ORAVAN OSA

K121285 · New Jersey Snoring Solutions · LRK · Mar 8, 2013 · Dental

Device Facts

• Record ID: K121285
• Device Name: ORAVAN OSA
• Applicant: New Jersey Snoring Solutions
• Product Code: LRK · Dental
• Decision Date: Mar 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults

Device Story

Oravan OSA is a custom-fitted, two-piece intraoral appliance designed to treat snoring and mild to moderate obstructive sleep apnea. The device consists of upper and lower acrylic trays that fit over the patient's teeth, connected by extension wings and adjustable advancement screws. It is fabricated from orthodontic acrylic based on individual dental impressions. The device functions by mechanically advancing the mandible to increase the pharyngeal opening, which improves airflow and reduces vibrations during sleep. The mandibular advancement is adjustable up to 6 mm using a supplied key. The device is intended for prescription use and is worn by the patient during sleep. It benefits patients by providing a non-invasive method to maintain airway patency.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Two-piece intraoral appliance; materials: medical-grade polymethylmethacrylate (PMMA) per ISO 20795-2:2005, medical-grade stainless steel screws/wires/ball clasps. Mechanical mandibular advancement mechanism; adjustable range up to 6 mm. Custom-fitted via dental impressions.

Indications for Use

Indicated for adults with snoring and mild to moderate obstructive 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

• Somnomed MAS RxA (K050592)
• The Moses Appliance (K093710)

Submission Summary (Full Text)

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1121285

MAR 0 8 2013

# 10(K) SUMMARY

### Submitter's Name and Contact Information 1.

Company Name: Address:

New Jersey Snoring Solutions 769 Northfield Avenue, Ste 154 West Orange, NJ 07052

Contact Person:

Deborah Stein Vice President, New Jersey Snoring Solutions

Email: Telephone: Fax:

[e-mail] 973-886-6855 973-325-6442

# Summary Preparation Date: January 14, 2013

### 2. Device Identification:

| Proprietary Name: | Oravan OSA |
|--------------------|---------------------|
| Common Name: | Anti-snoring device |
| Classification: | Class II |
| Product Code: | LRK |
| Regulation Number: | 21 CFR 872.5570 |
| Review Panel: | Dental |

### 3. Description of the Device:

The Oravan OSA has been developed for the treatment of mild to moderate obstructive sleep apnea. Each Oravan device is made for each individual patient. There are two unique acrylic pieces that fit over the top and bottom teeth. The Oravan is fully adjustable for maximum benefit to treat the symptoms of obstructive sleep apnea and snoring. The Oravan sleek design allows for comfortable mandibular movement. The Oravan is made of orthodontic acrylic. Each device is warranted for 2 full years against breakage from everyday use.

### 4. Indications for Use:

Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults

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### 5. Predicate Devices:

The Oravan OSA is substantially equivalent to the following devices:

- Somnomed MAS RxA (by Somnomed Ltd.), cleared under K050592 i.
- The Moses Appliance (by Allen J. Moses, DDS, Ltd.), cleared under ii. K093710

### Summary of Similar Technological Characteristics 6.

The proposed 'Oravan OSA' and the predicate devices are Anti-snoring devices intended to reduce snoring and mild to moderate sleep apnea in adults. Their fundamental scientific technology, design,t echnological characteristics and materials are also comparable, as outlined in the following table:

| | Subject Device | Predicate Device<br>K093710 | Predicate Device<br>K050592 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Oravan OSA | The Moses Appliance | Somnomed MAS RxA |
| | New Jersey Snoring<br>Solutions | Allen J. Moses, DDS,<br>Ltd. | Somnomed Ltd. |
| Characteristics<br>/ Features | | | |
| Indications for<br>Use | Oravan OSA is intended<br>to reduce snoring and<br>mild to moderate sleep<br>apnea in adults | The Moses appliance is<br>intended for use on<br>adult patients 18 years of<br>age and older as an aid<br>for the reduction and/or<br>alleviation of snoring<br>and mild to moderate<br>obstructive sleep apnea. | The SomnoMed MAS<br>RxA is intended to<br>reduce night time<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) in<br>adults. |
| Prescription /<br>OTC Use | Prescription only<br>Note: Custom-fitted to<br>each patient, based on<br>dental impressions | Prescription only<br>Note: Custom-fitted to<br>each patient, based on<br>dental impressions | Prescription only<br>Note: Custom-fitted to<br>each patient, based on<br>dental impressions |
| Device<br>components/<br>parts | Orthodontic Acrylic trays<br>Expansion Screws<br>Wire with Ball clasp | Orthodontic Acrylic tray<br>Expansion Screws<br>Wire with Ball clasp | Orthodontic Acrylic trays<br>Expansion Screws<br>Wire with Ball clasp |
| Device<br>configuration | Two-piece design:<br>Upper acrylic tray<br>covers top posterior<br>teeth<br>Lower acrylic tray<br>covers bottom posterior<br>teeth | One-piece design:<br>Acrylic tray covers top<br>and bottom posterior<br>teeth<br>In addition, a retainer is<br>used for the top anterior<br>teeth. No such retainer<br>is required for the<br>bottom anterior teeth | Two-piece design:<br>Upper acrylic tray<br>covers top teeth (both<br>posterior and anterior)<br>Lower acrylic tray<br>covers bottom teeth<br>(both posterior and<br>anterior) |
| | Subject Device | Predicate Device K093710 | Predicate Device K050592 |
| | Oravan OSA | The Moses Appliance | Somnomed MAS RxA |
| | New Jersey Snoring Solutions | Allen J. Moses, DDS, Ltd. | Somnomed Ltd. |
| Characteristics / Features | | | |
| Device Functionality | The device allows for increase in the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. | The device allows for increase in the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. | The device allows for increase in the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. |
| | Works by mandibular advancement using component advancement screws. | Works by mandibular advancement using component advancement screws. | Works by mandibular advancement using component advancement screws. |
| | Extension wings hold maxillary and mandibular sections in relative approximation once advancement is fixed | Extension wings hold maxillary and mandibular sections in relative approximation once advancement is fixed | Extension wings hold maxillary and mandibular sections in relative approximation once advancement is fixed |
| | Ball clasps hold the device on teeth | Ball clasps hold the device on teeth | Ball clasps hold the device on teeth |
| | Lower jaw advancement is adjustable using a supplied adjustment key | Lower jaw advancement is adjustable using a supplied adjustment key | Lower jaw advancement is adjustable using a supplied adjustment key |
| Mandibular Advancement range | Up to 6 mm | Up to 6 mm | Up to 6 mm |
| Materials | | | |
| · Orthodontic Acrylic | Two part Polymethylmethacrylate; supplied by Dentaurum; (Medical grade, biocompatible) | Two part Polymethylmethacrylate; supplied by Dentaurum; (Medical grade, biocompatible) | Two part Polymethylmethacrylate; supplied by Dentaurum; (Medical grade, biocompatible) |
| · Colorants | No colorants | Blue | Pink |
| · Screws<br>· Wire and ball clasp | Medical Grade Stainless Steel | Medical Grade Stainless Steel | Medical Grade Stainless Steel |

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### Non-Clinical Data 7.

The submission includes data regarding the physical properties of the Orthodontic Acrylic material used in the Oravan OSA. These physical properties are in accordance with the requirements and limits specified in standard ISO 20795-2:2005 - Dentistry -- Base polymers -- Part 2: Orthodontic base polymers.

### 8. Clinical Testing

The submission does not rely on any clinical data; therefore no clinical testing was performed

### 9. Conclusion:

Based on the intended use, design, technological characteristics and non-clinical information provided in the submission; the proposed 'Oravan OSA' is substantially equivalent to the predicate device, and does not raise any new concerns of safety of effectiveness.

/

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping, curved lines representing its wings or feathers.

## 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

March 8, 2013

Ms. Deborah Stein Vice President New Jersey Snoring Solutions 769 Northfield Avenue, Suite 154 WEST ORANGE NJ 07052

# Re: K121285

Trade/Device Name: Oravan OSA 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: January 16, 2013 Received: February 7, 2013

# Dear Ms. Stein:

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 - Ms. Stein

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,

Kwame O Ulmer 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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# Indications for Use

510(k) Number (if known): K12|285

Device Name:

Oravan OSA

Indications for Use:

Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults

Prescription Use (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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner -S 013:03.07 12:48:04 COLLIA 18 5'00'> 0 0

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

510(k) Number:

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