HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr

The HydroPICC and HydroMID catheters are intravascular catheters designed for short- or long-term peripheral venous access for intravenous therapy, medication administration, fluid delivery, blood sampling, and central venous pressure monitoring. These devices incorporate MIMIX® Technology, an anti-thrombogenic hydrogel material designed to minimize thrombus formation on device surfaces.

The proposed devices have identical technological characteristics to their predicates, including radiopaque hydrophilic polyol catheter material, Luer lock hubs, polyurethane extension tubing, suture wings, tapered shaft design, ethylene oxide sterilization, and MRI conditional safety. The HydroPICC devices are available in 4Fr and 5Fr single and dual lumen configurations rated for 5.0-6.0 mL/s power injection, while HydroMID is a 4Fr single lumen midline catheter rated for 6 mL/s.

ISO 11737-2:2019 was cited for sterilization validation demonstrating no inhibitory characteristics. The document references in vitro blood loop models and thrombosis assessment studies but does not cite specific consensus standards for these tests.

The devices are substantially equivalent because they have identical intended use, design, materials, and technological characteristics as the predicate devices (HydroPICC K193015, HydroPICC-251 K213550, and HydroMID K220772). The only change is adding language to the indications for use explicitly describing the MIMIX® Technology's anti-thrombogenic benefit, which the predicate devices already possess but did not highlight. In vitro testing demonstrates the devices reduce thrombus accumulation compared to conventional catheters, supporting the enhanced indications without introducing new safety or effectiveness concerns.