§ 886.5305 Electromechanical tear stimulator.

(a) Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted: (i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties; (ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and (iii) Use life testing. (3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device. (4) All patient-contacting components of the device must be demonstrated to be biocompatible. (5) Software verification, validation, and hazard analysis must be performed. (6) Physician and patient labeling must include: (i) A detailed summary of the device's technical parameters; (ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement; (iii) Information related to electromagnetic compatibility classification; (iv) Instructions on how to clean and maintain the device; (v) A summary of the clinical performance testing conducted with the device; (vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and (vii) Information on how the device operates and the typical sensations experienced during treatment.