TAP-T

K061732 · Airway Management, Inc. · LRK · Jul 12, 2006 · Dental

Device Facts

• Record ID: K061732
• Device Name: TAP-T
• Applicant: Airway Management, Inc.
• Product Code: LRK · Dental
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TAP T is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA

Device Story

The TAP T is an intraoral dental appliance used to treat snoring and mild to moderate obstructive sleep apnea. It consists of upper and lower trays fitted to the patient's teeth, connected by a hook mechanism. The device is used in home and sleep laboratory settings. By positioning the lower jaw, it helps maintain airway patency during sleep. It is a prescription device intended for single-patient, multi-use.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Intraoral dental appliance; consists of upper and lower trays and a hook mechanism; includes impression material for custom fitting; non-powered; mechanical operation.

Indications for Use

Indicated for adult patients 18 years and older with mild to moderate obstructive sleep apnea (OSA) and snoring.

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

• TAP (K962516)
• Thornton Oral Appliance - TOA (K972061)
• TAP II (K060388)

Submission Summary (Full Text)

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K061732

### Airway Management Inc. 6116 North Central Expressway Suite 605 Dallas, Texas 75206

## JUL 1 2 2006

### Non-Confidential Summary of Safety and Effectiveness Page 1 of 3 May 25, 2006

Airway Management Inc.
6116 North Central Expressway
Suite 605
Dallas, Texas 75225
Tel - [phone]
Fax - [phone]

| Official Contact: | Darren Henderson |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | TAP T |
| Common / Usual Name: | Dental Device - Anti Snoring / Obstructive Sleep Apnea Device |
| Classification Name: | Anti-Snoring /Obstructive Sleep Apnea Device |
| Device: | TAP T |
| Predicate Devices: | Nellcor Puritan Bennett - TAP - K962516 Thornton Oral Applicance -TOA- K972061 TAP II - K060388 |

Device Description: ----------------------------------------------------------------------------------------------------------------------------------------------------------

The TAP T Anti -- snoring device is comprised of --

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

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| Intended Use: | |
|------------------------|----------------------------------------------------------------------------------------------------------------------|
| Indicated Use - - | The TAP T is intended to reduce or alleviate night time snoring<br>and mild to moderate obstructive sleep apnea, OSA |
| Target population | Adult patients 18years and older |
| Environment of Use - - | Home and sleep laboratories |

and the comments of the comments of the comments of the comments of

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and the control control control control controllers and

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, suggesting a sense of community and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Mr. Darren Henderson Quality Manager Airway Management, Incorporated 6116 North Central Expressway Suite 605 Dallas. Texas 75206

Re: K061732

Trade/Device Name: TAP T Regulation Number: 872.5570 Regulation Name: Intraoral Device for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: May 25, 2006 Received: June 20, 2006

Dear Mr. Henderson:

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 - Mr. Henderson

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.

Quy Sulom for

Chiu Lin. PK 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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# 61732

ATIONS FOR USE INST 510(k) Number: (To be assigned) TAP T Device Name:

Intended Use: To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA). Home and sleep laboratories Environment of use:

Single patient – multi – use Disposable / Reusable:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User

(Per CFR 801.109)

or

Over-the-counter use_

Susan Ryan

sign-On).
ion of Anesthesiology, General Hospital,
ion Control, Dental Devices

) Number: 1561232