(a) Identification. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.

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

(1) Non-clinical performance testing must characterize the electrical stimulation, including the following: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.

(2) The patient-contacting materials must be demonstrated to be biocompatible.

(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety of the device.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Labeling must include the following:

(i) Instructions for use, including specific instructions regarding the proper placement of electrodes;

(ii) A summary of electrical stimulation parameters; and

(iii) Cleaning instructions and reuse information.

[86 FR 73971, Dec. 29, 2021]