Author(s): Matthew Burstein, MD, PhD, Marissa Novack, MD, Alan Posner, MD
Human Xtensions Ltd. received FDA approval for the HandX Monopolar Hook on February 1, 2021 (K203603).
The HandX platform allows for motorized 85 degree articulation across 4 degrees of freedom, and up to 540 degrees of rotation through conventional 5 mm laparoscopic ports, directly from the surgeon’s hand with natural finger movement. The monopolar instrument effector end (“HandX Monopolar Hook”) is intended for cutting and coagulation during laparoscopic surgical procedures with a conventional OR electrosurgical generator.
The HandX Monopolar Hook completed standard biocompatibility testing for a device with limited contact to tissues, as well as electrical safety and bench testing. Additionally, the HandX Monopolar Hook was tested in a porcine model to evaluate the device’s safety, functional performance, and usability. Device safety was assessed by a histopathology evaluation of slits performed by the Monopolar Hook in comparison to those performed by the predicate device Covidien’s SILS L-Hook (K091869).
The FDA has determined that this device is substantially equivalent to predicate devices, Human Xtensions’ HandX (K173919) which is the platform that enables articulation and rotatation, and Covidien’s SILS L-Hook (K091869), another articulating hook. The HandX Monopolar Hook’s electrosurgical characteristics were compared for usability and safety to the predicate device, the SILS L-Hook, under animal study. Of note, the predicate monopolar hook is manually operated unlike the HandX Monopolar Hook which is electromechanically operated and software controlled.
The FDA has approved the HandX for the application of monopolar diathermy for various surgical purposes during laparoscopic operations, including blunt and electrocautery dissection, transection of tissue, and small vessel cautery.
The HandX Monopolar Hook with monopolar activation is not intended for contraceptive coagulation of fallopian tissue but may be used to achieve hemostasis following transection of the fallopian tube. As with other monopolar electrodes, this system should not be used on patients with electronic implants such as cardiac pacemakers without proper shielding or deactivation.