(a) Identification. An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use, including the following:

(i) Electrical output testing;

(ii) Mechanical integrity testing of electrical components;

(iii) Testing to verify safe use of the electrical stimulator component in the presence of supplementary oxygen; and

(iv) If the device incorporates a feeding tube, feeding tube functionality testing, including mechanical integrity, liquid leakage, flow rate and connector compatibility.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance testing must demonstrate the sterility of the components intended to be provided sterile.

(4) Performance data must validate the reprocessing instructions for any reusable components of the device.

(5) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.

(6) Software verification, validation and hazard analysis must be performed for any software components of the device.

(7) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of any electrical components.

(8) A training program must be included with sufficient educational elements so that upon completion of the training program, the user can correctly operate the device.

(9) Usability testing must demonstrate that the device can be correctly used as per training and labeling.

(10) The labeling must include a shelf life for any sterile components.