myTAP2

K181482 · Airway Management, Inc. · LRK · Aug 31, 2018 · Dental

Device Facts

• Record ID: K181482
• Device Name: myTAP2
• Applicant: Airway Management, Inc.
• Product Code: LRK · Dental
• Decision Date: Aug 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The myTAP2 is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

Device Story

myTAP2 is an intraoral mandibular repositioning device (MRD) for snoring reduction; used in home settings by adult patients. Device consists of pre-formed upper and lower trays filled with impression material to mold to user's teeth. Principle of operation involves advancing the mandible via a screw adjustment mechanism to hold the lower jaw forward, thereby opening the airway. User-operated; allows for lateral and vertical movement. Benefits include reduction of snoring. Device is single-patient, multi-use; cleaned by rinsing with water and toothbrush.

Clinical Evidence

Bench testing only. Testing included functional durability (equivalent to 365 days of use), flexural strength, mechanical/tensile testing, and drop testing. Biocompatibility testing performed per ISO 10993-1 for mucosal membrane contact (>24 hours to 30 days), including cytotoxicity, sensitization, irritation, and acute systemic toxicity.

Technological Characteristics

Intraoral mandibular repositioning device. Materials evaluated per ISO 10993-1 for prolonged mucosal contact. Features pre-formed trays with impression material and screw-based advancement mechanism. Allows lateral and vertical movement. User-adjustable up to 5 mm. Non-powered, mechanical device.

Indications for Use

Indicated for adult patients 18 years of age or older as an aid for the reduction of snoring. Contraindicated for patients with central sleep apnea, under 18 years of age, history of TMD, dental implants/crowns/caps (unless approved by dentist), other dental appliances/dentures/orthodontic treatment, loose teeth/abscesses/severe gum disease, or history of chronic asthma/emphysema/respiratory disorder (unless approved by physician).

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

• SnoreRx (K170825)

Submission Summary (Full Text)

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Airway Management, Inc. Paul Dryden Consultant 3418 Midcourt Road Carrollton, Texas 75006

Re: K181482

Trade/Device Name: myTAP2 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: LRK Dated: June 3, 2018 Received: June 5, 2018

Dear 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

August 31, 2018

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mary S. Runner -S

For Tina Kiang, Ph.D. Acting 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K181482

Device Name

## myTAP2

Indications for Use (Describe)

The myTAP2 is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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| 510(k) Summary | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Page 1 of 4 |
| 30-Aug-18 | |
| Official Contact: | Eric Jarrett - Director of Quality and Regulatory<br>Airway Management<br>3418 Midcourt Road, #114<br>Carrollton, TX 75006<br>866.264.7667 x 354 |
| Proprietary or Trade Name: | myTAP2 |
| Common/Usual Name: | Intra-oral appliance |
| Classification Name: | LRK - Device, anti-snoring, Intraoral devices for snoring<br>and intraoral devices for snoring and obstructive sleep apnea<br>21 CFR 872.5570, Class 2 |
| Predicate Devices: | K170825 – Apnea Sciences – SnoreRx |

#### Device Description

The myTAP2 is an oral appliance design concept based upon the use of a standard set of upper and lower travs filled with an impression material. A screw is used to advance the lower tray. The myTAP2 is of a design often referred to as a "Boil and Bite" and the concept of advancement is commonly referred to as a Mandibular Repositioning Device (MRD).

The principle of advancing a lower or upper tray so that it advances the mandible to aid in reducing snoring is well known and there are a number of predicate devices.

#### Indications for Use

The myTAP2 is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

#### Environment of Use Home and clinical settings

## Contraindications

Oral Device-OA

The device is contraindicated for patients who:

- Has central sleep apnea
- . Is under the age of 18
- Has a history of TMD, temporomandibular disorder
- Has received dental implants, crowns, caps, unless approved by your dentist
- Has other dental appliances, dentures or is undergoing orthodontic treatment
- Has loose teeth, abscesses, or severe gum disease
- Have a history of chronic asthma, emphysema, or any respiratory disorder, unless approved ● by their physician

#### Comparison of myTAP2 to Predicate

We present in Table 1 a comparison of the subject device, myTAP2 compared to the predicate Apnea Sciences - SnoreRx - K170825.

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#### 510(k) Summary Page 2 of 4 30-Aug-18

## Table 5.1 – Comparison to Predicate

| | Proposed Device | Predicate Device |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | myTAP2 | SnoreRx<br>K170825 |
| | Attributes | |
| Indications for Use | The myTAP2 is intended for use on adult<br>patients 18 years of age or older as an aid for<br>the reduction of snoring. | The SnoreRx is intended for use on adult<br>patients 18 years of age or older as an aid for<br>the reduction of snoring. |
| Environments of use | Home | Home |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | • Has central sleep apnea<br>• Is under the age of 18<br>• Has a history of TMD,<br>temporomandibular disorder<br>• Has received dental implants, crowns,<br>caps, unless approved by your dentist<br>• Has other dental appliances , dentures or<br>is undergoing orthodontic treatment<br>• Has loose teeth, abscesses, or severe gum<br>disease<br>• Have a history of chronic asthma,<br>emphysema, or any respiratory disorder,<br>unless approved by their physician | • Has central sleep apnea<br>• Is under the age of 18<br>• Has a history of TMD, temporomandibular<br>disorder<br>• Has received dental implants within the<br>past year<br>• Has dentures or is undergoing orthodontic<br>treatment<br>• Has loose teeth, abscesses, or severe gum<br>disease<br>• Have a history of chronic asthma,<br>emphysema, or any respiratory disorder,<br>unless approved by their physician |
| Warnings | • Tooth movement or changes in dental<br>occlusion<br>• Dental sensitiveness after removing the<br>myTAP2<br>• Gingival (gum) or dental soreness<br>• Pain or soreness of the jaw<br>• Obstruction of oral breathing<br>• Excessive salivation | • Tooth movement or changes in dental<br>occlusion<br>• Gingival or dental soreness<br>• Pain or soreness to the<br>temporomandibular joint<br>• Obstruction of oral breathing<br>• Excessive salivation |
| OTC | Yes | Yes |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |
| Principle of operation /<br>means of mandibular<br>advancement | Adjustment of the relative position of the<br>trays by the use of screw adjustment. | Adjustment of the relative position of the<br>trays using fixed advancement on the side of<br>the trays. |
| Design | | |
| Tray Design | Pre-formed and fixed | Pre-formed and fixed |
| Allows lateral and<br>vertical movement | Allows for lateral and vertical movement | Does not allow for lateral and vertical<br>movement |
| Maximum adjustment<br>by the user | Up to 5 mm | Up to 6 mm |
| How it opens airway | Holds mandible / lower jaw forward | Holds mandible / lower jaw forward |
| Method of cleaning | Cleaned by simple rinsing with water and | Cleaned by simple rinsing with water and |
| | toothbrush | toothbrush |
| | Proposed Device<br>myTAP2 | Predicate Device<br>SnoreRx<br>K170825 |
| 30-Aug-18 | | |
| Performance Testing | | |
| Biocompatibility and | Cytotoxicity<br>Sensitization<br>Irritation<br>Surface Contacting, Mucosal membrane,<br>with duration of use prolonged<br>> 24 hours ≤ 30 days | Cytotoxicity<br>Sensitization<br>Irritation<br>Surface Contacting, Mucosal membrane,<br>with duration of use prolonged<br>> 24 hours ≤ 30 days |
| Patient contact | | |
| Durability testing | 1 year | N/A |
| Performance testing | • Functional testing for durability after<br>multiple cleanings equivalent to 365 days<br>use<br>• Flexural strength<br>• Mechanical / Tensile testing<br>• Drop test | Testing not available |

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#### 510(k) Summary Page 3 of 4 30-Aug-18

## Discussion of Substantial Equivalence for myTAP2

The myTAP2 is viewed as substantially equivalent to the predicate device because:

#### Indications -

Similar to predicate - SnoreRx - K170825 - indicated as an aid for the reduction of snoring. Discussion - The indications for use between the subject device and predicate are similar.

## Technology / Principle of Operation -

Similar to predicate - SnoreRx - K170825. Both devices use upper and lower trays with a means to advance the mandible / lower jaw.

Discussion - Both devices use separate upper and lower trays with a means to advance the mandible / lower jaw that is similar. Both devices use pre-formed trays filled with an impression material to mold to the individual's teeth and to keep the trays in place. The means of setting the advancement is done with a screw on the subject device while the predicate has latches on the side which are locked to keep the trays in the advanced position. The difference in advancement means does not raise different concerns of safety or effectiveness from the predicate.

## Environment of Use -

Similar to predicate - SnoreRx - K170825. They are used in Home settings. Discussion - Both devices have similar environments of use.

## Population -

Similar to predicate - SnoreRx - K170825 - 18 years and older Discussion - The patient population is similar.

## Labeling -

We made several changes which we believe are applicable and appropriate and have incorporated them in the proposed labeling.

#### Contraindications -

The contraindications are similar for both devices.

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#### 510(k) Summary Page 4 of 4 30-Aug-18

#### STOP Bang Survey -

There is the inclusion of the Stop Bang survey in both device labels. We propose a slight difference in wording from the subject device to the available predicate wording. The wording changes we believe that the intent and description is clear for the potential user.

The Instructions for Use have been designed to be nearly identical to the predicate labeling to reflect appropriate content for the user.

#### OTC Designation -

Both devices are designated for OTC. The predicate SnoreRx - K170825 was originally cleared as Rx Only and then recently was cleared for OTC designation under K170825. Discussion - Both are OTC designation and thus similar.

#### Non-clinical performance testing

The myTAP2 underwent the following testing:

- Functional testing for durability after multiple cleanings equivalent to 365 days use .
- . Flexural strength
- Mechanical / Tensile testing .

#### Biocompatibility of Materials

All the materials are considered per ISO 10993-1 as Surface Contacting, Mucosal membrane, with duration of use prolonged > 24 hours < 30 days, per FDA Guidance Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA dated 11/12/2002

Based upon the Guidance the ISO 10993-1 testing would be:

- . Cytotoxicity
- Sensitization
- Irritation ●

In addition to the aforementioned biocompatibility tests. Airway Management also performed Acute Systemic Toxicity.

#### Discussion of Differences

The differences between the myTAP2 and predicate - SnoreRx - K170825 are:

- The mechanism for advancing the trays is an adjustment screw for the myTAP2 and a manual ● clip mechanism for the predicate.
- . Labeling
- o Slight wording changes to the Stop Bang survey

These differences do not raise difference concerns of safety or effectiveness.

#### Substantial Equivalence Conclusion

Based upon the performance testing and comparison to the legally marketed predicate device for indications for use, technology, and performance demonstrates that myTAP2 is substantially equivalent to the predicate SnoreRx- K170825.