THE SUAD DEVICE

K023836 · Strong Dental, Inc. · LRK · Jul 8, 2003 · Dental

Device Facts

• Record ID: K023836
• Device Name: THE SUAD DEVICE
• Applicant: Strong Dental, Inc.
• Product Code: LRK · Dental
• Decision Date: Jul 8, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA).

Device Story

The SUAD™ Device is a custom-fitted, removable mandibular advancement device (MAD) used to treat snoring and obstructive sleep apnea. It consists of upper and lower frames that cover all occlusal and incisal surfaces, incorporating a casted metal framework for structural stability and a 'tube and rod' assembly for mandibular positioning. The device is worn intraorally by the patient during sleep. It functions by mechanically advancing the mandible to maintain airway patency. The device features buttons for optional elastic attachment and a redirected connecting tube angle to improve stability and seating. It is fabricated using vinyl base material, ethylene acrylic overlay, and steel components. The device is intended for use by patients under the guidance of a dental professional who manages the custom fitting and adjustment process.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Custom-fitted intraoral appliance; materials include vinyl base, ethylene acrylic overlay, steel components, and casted metal framework. Features 'tube and rod' mandibular advancement mechanism. Dimensions/form factor: custom-molded to patient dentition. No electronic components or software. Non-sterile, patient-specific device.

Indications for Use

Indicated for patients 18 years or older requiring a custom-fitted mandibular repositioning device to reduce or alleviate nighttime snoring and obstructive sleep apnea. Contraindicated for patients with central sleep apnea, severe respiratory disorders, edentulous arches, or loose teeth/advanced periodontal disease.

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

• Removable Herbst Appliance (K955822)

Reference Devices

• Klearway
• Silencer
• TAP

Submission Summary (Full Text)

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K023836

I.

| | | 510(k) Summary of Safety and Effectiveness | JUL 0 8 2003 |
|-------------------|-------------------------------|-----------------------------------------------|--------------|
| Submitter: | Patrick J. Strong | | |
| | Strong Dental Inc. | | |
| | 33 Princess Street, Suite 403 | | |
| | Leamington, Ontario, Canada | | |
| | N8H 5C5 | | |
| | | | |
| | Telephone: | 1-800-339-4452 | |
| | Facsimile: | [phone] | |
| | Contact Person: | Patrick J. Strong or Mary Lou Strong | |
| | Description of the Device: | | |
| Trade name: | | The SUAD™ Device | |
| Descriptive name: | | Mandibular advancement device/appliance (MAD) | |
| Common Name: | | Sleep apnea/Anti-snoring device | |
| Product code: | | LRK Anti-snoring device | |
| Device Class: | | Class II | |
| | Establishment Registration | | |
| Number: | | None | |
| Intended Use: | | To reduce or alleviate nighttime snoring and | |
| | | obstructive sleep apnea (OSA). | |

The Removable Herbs1 Appliance is the predicate device for the SUAD™ Device, having all the same functional characteristics. The Removable Herbst Appliance (510(k) K955822) is a custom-fitted mandibular device that allows patients to move their jaw laterally and vertically without disengaging the appliance. The device is adjusted to provide the anticipated relief of the condition by moving the mandible forward in 1mm increments by adding advancement shims onto the posts.

The SUAD" Device has the following modifications: the combination of the materials used, the assembly and the fabrication technique. Detailed drawings of The SUAD" device are available in the patent, Patent No. US 6,418,933 B1 [Reference 1 ].

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#### 1. 510(k) Summary of Safety and Effectiveness (continued)

The SUAD™ Device functions in a similar manner to other comparative predicate devices and the intended uses are the same (See Table 1). The general differences or modifications between the device and predicate devices are minor and do not raise new safety concerns. Table 2 lists the risks identified for this device and summarizes how Strong Dental Inc. has addressed the risk.

The casted framework is substantially equivalent to the casted framework used in dentures used prior to 1976. The "tube and rod" assembly of the pivot and ube is substantially equivalent to the Herbst appliance. The angle of the connecting tube to the pivot has been changed to allow for greater stability of the appliance. The framework is used to strengthen the device. The smooth "buttons," frames that cover all the occlusal and incisal surfaces, and the use of the vacuum-formed thermo-plastic to hold the appliance results in less exposed wires.

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دت بے بے اس

I. 510(k) Summary of Safety and Effectiveness (continued)

- ·

# Table 1. Substantial Equivalence Comparison

| Attribute | SUAD™ | Herbst | Klearway | Silencer | TAP |
|-----------------------------------------------------------------------------------------------|-------|--------|----------|----------|-----|
| USE | | | | | |
| Intraoral device | Yes | Yes | Yes | Yes | Yes |
| Reduce snoring | Yes | Yes | Yes | Yes | Yes |
| Reduce obstructive<br>sleep apnea | Yes | Yes | Yes | Yes | Yes |
| DESIGN | | | | | |
| Removable device | Yes | Yes | Yes | Yes | Yes |
| Custom fit | Yes | Yes | Yes | Yes | Yes |
| Adjustable | Yes | Yes | Yes | Yes | Yes |
| Allows lateral and<br>vertical movement | Yes | Yes | Yes | Yes | Yes |
| Clasps required | No | Yes | Yes | Yes | Yes |
| Frames cover all<br>occlusal and incisal<br>surfaces | Yes | Yes | Yes | Yes | Yes |
| Buttons attached to<br>frames to attach<br>conventional elastics | Yes | No | No | No | No |
| Angle of upper<br>connecting tube<br>redirected for greater<br>stability of the upper<br>form | Yes | No | No | No | No |
| Casted framework<br>inserted into upper<br>and lower frames | Yes | No | No | No | No |
| MATERIALS | | | | | |
| Base material, vinyl | Yes | Yes | Yes | Yes | Yes |
| Ethylene acrylic<br>overlay | Yes | Yes | Yes | Yes | Yes |
| Steel metal<br>components | Yes | Yes | Yes | Yes | Yes |
| Casted metal<br>framework | Yes | No | No | No | No |
| TESTING | | | | | |
| Not applicable | Yes | Yes | Yes | Yes | Yes |

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### I. 510(k) Summary of Safcty and Effectivencss (continued)

# Table 2. Risk Profile

| Identified risk | Special controls |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intraoral gingival, palatal, or dental soreness | The internal framework and specific materials<br>used provides for a comfortable fit. |
| Obstruction of oral breathing | The angle of the upper connecting tube has<br>been redirected, allowing for greater stability of<br>the upper form. With the retruded force of the<br>mandible, the new direction of the tube forces<br>the upper frame to stay in a properly seated<br>position. |
| Loosening or flaring of lower anterior teeth or<br>general tooth movement | The frames are designed to cover all the<br>occlusal and incisal surfaces. |

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Strong Dental Incorporated C/O Clyde A. Takeguchi, Ph. D. Phoenix Regulatory Associates, Limited 21525 Ridgetop Circle, Suite 240 Sterling, Virginia 20166

JUL 0 8 2003

Re: K023836 Trade/Device Name: SUAD™ Device Regulation Number: 21 CFR 872.5570 Regulation Name: Anti-Snoring Device Regulatory Class: II Product Code: LRK Dated: April 11, 2003 Received: April 11, 2003

Dear Dr. Takeguchi:

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. Takeguchi

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/dsma/dsmamain.html

Sincerely yours,

Suer Runner

Susan Runner, DDS, MA Interim 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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#### II. Indications for Usc

510(k) Number: K023836

Devicc Name: SUAD™ Devicc

A custom-fitted mandibular repositioning device intended to reduce or alleviate nighttimc snoring and obstructive slocp apnca.

Contraindications:

The device is contraindicated for paticnts who:

- Have central siccp apnea ●
- Have severe respiratory disorders .
- Have an edentulous arch .
- Have loose tecth or advanced periodontal discasc .

. .

- Are under 18 years of age. .
Keen Mely for MSP

ivision Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Denta

510(k) Number: K 023836