Search Results

The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery. Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.

The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and near-infrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment. ActivSight consists of the following reusable components: - ActivSight Imaging Module, consisting of optics and sensing electronics. The imaging module attaches physically between the third-party laparoscope and the third-party imaging system camera. Reprocessing of this component requires cleaning and disinfection between uses. - ActivSight Light Engine, equipment consisting of system electronics that provide laser fluorescence and near-infrared illumination, processing of video input from both the third-party Camera Control Unit (CCI) and the ActivSight lmaging Module, and outputs video to the surgical monitor. This component does not require reprocessing between uses. - ActivSight Light Cable, component consisting of a Y-shaped bifurcated light a cable that connects to the third party white-light source, the ActivSight Light Engine, and the third party laparoscope light post (providing white-light illumination of the surgical site through the laparoscope). Reprocessing of this component requires cleaning and steam sterilization. - ActivSight Sterilization Tray, stainless-steel sterilization tray designed to a properly secure the ActivSight Light Cable for disinfection and sterilization. Reprocessing of this component is accomplished in its use- cleaning and steam sterilization. ActivSight consists of the following disposable components: - ActivSight Sterile Drape, a sterilized plastic drape that is provided for each use = to provide a sterile barrier between the imaging module and the patient. - -ActivSight Calibration Target, a sterilized paper imaging target containing a checkerboard pattern for calibration of the ActivSight imaging module prior to each use of the device.