Arthrex Synergy Vision Imaging System

The Arthrex Synergy Vision Imaging System is a real-time visible light and near-infrared fluorescence imaging system designed for diagnostic and surgical procedures including laparoscopy, orthopedic, plastic, and spine surgery. It enables visualization of vessels, blood flow, tissue perfusion, bile ducts, and lymphatic structures when used with contrast agents ICG or pafolacianine, and includes accessory scopes for both endoscopic and open surgical applications.

The system uses integrated LED for visible light and an external 785 nm laser for near-infrared excitation with 810–940 nm detection bandwidth, delivering 95 W/m² intensity. It features CMOS imaging at 3840×2160 resolution with a 42° field of view, rigid rod lens scope design at 10 mm diameter, and supports multiple reprocessing methods (steam, hydrogen peroxide, or cleaning/disinfection). Key differences from the primary predicate include a single 0° scope angle versus multiple angles, and support for pafolacianine in addition to ICG.

Not stated in this summary.

Substantial equivalence is based on identical intended use, same or similar indications for use, equivalent technological characteristics (matching excitation wavelength, detection bandwidth, and light intensity to the primary predicate), and successful completion of design verification/validation testing including porcine fluorescence imaging studies demonstrating equivalent or better ICG visualization. Any differences between the subject device and predicates are considered minor and do not raise different questions about safety or effectiveness.