(191 days)
No
The summary describes a mechanical intra-oral appliance and a micro-recorder that tracks physical parameters (temperature, movement, head position) for compliance monitoring. There is no mention of AI or ML being used for data analysis, interpretation, or device function.
Yes
The device, the TAP® family of intra-oral appliances, is explicitly stated as "intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea." The DentiTrac® micro-recorder is an embedded component that measures compliance with this treatment.
No
The device is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea, and the embedded micro-recorder measures patient compliance to the oral device therapy. Its function is to treat and monitor therapy adherence, not to diagnose a medical condition.
No
The device description clearly states the inclusion of a "DentiTrac® micro-recorder" which is a hardware component embedded within the intra-oral appliance.
Based on the provided text, the device described (the TAP® family of intra-oral appliances with the embedded DentiTrac® micro-recorder) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TAP® appliance is an intra-oral device used to physically treat snoring and sleep apnea by adjusting the mandible. The DentiTrac® micro-recorder measures patient compliance by monitoring wear time, movement, and head position.
- Lack of Sample Analysis: Neither the TAP® appliance nor the DentiTrac® micro-recorder performs any analysis on samples taken from the body. They are physical devices used for treatment and monitoring of physical parameters.
Therefore, the device falls under the category of a therapeutic and monitoring medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TAP(r) family of intra-oral appliances are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea in patients 18 years or age or older.
The DentiTrac(t) micro-recorder is completely embedded into the TAP(r) intra-oral appliance, the micro-recorder is intended to measure patient compliance to oral device / appliance therapy when used in combination with the DentiTrac(t) System.
Product codes
PLC
Device Description
Airway Management, Inc. has a family of intra-oral appliances known and referred to as the Thornton Appliance Positioner ("TAP®") family.
There have been a number of 510(k) clearances and the TAP® versions are all fundamentally the same. They are:
- . Separate upper and lower trays
- Contain trays custom fitted to each patient ●
- Have a coupling mechanism (single point midline ) that allows adjustment by way of ● incremental advancement of the mandible
- Allows the sleep specialists to titrate the advancement for optimum treatment effect ●
- Both Customized trays and Standard sized trays ●
- Mandibular advancement acts to increase the patient's pharyngeal space during sleep .
This submission is to offer the option of an embedded micro-recorder, DentiTrac® which will record and track a patient's compliance to the prescribed oral appliance therapy.
The DentiTrac® can be incorporated into any of the TAP® family of intraoral appliances.
The DentiTrac® micro-recorder monitors the wear time through oral temperature, tracks movements, and head position. The DentiTrac® provided information when used with the DentiTrac® System. During scheduled visits, the DentiTrac® data can be transferred to a cloudbased web application for reporting and tracking.
The addition of the DentiTrac® does not alter the principle of operation, technological characteristics, or safety of the TAP® family of intraoral appliances, which are the reference devices.
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
18 years or age or older.
Intended User / Care Setting
Home, Dental offices, 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)
The modification is the addition of the DentiTrac® micro-recorder which has been cleared under K150369 and data is available under MAF2557.
Embedding the device does not alter the performance of the TAP® device as an intra-oral appliance; therefore no additional performance testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a group of people. The symbol is composed of three interconnected profiles facing to the right, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2016
Airway Management, Inc. c/o Paul Dryden Consultant 3418 Midcourt Road, Ste. 114 Carrollton, Texas 75006
Re: K160239
Trade/Device Name: TAP® 1 & TAP® 3 Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: PLC Dated: June 29, 2016 Received: June 30, 2016
Dear Mr. Paul Dryden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name TAP 1 and TAP 3
Indications for Use (Describe)
The TAP(r) family of intra-oral appliances are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea in patients 18 years or age or older.
The DentiTrac(t) micro-recorder is completely embedded into the TAP(r) intra-oral appliance, the micro-recorder is intended to measure patient compliance to oral device / appliance therapy when used in combination with the DentiTrac(t) System.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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3
| 510(k) Summary | |||
|---|---|---|---|
| Page 1 of 5 | |||
| 2-Aug-16 | |||
| Company | Airway Management, Inc. | ||
| 3418 Midcourt Road, Ste. 114 | |||
| Carrollton, TX 75006 | |||
| Tel – 866-264-7667 | |||
| Official Contact: | Dale Siebenmorgen | ||
| Manager of Quality and Regulatory | |||
| Proprietary or Trade Name: | TAP® 1 and TAP® 3 | ||
| Common/Usual Name: | Sleep appliances with patient monitoring | ||
| Product Code: | PLC | ||
| Class / CFR: | Class II, 21CFR 872.5570 | ||
| Device: | TAP® 1 and TAP® 3 | ||
| Predicate Device: | K150369 - SomnoMed SomnoDent® | ||
| with micro-recorder | |||
| Reference Devices: | K062951 - Airway Management - TAP® 3 | ||
| K964516 - NPB TAP® 1 |
Device Description:
Airway Management, Inc. has a family of intra-oral appliances known and referred to as the Thornton Appliance Positioner ("TAP®") family.
There have been a number of 510(k) clearances and the TAP® versions are all fundamentally the same. They are:
- . Separate upper and lower trays
- Contain trays custom fitted to each patient ●
- Have a coupling mechanism (single point midline ) that allows adjustment by way of ● incremental advancement of the mandible
- Allows the sleep specialists to titrate the advancement for optimum treatment effect ●
- Both Customized trays and Standard sized trays ●
- Mandibular advancement acts to increase the patient's pharyngeal space during sleep .
Modification
This submission is to offer the option of an embedded micro-recorder, DentiTrac® which will record and track a patient's compliance to the prescribed oral appliance therapy.
The DentiTrac® can be incorporated into any of the TAP® family of intraoral appliances.
The DentiTrac® micro-recorder monitors the wear time through oral temperature, tracks movements, and head position. The DentiTrac® provided information when used with the
4
510(k) Summary Page 2 of 5 2-Aug-16
DentiTrac® System. During scheduled visits, the DentiTrac® data can be transferred to a cloudbased web application for reporting and tracking.
The addition of the DentiTrac® does not alter the principle of operation, technological characteristics, or safety of the TAP® family of intraoral appliances, which are the reference devices.
Indications for Use:
The TAP® family of intra-oral appliances are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea in patients 18 years or age or older.
The DentiTrac® micro-recorder is completely embedded into the TAP® intra-oral appliance, the micro-recorder is intended to measure patient compliance to oral device / appliance therapy when used in combination with the DentiTrac® System.
Patient Population: Patients 18 years or older who snore or obstructive sleep apnea (OSA)
Environment of Use: Home. Dental and. Sleep laboratories
| | Proposed
TAP® Family with Micro-Recorder | SomnoMed
SomnoDent® with micro-recorder
K150369 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The TAP® family of intra-oral appliances
are intended for the treatment of night-time
snoring and mild to moderate obstructive
sleep apnea in patients 18 years or age or
older.
The DentiTrac® micro-recorder is
completely embedded into the TAP® intra-
oral appliance, the micro-recorder is
intended to measure patient compliance to
oral device / appliance therapy when used in
combination with the DentiTrac® System. | The SomnoDent® intra-oral devices are
intended for the treatment of night-time
snoring and mild to moderate obstructive
sleep apnea in patients 18 years or age or
older.
Optionally, if the DentiTrac® micro-
recorder is completely embedded into the
SomnoDent® device, the micro-recorder
is intended to measure patient compliance
to oral device / appliance therapy in
combination with the DentiTrac®
System. |
| Environments of use | Home, Dental offices, Sleep laboratories | Home, Dental offices, Sleep laboratories |
| Patient Population | Patients 18 years and older | Adult patients 18 years and older |
| Contraindications | Missing, infected or loose teeth Temporary crowns or fillings Temporomandibular Joint (TMJ) dysfunction | Missing, infected or loose teeth Temporary crowns or fillings Temporomandibular Joint (TMJ) dysfunction |
| Prescription | Prescription use | Prescription use |
| Duration of use | Single patient, multi-use | Single patient, multi-use |
Table 1 - Comparison of Proposed Device vs. Primary Predicate
5
510(k) Summary Page 3 of 5 2-Aug-16
| | Proposed
TAP® Family with Micro-Recorder | SomnoMed
SomnoDent® with micro-recorder
K150369 |
|----------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Design | | |
| Types of trays | Standard tray or customized upper and
lower trays are fitted to individuals | Standard tray or customized upper and
lower trays are fitted to individuals |
| Method of customized
fitting | Impression material or customized trays | Impression material or customized trays |
| Adjustable for setting the
amount of protrusion | Can we adjusted for degree of protrusion by
the dentist | Can we adjusted for degree of protrusion
by the dentist |
| Method for holding lower
jaw forward | Lower mandible is held in an advanced
position by an adjustable hook or post | Lower mandible is held in an advanced
position by an adjustable hook or post |
| Cleaning method | Cleaned by simple rinsing with water | Cleaned by simple rinsing with water |
| Method that DentiTrac®
is attached to tray | Embedded | Embedded |
Note that proposed TAP® Family with micro-recorder is identical to the reference devices cleared under K964516 (TAP® 1) and K062951 (TAP® 3) as far as the design, performance, and safety of the oral appliance without the micro-recorder.
Table 2 is a comparison of the proposed device with modification, micro-recorder, and the reference TAP® devices.
| | Proposed
TAP® Family with Micro-Recorder | Reference Devices
K964516 (TAP® 1)
K062951 (TAP® 3) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | PLC - sleep appliances with patient
monitoring | |
| | Cleared under LRK – device, anti-snoring
Intraoral devices for snoring and intraoral
devices for snoring and obstructive sleep
apnea | LRK - device, anti-snoring
Intraoral devices for snoring and intraoral
devices for snoring and obstructive sleep
apnea |
| CFR | 872.5570 | 872.5570 |
| Table 2 - Comparison of Proposed Device vs. and Reference TAP® devices | |||
|---|---|---|---|
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510(k) Summary Page 4 of 5 2-Aug-16
| | Proposed
TAP® Family with Micro-Recorder | Reference Devices
K964516 (TAP® 1)
K062951 (TAP® 3) |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attributes | | |
| Indications for Use | The TAP® family of intra-oral appliances
are intended for the treatment of night-time
snoring and mild to moderate obstructive
sleep apnea in patients 18 years or age or
older.
The DentiTrac® micro-recorder is
completely embedded into the TAP® intra-
oral appliance, the micro-recorder is
intended to measure patient compliance to
oral device / appliance therapy when used in
combination with the DentiTrac® System. | An intra-oral appliance intended for the
treatment of night-time snoring and mild
to moderate obstructive sleep apnea in
patients 18 years or age or older |
| Environments of use | Home, Dental offices, Sleep laboratories | Home, Dental offices, Sleep laboratories |
| Patient Population | Patients 18 years and older | Adult patients 18 years and older |
| Contraindications | Missing, infected or loose teeth Temporary crowns or fillings Temporomandibular Joint (TMJ) dysfunction | Missing, infected or loose teeth Temporary crowns or fillings Temporomandibular Joint (TMJ) dysfunction |
| Prescription | Prescription use | Prescription use |
| Duration of use | Single patient, multi-use | Single patient, multi-use |
| Design | | |
| Types of trays | Standard tray or customized upper and
lower trays are fitted to individuals | Standard tray or customized upper and
lower trays are fitted to individuals |
| Method of customized
fitting | Impression material or customized trays | Impression material or customized trays |
| Adjustable for setting the
amount of protrusion | Can we adjusted for degree of protrusion by
the dentist | Can we adjusted for degree of protrusion
by the dentist |
| Method for holding lower
jaw forward | Lower mandible is held in an advanced
position by an adjustable hook or post | Lower mandible is held in an advanced
position by an adjustable hook or post |
| Cleaning method | Cleaned by simple rinsing with water | Cleaned by simple rinsing with water |
| Method that DentiTrac®
is attached to tray | Embedded | No DentiTrac® |
As can be seen the Airway Management TAP® intra-oral appliances with micro-recorder are substantially equivalent to the predicate device SomnoMed, SomnoDent® with micro-recorder (K150369) for the embedded micro-recorder and identical in design as an intraoral appliance to the reference TAP® devices – K964516 – TAP® 1 and K062951 – TAP® 3.
The TAP® with micro-recorder is viewed as substantially equivalent to the predicate and reference devices because:
7
510(k) Summary Page 5 of 5 2-Aug-16
Indications -
Similar to predicate - K150369 - SomnoMed SomnoDent® with micro-recorder and K062951 -Airway Management TAP® 3 and K964516 - NPB TAP® 1 - Indicated to reduce or alleviate night time snoring and treat mild to moderate obstructive sleep apnea (OSA).
Technology -
Identical to predicate - K150369 - SomnoMed SomnoDent® with micro-recorder and the reference - K062951 – Airway Management TAP® 3 and K964516 – NPB TAP® 1 – both devices use a separate tray design with a means to adjust the lower jaw. Each is filed with an impression material to assure a tight fit for the user. Both incorporate the embedded DentiTrac® micro-recorder.
Materials -
The materials in contact with the patient are identical to the references K062951 - Airway Management TAP® 3 and K964516 - NPB TAP® 1.
Environment of Use -
Identical to predicate – K150369 – SomnoMed SomnoDent® with micro-recorder and K062951 - Airway Management TAP® 3 and K964516 - NPB TAP® 1.
Patient Population -
Identical to predicate - K150369 - SomnoMed SomnoDent® with micro-recorder and the references K062951 - Airway Management TAP® 3 and K964516 - NPB TAP® 1 - 18 years and older.
Performance Testing
The modification is the addition of the DentiTrac® micro-recorder which has been cleared under K150369 and data is available under MAF2557.
Embedding the device does not alter the performance of the TAP® device as an intra-oral appliance; therefore no additional performance testing is required.
Substantial Equivalence Conclusion
As detailed above, the indications for use, patient population, environment of use, technology or principle of operation, and performance are substantially equivalent to the predicate and reference devices.
Based upon the comparison to the predicate we can conclude that there are no new safety or effectiveness concerns and thus can determine then to be substantially equivalent.