TAP 3, TAP 1

K160239 · Airway Management, Inc. · PLC · Aug 10, 2016 · Dental

Device Facts

• Record ID: K160239
• Device Name: TAP 3, TAP 1
• Applicant: Airway Management, Inc.
• Product Code: PLC · Dental
• Decision Date: Aug 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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(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.

Device Story

TAP® 1 and TAP® 3 are intra-oral appliances consisting of custom-fitted upper and lower trays; a midline coupling mechanism allows dentists to titrate mandibular advancement to increase pharyngeal space during sleep. The DentiTrac® micro-recorder is embedded into the appliance to monitor patient compliance; it tracks wear time via oral temperature, movement, and head position. Data is transferred to a cloud-based application for clinician reporting. Used in home, dental, and sleep lab settings; prescribed by physicians/dentists. The device helps clinicians assess therapy adherence, potentially improving treatment outcomes for snoring and OSA.

Clinical Evidence

Bench testing only. The modification (addition of DentiTrac® micro-recorder) was previously cleared under K150369. No additional performance testing was required as the embedding process does not alter the performance of the TAP® appliance as an intra-oral device.

Technological Characteristics

Intra-oral appliance with custom-fitted upper/lower trays; adjustable mandibular advancement hook/post mechanism. Includes embedded DentiTrac® micro-recorder for compliance monitoring. Materials are identical to previously cleared TAP® devices. Connectivity via cloud-based web application for data reporting.

Indications for Use

Indicated for patients 18 years or older with night-time snoring and mild to moderate obstructive sleep apnea. Contraindications include missing, infected, or loose teeth, temporary crowns or fillings, and Temporomandibular Joint (TMJ) dysfunction.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• SomnoMed SomnoDent® with micro-recorder (K150369)

Reference Devices

• TAP® 3 (K062951)
• NPB TAP® 1 (K964516)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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.<br>3418 Midcourt Road, Ste. 114<br>Carrollton, TX 75006<br>Tel – 866-264-7667 | | |
| Official Contact: | Dale Siebenmorgen<br>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®<br>with micro-recorder | | |
| Reference Devices: | K062951 - Airway Management - TAP® 3<br>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

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#### 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<br>TAP® Family with Micro-Recorder | SomnoMed<br>SomnoDent® with micro-recorder<br>K150369 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The TAP® family of intra-oral appliances<br>are intended for the treatment of night-time<br>snoring and mild to moderate obstructive<br>sleep apnea in patients 18 years or age or<br>older.<br><br>The DentiTrac® micro-recorder is<br>completely embedded into the TAP® intra-<br>oral appliance, the micro-recorder is<br>intended to measure patient compliance to<br>oral device / appliance therapy when used in<br>combination with the DentiTrac® System. | The SomnoDent® intra-oral devices are<br>intended for the treatment of night-time<br>snoring and mild to moderate obstructive<br>sleep apnea in patients 18 years or age or<br>older.<br><br>Optionally, if the DentiTrac® micro-<br>recorder is completely embedded into the<br>SomnoDent® device, the micro-recorder<br>is intended to measure patient compliance<br>to oral device / appliance therapy in<br>combination with the DentiTrac®<br>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

| | Proposed<br>TAP® Family with Micro-Recorder | SomnoMed<br>SomnoDent® with micro-recorder<br>K150369 |
|----------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Design | | |
| Types of trays | Standard tray or customized upper and<br>lower trays are fitted to individuals | Standard tray or customized upper and<br>lower trays are fitted to individuals |
| Method of customized<br>fitting | Impression material or customized trays | Impression material or customized trays |
| Adjustable for setting the<br>amount of protrusion | Can we adjusted for degree of protrusion by<br>the dentist | Can we adjusted for degree of protrusion<br>by the dentist |
| Method for holding lower<br>jaw forward | Lower mandible is held in an advanced<br>position by an adjustable hook or post | Lower mandible is held in an advanced<br>position by an adjustable hook or post |
| Cleaning method | Cleaned by simple rinsing with water | Cleaned by simple rinsing with water |
| Method that DentiTrac®<br>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<br>TAP® Family with Micro-Recorder | Reference Devices<br>K964516 (TAP® 1)<br>K062951 (TAP® 3) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | PLC - sleep appliances with patient<br>monitoring | |
| | Cleared under LRK – device, anti-snoring<br>Intraoral devices for snoring and intraoral<br>devices for snoring and obstructive sleep<br>apnea | LRK - device, anti-snoring<br>Intraoral devices for snoring and intraoral<br>devices for snoring and obstructive sleep<br>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<br>TAP® Family with Micro-Recorder | Reference Devices<br>K964516 (TAP® 1)<br>K062951 (TAP® 3) |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attributes | | |
| Indications for Use | The TAP® family of intra-oral appliances<br>are intended for the treatment of night-time<br>snoring and mild to moderate obstructive<br>sleep apnea in patients 18 years or age or<br>older.<br><br>The DentiTrac® micro-recorder is<br>completely embedded into the TAP® intra-<br>oral appliance, the micro-recorder is<br>intended to measure patient compliance to<br>oral device / appliance therapy when used in<br>combination with the DentiTrac® System. | An intra-oral appliance intended for the<br>treatment of night-time snoring and mild<br>to moderate obstructive sleep apnea in<br>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<br>lower trays are fitted to individuals | Standard tray or customized upper and<br>lower trays are fitted to individuals |
| Method of customized<br>fitting | Impression material or customized trays | Impression material or customized trays |
| Adjustable for setting the<br>amount of protrusion | Can we adjusted for degree of protrusion by<br>the dentist | Can we adjusted for degree of protrusion<br>by the dentist |
| Method for holding lower<br>jaw forward | Lower mandible is held in an advanced<br>position by an adjustable hook or post | Lower mandible is held in an advanced<br>position by an adjustable hook or post |
| Cleaning method | Cleaned by simple rinsing with water | Cleaned by simple rinsing with water |
| Method that DentiTrac®<br>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.