Grenoble, France-based eCential Robotics, a company specializing in surgical robotics, has been granted FDA 510(k) clearance for its SURGIVISIO Device.
The SURGIVISIO Device is a 3D imaging, navigation, and robotics guidance system.
According to the FDA document, the SURGIVISIO Device is intended to be used “during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis, or articulation structures are visualized.”
Additionally, the SURGIVISIO Device “through its freehand navigation feature is intended as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.”
Furthermore, the SURGIVISIO Device “through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.”
Moreover, the SPX1 instruments and Spine CoBot instruments are intended to be used with the SURGIVISIO Device. The Spine CoBot instrument is a robotic arm that performs the surgeon’s preplanned action. For more information on the CoBot instrument, see “eCential Robotics Is Giving Surgeons a Hand.”
In order to qualify for shorter and earlier 510(k) clearance, the device must be substantially equivalent to a predicate device. Per the FDA document, eCential Robotics claimed equivalence to the following two devices: “Stryker SpineMap® 3D Navigation System (available with SpineMask™ tracking device) by Stryker Leibinger GmbH & Co for the free hand navigation feature of the SURGIVISIO Device [Primary]” and “ROSA® ONE Spine application by Medtech S.A.(Zimmer Biomet) for the robotic guidance feature of the SURGIVISIO Device.”
eCential Robotics Chief Strategy Officer and USA CEO Laurence Chabanas commented, “The FDA clearance of the eCential Robotics unified platform recognizes reliability and robustness of our product, confirms the confidence in eCential Robotics’ unique concept of focusing surgical workflows on the essential via a unified, open and multi-app system, and also encourages our ambition to expand our footprint in the United States.”
