Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)

The Polywin Safety and Polywin Safety Adva IV Catheters are over-the-needle peripheral intravenous catheters intended for short-term use (less than 30 days) to sample blood or administer fluids, solutions, parenteral nutrition, and drugs. They incorporate a passive safety clip to prevent needle-stick injuries, with the Adva model featuring quick flashback technology for enhanced vein visualization.

The devices are identical to the predicate in all respects except for the addition of new length options. The catheter is composed of medical-grade polyurethane with barium sulfate for radiopacity, the needle is stainless steel 304, and all components are non-conductive, non-metallic polymers. The only modification is expansion of the length range from 19mm-45mm to 14mm-64mm across existing gauge sizes (14G to 26G).

ISO 10555-1:2023, ISO 10555-5:2013, ISO 80369-7:2021, ISO 9626:2016, ISO 11607-1:2019, ISO 10993-1:2018, ISO 10993-7, ASTM F2503-23, ASTM D4169, and ASTM F1980 were used for dimensional verification, biocompatibility, sterilization validation, fluid path integrity, mechanical strength, and power injection testing.

The subject devices are substantially equivalent to the predicate (K231401) because they maintain identical intended use, design, materials, manufacturing processes, and safety features while only adding new length options to existing gauges. Comprehensive design controls, verification, validation, and performance testing confirmed that all new lengths meet specifications and maintain the same safety and effectiveness profile as the predicate, with no new questions of safety or effectiveness raised.