21 CFR 876.5330 — Cutaneous Electrode Stimulator For Urinary Incontinence
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5330
Identification
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence | 2 | 5 |
Special Controls
QAJ — Cutaneous Electrode Stimulator For Urinary Incontinence
In combination with the general controls of the FD&C Act, the transcutaneous electrical continence device is subject to the following special controls:
De Novo Order DEN170049
QAJ — Cutaneous Electrode Stimulator For Urinary Incontinence
*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.
eCFR
QAJ — Cutaneous Electrode Stimulator For Urinary Incontinence
(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.
Ecfr Llm
