SNORE-AID MAX

K022284 · Dental Imagineers, LLC · LRK · Dec 10, 2002 · Dental

Device Facts

• Record ID: K022284
• Device Name: SNORE-AID MAX
• Applicant: Dental Imagineers, LLC
• Product Code: LRK · Dental
• Decision Date: Dec 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Snore-Aid® Max is prescribed for the patient by the healthcare professional. A. Snore-Aid® Max is indicated for use in patients with benign snoring, or snoring and mild to moderate obstructive sleep apnea (OSA) where mandibular advancement and tongue positioning can increase pharyngeal air space. B. Snore-Aid® Max is indicated to prevent symptoms of nocturnal parfunctional jaw activity in patients who are undergoing treatment for snoring and/or OSA by mandibular advancement and tongue positioning.

Device Story

Snore-Aid® Max is a mandibular advancement and tongue positioning orthotic (MAPTO) used to treat snoring and mild-to-moderate obstructive sleep apnea. The device functions by mechanically advancing the mandible and positioning the tongue to increase pharyngeal air space. It is a hybrid appliance that utilizes either an external or internal lip shield; the internal shield requires a vacuum-formed tray to protect gingival tissue and distribute pressure. The device is customized chair-side by a healthcare professional using polycaprolactone, which is molded to the patient's anatomy. No hinges are required. By maintaining the mandible in an advanced position, the device reduces airway obstruction during sleep, potentially benefiting patients by reducing snoring and OSA symptoms. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Mandibular advancement orthotic; hybrid design with external or internal lip shield. Materials: polycaprolactone (thermoplastic). No hinges. Custom-molded chair-side. Non-powered, mechanical device.

Indications for Use

Indicated for patients with benign snoring or mild to moderate obstructive sleep apnea (OSA) and for prevention of nocturnal parafunctional jaw activity symptoms in patients undergoing treatment for snoring/OSA via mandibular advancement and tongue positioning.

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

• Snore-Aid® Plus (K991449)
• Quiet Knight (K962516)
• Snore Guard (K882303)

Submission Summary (Full Text)

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DEC 1 0 2002

### 510 (k) Summary

June 21, 2002

William A. Belfer, DMD, MSc.D Dental Imagineers, LLC 804 West Park Avenue Ocean, New Jersey 07712

Phone: [phone] Fax: [phone]

| Device/Trade Name: | Snore-Aid® Max |
|-------------------------------|----------------------------------------------------------|
| Descriptive Name:<br>Orthotic | Mandibular Advancement and Tongue Positioning<br>(MAPTO) |
| Common Name: | Anti-snoring Device |
| Classification Name: | Device, Anti-snoring |

Substantial Equivalence Devices: The Snore-Aid® Max appliance is substantially equivalent to its predicate Snore-Aid® Plus device ( K 991449), Quiet Knight (K962516), and Snore Guard (K882303) devices.

Snore-Aid® Plus is a single plate mandibular advancement and tongue positioning orthotic consisting of an occlusal bite plate, an external maxillary lip shield, and a wide occlusal surface. The primary function of the Snore-Aid® Max is to oven the pharvngeal airway by mandibular advancement and tongue positioning in order to reduce snoring and obstructive sleep apnea

Intended Use: Snore-Aid® Max is prescribed for the patient by the healthcare professional.

- Snore-Aid® Max is indicated for use in patients with benign snoring, or snoring A. and mild to moderate obstructive sleep apnea (OSA) where mandibular advancement and tongue positioning can increase pharyngeal air space.
B. Snore-Aid® Max is indicated to prevent symptoms of nocturnal parfunctional jaw activity in patients who are undergoing treatment for snoring and/or OSA by mandibular advancement and tongue positioning.

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Technological Characteristics: Quiet Knight is a dual plate appliances in which the upper and lower plates are connected by an adjustable hook and screw assembly that holds the mandible in an advanced position. Adjustments are made by turning the screw with a special wrench until the advancement is 70% of the maximum protrusion. Quiet knight uses unique material polycaprolactone instead of EVA to form the retentive portion of the appliance. With Snore Guard the mandibular advancement takes place by having the patient bite into the softened EVA material in an edge toe edge position. With both the predicate and the Snore-Aid® Max the adjustment is effected by poisoning the lip shield rearwardly in successive increments until the appliance reduces snoring and OSA. The Snore-Aid® Max is a hybrid appliance that may utilize the external lip shield or it may utilize an internal lip shield. In the latter case, the lip shield must be applied against a thin vacuum formed tray to protect the gingival tissue and adsorb pressure across the maxillary arch. The value of both methods is that there is no hinge required in the appliance. Also, the design of Snore-Aid® Max facilitates a simple and inexpensive chair side process using polycaprolactone to mold and customize the body of the appliance.

#### Clinical Data: See section on performance

Conclusion: The Snore-Aid® Max is appropriate for its intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2002

Mr. William A. Belfer Dental Imagineers, LLC 804 West Park Avenue Ocean, New Jersey 07712

Re: K022284

Trade/Device Name: Snore-Aid® Max Regulation Number: None Regulation Name: Anti-Snoring Device Regulatory Class: Unclassified Product Code: LRK Dated: October 9, 2002 Received: October 7, 2002

Dear Mr. Belfer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 Amendments, 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 controls provisions of the Act. The general controls provisions of the Act include requirements for 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 your device can be found 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.

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#### Page 2 - Mr. Belfer

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. You must comply with all the Act's requirements, including, but not limited to: registration 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), 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 Ulatowski

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

Enclosure

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K 022284

510(k) Number (if known):

Snore-Aid® Max Device Name:

Indications For Use:

Snore-Aid® Max is prescribed for the patient by the healthcare professional.

A. Snore-Aid® Max is indicated for use in patients with benign snoring or snoring and mild to moderate obstructive sleep apnea (OSA) where mandibular advancement and tongue positioning can increase pharyngeal air space.

B. Snore-Aid® Max is indicated to prevent symptoms of nocturnal parafunctional jaw D. Short-Podes Max is marce to pg treatment for snoring and/or OSA by mandibular advancement and tongue positioning.

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

# Concurence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ?ct 21 CFR 801.109)

Susan Raaser

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices KONYO

510(k) Number

OR

3-1

Over-The-Counter Use

(Optional Formal 1-2-96)