Liv Pre-lubricated Intermittent Catheter

The Liv Pre-lubricated Intermittent Catheter is a ready-to-use, water-based gel lubricated PVC catheter with a straight tip, measuring 3.75 inches in effective length and available in sizes 8 Fr to 14 Fr. It is inserted through the urethra by female patients to drain urine from the bladder and is provided as a single-use, ethylene oxide sterilized, disposable device.

The subject device is substantially similar to the predicate Cure Twist Female Catheter (K250699) in material (PVC), tip design (straight), lubrication (gel), sterilization method (ethylene oxide), and intended patient population (adult females). The primary difference is a slightly longer effective length (3.75 inches vs. 3.25 inches) and a validated 3-year shelf life, neither of which impacts safety or effectiveness.

Testing followed FDA-recognized consensus standards including AAMI/ISO 11135-1:2014, ISO 10993 series (biocompatibility), ISO 11607 (sterile packaging), ASTM D3078-02, ASTM F1886-16, ASTM F88/F88M-21, ASTM F1980-21 (accelerated aging), ASTM F623-19 (flow rate), and ISO 20696:2018 (mechanical properties). Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and subacute/subchronic toxicity assessments.

The Liv Pre-lubricated Intermittent Catheter is substantially equivalent to the Cure Twist Female Catheter because both devices share identical indications for use, intended patient population, and design principles. Design verification and validation testing confirmed that the subject device performs as intended and is as safe and effective as the predicate, despite minor differences in length and documented shelf life that do not affect clinical performance.