Arthrex Synergy Vision Endoscopic Imaging System
Arthrex, Inc.The Arthrex Synergy Vision Endoscopic Imaging System is an advanced camera system used in endoscopic surgery to provide live imaging in visible and near-infrared light. It helps surgeons visualize vessels, blood flow, lymphatic system, and tissues during minimally invasive surgeries, improving surgical precision and patient outcomes.
Intended Use
The Arthrex Synergy Vision Endoscopic Imaging System is intended to be used as an endoscopic video camera to provide visible light imaging in various endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, urology, and thoracic cavity procedures. The system also provides real-time visible and near-infrared fluorescence imaging to visualize vessels, blood flow, bile ducts, lymphatic system, and tissues that uptake fluorescence contrast agents.
Technology
The system includes a camera control unit (CCU) console, camera heads, endoscopes, and a laser light source. It uses integrated LED light for visible imaging and interacts with an external laser light source for near-infrared fluorescence imaging using fluorescent contrast agents such as indocyanine green (ICG) and pafolacianine. The fluorescent response is captured by the camera, processed and displayed on a monitor in real time, aiding minimally invasive surgery.
Performance
The device underwent design verification including inspection, engineering analysis, and functional testing to meet product requirements and design specifications. Biocompatibility and sterility data were leveraged from predicate devices. EMT and EMC safety testing was conducted and met standards. Software testing confirmed software updates met requirements. The device did not require animal or human clinical testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/11/2025
1 month - 2
FDA Approval
5/5/2025
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