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(a) Identification. An oral electronic vision aid is a battery-powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Analysis/testing must validate electromagnetic compatibility.
(5) Analysis/testing must validate electrical safety.
(6) Analysis/testing must assess and validate wireless coexistence concerns.
(7) Any elements of the device that contact the patient must be demonstrated to be biocompatible.
(8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use.
(9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use).
[80 FR 57092, Sept. 22, 2015]
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