The Food and Drug Administration issued Class II medical device clearance to Coapt, LLC for the Complete Control System, a myoelectric pattern recognition system.
Myoelectric pattern recognition algorithms are currently used in prostheses, although the sensory-motor integration needed to include sensory feedback is largely confined to academia. Myoelectric control is one of two types of prosthesis control, along with body-powered or mechanical prosthesis.
This recognition on May 1 is the first time the FDA has approved a myoelectric pattern recognition system for marketing in the United States.
“Earning an FDA Class II clearance for this technology is an incredible milestone for Coapt and for the profession,” said Matthew Garibaldi, director of Orthotic and Prosthetic Centers and associate clinical professor at the University of California, San Francisco. “This achievement sets a new precedent in prosthetic device innovation.”
Coapt’s Complete Control uses electrodes to intercept the electrical signals sent from the user’s muscles to the missing limb. The prosthesis can then be moved in a way that intuitively mimics the absent limb. In order to make the prosthesis more comfortable for the user and easier to use, Complete Control allows for electrode placement to be simplified so that less testing is required in order to determine placement. The prosthesis can be controlled using Complete Control without co-contractions or impulse switching, and it is not limited by activation thresholds.
“Until the advent of pattern recognition technology, the evolution of upper extremity prosthetic hardware had far exceeded the capability of traditional control mechanisms. Thus, highly technical and capable prosthetic applications had in large part been wholly underutilized,” said Garibaldi. “Pattern recognition unlocks the potential of prosthetic users by allowing for discrimination of multiple degrees of freedom and simultaneous control – meaning, they can move their prostheses in more ways, in a manner more like a natural upper limb.”
Coapt provides a list of compatible upper body prosthetics.