Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

The Anovo Surgical System Model 6Ne is an endoscopic instrument control system that assists surgeons in accurately controlling robotic instrument arms during minimally invasive benign gynecological and abdominal procedures, including hysterectomy, salpingectomy, oophorectomy, adnexectomy, ovarian cyst removal, and ventral hernia repair. The system is used by trained physicians in operating rooms on adult patients and includes curved scissors and hook electrode instruments for tissue manipulation using monopolar energy.

The Anovo 6Ne is an enhanced configuration of the predicate Anovo 6N, incorporating off-the-shelf controllers into the surgeon console with minor modifications to the robotic control unit and allowing use of an optional off-the-shelf endoscope arm. These modifications were made for commercialization and user experience but do not alter key device functionalities, system instruments, or accessories. No changes were made to the surgical instruments, system components, or procedures for this submission.

Not stated in this summary.

The device is substantially equivalent because the 6Ne has identical intended use, indications for use, and performance specifications to the predicate 6N device. No physical or functional changes were made to the instruments or core system performance. Design validation using female cadaver models demonstrated safe and effective performance for transabdominal ventral hernia procedures. The only operational difference is transabdominal versus transvaginal access and instrument arm entry, which are performed using the same procedures as the cleared predicate device.