NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE

K020893 · Dennis R. Bailey, Dds · LRK · May 28, 2002 · Dental

Device Facts

• Record ID: K020893
• Device Name: NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
• Applicant: Dennis R. Bailey, Dds
• Product Code: LRK · Dental
• Decision Date: May 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NOrAD device (appliance) is indicated for use in patients who are snorers or have mild to moderate obstructive sleep apnea that has been medically diagnosed or are intolerant to nasalCPAP and wish to reducc and manage their condition while sleeping. The device may be used in individuals who have had an overnight sleep study and do not have apaca or have mild to moderate obstructive sleep apnea and their physician has recommended the appliance. The device may also be indicated for a patient that snores and may have obstructive sleep apnea but their physician does not feel a sleep study is indicated and has recommended or referred the patient for appliance therapy. In many instances the decision will have been made after consultation has occurred between the dentist and the physician.

Device Story

NOrAD is a mandibular repositioning appliance for snoring and sleep apnea management. Device consists of a hard outer component containing heat-sensitive material for custom fitting to patient teeth. Features hooks on upper and lower components for attachment of conventional orthodontic elastics to prevent mandibular retrusion; includes ramps on both components to guide mandible forward during occlusion and provide posterior support. Provides full dental coverage to prevent tooth movement. Allows for vertical, lateral, and limited horizontal jaw movement during sleep, enabling patient-determined jaw positioning based on sleep posture. Used in clinical settings; prescribed by dentists in consultation with physicians. Benefits include airway improvement, reduction of snoring, and management of sleep apnea without locking the jaw into a fixed position.

Clinical Evidence

No clinical data specific to the NOrAD device was provided. Evidence relies on literature regarding oral appliance therapy for snoring and sleep apnea, including a 1998 Pancer et al. study (CHEST) reporting 95% success in snoring reduction and 83% effectiveness in sleep apnea management, and 1995 American Academy of Sleep Medicine Standards of Practice and Guidelines supporting oral appliance efficacy for mild to moderate sleep apnea.

Technological Characteristics

Hard outer component with heat-sensitive material for custom dental fit. Features orthodontic elastic hooks (two upper, one lower) and integrated ramps for mandibular guidance and posterior support. Full dental coverage design. Non-locking mechanism allows vertical, lateral, and limited horizontal jaw movement. Standalone device; no energy source or software.

Indications for Use

Indicated for patients who are snorers or have medically diagnosed mild to moderate obstructive sleep apnea, or are intolerant to nasal CPAP. Applicable to individuals who have undergone an overnight sleep study or patients for whom a physician has recommended appliance therapy 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
• TAP
• EMA

Submission Summary (Full Text)

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# MAY 2 8 2002

K020893

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

Elow, Nesemy of Crisity - Feliavy, International College of Develse, Thisman, Americal Router of Partical Partilat Por " "Patomy of Circuidiatory - Rilow, Repressonal Caling of Devels - Pakenal Policial Proience Posterial Proinces Preisy

> GENERAL DENTIST: PRACTICE RESTRICTED TO CRANIOFACIAL PAIN & RELATED HEADACHE DISORDERS. OROFACIAL PAIN & TEMPOROMANDIBULAR JOINT DISORDERS, INTRAORAL APPLIANCE THERAPY FOR SNORING & RELATED BHEATHING DISORDERS. ORTHODONTICS

> > Premarket Notification [510(k)] Summary

Contact Person:

Date Prepared :

Dennis R. Bailey, DDS March 7, 2002

Name of the Device:

Trade Name:

NOrAD

NOrAD

Common Name:

Mandibular repositioning appliance (device) Device, Anti-Snoring and to Manage Sleep Apnea Classification Name: Substantial Equivalence is being made to other "boil and bite" or "boil and fit" devices, specifically the Silencer Custom and the TAP, as well as a custom fit Device (EMA) that uses an elastic module to secure the upper and lower as well as reposition the jaw and are advocated for the management of snoring and sleep apnea.

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

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7901 F. Belleview Aventie - Suite 200 Finglewood, Colorado 80111 Pirone 303-770-3300 * Fax [phone]

o-mail [e-mail]

801 N. Cascado Avenue - Suite 35 Colorado Springs, Colorado 80903 Phone [phone] * Fax [phone]

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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 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 reduction and management of sleep apnea, as well as snoring.

Technologic Characteristics: Compared to the Silencer Custom, the EMA and the TAP appliance 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. In addition the literature supports the historical significance of oral devices that reposition the

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jaw and reduce and mange snoring as well as sleep apnea. Pancer et al described this in an article published in the journal CHEST in 1998, where they concluded that mandibular repositioning appliances were 95% successful in reducing and/or controlling snoring and were 83% effective in managing sleep apnea. 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 and mild to moderate sleep apnea.

Based on clinical data, it is demonstrated in a variety of articles that looked at oral appliances and their use for the treatment of snoring and sleep apnea, oral appliance therapy is an effective means by which these conditions 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 and sleep apnea.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 2 8 2002

Dr. Dennis R. Bailey 7901 East Belleview Avenue, Suite 200 Englewood, Colorado 80111

Re: K020893

Trade/Device Name: NOrAD Regulation Number: None Regulation Name: Intra-Oral Mandibular Repositioner Regulatory Class: Unclassified Product Code: LRK Dated: March 7, 2002 Received: March 19, 2002

Dear Dr. Dennis R. Bailey:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have to revea you and have determined 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 mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include comeons provincias or annual registration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 will), it ind of our anyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further 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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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#### Page 2 - Dr. Dennis R. Bailey

You must comply with all the Act's requirements, including, but not limited to: registration You must comply with and the riobeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labeling (21 cm (QS) regulation (21 CFR Part 820); and if requirents as act fortin in the quarty by steam (Sections (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 11113 letter will and w you to cogin interest in 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 If you desire specific as not 2009.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and 160 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 notheation (11 OF ICP at 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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# K020893

Page 1 of 1

510(k) Number (if known): NO-AD Device Name:_

Indications For Use:

The NOrAD device (appliance) is indicated for use in patients who are snorers or have mild to moderate obstructive sleep apnea that has been medically diagnosed or are intolerant to nasalCPAP and wish to reducc and manage their condition while sleeping.

The device may be used in individuals who have had an overnight sleep study and do not have apaca or have mild to moderate obstructive sleep apnea and their physician has recommended the appliance. The device may also be indicated for a patient that snores and may have obstructive sleep apnea but their physician does not feel a sleep study is indicated and has recommended or referred the patient for appliance therapy. In many instances the decision will have been made after consultation has occurred between the dentist and the physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use_

(Optional Formal 1-2-9(

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