Amethyst HP PTA OTW 0.035 Catheter

The Amethyst HP PTA OTW 0.035" Catheter is a balloon catheter used for percutaneous transluminal angioplasty (PTA) in peripheral blood vessels including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries, as well as for treating blockages in dialysis fistulae and post-dilatation of stents. The device features a non-compliant balloon at the distal tip, two radiopaque markers for positioning, and is supplied sterile for single use.

The subject device expands the predicate's balloon diameter range from 7.0–10.0 mm to 4.0–12.0 mm, adds 30 and 35 ATM rated burst pressures (predicate had 35 and 40 ATM), changes the soft tip material from radiopaque to non-radiopaque Pebax, and adds compatibility with 8F introducers. All other materials, design, balloon lengths (20–100 mm), guide wire diameter (0.035"), and sterilization method remain identical to the predicate (K241040).

ISO 10993-1 (Biological Evaluation of Medical Devices), 21 CFR Part 58 (Good Laboratory Practice), and applicable FDA guidance documents. Biocompatibility testing included acute systemic toxicity, cytotoxicity, hemolysis, complement activation, thromboresistance, and hematology assays.

The Amethyst HP PTA OTW 0.035" Catheter is substantially equivalent based on identical indication for use, comparable device design and materials (except non-radiopaque soft tip), and non-clinical performance testing demonstrating that the expanded balloon size range and new pressure ratings meet predetermined acceptance criteria. Radiopacity and packaging validation were leveraged from the predicate device since those aspects remain unchanged.