DEKA Integrated Solutions has obtained the US Food and Drug Administration’s (FDA) marketing approval for its DEKA Arm system, a prosthetic arm that performs multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.
Approval of the DEKA Arm system is based on the FDA’s review of study data, including Department of Veterans Affairs’ four-site study, in which 90% of study participants who used the device were able to perform complex tasks.
A total of 36 study participants have provided data on how the arm performed in common household and self-care tasks in the Department of Veterans Affairs study.
In addition, the FDA reviewed data on testing of software and electrical and battery systems, mitigations to prevent or stop unintended movements of the arm and hand mechanisms, durability testing, and impact testing.
DEKA Arm system has been reviewed by the FDA 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 added.
DEKA Arm system incorporates flexible socket design, innovative control features, software and hardware. The device features EMG electrodes, switches, movement sensors, and force sensors.
The 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. Using a combination of switches, movement sensors and force sensors the arm can then make up to ten specific movements.
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.