EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

The EZ-Protect Hydrophilic Closed System Intermittent Catheter is a sterile, single-use, disposable catheter coated with a hydrophilic material and packaged with a water sachet and collection bag. It is intended to drain urine from the bladder and is available in sizes 8-18 French with straight or coude tips, designed to allow insertion without touching the catheter.

The device is 16 inches long, made of PVC with hydrophilic coating, uses sterile water to activate the coating (versus saline in the predicate), has a prolonged contact duration classification (>24 hours–30 days) versus the predicate's limited contact (<24 hours), and has a 3-year shelf life versus the predicate's 5 years. The device tip options and overall design are substantially similar to the predicate.

ASTM F88/F88M-21 (seal strength), ASTM F1929-15 and F1886-16 (seal integrity), ASTM F623-19 (flow rate), ASTM F2096-11 (surface finish, diameter), ISO 20696:2018 (tensile force, strength, shaft length, kink stability), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (intracutaneous reactivity), ISO 10993-11:2017 (acute and systemic toxicity, pyrogenicity), and ASTM D4169-23 (shipping container).

The subject device is substantially equivalent to the Rusch Hydrophilic Intermittent Catheters (K183461) predicate because it shares the same intended use, basic design geometry, materials (PVC), sterilization method (ethylene oxide), length, size range, tip configurations, and hydrophilic coating technology. The primary differences—use of sterile water instead of saline for activation and a longer contact duration classification—do not affect safety or effectiveness, as demonstrated by comprehensive biocompatibility and performance testing showing the device meets all applicable specifications.