ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE

K973884 · Frantz Design, Inc. · LRK · Jan 9, 1998 · Dental

Device Facts

• Record ID: K973884
• Device Name: ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
• Applicant: Frantz Design, Inc.
• Product Code: LRK · Dental
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary treatment of obstructive sleep apnea and snoring to determine in which patients mandibular advancement and opening the bite will increase the patients air space

Device Story

Disposable oral appliance used in sleep laboratories to identify obstructive sleep apnea (OSA) and snoring patients responsive to mandibular advancement. Device consists of one-size-fits-all maxillary and mandibular hard plastic trays; retained via dental silicone putty impression material. Maxillary tray features anterior midline rod; mandibular tray features Styrene Block Copolymer strap with 3mm increment holes. Sleep technician performs chairside impression; secures trays with silicone wash. Technician advances mandible during polysomnogram by adjusting strap position on rod. Output is clinical observation of apnea reduction/elimination on polysomnogram. Enables clinicians to predict treatment success before prescribing permanent custom-made oral appliances; avoids costs of custom devices for non-responders.

Clinical Evidence

Clinical study at University of Texas Medical Branch at Galveston. 12 OSA patients underwent overnight sleep studies using the EMA-T device. 5 patients (41.7%) were identified as responders and subsequently fitted with permanent oral appliances. 100% of those receiving permanent appliances responded favorably to treatment.

Technological Characteristics

Hard plastic trays; Styrene Block Copolymer strap; dental silicone putty/wash for retention. Mechanical advancement via rod-and-strap system. Dimensions: one-size-fits-all. Non-powered. No software.

Indications for Use

Indicated for adult patients with obstructive sleep apnea and snoring to determine suitability for mandibular advancement therapy. 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

• Elastic Mandibular Advancement (EMA) appliance (K971794)

Submission Summary (Full Text)

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K973884

Image /page/0/Picture/1 description: The image is a logo for Design Frantz Incorporated. The logo is in a rectangular box with rounded corners. The word "DESIGN" is at the top of the box, and the word "INCORPORATED" is at the bottom. The name "FRANTZ" is in the middle of the box in a larger, bolder font. A curved line is above the name "FRANTZ".

JAN - 9 1998

# 510(k) Summary

October 10, 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 Titration (EMA-T) appliance

Common Name: Temporary sleep apnea/anti snoring device Classification Name: Activator dental appliance

#### Substantial Equivalence Comparison:

The Elastic Mandibular Advancement Titration (EMA-T) appliance is substantially equivalent to the Elastic Mandibular Advancement (EMA) appliance [510(k) # K 971794].

#### Description:

Currently, there is no method to predict which patients will respond to treatment of obstructive sleep apnea (OSA) and snoring with an oral mandibular advancement device. The disposable Elastic Mandibular Advancement - Titration appliance will allow sleep laboratories to identify those OSA and snoring patients who will respond to mandibular advancement with an oral device avoiding the unnecessary costs of manufacture of a custom made appliance for treating patients who do not respond.

The EMA-T appliance is a modified functional orthodontic appliance. The modifications are: 1) clasps are not needed as the appliance is retained firmly to the teeth by dental impression material into undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened with bite planes as in the Elastic Mandibular Advancement appliance. 3) the mandible is advanced with an elastic strap similar to the Elastic Mandibular Advancement appliance.

Frantz Design Incorporated · 400 Medical Center, #200 · Webster, Texas 77508 · Voice [phone]

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The appliance is designed for universal application in adults with the use of one-sizefits all maxillary and mandibular hard plastic trays. On the night of the titration polysomnogram, the sleep technician makes impressions of the maxillary and mandibular teeth by placing a fast setting dental silicone putty material (such as E and D Dental Products Incorporated) in the tray and pushing the tray onto the patient's teeth. The trays and putty with the patient's impression are removed from the mouth. Just before the start of the sleep study, the impression and the patient's teeth are dried off. A liguid silicone "wash" is placed onto the patient's impression and placed on the maxillary and mandibular teeth and arches for the duration of the study. This "wash" holds the trays firmly on the patient's teeth and prevents their dislodgment during sleep. On the anterior of the maxillary tray is a rod that protrudes at the midline in front of the patient's central incisors. A Styrene Block Copolymer strap with a pull tab and holes 3 millimeters apart is connected to the mandibular tray. Mandibular advancement is achieved by pulling the tab forward and inserting the rod into one of the holes on the pull tab. The mandible is thereby held in an advanced position by the stationary maxilla, and is advanced in 3 millimeter increments. As the sleep lab technician advances the mandible, the polysomnogram will show a decrease, or even an elimination, of the patient's apneas on those responding. A prescription will then be given to the patient for a permanent custom made oral appliance.

Temporary treatment of nasal respiratory dysfunction of obstructive Intended Use: sleep apnea and snoring to determine in which patients mandibular advancement and opening the bite will increase the patients air space.

#### Technological characteristics:

The EMA and EMA-T 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 pharyngeal airway. Both devices are prescribed for patients after diagnosis of obstructive sleep apnea by a physician. Neither of the appliances is indicated for the treatment of central sleep apnea.

The EMA and EMA-T appliances are similar in that they both are individually customized mouthpieces that fit uniquely into patients mouths. Neither of the appliances allow for movement of the teeth.

The EMA and EMA-T appliances all allow for nasal and/or oral breathing.

### Clinical Data:

Clinical testing was done at The University of Texas Medical Branch at Galveston. Overnight sleep studies with the EMA - T device were performed on 12 obstructive sleep apnea (OSA) patients. To date 5 of those patients have been given a permanent oral device to treat their OSA and snoring as a result of the titration testing. To this date 100 % of the patients obtaining a permanent custom appliance have responded favorably.

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### Clinical tests conclusions:

The EMA-T device effectively determined which obstructive sleep apnea and snoring patients will respond favorably to mandibular advancement and bite opening.

Sincerely,

Ronald Trantham D.D.S.

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

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 1998

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

Re : K973884 Elastic Mandibular Advancement - Titration Trade Name: (EMA-T) Appliance Requlatory Class: Unclassified Product Code: LRK Dated: October 10, 1997 October 14, 1997 Received:

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, Druq, 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 General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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 (301)-594-4618. Additionally, for questions on and a 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,

and the formation of the first of the first of the first of the first of the first of the first of the first of the first of the formation of the form of the formation of the

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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## Attachment VII Indications for Use Statement

510 (k) Number: Being applied for

Device Name:Elastic Mandibular Advancement Titration (EMA-T) appliance

Indications For Use: Temporary treatment of obstructive sleep apnea and snoring to determine in which patients mandibular advancement and opening the bite will increase the patients air space

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Concurrence of CDRH, Office of Device Evaluation (ODE) NOW unsel

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 2866 STORES NY Use

Over-The Counter

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