Rubber Utility Catheter

The BD Rubber Utility Catheter is an uncoated, sterile, single-use latex intermittent urethral catheter intended for urine drainage from the bladder in adult and pediatric patients (2 years and older) who cannot urinate voluntarily. It features a straight tip design with eyelets to funnel urine and is available in French sizes 8-18 with effective lengths of 385 mm (12 or 16 inch overall lengths).

The subject device matches the predicate (Dover Red Rubber Robinson Catheter, K041243) in regulation, classification, material (natural rubber latex), sterilization method (ethylene oxide), design (single lumen with eyelets), tip configuration (straight), and intended use. The key difference is that the subject device specifies a broader diameter range (8-18 French) and explicitly targets both adult and pediatric patients, whereas the predicate's target population was not stated.

ISO 10993 series (biocompatibility per Parts 1, 5, 6, 10, 11, 12, 23); ISO 20696 (sterile urethral catheters); ASTM F623-19 (Foley catheter performance); ASTM D8389-21 (urinary intermittent catheter performance); ASTM F88/F88M-21 (seal strength); ASTM F2096-11 (gross leak detection); ASTM F1980-21 (accelerated aging); ISO 11135 (ethylene oxide sterilization validation).

The BD Rubber Utility Catheter is substantially equivalent to its predicate because it has identical intended use (intermittent urethral catheterization for urine drainage), the same technological characteristics (material, design, sterilization), and all testing demonstrates performance meeting predetermined acceptance criteria. Minor differences (broader French size range, explicit pediatric indication) do not raise different safety or effectiveness questions, as they are minor variations appropriately mitigated through testing.