DEKA Integrated Solutions has obtained marketing approval from the US Food and Drug Administration (FDA) for its DEKA Arm system, a prosthetic arm that performs multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
The FDA has approved the DEKA Arm system after reviewing data, including US Department of Veterans Affairs' four-site study, with 90% of study participants who used the device able to perform complex tasks.
In the study, 36 participants provided data on how the arm performed in common household and self-care tasks.
The FDA has also reviewed data related to testing of software and electrical and battery systems, mitigations to prevent or stop unintended movements of the arm and hand mechanisms, durability testing such as the ability to withstand exposure to common environmental factors such as dust and light rain, and impact testing.
The FDA reviewed the DEKA Arm system through its de novo classification process.
FDA Center for Devices and Radiological Health Office of Device Evaluation director Christy Foreman said that this innovative prosthesis provides a new option for people with certain kinds of arm amputations.
"The DEKA Arm system may allow some people to perform more complex tasks than they can with current prostheses in a way that more closely resembles the natural motion of the arm," Foreman said.
DEKA Integrated Solutions' DEKA Arm system features EMG electrodes, switches, movement sensors, and force sensors.
The system incorporates major technological advances such as flexible socket design, innovative control features, software, and hardware that together enable enhanced functionality that promises to surpass any currently available prosthetic device.
EMG electrodes attached to the arm above the prosthesis detect electrical activity caused by muscles contraction and send those electrical signals to a computer processor in the arm.
With the electrical signals, the arm can then make up to ten specific movements using a combination of switches, movement sensors and force sensors.
The DEKA Arm system could be used by people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm, but not at the elbow or wrist joint.