ARION ARC System

The ARION ARC System is a plasma-based surgical device intended for soft tissue coagulation during open surgery. It generates argon plasma through an internal arc discharge to create a thin coagulated layer on tissue surfaces, stopping bleeding and reducing fluid loss. The system consists of a generator, trolley, reusable handpiece (rated for 30 uses), and single-use sterile accessories including drapes and spacers.

Key differences from the predicate include a reusable handpiece (versus single-use), sterile single-use spacers and drape for maintaining optimal working distance, a reposable design with electrode components rated for minimum 30 uses of 5 minutes each, and enhanced UI with three operational stages including cooldown/shutdown. Both devices use identical argon gas parameters (0.2-0.7 l/min), energy source (30-60V DC), power range (20-170W typical, 300W max), and achieve the same tissue penetration depth (typically 2.5mm).

Biocompatibility (ISO 10993-1, -5, -9, -10, -11, -12, -23), sterilization validation (ISO 11135, 11138-3, 17665-1, 11607-1, -2), reprocessing validation (ANSI AAMI ST98), electrical safety (IEC 60601-1-1), electromagnetic compatibility (IEC 60601-1-2), human factors/usability (IEC 62366-1), and package performance (ASTM 4169-22, ASTM F88/F88M-23).

The ARION ARC System is substantially equivalent to the predicate PlasmaJet System because both devices use identical plasma generation and coagulation principles with the same argon gas parameters, power specifications, and tissue effects. Although the subject device introduces design enhancements (reusable handpiece, sterile spacers, enhanced UI), comprehensive testing demonstrates these differences do not raise new questions of safety or effectiveness. The core mechanism of argon plasma ionization, energy delivery, and tissue interaction remains unchanged.