SNORKEL

K112766 · Fellmar Company · LQZ · Jun 4, 2012 · Dental

Device Facts

• Record ID: K112766
• Device Name: SNORKEL
• Applicant: Fellmar Company
• Product Code: LQZ · Dental
• Decision Date: Jun 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.

Device Story

The Snorkel is a custom-fitted oral mandibular advancement device; used by patients during sleep. Device consists of acrylic upper and lower body components; coupled together to protrude mandible forward. Silicon band provides tension to pull mandible and tongue forward; reducing tongue-induced airway obstruction. Device is custom-made based on dental impressions. Patient self-operates device at home. Output is physical repositioning of mandible; intended to improve airway patency and reduce snoring/apnea symptoms.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing and comparison of technological characteristics and materials to the predicate device.

Technological Characteristics

Oral mandibular advancement device; acrylic upper and lower body components; silicon band for tension; custom-fitted via dental impressions. No electronic components or software.

Indications for Use

Indicated for patients with mild to moderate obstructive sleep apnea to reduce tongue-induced airway obstructions.

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

• Adjustable PM Positioner (K955503)

Submission Summary (Full Text)

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KI12766

## 510(k) SUMMARY

JUN - 4 2012

Date Prepared: August 01, 2011. Updated: April 12, 2012 Submitter Information:

John Felldin, Inventor/Owner Fellmar Co. 2670 S. Myrtle Ave. #106 Monrovia, CA 91016 Email: [e-mail] Ph: 626-205-0122

Preparer: Wayne Marshall, Acting Manager Fellmar Co. 2670 S. Myrtle Ave. #106 Monrovia, CA 91016 Email: [e-mail] Ph: 213-537-5924

Device Information:

| Trade Name: | The Snorkel, Jaw Repositioning Device, K112766 |
|----------------------|------------------------------------------------|
| Common Name: | The Snorkel |
| Classification Name: | Mandibular Repositioning Device |
| Product Code: | LQZ |
| Regulation: | 21 CFR 872.5570 |

Device for which Substantial Equivalence (SE) is claimed:

| Common Name: | Adjustable PM Positioner, K955503 |
|----------------------|-----------------------------------|
| Classification Name: | Mandibular Repositioning Device |
| Product Code: | LQZ |
| Regulation: | 21 CFR 872.5570 |

Like the Adjustable PM Positioner (K955503), the Snorkel is a mouth splint appliance comprised of an acrylic upper body and an acrylic lower body, which are coupled together to push the lower jaw forward. The Snorkel is intended for use in patients, for the reduction of snoring and to treat mild to moderate obstructive sleep apnea.

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## DEVICE DESCRIPTION

The Snorkel is an oral mandibular advancement device whose function is to artificially protrude the chin (mandible) forward so as to pull the tongue away from the back of the throat, thereby reducing tongue-induced airway obstruction.

The Snorkel device is custom-made and fitted based on dental impressions and used by the patient during sleep. The single mouth piece fits snugly onto the upper and lower crowns of the patient's teeth. As the patient falls asleep, thus relaxing their mandible, a silicon band provides tension such that the mandible is pulled forward along with the tongue.

#### INDICATIONS FOR USE

The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.

### SUMMARY OF NON-CLINICAL TESTING

The non-clinical testing included assessment of the physical properties of the SNORKEL and its ability to achieve its intended use. The Snorkel meets the same specifications as set for the predicate device.

A biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible, based on the similarity of the materials of construction to the predicate device (The Adjustable PM Positioner) marketed by Airway Management Inc.

### SUMMARY OF CLINICAL TESTING

Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the Snorkel. The Snorkel does not: Use designs dissimilar from the predicate device and other previously cleared devices under a 510(k); The Snorkel does not use new technologies different from legally marketed intramandibular repositioning devices for snoring and/ or obstructive sleep apnea; and the Snorkel does not deviate from the indications for use identified in the predicate device: Adjustable PM Positioner.

In lieu of human clinical testing, the risks and mitigating controls associated with the use of mandibular repositioning devices, as identified by the FDA, have been addressed in the "Risk Assessment". In addition, adequate warnings and precautions are found in the "Instructions for Use" manual.

#### STATEMENT OF EQUIVALENCE

The Snorkel is substantially equivalent to the currently marketed Adjustable PM Positioner based on a comparison of the indications for use and the technological characteristics of the device. The only design difference is in the nature of the adjustable mechanisms in the two devices.

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### CONCLUSION

The Snorkel is substantially equivalent to the currently marketed Adjustable PM Positioner based on the indications for use, technological characteristics, and materials of construction and principals of operations of the device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.

#### Public Health Service

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

Mr. Wayne Marshall Acting Manager Fellmar Co. 2670 S Myrtle Avenue #106 Monrovia, California 91016

JUN - 4 2012

Re: K112766

Trade/Device Name: The Snorkel 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: LQZ Dated: May 8, 2012

Received: May 14, 2012

Dear Mr. Marshall:

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 - Mr. Marshall

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,

ನ್ನಾಗಿ

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

510(k) Number (if known): K112766

Device Name: The Snorkel

Indications For Use:

The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.

Prescription Use · AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rinner

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

510(k) Number. K112766