene dilator tubes, and a polyvinylpyrrolidone hydrophilic coating. The proposed device offers slightly narrower diameter options (9.5, 11, 12, 13 Fr vs. predicate's 10–16 Fr) and connector types limited to straight and Y-shaped (vs. predicate's straight, Y, W, and cross-shaped).

ISO 11135:2014+A1:2018 (EtO sterilization validation), ASTM D4169-23 (shipping container performance), ASTM F1980-21 (accelerated aging of sterile barriers), ISO 11607-1:2019 and ISO 11607-2:2019 (packaging for sterilized devices), and ISO 10993-1 (biocompatibility evaluation including cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogen testing).

The device is substantially equivalent because it shares identical indications for use, regulatory classification, and core technological design with the cleared predicate Disposable Ureteral Guide Sheath (K241181). Both establish a conduit for endoscopic urological procedures using biocompatible materials, identical sterilization methods, and comparable structural components. The proposed device's narrower size range and fewer connector options represent minor design variations that do not affect the fundamental function or safety profile, and comprehensive bench testing (tensile, coating, connector, compatibility, bending resistance, suction, and radiopacity) and biocompatibility studies confirm performance meets acceptance criteria equivalent to the predicate.