Luja Coudé

The Luja Coudé is a single-use, sterile, hydrophilic-coated catheter for intermittent urinary catheterization in male patients (ages 1 year and older) with urine retention or post-void residual volume due to neurogenic or non-neurogenic voiding dysfunction. The catheter has a flexible curved tip with micro drainage holes and is pre-filled with saline and polyethylene glycol for lubrication.

The subject device is identical to the predicate (K241210, also Luja Coudé) in all major respects: same catheter materials (polyurethane), same sterility level (SAL 10⁻⁶), same sterilization method (e-beam), same shelf life (2 years), same sizes (8–18 Fr), same tip configuration (flexible curved), and same packaging. The only modification is a reformulated hydrophilic coating using a modified polyvinylpyrrolidone (PVP) formulation versus the predicate's modified PVP-based formulation.

ISO 10993-1, 10993-5, 10993-10, 10993-11, 10993-12, 10993-23 (biocompatibility); USP<151> (pyrogen); ISO 20696:2018 (catheter performance); Coloplast internal methods TM6030, TM6058, TM6129, TM0507, TM6032; ASTM D4169-22 (shipping); ASTM F1980-21 (aging).

The modified hydrophilic coating formulation underwent biocompatibility testing (cytotoxicity, irritation, sensitization, pyrogenicity, acute and subacute systemic toxicity) and bench performance testing (friction, kink resistance, pH, osmolality) on final sterilized devices, all meeting pre-determined acceptance criteria. Since the device is materially, functionally, and performatively equivalent to the predicate with only a modified coating that has been validated for safety and performance, the subject device poses no new safety or effectiveness risks compared to the legally marketed predicate.