Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250

The Hoover Negative Pressure Access Sheath is a single-use medical device designed to establish a conduit during endoscopic urological procedures. It facilitates passage of endoscopes and instruments into the urinary tract for treatment of urinary stones, foreign bodies, and other urinary diseases. The device consists of a hydrophilic-coated dilator with locking mechanism and a guide sheath fitted with a Y-connector to enable negative pressure aspiration.

The device is constructed of medical-grade thermoplastic elastomer reinforced with stainless-steel coil, with hydrophilic coating on both dilator and sheath. It features a bifurcated Y-connector with one straight tube contiguous to the sheath and one oblique tube with pressure control vent for negative pressure aspiration. The device is offered in six models with inner diameters of 10Fr, 11Fr, or 12Fr and lengths of 400mm or 500mm. All models are sterilized via ethylene oxide and supplied sterile for single use only.

ISO 10993-5:2009 (Cytotoxicity), ISO 10993-23:2021 (Irritation), ISO 10993-10:2021 (Sensitization), EN ISO 11135:2014 (Ethylene oxide sterilization validation). General performance testing included connection strengths, coefficients of friction, dimensional analysis, and fluid leakage testing.

The Hoover device and predicate (ClearPetra Ureteral Access Sheath) share identical indications for use, same material composition (medical-grade thermoplastic elastomer with stainless-steel reinforcement), comparable mechanical characteristics, and both are single-use devices sterilized with ethylene oxide. Comparative bench testing demonstrated the Hoover meets all predetermined acceptance criteria and performs substantially equivalently to the predicate across connection strength, friction, dimensions, and fluid leakage. Biocompatibility testing confirmed patient-contact materials are biocompatible, and the predicate has no design-related recalls.