(92 days)
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance metrics associated with AI/ML indicate it is a mechanical oral appliance.
Yes
The device is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA), which are medical conditions, thereby classifying it as a therapeutic device.
No
The device description states its intended use is to "reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA)," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines physical components like upper and lower trays, impression material, and a hook and base mechanism, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce or alleviate snoring and sleep apnea. This is a therapeutic purpose, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device is a physical appliance worn in the mouth. It does not involve the analysis of biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD-related information: The description does not mention any processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the TAP II Anti-Snoring device is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).
Product codes
LRK
Device Description
The TAP II 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and sleep laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nellcor Puritan Bennett - TAP-K962516, Thornton Oral Appliance - TOA-K972061, OASYS Oral Airway System - K030440
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image shows a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the numbers '060388'. The characters are all in bold and appear to be handwritten.
Airway Management Inc. 6116 North Central Expressway Suite 605 Dallas, Texas 75206
-
- 7 1. 1
Non-Confidential Summary of Safety and Effectiveness May 7, 2006
Airway Management Inc. 6116 North Central Expressway Suite 605 Dallas, Texas 75225
Tel- (972) 369-0978
Fax- (214) 691-3151
| Official Contact | Darren Edward Henderson |
|---|---|
| Proprietary or Trade Name | TAP II |
| Common / Usual Name | Oral Appliance - anti snoring device. |
| Classification Name | Anti -Snoring device |
| Device: | TAP II |
| Predicate Device | Nellcor Puritan Bennett - TAP-K962516 |
| Thornton Oral Appliance - TOA-K972061 | |
| OASYS Oral Airway System - K030440 |
Device Description: July 2017 11:00 11:00 11:00 11:00 11:00 1
The TAP II 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: Indicated Use --The TAP II is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA. . . . . . . . . . . .
Environment of Use --Home and sleep laboratories.
3
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which is the symbol of the HHS.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2006
Mr. Darren Henderson Quality Manager Airway Management, Incorporated 6116 North Central Expressway, Suite 605 Dallas, Texas 75206
Re: K060388
Trade/Device Name: Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appli 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 10, 2006 Received: May 11, 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.
2
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 (OS) 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 vour 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 (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,
C
Tin Liu, 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
3
K060388 (To be assigned) 510(k) Number:
Device Name:
TAP II
Intended Use:
To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).
Environment of use:
Disposable / Reusable:
Single patient -- multi -- use
Home and sleep laboratories
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runnes
Sign-Off n of Anesthesiology, General Hospital. on Control, Der
Number: K060388
Prescription Use
or
14
Over-the-counter use
(Per CFR 801.109)