FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)

The FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/4Fr 3-Sphere Configuration) is a flexible, over-the-wire rotational device used to remove atherosclerotic plaque from peripheral arteries. It is indicated for patients with occlusive atherosclerotic disease in peripheral arteries who are acceptable candidates for percutaneous transluminal atherectomy, targeting vessels 2.0 to 3.0 mm in diameter.

The subject device differs from the predicate (H6004/5Fr 3-Sphere) in two minor modifications: smaller sphere diameter (1.25 mm versus 1.50 mm) and smaller catheter tubing diameter (4Fr versus 5Fr). Both share the same mechanism—three diamond-coated, eccentrically mounted spheres rotating at 50,000 or 76,000 RPM on an electric motor-driven driveshaft—and identical system components, working length (150 cm), rotational speeds, saline flow rate, sterilization method, and sterility assurance level.

The submission references FDA Guidance: Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions, May 20, 2021. No specific ISO, IEC, or ASTM standards are explicitly cited in this summary.

The H6005 is substantially equivalent because it uses the identical orbital atherectomy mechanism, same intended use, same indications, and same system architecture as the predicate. The two dimensional changes (smaller spheres and catheter tubing) are minor modifications required for compatibility with a 4Fr introducer sheath while remaining within the predicate's overall vessel diameter range (2.0–4.0 mm). Comprehensive bench testing including simulated-use, kink resistance, heat generation, torsional/tensile strength, plaque removal efficiency, and cadaveric model evaluations all demonstrated equivalent performance to established acceptance criteria, with no new safety or effectiveness questions raised.