Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact

The Wellead® Hydrophilic Intermittent Catheter is a sterile, single-use urethral catheter with a polyvinyl pyrrolidone (PVP) hydrophilic coating, designed to drain urine from the bladder for patients with urinary retention or incomplete bladder emptying. It is available in two forms: Ready to Use (in a foil pouch with wetting liquid) and Compact (in a container with screw cap, connector, and plug), with sizes ranging from 8Fr to 18Fr.

The subject device uses polyurethane material with PVP hydrophilic coating, radiation sterilization, and is available in multiple configurations (Standard, Female, Tiemann, and Compact). It is identical in material composition, sterilization method, and catheter dimensions to the predicate devices SpeediCath Standard and SpeediCath Compact, with outer diameters within the same range (8Fr–18Fr).

ISO 20696:2018 (sterile urethral catheters), ASTM F623-19 (Foley catheter performance), ISO 10993 series (biocompatibility: cytotoxicity, irritation, sensitization, implantation), ASTM F1980-16 (accelerated aging), ASTM F88/F1886/F1929 (packaging integrity), and ISO 11137-1/-2 (sterilization by radiation).

The subject device shares the same intended use (emptying the bladder for urinary retention), catheter material (polyurethane), hydrophilic coating (PVP), sterilization method (radiation), and outer diameter range as the predicate devices. Biocompatibility testing based on ISO 10993-1:2009 confirms equivalence, and both Ready to Use and Compact packaging designs are supported by predicate evidence. Performance testing demonstrates compliance with the same standards as predicates, supporting substantial equivalence.