Processo de certificação médica do RDFixer

Abstract

During Minimally Invasive Surgery (MIS), many errors occur because the lack of depth perception. Surgeons see their hand-eye coordination affected negatively by one particular optical aberration called radial distortion. Radial distortion cannot be avoided in those small lenses with a wide FOV used in MIS that hinders depth perception and notion of relative distance. To overcome this need, Perceive 3D S.A. (P3D) created RDFixer. It is a plug-and-play device that intercepts the video feed from any endoscopic equipment and outputs the corrected image signal to the display. It is a software based device that offers new features and brings to the table some benefits in comparison with other devices. Considered as a medical device, to place it in the market it is required the CE marking under the applicable directive. The Medical Devices Directive (MDD) is 93/42/EEC (EEC stands for European Economic Community), then every device that is developed must be manufactured according to it. By looking at the directive, we identify some aspects very important like the quality management system (product or company), risk management, clinical evaluation, classification, and others. During this work we can find an introduction to concepts related with the functioning of this particular device, as well as technical and regulation requirements to design new equipments. The main objective is to understand these steps and apply them to the RDFixer towards establishing a clear regulatory path for the product and advance as much as possible with documents to certify the device. In addition, we also investigate the impact that RDFixer can have in different medical endoscopic domains by assessing the amount of distortion present in a collection of 10 scopes of different specialities.