Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)

The Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM and PICC-252CM) are peripherally inserted central catheters made of radiopaque hydrophilic material. They are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, central venous pressure monitoring, and power injection of contrast media. The devices are rated for maximum power injection flow rates of 4.0 mL/s (PICC-251CM) and 5.0 mL/s (PICC-252CM).

The PICC-251CM maintains identical design, materials, chemical composition, and principle of operation as the predicate device. The PICC-252CM is identical to the predicate except for a reduction in catheter length from 55 cm to 45 cm. Both devices retain the same hydrophilic material composition, suture wing, Luer lock hub, and extension tubing as their predicate comparators.

Not stated in this summary.

Both proposed devices share the same technological characteristics and intended use as the predicate device (K213550 Dual Lumen 5Fr HydroPICC Catheter). The only modifications are increases to the power injection flow ratings and a reduction in length for one model. Testing via power injection cyclical and static burst testing plus dimensional verification demonstrated these changes do not adversely impact device performance. Since the materials, design, and function remain substantially unchanged and testing confirms acceptable performance at the modified ratings, the devices are substantially equivalent to the predicate.