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Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Page Type
Product Code
Definition
A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.
Physical State
The device is an intraoral removable mouthpiece that delivers a series of electrical pulse bursts with rest periods to electrodes that sandwich the tongue
Technical Method
The device is an external tongue muscle stimulator that delivers neuromuscular electrical stimulation to intrinsic and extrinsic tongue muscles in the daytime in order to increase muscle tone and prevent excess tongue muscle relaxation during sleep.
Target Area
The device is placed in the mouth but specifically targets the musculature of the tongue
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5575
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea

§ 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.

(a) Identification. A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.

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

(1) Performance testing must demonstrate the wireless compatibility, electrical safety, battery safety, and electromagnetic compatibility of the device in its intended use environment.

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

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

(4) Patient labeling must include:

(i) Information on device components, setup, and use of the device including placement of sensors and mouthpieces, and images or illustrations;

(ii) A summary of technical specifications;

(iii) Instructions on how to clean and maintain the device;

(iv) A statement that the patient should maintain regular follow up visits with dentist and sleep specialist; and

(v) A statement that patients should have a comprehensive dental examination prior to using this device.

(5) A human factors assessment must evaluate simulated use of the device to demonstrate that the user can correctly use device based on the labeling and instructions for use.

[89 FR 71154, Sept. 3, 2024]

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Page Type
Product Code
Definition
A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.
Physical State
The device is an intraoral removable mouthpiece that delivers a series of electrical pulse bursts with rest periods to electrodes that sandwich the tongue
Technical Method
The device is an external tongue muscle stimulator that delivers neuromuscular electrical stimulation to intrinsic and extrinsic tongue muscles in the daytime in order to increase muscle tone and prevent excess tongue muscle relaxation during sleep.
Target Area
The device is placed in the mouth but specifically targets the musculature of the tongue
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5575
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea

§ 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.

(a) Identification. A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.

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

(1) Performance testing must demonstrate the wireless compatibility, electrical safety, battery safety, and electromagnetic compatibility of the device in its intended use environment.

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

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

(4) Patient labeling must include:

(i) Information on device components, setup, and use of the device including placement of sensors and mouthpieces, and images or illustrations;

(ii) A summary of technical specifications;

(iii) Instructions on how to clean and maintain the device;

(iv) A statement that the patient should maintain regular follow up visits with dentist and sleep specialist; and

(v) A statement that patients should have a comprehensive dental examination prior to using this device.

(5) A human factors assessment must evaluate simulated use of the device to demonstrate that the user can correctly use device based on the labeling and instructions for use.

[89 FR 71154, Sept. 3, 2024]