FDA denovo Rules Pass Mind-Controlled Robotic Arm

The U.S. FDA has cleared for marketing the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.

Background

The EMG electrodes in the DEKA Arm System detect electrical activity caused by the contraction of muscles close to where the prosthesis is attached. The electrodes send the electrical signals to a computer processor in the prosthesis that translates them into up to 10 specific powered movements.

The DEKA Arm is the same shape and weight as an adult arm and contains a combination of mechanisms including switches, movement sensors, and force sensors that cause the prosthesis to move.

The FDA reviewed the DEKA Arm System through its de novo classification process, a regulatory pathway for some novel low- to moderate-risk medical devices that are first-of-a-kind. The agency’s review of clinical information relating to the device, included a 4-site Department of Veterans Affairs study in which 36 DEKA Arm System study participants provided data on how the arm performed in common household and self-care tasks. The study found that approximately 90 percent of study participants were able to perform activities with the DEKA Arm System that they were not able to perform with their current prosthesis, such as using keys and locks, preparing food, feeding oneself, using zippers, and brushing and combing hair.

The review also included 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 ability to withstand exposure to common environmental factors such as dust and light rain), and impact testing.

The DEKA Arm System can be configured for people with limb loss occurring at the shoulder joint, mid-upper arm, or mid-lower arm. It cannot be configured for limb loss at the elbow or wrist joint.

FDA comments

“This innovative prosthesis provides a new option for people with certain kinds of arm amputations,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “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.”

Source: DEKA Integrated Solutions

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