Auryon Atherectomy System

The Auryon Atherectomy System is a laser-based peripheral atherectomy device consisting of a single-use catheter with optic fibers and a blunt blade, connected to a laser console. It delivers short, high-intensity ultraviolet pulses to remove plaque from narrowed or blocked infra-inguinal arteries in the legs, with or without thrombus aspiration capability, and is indicated for treating stenoses, occlusions, and in-stent restenosis.

The subject device is identical to the predicate in all key technological aspects: same Nd:YAG laser at 355 nm wavelength, identical fluence levels (50 and 60 mJ/mm²), same pulse rate (40 Hz) and duration (10-25 ns), and same maximum output (33.5 mJ). The primary modification is the addition of 0.9mm and 1.5mm Rapid Exchange catheter configurations with hydrophilic coating, which were tested using the same methods and acceptance criteria as the predicate device.

ISO 10993 (Biological Evaluation of Medical Devices) for biocompatibility testing including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility; ISO 13485 for quality management systems; ethylene oxide sterilization validation per applicable standards.

Substantial equivalence is established because the proposed and predicate devices share identical operating principles, mechanism of action, intended patient population, regulatory classification (Class II, Pro-Code MCW), and all key laser and delivery parameters. The only modification—adding two new rapid exchange catheter sizes with hydrophilic coating—does not introduce new risks or raise new safety/effectiveness questions, as these were tested using identical predicate methods and demonstrated no impact to risk profiles.