HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

The HydroMID 5F Dual Lumen Midline Catheter is a 5 French, dual-lumen intravascular catheter indicated for short-term peripheral venous access (less than 30 days) to deliver fluids, medications, and sample blood. It features a radiopaque hydrophilic catheter with dual lumens rated for maximum power injection flow of 6 mL/s.

The proposed device differs from the 4F single-lumen predicate (K220772) by increasing French size to 5F, adding a second lumen, and changing lumen cross-section from circular 1mm to D-shaped design of similar area. The power injection rating increases from the reference device (K213550) specification of 3.5 mL/s to 6.0 mL/s. Materials, sterilization, and accessories remain identical to the predicate.

Not stated in this summary. The document references bench testing (power injection flow rate, static burst strength, tensile strength, dimensional verification, kink resistance, particulate, packaging, sterility, MR compatibility, and shelf-life) but does not cite specific consensus standards by name.

The 5F dual-lumen configuration is substantially equivalent because the reference device (HydroPICC-251 5F Dual Lumen, K213550) already established a cleared predicate with identical French size, dual lumens, and D-shaped lumen design. The power injection rating increase to 6 mL/s is supported by performance testing at T=0 and over shelf life that demonstrates it raises no new safety or effectiveness questions. All bench testing passed acceptance criteria identical to predicate standards, and intended use, indications, classification, and materials remain unchanged.