Luja Set

The Luja Set is an intermittent, ready-to-use, sterile urological catheter with an integrated urine collection bag. It is indicated for male patients (adults and pediatric above age 1 year) with urine retention or post-void residual volume due to neurogenic and non-neurogenic voiding dysfunction. The hydrophilic-coated catheter with a straight tip is inserted into the urethra to allow urine to drain into the attached collection bag.

The subject device shares nearly identical technological characteristics with the predicate Luja Coudé, including the same regulation, classification, materials (polyurethane catheter with PVP-based hydrophilic coating), sterilization method (e-beam), and shelf life (2 years). The key differences are the straight tip configuration (versus the predicate's flexible curved tip) and the integrated collection bag design. Available sizes are CH10, CH12, CH14, and CH16, compared to the predicate's CH8–CH18 range.

ISO 20696:2018 (Sterile urethral catheters for single use) and ASTM F623-19 (Standard performance specification for Foley Catheter). Testing was performed on final, finished, and sterilized devices to verify acceptance criteria.

The subject device is substantially equivalent because it shares the same intended use (intermittent catheterization), indications (urine retention and post-void residual volume management), regulation (21 CFR 876.5130), and technological platform as the predicate. Although it differs in tip configuration (straight versus curved) and includes an integrated collection bag, these design differences do not alter the fundamental safety and effectiveness profile. Risk assessment identified flow rate and kink stability as the key performance risks, and bench testing using both the predicate and reference device (SpeediCath Flex Set) demonstrated the subject device meets pre-determined acceptance criteria for these parameters, establishing that it is as safe and effective as the predicate.