Authors: Manuel E. Sanchez-Casalongue, MD, PhD, David M. Pechman, MD
TransEnterix® received FDA approval for their Intelligent Surgical Unit (ISU) on March 13, 2020.
The Intelligent Surgical Unit is TransEnterix®’s most recent addition to their Senhance® Robotic platform. As a system, Senhance® features independent robotic arms, infra-red eye tracking, and haptic force feedback. The company has been working toward digitizing some aspects of robotic surgery, in particular camera management, by facilitating camera movement via eye-sensing.
The ISU enhances their current technology with image processing features to augment endoscope movement capabilities. In particular, the FDA form (510k), denotes three optional novel methods for camera control beyond eye-tracking.
The ISU independently captures and interprets visual information of the surgical field before passing on data to the surgeon. In this manner, it can recognize objects and locations in the surgical field. The ISU also responds to voice commands to maneuver the camera. These steps are the first towards the introduction of augmented intelligence and machine vision to robotic surgery. Advocates of the system have identified several possible applications of this technology, including automatic camera adjustment based on machine-identification of key structures and instrument recognition and tracking.
The ISU is compatible with Senhance® surgical systems and also with third-party vision systems that they support.
A single-center, un-blinded, observational, simulated use evaluation was conducted on a live porcine model. In this simulated use environment, users were able to independently perform all critical tasks without use errors that would lead to harm. Primary data for the study is not currently available through the FDA listing.
The FDA has determined the ISU to be substantially equivalent to predicate device Senhance® Surgical System (K192877).
The ISU is approved by the FDA for use for adult patients undergoing laparoscopic gynecological surgery, colorectal surgery, cholecystectomy or inguinal hernia repair. It is to be used by trained physicians in an operating room environment in accordance with the provided instructions for use.
