V-DAC Catheter

The V-DAC Catheter is a single-lumen, coil-reinforced percutaneous catheter with a hydrophilic coating designed to facilitate insertion and guidance of microcatheters into blood vessels in the peripheral and neurovascular systems. It consists of a distal access catheter and a peel-away introducer sheath, provided sterile for single use only.

The V-DAC Catheter shares the same fundamental design, materials (stainless steel, PTFE, polyurethane, Pebax, nylon 12, tungsten, platinum/iridium), and operating principles as the predicate AXS Catalyst 7. Key differences include longer hydrophilic coating length (50 cm vs. 30 cm on predicate) and slightly different dimensional specifications, but these do not raise new safety or effectiveness concerns.

ISO 10555-1 for catheter performance testing; ISO 10993-1 and applicable sub-parts for biocompatibility; EN ISO 10993-7 for ethylene oxide residuals; ISO 11607-1 and ISO 11607-2 for packaging and sterilization validation; ASTM F756 for hemolysis testing; 21 CFR Part 58 for good laboratory practice in animal studies.

The V-DAC Catheter is substantially equivalent to the AXS Catalyst 7 predicate device based on identical intended use (facilitating microcatheter insertion and guidance), similar indications, comparable materials and design, and the same operating principles. Bench testing, biocompatibility studies, shelf-life testing, and animal studies all demonstrated performance comparable to the predicate with no new safety or effectiveness questions raised.