SOMNODENT HERBST; CLASSIC, FLEX

K130558 · Somnomed, Inc. · LRK · May 17, 2013 · Dental

Device Facts

• Record ID: K130558
• Device Name: SOMNODENT HERBST; CLASSIC, FLEX
• Applicant: Somnomed, Inc.
• Product Code: LRK · Dental
• Decision Date: May 17, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SomnoDent Herbst is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Device Story

SomnoDent Herbst is a custom-fitted, patient-specific intraoral mandibular repositioning device. It functions by increasing pharyngeal space during sleep to improve airway exchange. The device consists of separate upper and lower trays with an adjustable Herbst-style titration mechanism, allowing dentists or physicians to set the degree of mandibular advancement. It is intended for use at home or in sleep laboratories. Patients clean and inspect the device daily. The device allows for mouth breathing and easy removal by disengaging the trays. By maintaining mandibular advancement, it helps alleviate snoring and mild to moderate obstructive sleep apnea, potentially improving patient sleep quality.

Clinical Evidence

Bench testing only. Mechanical testing was performed on the Herbst-style titration mechanism to ensure it meets performance requirements and withstands applicable pressures. No clinical data was provided.

Technological Characteristics

Intraoral mandibular repositioning device. Materials include acrylic or soft lining adhered to acrylic. Advancement mechanism constructed of surgical grade stainless steel. Adjustable coupling mechanism for titration. Customized fit for each patient. Non-powered, mechanical device.

Indications for Use

Indicated for treatment of nighttime snoring and mild to moderate obstructive sleep apnea 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

• SomnoDent Classic (K050592)
• SomnoDent Flex (K073004)
• SomnoDent G2 (K121340)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for SomnoMed, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic above the company name, with the words "Dental - Sleep - Medical" appearing in smaller font beneath the name. The overall design is clean and professional, reflecting the company's focus on healthcare and well-being.

### 510(k) Summary (21 CFR 807.92)

MAY 1 7 2013

### Page 1 of 3

### 510(k) Number: K (3 0558

Submission Owner:

Date Prepared:

Common Name:

Product Code:

Class:

Panel:

Trade Name:

SomnoMed. Inc. 7460 Warren Parkway Suite 190 Frisco, TX 75034 Phone: [phone] x106 Fax: [phone] Email: [e-mail] Official Correspondent: Kathryn A. Jayne March 1, 2013 SomnoDent® Herbst Intraoral device for snoring and mild to moderate obstructive sleep apnea (OSA) Classification Name: Device. Anti-Snoring Regulation Number: 21 CFR 872.5570 LRK . Dental Predicate Devices: K050592, SomnoDent Classic K073004, SomnoDent Flex K121340, SomnoDent G2

#### Description of the device:

The SomnoDent Herbst is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is patient specific (it is customized for each patient) and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Herbst is a modification to the SomnoDent Classic (K050592) and SomnoDent Flex (K073004). The labeling is a modification to the SomnoDent G2 (K121340). The SomnoDent Herbst is identical to SomnoDent Classic and SomnoDent Flex, except for differences in the adjustment mechanism (which is a Herbst style titration mechanism). Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

#### Indications for Use:

The SomnoDent Herbst is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

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Image /page/1/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized black graphic above the company name. Below the name, in smaller font, are the words "Dental, Sleep, Medical".

# 510(k) Summary (21 CFR 807.92)

Page 2 of 3

### Substantial Equivalence:

.

··

Substantial Equivalence Table

:

: .

| | SomnoDent<br>Herbst | SomnoDent<br>Classic<br>K050592 | SomnoDent<br>Flex<br>K073004 | SomnoDent<br>G2<br>K121340 |
|------------------------------------------------------------------------------------------|----------------------------|---------------------------------|------------------------------|----------------------------|
| Intended Use | | | | |
| Intended as an intraoral<br>device | Yes | Yes | Yes | Yes |
| Intended to reduce<br>snoring or help alleviate<br>snoring | Yes | Yes | Yes | Yes |
| Treatment of mild to<br>moderate obstructive<br>sleep apnea | Yes | Yes | Yes | Yes |
| Intended for nighttime use | Yes | Yes | Yes | Yes |
| Indicated for single<br>patient multiuse | Yes | Yes | Yes | Yes |
| Indicated for use at home<br>or sleep laboratories | Yes | Yes | Yes | Yes |
| Target population: adults | Yes | Yes | Yes | Yes |
| Prescription device | Yes | Yes | Yes | Yes |
| Design | | | | |
| Customized fit for each<br>patient (patient specific) | Yes | Yes | Yes | Yes |
| Separate upper and lower<br>tray pieces | Yes | Yes | Yes | Yes |
| Works by mandibular<br>advancement | Yes | Yes | Yes | Yes |
| Can be adjusted or refit | Yes | Yes | Yes | Yes |
| Lower jaw adjustment<br>using supplied<br>components | Yes | Yes | Yes | Yes |
| Permits patient to breathe<br>through mouth | Yes | Yes | Yes | Yes |
| Upper and lower trays<br>disengage for easy<br>removal | Yes | Yes | Yes | Yes |
| Cleaned and inspected<br>daily by patient | Yes | Yes | Yes | Yes |
| | SomnoDent Herbst | SomnoDent Classic<br>K050592 | SomnoDent Flex<br>K073004 | SomnoDent G2<br>K121340 |
| Material | | | | |
| Trays constructed from a<br>soft lining material<br>adhered to a hard surface<br>acrylic | Yes (Flex)<br>No (Classic) | No | Yes | Yes (Flex)<br>No (Classic) |
| Advancement mechanism<br>constructed of surgical<br>grade stainless steel | Yes | Yes | Yes | No |

・

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Image /page/2/Picture/0 description: The image shows the logo for SomnoMed, a company specializing in dental, sleep, and medical solutions. The logo features a stylized graphic above the company name, resembling two overlapping shapes. Below the name, the words "Dental • Sleep • Medical" are printed in a smaller font, indicating the company's areas of focus.

## 510(k) Summary (21 CFR 807.92)

Page 3 of 3

### Substantial equivalence discussion:

The SomnoDent Herbst is considered to be substantially equivalent to the SomnoDent Classic, Flex, and G2 device. The SomnoDent Herbst and predicate devices function as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The devices are customized for each patient and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Herbst is identical to SomnoDent Classic, Flex, and G2 except for differences in the adjustment mechanism (which is a Herbst style titration mechanism. The SomnoDent Herbst will be available in one of two material types, acrylic (identical to SomnoDent Classic) or soft lining adhered to acrylic (SomnoDent Flex). Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

### Summary of Testing:

To demonstrate substantial equivalence, testing was conducted on the advancement mechanism to ensure the device performed as intended and is safe and effective. Mechanical testing was conducted on the Herbst style titration mechanism of the subject device. Testing results indicate that the mechanism withstands applicable pressures, ensuring the device is safe and effective. The testing concluded that the advancement of the subject device is substantially equivalent to the predicate device with regards to mechanical performance. Testing demonstrates that the subject device, the SomnoDent Herbst, is as safe, as effective, and performs as well as or better than the predicate devices, the SomnoDent Classic and SomnoDent Flex.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized waves or curves, stacked vertically.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

### May 17, 2013

Ms. Kathryn A. Jayne SomnoMed, Incorporated 7460 Warren Parkway, Suite 190 FRISCO TX 75034

Re: K130558

Trade/Device Name: SomnoDent Herbst 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: April 5, 2013 Received: April 17, 2013

Dear Ms. Jayne:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows the logo for SomnoMed, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic above the company name, with the words "Dental - Sleep - Medical" written in a smaller font below. The logo is simple and modern, and it conveys the company's focus on health and wellness.

### Indications for Use

510(k) Number (if known): K130558

Device Name: SomnoDent Herbst

Indications for Use:

The SomnoDent Herbst is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner, DDSMA

Digitally signed by Mary S. Runner -S
DN: US/o=U.S. Government, ou=HHS,
Our FDA, ou People, cn=Mary S. Runner

0.9.2342.19200300.100.1.1-1300087950
Date: 2013.05.17 11:39:00-04'00'

ivision Sign-Offi on of Anesthesiology, General Hospital Infection Control. Dent

510(k) Number: k120558

SomnoMed Herbst Special 510(k) Submission