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Non-Invasive Vagus Nerve Stimulator - Headache

Page Type
Product Code
Definition
The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.
Physical State
The device is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, a control to power on the device and control stimulation intensity, and a pair of stainless steel skin contact surfaces.
Technical Method
The device produces a low voltage electric signal that generates an electric field in the vicinity of the vagus nerve. The strength of the stimulation is lower than that required to activate efferent vagus nerve stimulation that mediates cardiac specific effects. Conductive electrode gel is provided for use with the device.
Target Area
The device is used on the side of the neck for non-invasive Vagus Nerve Stimulation (nVNS).
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5892
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5892 External vagal nerve stimulator for headache

§ 882.5892 External vagal nerve stimulator for headache.

(a) Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.

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

(1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm

2, r.m.s.), maximum average current (mA), maximum average power density (W/cm

2), and the type of impedance monitoring system shall be fully characterized through non-clinical performance testing.

(2) Software verification, validation, and hazard analysis shall be performed.

(3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.

(4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).

(5) The labeling must include:

(i) Instructions for proper use of the device, including placement of the device on the patient; and

(ii) Instructions on care and cleaning of the device.

[82 FR 61169, Dec. 27, 2017]

Non-Invasive Vagus Nerve Stimulator - Headache

Page Type
Product Code
Definition
The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.
Physical State
The device is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, a control to power on the device and control stimulation intensity, and a pair of stainless steel skin contact surfaces.
Technical Method
The device produces a low voltage electric signal that generates an electric field in the vicinity of the vagus nerve. The strength of the stimulation is lower than that required to activate efferent vagus nerve stimulation that mediates cardiac specific effects. Conductive electrode gel is provided for use with the device.
Target Area
The device is used on the side of the neck for non-invasive Vagus Nerve Stimulation (nVNS).
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5892
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5892 External vagal nerve stimulator for headache

§ 882.5892 External vagal nerve stimulator for headache.

(a) Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.

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

(1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm

2, r.m.s.), maximum average current (mA), maximum average power density (W/cm

2), and the type of impedance monitoring system shall be fully characterized through non-clinical performance testing.

(2) Software verification, validation, and hazard analysis shall be performed.

(3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.

(4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).

(5) The labeling must include:

(i) Instructions for proper use of the device, including placement of the device on the patient; and

(ii) Instructions on care and cleaning of the device.

[82 FR 61169, Dec. 27, 2017]