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 including cutting, dissecting, and coagulating using monopolar energy. They are used with the Anovo Surgical System to assist in minimally invasive transvaginal benign gynecological procedures such as hysterectomy, salpingectomy, and ovarian cyst removal in adult patients.

The subject devices are identical to their predicate devices in terms of intended use, indication for use, design, technology, and performance specifications. The only modification is a labeling update to include compatibility with the Anovo Surgical System Model 6Ne, which is an enhanced configuration of the previously cleared Model 6N with an enhanced Surgeon Console and Robotic Control Unit. No physical or functional changes were made to the instruments themselves.

Not stated in this summary.

Substantial equivalence is established because: (1) the subject devices are physically and functionally identical to the predicate devices with no design or technology changes; (2) the labeling modification merely adds compatibility with an FDA-cleared enhanced system model (6Ne) rather than changing the device's operation; (3) design validation testing in female cadaver models confirmed the instruments met all predefined requirements for transvaginal clinical compatibility, performance, and safety when used with the 6Ne system; and (4) the predicate device was previously cleared for use with the Model 6N system, so extending compatibility to its enhanced version does not introduce new risks or alter fundamental operating principles.