Anovo Surgical System (6Ne)

The Anovo Surgical System (6Ne) is an endoscopic instrument control system that assists physicians in accurately controlling robotic instrument arms during single-site, transvaginal benign laparoscopic-assisted surgical procedures such as hysterectomy, salpingectomy, oophorectomy, and ovarian cyst removal. The surgeon operates from a console outside the sterile field, viewing the surgical site through a standard laparoscopic camera and manipulating instrument controllers.

The Anovo Surgical System 6Ne incorporates software updates and console hardware modifications to support optional integration of an off-the-shelf FDA-cleared endoscope arm (SOLOASSIST II by AKTORmed) for camera control, replacing manual manipulation by surgical staff. The annotation feature was removed and replaced with an endoscope control pedal. The system RCU, instruments, and other accessories remain unchanged from the predicate device.

IEC 60601-1 (basic safety and essential performance), IEC 60601-1-6 (usability), IEC 80601-2-77 (robotically assisted surgical equipment), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-4-2 (electromagnetic immunity), IEC 60601-2-2 (high-frequency surgical equipment), ISO/IEC 62366-1:2015 (usability engineering), and IEC 62304 (software development).

The subject device shares the same intended use and indications as the predicate (K242157). The modifications (endoscope arm support, annotation removal, software/hardware updates) do not raise different safety or effectiveness questions because they are limited to console interface changes that enable optional accessory integration. Non-clinical testing (bench, software, cybersecurity, electrical safety, human factors, and cadaver studies) demonstrated safe and effective operation, with all use-related risks acceptable and no additional risks identified compared to the predicate.