K Number
K013049
Device Name
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
Date Cleared
2001-11-29

(79 days)

Product Code
Regulation Number
872.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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 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.
More Information

the Silencer Custom, the Therasnore

Not Found

No
The device description focuses on mechanical components and materials for fitting and positioning the jaw. There is no mention of any computational or data-driven elements that would suggest AI/ML.

Yes.
The device is indicated for use in snorers to reduce or manage snoring, which is a health-related condition, and its function involves physical interaction to reposition the mandible.

No

The provided text describes the device's function as reducing or managing snoring by repositioning the mandible. It does not mention any diagnostic capabilities like analyzing biological data to identify a condition or disease.

No

The device description clearly details a physical, hard outer component with heat-sensitive material, hooks for elastics, and ramping, indicating it is a hardware device intended for physical placement in the mouth.

Based on the provided information, the NOrAD device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs are used to examine specimens from the human body. The NOrAD device is a physical appliance worn in the mouth to manage snoring. It does not analyze blood, urine, tissue, or any other biological sample.
  • The intended use is to reduce snoring. The device's function is mechanical, repositioning the jaw to help manage snoring. It is not used to diagnose a condition or provide information about a patient's health status based on laboratory analysis.
  • The device description focuses on its physical components and how it fits and functions within the mouth. There is no mention of reagents, assays, or any other elements typically associated with IVDs.

The NOrAD device falls under the category of a medical device, specifically likely a dental or oral appliance, used for a therapeutic or management purpose (reducing snoring).

N/A

Intended Use / 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.

Product codes

LRK

Device Description

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

the Silencer Custom, the Therasnore

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
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.(b)
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.”

0

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

1

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

Page 5-2

2

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

4

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

5

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)