SLEEP SPLINT

K060122 · Nakagawa Dental Clinic · LRK · May 19, 2006 · Dental

Device Facts

• Record ID: K060122
• Device Name: SLEEP SPLINT
• Applicant: Nakagawa Dental Clinic
• Product Code: LRK · Dental
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sleep Splint is intended to be prescribed to adult patients to aid in the reduction and management of snoring and mild to moderate obstructive sleep apnea.

Device Story

Sleep Splint is a prescription-only, custom-fitted intraoral appliance; worn during sleep to reduce snoring and mild to moderate obstructive sleep apnea. Device consists of upper and lower splints covering only the bite surface of teeth; fabricated from copolyester using an orthodontic resin bond. Dentist custom-fits device to patient; appliance mechanically holds mandible in a forward position (5 mm to 7 mm) to maintain airway patency. Minimal tooth coverage design facilitates tongue repositioning and improves comfort for patients with artificial front teeth. Device is non-invasive; intended for home use by the patient.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design comparison and established clinical/non-clinical data for similar intraoral mandibular repositioning devices.

Technological Characteristics

Intraoral mandibular repositioning appliance. Materials: Copolyester. Design: Minimal coverage of teeth (bite surface only). Mechanism: Mechanical mandibular advancement (5-7 mm). Custom-fitted by dentist. No software, electronics, or energy source.

Indications for Use

Indicated for adult patients for the reduction and management of 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

• Snore Guard (K882303)
• The Silencer (K954530)

Submission Summary (Full Text)

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Kobo122

MAY 19 2005

# 510(K) SUMMARY REPORT

Kenzo Nakagawa, DDS, PhD Submitter: Nakagawa Dental Clinic 13-20 Higashiyanagida-cho, Koshigaya, Saitama 343-0814 Japan Tel: [phone] Fax: [phone] E-mail: [e-mail] Contact Person: Maki Sakuraba (Official Correspondent) Makimed, Inc. 225 First Street, Mineola, NY 11501 Tel: [phone] Fax: [phone] E-mail: [e-mail] May 8, 2006 Date Prepared: 21 CFR 872.5570 Classification Reference: Device Class: Class II LRK - Anti-Snoring Device Product Code: Common /Usual Name: Oral Appliance Device/Trade Name: Sleep Splint Snore Guard (K882303) Predicate Device(s): The Silencer (K954530)

## Intended Use:

The Sleep Splint is intended to be prescribed to adult patients to aid in the reduction and management of snoring and mild to moderate obstructive sleep apnea.

#### Device Description/Technical Characteristics:

The Sleep Splint is a prescription only, intraoral appliance that is fitted to the upper and lower teeth, and worn during sleep for the purpose of reducing the incidence of snoring and obstructive sleep apnea.

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The Sleep Splint is made of copolyester (acrylic resin for the previous version) and features an orthodontic resin bond which can be custom-fitted by a dentist. It comfortably holds the mandible 5 mm to 7 mm forward.

An important technical characteristic of this device is its minimal coverage of teeth; only the bite surface is covered by the upper and lower splints. This makes tongue repositioning more comfortable and also enhances fit for patients who have artificial front teeth. Also, by blocking out undercuts of the mold in the process of fabricating the Sleep Splint, it will not only fit the patient more comfortably but also have less impact on each tooth. Clinical/non-clinical data support that these unique characteristics have significantly enhanced patient comfort and ease without sacrificing effectiveness.

### Comparisons to Predicate Devices:

The difference between this device and predicate devices is only the design of the device. This difference does not have a significant impact on the safety or effectiveness of the device. All the devices are custom-fitted by a dentist, utilize heat sensitive acrylic or thermoplastic dental/medical grade materials, and comfortably reposition the mandible to keep the airway open.

Published clinical/non-clinical data suggest that the Sleep Splint works in a similar manner to other comparable devices, and the intended use is the same. The general differences between the device and predicate devices are minor and do not raise new safety concerns.

#### Conclusion:

The Sleep Splint is appropriate for its intended use, and raises no new concerns of safety and effectiveness over the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nakagawa Dental Clinic C/O Dr. Maki Sakuraba Official Correspondent Makimed, Incorporated 225 First Street Mineola, New York 11501

MAY 19 2006

Re: K060122 Trade/Device Name: Sleep Splint Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep apnea Regulatory Class: II Product Code: LRK Dated: May 8, 2006 Received: May 11, 2006

Dear Dr. Sakuraba:

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.

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

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu, Lin, Ph.D.

Chiu Lin, Ph.D. 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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K060122

# Indications for Use

510(k) Number (if known): K (66(x)22

Sleep Splint

Device Name:

Indications For Use:

The Sleep Splint is intended to be prescribed to adult patients to aid in the reduction and management of snoring and mild to moderate obstructive sleep apnea.

1 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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 Rumsey

of Amosthesialogy, General Hoaplikal a Control. Lontal

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Sleep Splint 510(k)