The provided text is a summary of safety and effectiveness for a medical device (TAP III), not a study. It compares the TAP III to predicate devices but does not describe acceptance criteria for studies or report device performance against such criteria in the way a clinical study would. The document states "Non applicable under Section 514" for "Performance Testing," indicating that a new performance study was not required for this 510(k) submission.

Therefore, the following information cannot be extracted from the provided text:

Acceptance criteria and reported device performance (as these relate to a study's outcomes)
Sample size used for the test set and data provenance
Number of experts used to establish ground truth and their qualifications
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study details
Standalone performance details
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

The only performance-related information mentioned is a "Reduced AHI in patients" of "72%" for the TAP III, which is also listed for all predicate devices. This appears to be a characteristic of the device type rather than a specific result from a study conducted on the TAP III itself for this submission. The document explicitly states "Non applicable under Section 514" for Performance Testing, suggesting that the substantial equivalence of the TAP III to existing devices means a new performance study was not deemed necessary by the FDA for this particular submission.

Summary

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K062951

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

BEC 】 2 2006

Non-Confidential Summary of Safety and Effectiveness

September 28, 2006

Airway Management Inc.	Tel- (972) 369-0978
6116 North Central Expressway
Suite 605
Dallas, Texas 75225	Fax- (214) 691-3151

Official Contact	Darren Edward Henderson
Proprietary or Trade Name	TAP III
Common / Usual Name	Dental Device - Anti Snoring / Obstructive Sleep Apneadevice
Classification Name	Anti -Snoring / Obstructive Sleep Apnea Device
Device:	TAP III
Predicate Device	Nellcor Puritan Bennett - TAP-K962516Thornton Oral Appliance - TOA-K972061TAP II - K060388

Device Description:

The TAP III Anti-Snoring device is comprised of:

� Lower tray fitted over the lower teeth.
© Upper tray fitted over the upper teeth.
& Impression material
� Hook and Base mechanism to attach lower tray to upper tray.

. Intended Use: 1 . 1 . 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indicated Use --	The TAP III is intended to reduce or alleviate night timesnoring and mild to moderate obstructive sleep apnea,OSA.
Target population --	Adult patients 18 years and older
Environment of Use--	Home and sleep laboratories.

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Non-Confidential Summary of Safety and Effectiveness (continued) September 28,2006 :

Comparison to Predicate Devices:
Attribute	TAP III	TOAK972061	TAPK962516	TAPIIK060388
Use
Intended as an intraoral device	Yes	Yes	Yes	Yes
Intended to reduce snoring orHelp alleviate snoring	Yes	Yes	Yes	Yes
Indicated for use with patientswith mild to moderate OSA	Yes	Yes	Yes	Yes
Indicated for single patientMulti-use	Yes	Yes	Yes	Yes
Indicated for use at home orSleep laboratories	Yes	Yes	Yes	Yes
Design
Rigid tray pieces	Yes	Yes	Yes	Yes
Heat sensitive impermissibleMaterial for fitting to teeth	Yes	Yes	Yes	Yes
Separate tray pieces	Yes	Yes	Yes	Yes
Custom fit for each patient	Yes	Yes	Yes	Yes
Works by holding lower jawForward	Yes	Yes	Yes	Yes
Can be adjusted or refit	Yes	Yes	Yes	Yes
Placed in patient mouth eachEvening	Yes	Yes	Yes	Yes
Comparison to Predicate Devices:
Attribute	TAP III	TOAK972061	TAPK972516	TAP IIK060388
Design (continued)
Upper and lower tray unhookFor easy removal from mouth	Yes	Yes	Yes	Yes
Permits patient to talk and drinkWith device in place	Yes	Yes	Yes	No
Permits patient to breaththrough mouth	Yes	Yes	Yes	No
Materials
Rigid tray material	Yes	Yes	Yes	Yes
Heat sensitive impressionmaterial	Yes	Yes	Yes	Yes
Performance Testing
Non applicable under Section 514	Yes	Yes	Yes	Yes
Reduced AHI in patients	72%	72%	72%	72%
Differences Between Other Legally Marketed Predicate Devices

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Non-Confidential Summary of Safety and Effectiveness (continued) September 28,2006

The difference between the intended device and predicates devices is the design of the base and hook. The TAP III base and hook is a smaller design. This difference does not have a significant effect on the safety or effectiveness of the device,

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the department's name encircling an emblem. The emblem features a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads, "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2006

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

Re: K062951

Trade/Device Name: TAP III Anti-Snoring Device 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: September 28, 2006 Received: September 29, 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), 1 please contact the Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clive
Chin 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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K062951

CATIONS FOR USE

510(k) Number:	(To be assigned)
Device Name:	TAP III
Intended Use:	To reduce or alleviate night time snoring and mild to moderateobstructive sleep apnea (OSA).
Environment of use:	Home and sleep laboratories
Disposable / Reusable:	Single patient - multi - use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per CFR 801.109)

: 上一篇:

Over-the-counter use__________________________________________________________________________________________________________________________________________________________

Susan Dunne

125 The First Court of Children 1984 233

ા ર

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
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.(b)
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.”