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Cutaneous Electrode Stimulator For Urinary Incontinence

Page Type
Product Code
Definition
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Physical State
Electrodes
Technical Method
Current applied to pelvic floor muscles to improve strength.
Target Area
Pelvic floor muscles
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5330
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5330 Transcutaneous electrical continence device

§ 876.5330 Transcutaneous electrical continence device.

(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]

Cutaneous Electrode Stimulator For Urinary Incontinence

Page Type
Product Code
Definition
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Physical State
Electrodes
Technical Method
Current applied to pelvic floor muscles to improve strength.
Target Area
Pelvic floor muscles
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5330
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5330 Transcutaneous electrical continence device

§ 876.5330 Transcutaneous electrical continence device.

(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]