K Number
K022284
Device Name
SNORE-AID MAX
Date Cleared
2002-12-10

(148 days)

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

K 991449, K962516, K882303

Not Found

No
The description focuses on the mechanical design and materials of a mandibular advancement device and does not mention any computational or data-driven features indicative of AI/ML.

Yes
The device is prescribed by a healthcare professional and is indicated for treating conditions like benign snoring and obstructive sleep apnea, which are medical conditions, aligning with the definition of a therapeutic device.

No
Explanation: The "Intended Use / Indications for Use" section describes the device as being "indicated for use in patients with benign snoring, or snoring and mild to moderate obstructive sleep apnea (OSA)" and "to prevent symptoms of nocturnal parfunctional jaw activity." These are therapeutic or preventative uses, not diagnostic. The device aims to treat conditions, not to identify or diagnose them.

No

The device description explicitly states it is a "hybrid appliance" and describes physical components like lip shields, vacuum formed trays, and the use of polycaprolactone for molding, indicating it is a physical device, not software-only.

Based on the provided information, the Snore-Aid® Max is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens from the human body. They are used to diagnose diseases or conditions based on tests performed on samples like blood, urine, tissue, etc.
  • The Snore-Aid® Max is a physical appliance. It is placed in the mouth to physically alter the position of the jaw and tongue to address snoring and sleep apnea. It does not involve the analysis of any biological specimens.

The description clearly indicates it's a device used in the patient's mouth, not a device used to test samples from the patient.

N/A

Intended Use / 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 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.

Product codes

LRK

Device Description

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.

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

healthcare professional

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)

K 991449, K962516, K882303

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

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: (732) 493-4747 Fax: (732) 493-4742

Device/Trade Name:Snore-Aid® Max
Descriptive Name:
OrthoticMandibular Advancement and Tongue Positioning
(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.

1

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.

4-2

2

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.

3

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 (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 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

4

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)