ACRYLIC HERBST APPLIANCE

K113126 · Gergens Orthodontic Lab · LRK · Jul 17, 2013 · Dental

Device Facts

• Record ID: K113126
• Device Name: ACRYLIC HERBST APPLIANCE
• Applicant: Gergens Orthodontic Lab
• Product Code: LRK · Dental
• Decision Date: Jul 17, 2013
• 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 for treatment of snoring and mild-to-moderate obstructive sleep apnea. Device consists of upper and lower acrylic splints connected bilaterally by a telescoping Herbst mechanism. Operated by a physician or dentist, the device is worn by the patient to increase pharyngeal space via anterior mandibular repositioning, thereby improving air exchange. Device is non-sterile and customized to individual patient anatomy. Clinical benefit is the reduction of snoring and apnea symptoms.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing regarding material properties, including water solubility, absorption, tensile strength, flexural strength, and elastic modulus. Risk analysis performed.

Technological Characteristics

Materials: Medical grade polymethylmethacrylate (acrylic) and stainless steel. Design: Upper and lower customized splints with bilateral telescoping Herbst mechanism. Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile.

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)
• Embassy Dental (K111009)

Submission Summary (Full Text)

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# K113126

### 510(k) Summary

| 510(k) Summary | | | JUL 1 7 2013 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|
| Date: | 5 June 2013 | | |
| Sponsor: | GERGEN'S ORTHODONTIC LAB INC | | |
| | 1745 West Deer Valley Rd, Suite 112 | | |
| | Phoenix, AZ 85027 | | |
| | Phone: | 623-879-6066 | |
| | Fax: | 623-879-6166 | |
| Contact Person: | Chris Morrison, Lab Manager | | |
| Proposed Trade Name: | Acrylic Herbst Appliance | | |
| Common Name: | Anti-snoring appliance | | |
| Device Classification | Class II | | |
| Classification Name: | Device, Anti-Snoring | | |
| Regulation and Name: | 872.5570, Intraoral devices for snoring and intraoral devices for snoring and<br>obstructive sleep apnea | | |
| Device Product Code: | LRK | | |
| Device Description: | The Acrylic Herbst Appliance is comprised of upper and lower customized<br>acrylic splints which are connected bilaterally via a telescoping Herbst<br>mechanism for the treatment of mild to moderate sleep apnea. | | |
| | The device aims to improve the patient's air exchange thereby reduce<br>snoring and apnea by increasing the pharyngeal space through anterior<br>repositioning of the mandible. | | |
| Intended Use: | The Acrylic Herbst Appliance is intended for the reduction of night time<br>snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18<br>years of age or older. | | |
| Materials: | Medical grade polymethylmethacrylate (acrylic splints) and stainless steel<br>(Herbst mechanism) | | |
| Predicate Devices: | Allesee Orthodontic Appliances, Inc. (K070327) | | |
| | Specialty Appliances Works, Inc. (K083209) | | |
| | Dynaflex Inc. (K103076) | | |
| | Embassy Dental (K111009) | | |
| Performance Data: | Data regarding performance testing of the device material was provided in<br>support of clearance. The data included general properties (water solubility<br>and absorption) and physical properties (tensile and flexural strength, and<br>elastic modulus). | | |
| | In addition, a risk analysis found no new safety concerns specific to the<br>Gergen's Orthodontic Acrylic Herbst Appliance. | | |
| | Clinical testing of the subject device was not used in support of clearance. | | |
| Technological<br>Characteristics: | The fundamental scientific technology of the Gergen's Orthodontic Acrylic<br>Herbst Appliance is the same as previously cleared devices as shown<br>below, i.e., each of the design features is common to one or more of the | | |

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| System: | Gergen's<br>Orthodontic -<br>Acrylic Herbst<br>Appliance | Embassy<br>Dental -<br>Acrylic<br>Herbst<br>Appliance | Allesee<br>Orthodontic<br>- Removable<br>Acrylic<br>Herbst | Specialty<br>Appliances -<br>Acrylic<br>Herbst Splint<br>Appliance | Dynaflex Inc.<br>- Adjustable<br>Herbst<br>Appliance |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------|
| Intended<br>use/Indications<br>for use :: | The reduction of night<br>time snoring and mild<br>to moderate<br>obstructive sleep<br>apnea (OSA) | Same - | Same | Same | Same |
| Target population: | Adults | Same | Same | Same | Same |
| Prescription use: | Prescription only | Same | Same | Same | Same |
| Basic Design: | Upper and lower<br>trays connected<br>bilaterally by<br>telescoping Herbst<br>mechanisms | Same | Same | Same | Same |
| Function: | To increase the<br>patient's the<br>pharyngeal space<br>and improve air<br>exchange thereby<br>reduce snoring and<br>apnea by anterior<br>repositioning of the<br>mandible | Same | Same | Same | Same |
| Materials of<br>manufacture: | Medical grade acrylic<br>and stainless steel | Same | Same | Same | Same |
| Adjustability: | Yes, by prescribing<br>dentist or physician | Same | Same | Same | Same |
| Method of<br>manufacture: | Customized to the<br>specifications of a<br>single patient | Same | Same | Same | Same |
| Sterility: | Non-sterile | Same | Same | Same | Same |

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 is as safe and as effective for its intended use, and performs as well as the predicate devices. The Acrylic Herbst Appliance can be found substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G68 Silver Spring, MD 20993-0002

#### July 17, 2013

Gergens Orthodontic Lab C/O Karen E. Warden, Ph.D. President BackRoads Consulting, Incorporated 11825 Sate Route 40 Suite 101 DUNLAP IL 61525

Re: K113126

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 5, 2013 Received: June 6, 2013

Dear Dr. Warden:

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: CDRII 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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Image /page/3/Picture/6 description: The image shows the name "Mary S. Runner - S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The text appears to be a signature or a name tag.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## GERGENS ORTHODONTIC LAB INC

1745 West Deer Valley Rd Suite 112 Phoenix, AZ 85027

510(k) Number: K113126

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 | <span> X </span> |
|-----------------------|----------------------------------------------|
| | 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)

| | Mary S. Runner -S |
|--|---------------------------------|
| | Susan Runner DDS, MA 2013.07.17 |
| | 15:48:43 -04'00' |

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K113126 |
|----------------|---------|
|----------------|---------|

Gergens Othodontic Lab, Inc