InjecSURE Injection System

The InjecSURE Injection System is a sterile, single-use accessory for cystoscopes that delivers injectable materials into urethral tissues of the lower urinary tract during cystoscopic procedures. It consists of a 20 Ga needle (available with pencil-point or spinal tip), a disposable sheath compatible with 2.7 mm cystoscopes, and fluid ports with luer connectors.

The InjecSURE uses a 20 Ga needle compared to the predicate's 23 Ga; has an introducer >0.036 inch versus 0.064 inch; needle assembly length of 12.7 cm versus 32.4 cm; working length 11.0–13.0 cm versus 8.06 inches (20 cm); introducer outer diameter 6.1–8.4 mm versus 7 mm; sterilized by ethylene oxide (EtO) rather than gamma radiation; and targets urethral tissues rather than bladder wall.

ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2019 (sterility); ISO 11607-1:2019, ISO 11607-2:2019, ASTM D4169-22, ASTM D4332-22 (packaging); ASTM F1980-21, F88/F88M-15, F1929-23 (shelf-life); ISO 8600-4:2023 (dimensional); ISO 62366-1:2015 (simulated use); ISO 7864:2016, ISO 8871-5:2016 (fragmentation); ISO 10993-1 (biocompatibility).

The InjecSURE is substantially equivalent to the Repris Bladder Injection System because both share the same intended use (delivery of injectable materials via cystoscopic accessory) and fundamental principles of operation. Although technological differences exist in needle gauge, introducer dimensions, working length, sterilization method, and anatomical target site, these differences do not alter the intended use or introduce new mechanisms of action. Non-clinical performance testing demonstrates these differences do not raise new safety or effectiveness concerns.