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The Arthrex SynergyID Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, plastic surgical procedures within the thoracic cavity. The device is also intended to be used as an accessory for microscopic surgery. The Arthrex SynergyID Endoscopic Imaging System is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. Upon intravenous administration and use of ICG consistent with its approved label, the system enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the Arthrex SynergyID Endoscopic Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for billary duct visualization. Upon interstitial administration and use of ICG consistent with its approved label, the Arthrex SynergyID Endoscopic Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The Arthrex Synergy® Endoscopic Imaging System includes a non-sterile camera control unit (CCU) console, camera heads, a laser light source, and laparoscopes. The system integrates ultra-high-definition camera technology, LED lighting, and an image management system into a single console with a tablet interface. The system provides real-time visible and near-infrared light illumination and imaging. The Arthrex Synergy® Endoscopic Imaging System CCU interacts with the laser light source to be able to provide near-infrared (NIR) imaging to visualize the presence of Indocyanine Green (ICG). The ICG fluoresces when illuminated through a laparoscope with NIR excitation light from the laser light source and the fluorescence response is then imaged with the camera, processed and displayed on a monitor.