Arthrex Synergy Vision Endoscopic Imaging System

The Arthrex Synergy Vision Endoscopic Imaging System is an endoscopic video camera for minimally invasive surgical procedures (laparoscopy, orthopedic, plastic surgery, spine, urology, etc.). It provides real-time visible light imaging and near-infrared (NIR) fluorescence imaging when used with contrast agents like indocyanine green (ICG) or pafolacianine to visualize vessels, tissue perfusion, biliary ducts, and lymphatic systems.

The system includes a camera control unit, camera heads, endoscopes, and an external NIR laser light source. It offers dual imaging modes (white light and NIR fluorescence), CMOS image sensors with resolutions up to 3840×2160 at 60 fps, rigid rod-lens endoscopes and chip-on-tip designs at 5.5–10 mm diameters, and 785 nm laser excitation with 810–940 nm detection bandwidth. Minor updates include additional Nano-scope models with higher resolution variants.

EMT safety and EMC standards; FDA-recognized standards for biological safety; FDA guidance for software testing; biocompatibility and sterilization validation standards leveraged from predicate devices.

The device shares the same intended use (endoscopic imaging for minimally invasive surgery) and nearly identical technological characteristics as the primary predicate K241361, differing only in minor software updates and additional Nano-scope model variants. Non-clinical verification testing (design, EMT/EMC, software, biocompatibility, sterility) confirmed compliance with the same standards. No animal or human studies were required because the differences are minor and do not raise new safety or effectiveness concerns compared to legally marketed predicates.