Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode

The Anovo Instrument ARM Curved Scissors and Hook Electrode are sterile, single-use surgical instruments designed for tissue manipulation (cutting, dissecting, coagulating) using monopolar electrosurgical energy. They attach to the Anovo Surgical System, a robotic control platform, to assist in transvaginal laparoscopic-assisted gynecological procedures including hysterectomy, salpingectomy, oophorectomy, adnexectomy, and ovarian cyst removal in adult patients.

Both subject and predicate devices are sterile, single-use components with identical mechanical structure (end-effector, flexible joints, rigid section, handle). The key difference is the end-effector type and energy source: the predicate Grasper uses bipolar and monopolar energy, while the subject devices (Curved Scissors and Hook Electrode) use monopolar energy only. No changes were made to the Anovo System components, robotic control unit, or user interface.

ISO 10993-1:2018 for biocompatibility testing; FDA Guidance for Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (March 2020); Draft FDA Guidance on Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (March 2024).

The subject devices share the same indications for use, principles of operation, and technological platform as the predicate. The minor differences (monopolar-only energy versus bipolar/monopolar, and different end-effector geometry) raise no new safety or effectiveness questions. Bench testing confirmed design requirements were met, pre-clinical animal studies in sheep demonstrated safe and effective surgical task performance, and thermal damage testing showed equivalent thermal effects to cleared off-the-shelf electrosurgical tools. Biocompatibility testing confirmed material safety. These data provide reasonable assurance the new end-effectors are as safe as the predicate.