NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE

K013049 · Dennis R. Bailey, Dds · LRK · Nov 29, 2001 · Dental

Device Facts

• Record ID: K013049
• Device Name: NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
• Applicant: Dennis R. Bailey, Dds
• Product Code: LRK · Dental
• Decision Date: Nov 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for the control, reduction and management of snoring, primarily nocturnal, allowing for quieter sleep with less sleep fragmentation. Sleep fragmentation is equivalent to sleep disruption and has been shown to be responsible for daytime hypersomnolence.

Device Story

NOrAD is a mandibular repositioning appliance for snoring management. Device consists of hard outer component with heat-sensitive material for custom dental fitting; includes hooks for orthodontic elastics to prevent mandibular retrusion. Features ramps on upper and lower components to guide mandible forward during occlusion and provide posterior support. Allows full dentition coverage to prevent tooth movement; anterior indexing allows patient-determined jaw positioning during sleep while permitting vertical and lateral movement. Used by patients during sleep; fitted by dental professionals. Benefits include reduced snoring and sleep fragmentation. Unlike predicate devices, NOrAD does not lock the jaw into a fixed position, allowing for natural jaw movement during sleep without increased muscle activity.

Clinical Evidence

No clinical data specific to the NOrAD device was provided. Evidence relies on literature reviews, including Pancer et al. (1998) reporting 95% success in snoring reduction with mandibular repositioning appliances, and American Academy of Sleep Medicine guidelines (1995) supporting oral appliance therapy for snoring management.

Technological Characteristics

Mandibular repositioning appliance; hard outer component with heat-sensitive material for custom dental fit. Features hooks for orthodontic elastics and guiding ramps for mandibular advancement. Allows vertical and lateral jaw movement. Non-locking design. No electronic components or software.

Indications for Use

Indicated for patients who are primary snorers wishing to reduce or manage snoring. Intended for individuals determined not to be at risk for sleep apnea, including those with a Respiratory Disturbance Index (RDI) below the threshold for sleep apnea diagnosis, or those determined by a physician to be candidates for snoring management without a sleep study.

Regulatory Classification

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Predicate Devices

• Silencer Custom
• Therasnore

Submission Summary (Full Text)

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K013049

## Dennis R. Bailey, D.D.S.

Fellow, Academy of Gencral Dentisty - Fellow, International Cinitege of Denoss - Diplomate, American Board of Cro President Sleep Disorders Dental Society (1998-1999) - crediteritiation Board of the Sleep Disorders De

GENERAL CREVIST PRACTICE RESTRICTED TO OROFACIAL PAIN & TEMPOR NOV 2 9 2001 INTRAORAL APPLIANCE THER

## Premarket Notification [510(k)] Summary

Contact Person: Dennis R. Bailey, DDS

Date Prepared : September 5, 2001

NOrAD Name of the Device:

Trade Name: NOrAD

Common Name: Mandibular repositioning appliance (device)

Classification Name: Device, Anti-Snoring

Substantial Equivalence is being made to other "boil and bite" or "boil and fit" devices, specifically the Silencer Custom and the Therasnore, which are

advocated for the management of snoring.

Description of the Device: This device has a hard outer component with heat sensitive material contained within that component. The heat sensitive material is softened and is what fits the appliance to the patient's teeth for securing the appliance in place. Hooks for conventional Orthodontic elastics exist on the outer component for the purpose of attaching the elastics to prevent the mandible from retruding. The upper component has two (2) hooks and the lower component has one (1) hook. This allows for various methods of elastic placement depending on the need(s) of the patient. There is ramping on both the upper and the lower to facilitate and guide the mandible forward when the Page 5-1

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patient is in occlusion. These ramps also provide a posterior stop for support of the mandible. The appliance also provides for full coverage of the dentition to prevent any tooth movement or occlusal changes. The teeth at the anterior of the appliance allow for indexing of the appliance at a position most acceptable to the patient during wear and allows the patient to determine the most effective jaw position for repositioning dependent on sleep position. The teeth index in such a way to allow for freedom of movement of the jaw during sleep while remaining in an indexed position.

Intended Use: This device is intended for the control, reduction and management of snoring, primarily nocturnal, allowing for quieter sleep with less sleep fragmentation. Sleep fragmentation is equivalent to sleep disruption and has been shown to be responsible for daytime hypersomnolence.

Technologic Characteristics: Compared to the Silencer Custom and the Therasnore the NOrAD appliance does not hold or lock the jaw into a set position while also repositioning the mandible. The NOrAD allows for free movement both vertically as well as laterally and to some degree horizontally. This allows the patient the ability to move the jaw during sleep without inducing increased muscle activity.

Substantial Equivalence is based on non-clinical data as it relates to the historical significance of oral devices that reposition the jaw and reduce or mange snoring. Pancer et al described this in an article published in the iournal CHEST in 1998, where they concluded that mandibular repositioning

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appliances were 95% successful in reducing and/or controlling snoring. In addition the American Academy of Sleep Medicine (formerly the American Sleep Disorders Association) published in 1995 their Standards of Practice and Guidelines which demonstrated that oral appliances were effective in the management of snoring.

Based on clinical data, repeatedly demonstrated in a variety of articles that looked at oral appliances and their use for the treatment of snoring, oral appliance therapy is an effective means by which snoring can be managed. This effectiveness is embraced from a variety of aspects including safety, convenience and cost.

In conclusion, a number of studies have shown improvement of the airway utilizing imaging associated with the use of oral appliances (also referred to as Oral Airway Dilators), which aids in the management and reduction of snoring.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles three stylized birds in flight. The emblem is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2001

Dr. Dennis R. Bailey Dennis R. Bailey, DDS 7901 East Belleview Avenue, Suite Englewood, Colorado 80111

Re: K013049

K015049
Trade/Device Name: Norad, Noctural Oral Airway Dilator Appliance Regulation Number: None Regulation Name: Intra-Oral Mandibular Repositioner Regulatory Class: Unclassified Product Code: LRK Dated: September 7, 2001 Received: September 11, 2001

Dear Dr. Bailey:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becares is a read the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate conmisece proct to may 20, 20, 2017 reclassified in accordance with the provisions of Alliendinents, or to de roses and metic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Commay, therefore, market the device, subject to the general approval application (1 Mary). The general controls provisions of the Act include controls provisions of the ristration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is olubbined (200 as a difional controls. Existing major regulations affecting (PMA), it may oc subject to back adata f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements meall that I DA nas made a december and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and regirements, including, but not limited to: registration

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## Page 2 - Dr. Bailey

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 2 9 2001

**Page** of

510(k) Number (if known): KO13049 Nor AD Device Name: __

Indications For Use:

The NOrAD device is indicated for use in patients who are snorers and wish to reduce or otherwise manage their snoring while sleeping.

The device is to be used with individuals in whom it has been determined that they are primary snorers and are not at risk for sleep apnea. In many instances these individuals may have had a sleep study and have been found to have a Respiratory Disturbance Index (RDI) below the level that necessitates a diagnosis for sleep apnea. They may also be individuals who are snorers and whose physician has determined that they are not candidates for a sleep study and may proceed with management of their snoring utilizing this device. Many times this decision will have been achieved after consultation has occurred between the dentist and their physician.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suesan Runng

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K013041

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use .

(Optional Format 1-2-96)