(74 days)
No
The device description and summary of performance studies describe a mechanical oral appliance with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to alleviate mild to moderate obstructive sleep apnea (OSA) and reduce night time snoring, which directly addresses a medical condition and its symptoms.
No
The device is described as an anti-snoring device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea. Its function is descriptive of a therapeutic device that acts directly to treat a condition, rather than a diagnostic one that identifies or characterizes a disease or condition. While performance studies mention a "Reduced AHI in patients 72%", this refers to the effect of the device rather than its diagnostic capability.
No
The device description clearly lists physical components (lower tray, upper tray, impression material, hook and base mechanism) which are hardware.
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 Diagnostic Function: The device's function is to physically adjust the airway, not to detect or measure any biological markers or processes related to sleep apnea or snoring.
Therefore, the TAP III Anti-Snoring device, as described, falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TAP III is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA.
Product codes
LRK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
Indicated Patient Age Range
Adult patients 18 years and older
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)
Performance Testing
Non applicable under Section 514
Reduced AHI in patients: 72%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TAP-K962516, TOA-K972061, TAP II - K060388
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Apnea |
| device | |
| Classification Name | Anti -Snoring / Obstructive Sleep Apnea Device |
| Device: | TAP III |
| Predicate Device | Nellcor Puritan Bennett - TAP-K962516 |
| Thornton Oral Appliance - TOA-K972061 | |
| TAP 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 time
snoring and mild to moderate obstructive sleep apnea,
OSA. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Target population -- | Adult patients 18 years and older |
| Environment of Use-- | Home and sleep laboratories. |
1
Non-Confidential Summary of Safety and Effectiveness (continued) September 28,2006 :
| Comparison to Predicate Devices: | ||||
|---|---|---|---|---|
| Attribute | TAP III | TOA | ||
| K972061 | TAP | |||
| K962516 | TAPII | |||
| K060388 | ||||
| Use | ||||
| Intended as an intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce snoring or | ||||
| Help alleviate snoring | Yes | Yes | Yes | Yes |
| Indicated for use with patients | ||||
| with mild to moderate OSA | Yes | Yes | Yes | Yes |
| Indicated for single patient | ||||
| Multi-use | Yes | Yes | Yes | Yes |
| Indicated for use at home or | ||||
| Sleep laboratories | Yes | Yes | Yes | Yes |
| Design | ||||
| Rigid tray pieces | Yes | Yes | Yes | Yes |
| Heat sensitive impermissible | ||||
| Material 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 jaw | ||||
| Forward | Yes | Yes | Yes | Yes |
| Can be adjusted or refit | Yes | Yes | Yes | Yes |
| Placed in patient mouth each | ||||
| Evening | Yes | Yes | Yes | Yes |
| Comparison to Predicate Devices: | ||||
| Attribute | TAP III | TOA | ||
| K972061 | TAP | |||
| K972516 | TAP II | |||
| K060388 | ||||
| Design (continued) | ||||
| Upper and lower tray unhook | ||||
| For easy removal from mouth | Yes | Yes | Yes | Yes |
| Permits patient to talk and drink | ||||
| With device in place | Yes | Yes | Yes | No |
| Permits patient to breath | ||||
| through mouth | Yes | Yes | Yes | No |
| Materials | ||||
| Rigid tray material | Yes | Yes | Yes | Yes |
| Heat sensitive impression | ||||
| material | 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 |
:
:
2
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,
3
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.
4
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
5
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 moderate |
| obstructive 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
.
:
or
(Per CFR 801.109)
: 上一篇:
Over-the-counter use__________________________________________________________________________________________________________________________________________________________
Susan Dunne
125 The First Court of Children 1984 233
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