TOA

K972061 · W. Keith Thornton, D.D.S. · LRK · Aug 21, 1997 · Dental

Device Facts

• Record ID: K972061
• Device Name: TOA
• Applicant: W. Keith Thornton, D.D.S.
• Product Code: LRK · Dental
• Decision Date: Aug 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To reduce or alleviate night time snoring and obstructive sleep apnea (OSA)

Device Story

TOA is an intraoral anti-snoring device consisting of upper and lower rigid trays fitted to the patient's teeth using heat-sensitive impression material. The device uses a hook mechanism to attach the trays, holding the lower jaw in a forward position during sleep. It is intended for use by adult patients in home or sleep laboratory settings. By maintaining mandibular advancement, the device helps keep the airway open to reduce snoring and OSA. The two-piece design allows for lateral and vertical jaw movement, enabling the patient to talk, drink, and breathe through the mouth while wearing the appliance. The device is custom-fitted by a clinician and is intended for single-patient, multi-use.

Clinical Evidence

No clinical trials were conducted for this submission. The document cites a 72% reduction in AHI for patients using the device, noting performance is comparable to CPAP and the TAP predicate device.

Technological Characteristics

Intraoral appliance consisting of upper and lower rigid trays and a hook attachment mechanism. Uses heat-sensitive impression material for custom fitting to the patient's dentition. Designed for single-patient, multi-use. No electronic components, energy sources, or software.

Indications for Use

Indicated for adult patients to reduce or alleviate night time snoring and obstructive sleep apnea (OSA).

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

• Nellcor Puritan Bennett - TAP - K962516
• SnoreFree - OSAP - K960673
• Distar, Inc. - TheraSnore - K926382

Submission Summary (Full Text)

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## W. Keith Thornton, D.D.S. 6131 Luther Lane, Suite 208 Dallas, TX 75225

K972061..

AUG 21 1997

# Non-Confidential Summary of Safety and Effectiveness

page 1 of 3 June 2, 1997

Tel - [phone] W. Keith Thornton, D.D.S. 6131 Luther Lane Suite 208 Fax - [phone] Dallas, TX 75225

| Official Contact: | Keith Thornton, D.D.S. |
|----------------------------|-----------------------------------------|
| Proprietary or Trade Name: | TOA |
| Common/Usual Name: | Oral Appliance - anti-snoring device |
| Classification Name: | Anti-snoring device |
| Device: | TOA |
| Predicate Devices: | Nellcor Puritan Bennett - TAP - K962516 |
| | SnoreFree - OSAP - K960673 |
| | Distar, Inc. - TheraSnore - K926382 |

### Device Description:

The TOA Anti-snoring device is comprised of -

- * Lower tray fitted over the lower teeth.
- * Upper tray fitted over the upper teeth.
- * Impression material
- * Hook mechanism to attach lower tray to upper tray

| Intended Use: | |
|-----------------------|----------------------------------------------------------------------------------------------------|
| Indicated Use -- | The TOA is intended to reduce or alleviate night time snoring<br>and obstructive sleep apnea, OSA. |
| Target population -- | Adult patients |
| Environment of Use -- | Home and sleep laboratories |

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# Non-Confidential Summary of Safety and Effectiveness (continued)

page 2 of 3

June 2, 1997

Comparison to Predicate Devices: Devices: Devices Comments Comparison

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| Attribute | TOA | NPB TAP<br>K962516 | OSAP<br>K960673 | TheraSnore<br>K92638 |
|---------------------------------------------------------------|-----|--------------------|-----------------|----------------------|
| Use | | | | |
| Intended as an intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce snoring or<br>help alleviate snoring | Yes | Yes | Yes | Yes |
| Indicated for use with patients<br>with mild to moderate OSA | Yes | Yes | Yes | Yes |
| Indicated for single patient<br>multi - use | Yes | Yes | Yes | Yes |
| Indicated for use at home or<br>sleep laboratories | Yes | Yes | Yes | Yes |
| Design | | | | |
| Rigid tray pieces | Yes | Yes | Yes | Yes |
| Heat sensitive impermissible<br>material for fitting to teeth | Yes | Yes | Yes | Yes |
| Separate tray pieces | Yes | Yes | No | No |
| Custom fit for each patient | Yes | Yes | Yes | Yes |
| Works by holding lower jaw forward | Yes | Yes | Yes | Yes |
| Can be adjusted or refit | Yes | Yes | Yes | Yes |
| Placed in patient mouth each<br>evening | Yes | Yes | Yes | Yes |
| Cleaned daily | Yes | Yes | Yes | Yes |
| Permits lateral and / or vertical<br>jaw movement | Yes | Yes | No | No |
| Attribute | TOA | NPB TAP<br>K962516 | OSAP<br>K960673 | TheraSnore<br>K92638 |
| Design (continued) | | | | |
| Upper and lower tray unhook<br>for easy removal from mouth | Yes | Yes | No | No |
| Permits patient to talk and drink<br>with appliance in place | Yes | Yes | No | No |
| Permits patient to breath<br>through mouth | Yes | Yes | No | No |
| Materials | | | | |
| Rigid tray material | Yes | Yes | Yes | Yes |
| Heat sensitive impression<br>material | Yes | Yes | Yes | Yes |
| Performance Testing | | | | |
| None applicable under Section 514 | Yes | Yes | Yes | Yes |
| reduced AHI in patients | 72% | 72% | Yes | Yes |
| AHI performance comparable to<br>CPAP | Yes | Yes | Yes | Unknown |

page 4 of 30

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# Non-Confidential Summary of Safety and Effectiveness (continued)

page 3 of 3

June 2, 1997

#### Comparison to Predicate Devices: (continued)

#### Differences Between Other Legally Marketed Predicate Devices

The difference between the intended device and predicates, except the Nellcor Puritan Bennett - TAP device, is that the intended device is a 2 piece construction. This difference does not have a significant effect on the safety or effectiveness of the device.

page 5 of 30

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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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

W. Keith Thornton, D.D.S. ·6131 Luther Lane, Suite 208 Dallas, Texas 75225 -

AUG 2 1 1997

Re: K972061 Trade Name: TOA Unclassified Requlatory Class: Product Code: LRK Dated: June 2, 1997 Received: June 3, 1997

Dear Dr. Thornton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Thornton "

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ülatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS POR USE

Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding tisting of Indications for Use on a separate sheet, the following is per that request.

| 510(k) Number: | (To be assigned) |
|------------------------|--------------------------------------------------------------------------------|
| Device Name: | TOA Anti-snoring Device |
| Intended Use : | To reduce or alleviate night time snoring and obstructive<br>sleep apnea (OSA) |
| Environment of use: | Home and sleep laboratories |
| Disposable / Reusable: | Single patient - multi- use |

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Susan Runner

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

510(k) Number K972961

**Prescription Use**
(Per CFR 801.109)

Over-the-counter use _

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