Symani Surgical System (820-03830)

The Symani Surgical System is an electromechanical device for microsurgery that provides motion scaling (7x to 20x) to reduce surgeon tremor and improve precision during anastomosis, suturing, and ligation of small blood vessels and lymphatic ducts (0.1-2.5 mm) in open free-flap and lymphatic surgery. It consists of a CMM, console, and wristed instruments, and is intended for use by trained physicians in adults.

The subject device has identical technological characteristics to the predicate device (DEN230032) with one addition: the new Supermicro Needle Holder Suture Cut instrument, which combines the existing Supermicro Needle Holder design with an integrated small (micro) blade mounted on the driving tip for improved cutting capability.

Not stated in this summary. The document references simulated use tests, gripping force and torque testing, and structural integrity tests, but does not cite specific consensus standards (ISO, IEC, ASTM) or regulatory testing methodologies.

The subject device is substantially equivalent because it maintains the same intended use, indications for use, and core technological characteristics as the predicate device. The only change is the addition of a new instrument (Supermicro Needle Holder Suture Cut) that combines the existing Supermicro Needle Holder design with a small blade; performance testing (simulated use, gripping force/torque, and structural integrity) demonstrated this new instrument performs as safely and effectively as current instruments, therefore the overall system remains substantially equivalent.