Disposable Intermittent Catheter (TPU Catheter)

The Disposable Intermittent Catheter (TPU Catheter) is a sterile, single-use device made from thermoplastic polyurethane for intermittent urinary catheterization. It is inserted through the urethra to drain urine from the bladder and is available in pediatric and adult sizes for males and females, in uncoated, coated, water sachet, and ready-to-use formulations with a duration of use ≤24 hours.

The subject device uses TPU (thermoplastic polyurethane) tubing instead of the predicate's PVC, with optional hydrophilic PVP coating and an optional LDPE free contact sleeve. It employs gamma radiation sterilization (18.7–30.0 kGy) instead of ethylene oxide, carries a 3-year shelf life, and is packaged in peel packs with either sterile water or physiological saline depending on type.

ISO 20696 (sterile urethral catheters), ISO 11137-1 and -2 (radiation sterilization validation and dose), ISO 11737-1 and -2 (microbiological sterilization testing), ASTM F88/F88M-21, F1929-15, F1140/F1140M-13, F1980-21 (packaging and seal integrity), ISO 8295, ISO 13868 (material properties and kinking), and ISO 10993 biocompatibility (cytotoxicity, skin sensitization, irritation, acute and sub-acute systemic toxicity).

Although the subject device differs from the predicate in tube material (TPU vs. PVC), sterilization method (radiation vs. ethylene oxide), and shelf life (3 years vs. unknown), these differences do not raise new safety or effectiveness questions because: (1) biocompatibility testing per ISO 10993-1 confirmed TPU poses no new concerns; (2) radiation sterilization achieves the same SAL 10⁻⁶ sterility assurance level with validation testing; and (3) accelerated aging testing validated the 3-year shelf life. The devices share identical indications, intended populations, clinical use (intermittent single-use urinary catheterization), design (straight and coude tips with eyelets, same size ranges and lengths), and coating composition, thus maintaining substantial equivalence despite these manufacturing differences.