(191 days)
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.
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.
The provided text is a 510(k) summary for the TAP® 1 and TAP® 3 intra-oral appliances with an embedded DentiTrac® micro-recorder. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study with acceptance criteria for device performance.
Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in your request.
Instead, it relies on demonstrating that the modified device (TAP® with DentiTrac®) is substantially equivalent to a predicate device (SomnoMed SomnoDent® with micro-recorder) and reference devices (TAP® 1 and TAP® 3 without the micro-recorder). The rationale is that the DentiTrac® micro-recorder has already been cleared under K150369, and its embedding does not alter the performance of the TAP® device as an intra-oral appliance, thus requiring no additional performance testing.
Here's a breakdown of what is and isn't present in the document based on your request:
-
A table of acceptance criteria and the reported device performance:
- Not present. The document focuses on comparing the proposed device's characteristics (indications for use, technology, materials, environment of use, patient population) with predicate and reference devices, not on quantifiable performance metrics against specific acceptance criteria.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. No new performance study or test set is described for the combined device. The reliance is on existing clearances for the components.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not present. No new study requiring expert ground truth establishment is detailed.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present. No new study requiring adjudication is detailed.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not present. This device is an intra-oral appliance with a compliance micro-recorder, not an AI-assisted diagnostic tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not present. While the DentiTrac® micro-recorder likely has internal algorithmic functions for data collection (temperature, movement, head position), the document doesn't detail its standalone performance or validation studies. It states that "data is available under MAF2557" for the DentiTrac® micro-recorder, implying its individual performance was assessed previously.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not present for the combined device. For the original clearance of the DentiTrac® micro-recorder (K150369), there would have been ground truth for its compliance measurement function (e.g., actual wear time compared to recorded wear time), but this is not discussed here.
-
The sample size for the training set:
- Not present. This is not a machine learning or AI device that typically involves a training set in the conventional sense.
-
How the ground truth for the training set was established:
- Not present. Follows from point 8.
In summary, the document serves as a regulatory submission demonstrating substantial equivalence based on the concept that embedding an already cleared component (DentiTrac® micro-recorder) into an already cleared device (TAP® intra-oral appliance) does not introduce new safety or effectiveness concerns, and therefore, no new performance data or acceptance criteria for the combined device are required to be presented in this 510(k) summary.
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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.
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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
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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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| 510(k) Summary | |||
|---|---|---|---|
| Page 1 of 5 | |||
| 2-Aug-16 | |||
| Company | Airway Management, Inc.3418 Midcourt Road, Ste. 114Carrollton, TX 75006Tel – 866-264-7667 | ||
| Official Contact: | Dale SiebenmorgenManager 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® 3K964516 - 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
| ProposedTAP® Family with Micro-Recorder | SomnoMedSomnoDent® with micro-recorderK150369 | |
|---|---|---|
| Indications for Use | The TAP® family of intra-oral appliancesare intended for the treatment of night-timesnoring and mild to moderate obstructivesleep apnea in patients 18 years or age orolder.The DentiTrac® micro-recorder iscompletely embedded into the TAP® intra-oral appliance, the micro-recorder isintended to measure patient compliance tooral device / appliance therapy when used incombination with the DentiTrac® System. | The SomnoDent® intra-oral devices areintended for the treatment of night-timesnoring and mild to moderate obstructivesleep apnea in patients 18 years or age orolder.Optionally, if the DentiTrac® micro-recorder is completely embedded into theSomnoDent® device, the micro-recorderis intended to measure patient complianceto oral device / appliance therapy incombination 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
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510(k) Summary Page 3 of 5 2-Aug-16
| ProposedTAP® Family with Micro-Recorder | SomnoMedSomnoDent® with micro-recorderK150369 | |
|---|---|---|
| Design | ||
| Types of trays | Standard tray or customized upper andlower trays are fitted to individuals | Standard tray or customized upper andlower trays are fitted to individuals |
| Method of customizedfitting | Impression material or customized trays | Impression material or customized trays |
| Adjustable for setting theamount of protrusion | Can we adjusted for degree of protrusion bythe dentist | Can we adjusted for degree of protrusionby the dentist |
| Method for holding lowerjaw forward | Lower mandible is held in an advancedposition by an adjustable hook or post | Lower mandible is held in an advancedposition 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.
| ProposedTAP® Family with Micro-Recorder | Reference DevicesK964516 (TAP® 1)K062951 (TAP® 3) | |
|---|---|---|
| Product Classification | PLC - sleep appliances with patientmonitoring | |
| Cleared under LRK – device, anti-snoringIntraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea | LRK - device, anti-snoringIntraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea | |
| 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
| ProposedTAP® Family with Micro-Recorder | Reference DevicesK964516 (TAP® 1)K062951 (TAP® 3) | |
|---|---|---|
| Attributes | ||
| Indications for Use | The TAP® family of intra-oral appliancesare intended for the treatment of night-timesnoring and mild to moderate obstructivesleep apnea in patients 18 years or age orolder.The DentiTrac® micro-recorder iscompletely embedded into the TAP® intra-oral appliance, the micro-recorder isintended to measure patient compliance tooral device / appliance therapy when used incombination with the DentiTrac® System. | An intra-oral appliance intended for thetreatment of night-time snoring and mildto moderate obstructive sleep apnea inpatients 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 andlower trays are fitted to individuals | Standard tray or customized upper andlower trays are fitted to individuals |
| Method of customizedfitting | Impression material or customized trays | Impression material or customized trays |
| Adjustable for setting theamount of protrusion | Can we adjusted for degree of protrusion bythe dentist | Can we adjusted for degree of protrusionby the dentist |
| Method for holding lowerjaw forward | Lower mandible is held in an advancedposition by an adjustable hook or post | Lower mandible is held in an advancedposition 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:
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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.
§ 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.”