Silicone Urethral Catheter (Silicone Urethral Catheter)

The Silicone Urethral Catheter is inserted through the urethra into the bladder to drain urine or for routine post-operative drainage and bladder irrigation. It is intended for use in male, female, and pediatric patients aged 2 to less than 12 years old. The device is single-use, sterile, and has a maximum indwelling time of 30 days.

The device consists of a silicone shaft, drainage funnel, inflation funnel, irrigation funnel (if present), balloon, and valve. It is available in 2-way and 3-way configurations in sizes ranging from 6Fr to 24Fr. The key difference from the predicate is material composition: the proposed device is made entirely of silicone, while the predicate is latex with silicone coating. Both devices share the same balloon volumes, tip shapes (straight and Coude), operating principles, sterilization method (EtO), and duration of use.

Bench testing was conducted per ASTM F623-19, ISO 20696:2018, and FDA guidance on Conventional Foley Catheters. Biocompatibility testing followed ISO 10993-1 (2018) including cytotoxicity, intracutaneous reactivity, skin sensitization, acute and subacute toxicity, implantation, and pyrogenicity testing. Sterilization validation used ISO 11135:2014 for ethylene oxide sterilization.

Although the proposed device uses silicone instead of latex (the material difference), both materials meet all biocompatibility requirements tested per ISO 10993-1, and the materials in contact were tested to confirm safety. The devices share identical indications for use, intended patient populations, operating principles, device types (2-way and 3-way), balloon volumes, tip shapes, sterilization methods, and regulatory classification. The bench performance testing demonstrates that the silicone catheter meets all pre-determined acceptance criteria. The minor material change does not introduce new safety or effectiveness questions because both materials are biocompatible and the device operates identically.