ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE

K971794 · Frantz Design, Inc. · LRK · Sep 29, 1997 · Dental

Device Facts

• Record ID: K971794
• Device Name: ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
• Applicant: Frantz Design, Inc.
• Product Code: LRK · Dental
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where repositioning of the mandible can increase the patients air space.

Device Story

Customized dental appliance; retains position via pressure-formed plastic in tooth undercuts; advances mandible and opens bite using removable elastic bands/straps of varying thicknesses. Used by patients to treat obstructive sleep apnea and snoring; prescribed by physicians. Device pulls tongue forward by positioning mandible anteriorly and inferiorly; increases patient airspace; reduces upper airway obstruction. Unlike rigid predicate devices, allows for mouth opening and variable advancement amounts. Patient benefits from reduced apnea-hypopnea index.

Clinical Evidence

Clinical study at University of Texas Medical Branch; 13 obstructive sleep apnea patients. Mean apnea-hypopnea index (AHI) 60 events/hr without device; reduced to 21 events/hr with EMA device. Average mandibular advancement of 9 mm.

Technological Characteristics

Custom-fitted dental appliance; pressure-formed plastic construction; non-rigid retention via tooth undercuts; mechanical mandibular advancement via replaceable elastic bands/straps; allows for variable bite opening; no electronic components; non-sterile.

Indications for Use

Indicated for patients diagnosed with obstructive sleep apnea and snoring where mandibular advancement and bite opening can increase airway space. Not indicated for central sleep apnea.

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

• NAPA (K902790)
• SNOAR (K880956)

Submission Summary (Full Text)

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K971794

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SEP 2 9 1997

# 510(k) Summary

May 14, 1997 Date:

Donald Frantz, D.D.S. Frantz Design Incorporated 400 Medical Center. # 209 Webster. Texas 77598

Phone: [phone] [phone] Fax:

Device Name:

Trade/Proprietary Name: Elastic Mandibular Advancement (EMA) appliance Common Name: Sleep Apnea/Anti-snoring device Classification Name: Activator dental appliance

#### Substantial Equivalence Comparison:

The Elastic Mandibular Advancement (EMA) appliance is substantially equivalent to the NAPA [510(k) # K902790] and the SNOAR [510(k) # K880956] appliances.

#### Description:

The Elastic Mandibular Advancement appliance is a modified functional orthodontic The modifications are: 1) clasps are not needed as the appliance is appliance. retained firmly to the teeth by pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thicknesses. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in a fixed position , but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.

#### Intended Use:

Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where repositioning of the mandible can increase the patients air space.

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### Technological characteristics:

The NAPA. SNOAR and EMA appliances advance the mandible to an anterior and inferior position with regard to the maxilla. This repositioning of the mandible pulls the tongue forward and increases the patient's airspace, thereby decreasing upper airway obstruction. Such obstruction can be a causative factor in snoring and obstructive sleep apnea. All three devices are prescribed for patients after diagnosis of obstructive sleep apnea by a physician. None of the appliances are indicated for the treatment of central sleep apnea.

The NAPA, SNOAR and EMA appliances are similar in that they all are individually customized mouthpieces that fit uniquely into patients mouths. None of the appliances allow for movement of the teeth. While the NAPA and SNOAR appliances maintain dental integrity with the use of wire the EMA appliance extends the appliance material into the undercut areas of the teeth, therefore maintaining integrity.

The NAPA, SNOAR and EMA appliances all allow for nasal and/or oral breathing. The NAPA and SNOAR appliances advance the mandible and hold it in place rigidly. The EMA appliance advances the mandible but allows for opening of the mouth therefore eliminating the need for a "breathing beak" as the NAPA appliance has.

## Clinical Data:

Clinical testing was done at The University of Texas Medical Branch at Galveston. Overnight sleep studies with and without the EMA device were performed on 13 obstructive sleep apnea (OSA) patients with a mean apnea-hypopnea index of 60 events/hr. without the appliance. The EMA appliance advanced the mandible by an average 9 mm. EMA reduced the mean apnea-hypopnea index to 21 events/hr.

## Clinical tests conclusions:

Use of the EMA device significantly reduced episodes of obstructive sleep apnea.

Sincerely,

Donald Frantz A.O.S.

Donald Frantz, D.D.S. 400 Medical Center, #209 Webster. Texas 77598 Phone [phone] Fax [phone]

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

# SEP 2 9 1997

Donald Frantz, D.D.S. Frantz Design Incorporated 400 Medical Center, #209 Webster, Texas 77598

Re : K971794 Elastic Mandibular Advancement (EMA) Trade Name: Appliance Regulatory Class: Unclassified Product Code: LRK July 17, 1997 Dated: Received: July 21, 1997

Dear Dr. Frantz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Frantz

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot A 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Advancement (EMA) appliance Device Name: Elastic Mandibular

Indications For Use:

Indications for use: Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where advancement of the mandible and opening the bite can increase the patients air space.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

Prescription Use r 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)