ACRYLIC HERBST APPLIANCE

K111009 · Embassy Dental Laboratory · LRK · Jul 22, 2011 · Dental

Device Facts

• Record ID: K111009
• Device Name: ACRYLIC HERBST APPLIANCE
• Applicant: Embassy Dental Laboratory
• Product Code: LRK · Dental
• Decision Date: Jul 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

Device Story

Acrylic Herbst Appliance is a custom-fabricated intraoral device used to treat snoring and mild-to-moderate obstructive sleep apnea. It consists of upper and lower acrylic splints (methylmethacrylate) connected bilaterally by a telescoping stainless steel Herbst mechanism. The device is fabricated by a dental laboratory based on a prescription for a specific patient. It functions by repositioning the mandible to maintain airway patency during sleep. It is intended for use by adults; prescribed by a clinician. The device is worn intraorally at night. By advancing the mandible, the appliance helps prevent airway collapse, thereby reducing snoring and OSA symptoms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraoral mandibular repositioning device. Materials: methylmethacrylate (acrylic splints) and stainless steel (telescoping Herbst mechanism). Design: bilateral Herbst mechanism connecting upper and lower acrylic trays. Custom-fabricated per patient prescription. No software or electronic components.

Indications for Use

Indicated for reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

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

• Allesee Orthodontic Appliances, Inc. (K070327)
• Specialty Appliances Works, Inc. (K083209)
• Dynaflex Inc. (K103076)

Submission Summary (Full Text)

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JUL 2 2 2 2011

Image /page/0/Picture/1 description: The image shows a logo for Embassy Dental Lab. The logo is in a diamond shape with the words "Embassy Dental Lab" written in a stylized font. The word "Embassy" is written in a larger font than the words "Dental Lab". The diamond shape is surrounded by a black and white patterned border. The logo is likely used to represent the dental lab in its branding and marketing materials.

| 510(k) Summary | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 8 April 2011 |
| Sponsor: | Embassy Dental Laboratory, Inc.<br>11825 North Route 40, #103<br>Dunlap, IL 61525 |
| | Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Rodney Willey, DDS, President |
| Proposed Trade<br>Name: | Acrylic Herbst Appliance |
| Device Classification | Class II |
| Classification Name: | Device, Anti-Snoring |
| Regulation and<br>Name: | 872.5570, Intraoral devices for snoring and intraoral devices for<br>snoring and obstructive sleep apnea |
| Device Product<br>Code: | LRK |
| Device Description: | The Acrylic Herbst Appliance is comprised of custom-fabricated<br>acrylic splints (methylmethacrylate) which are connected bilaterally<br>via a telescoping Herbst mechanism (stainless steel). |
| Intended Use: | The Acrylic Herbst Appliance is intended for the reduction of night<br>time snoring and mild to moderate obstructive sleep apnea (OSA) in<br>adults 18 years of age or older. |
| Predicate Devices: | Allesee Orthodontic Appliances, Inc. (K070327) |
| | Specialty Appliances Works, Inc. (K083209)<br>Dynaflex Inc. (K103076) |
| Technological<br>Characteristics: | The Acrylic Herbst Appliance possesses the same technological<br>characteristics as one or more of the predicate devices. These<br>include: |
| | <ul><li>Anatomic location (intraoral),</li></ul> |
| | <ul><li>Basic design (mandibular repositioning using upper and lower acrylic trays with bilateral Herbst mechanisms),</li></ul> |
| | <ul><li>Materials (methylmethacrylate and stainless steel) and</li></ul> |
| | <ul><li>Manufacture (appliance is fabricated by prescription to the specific requirements of a single patient)</li></ul> |
| | The fundamental scientific technology of the Acrylic Herbst Appliance<br>is the same as previously cleared devices. |

KMOOQ

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## Conclusion:

In comparison to the predicate devices, the Acrylic Herbst Appliance has

- the same intended use (as described above), .
- the same technological characteristics (as described above) .

and so does not raise new questions of safety and effectiveness. Therefore the Acrylic Herbst Appliance can' be found substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Embassy Dental Laboratory C/O Karen E. Warden, PhD President Backroads Consulting, Incorporated 8202 Sherman Road Chesterland, Ohio 44026

JUL 2 2 2011

Re: K111009

Trade/Device Name: Acrylic Herbst Appliance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: June 22, 2011 Received: June 27, 2011

Dear Dr. Werden:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Dr. Warden

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Richard C. Chapman for

Anthony D. Watson, B.S., M.S., M.B.A. 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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## Indications for Use Statement

510(k) Number:

Device Name: Acrylic Herbst Appliance

Indications for Use:

The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

Prescription Use _ X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use_

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Ayers 7/22/"1

(Division Sign-Off) rivision of Anesthesiology, General Hospital rection Control, Dental Devices

10(k) Number: K1111009