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).

AI/ML Overview

Based on the provided text, the device in question is the myTAP2, an intraoral device intended for the reduction of snoring. The document is a 510(k) summary for its premarket notification to the FDA.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance data is provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (SnoreRx - K170825) rather than presenting a detailed clinical study with pre-defined acceptance metrics for efficacy (e.g., percentage reduction in AHI, or snore count).

The "study" in this context is the non-clinical performance testing and biocompatibility testing conducted to show the myTAP2 is as safe and effective as its predicate.

Non-Clinical Performance Testing and Biocompatibility (The "Study")

The provided text describes the non-clinical and biocompatibility tests conducted to support the substantial equivalence of the myTAP2 to the predicate device, SnoreRx (K170825). It does not describe a clinical study of human performance or a multi-reader multi-case (MRMC) study.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a quantitative table of acceptance criteria or performance results like sensitivity, specificity, or AUC for snoring reduction. The "acceptance" here is demonstrated by meeting the safety and basic functional requirements through non-clinical testing and by being substantially equivalent to a legally marketed predicate.

The table below summarizes the types of testing performed and the general conclusion regarding their success in supporting substantial equivalence.

Acceptance Criteria (Category)	Reported Device Performance (MyTAP2)
Functional / Durability	Functional testing for durability after multiple cleanings equivalent to 365 days use.
Mechanical Properties	Flexural strength testing performed. Mechanical / Tensile testing performed. Drop test performed.
Biocompatibility (ISO 10993-1)	All materials considered: Surface Contacting, Mucosal membrane, with duration of use prolonged > 24 hours ≤ 30 days. Tests performed: - Cytotoxicity - Sensitization - Irritation - Acute Systemic Toxicity Conclusion: Tests appear to have been passed, as the claim of substantial equivalence is made with these tests as supporting evidence, indicating the device materials are safe for their intended use and contact duration. Specific numerical results are not provided.
Operational Principle	Uses a screw adjustment mechanism to advance the lower jaw, similar to the predicate's principle of mandibular repositioning. Conclusion: The document asserts, "The difference in advancement means does not raise different concerns of safety or effectiveness from the predicate."
Indications for Use	Intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring. Conclusion: "Similar to predicate - SnoreRx - K170825 - indicated as an aid for the reduction of snoring."
Patient Population	Adult patients 18 years and older. Conclusion: "Similar to predicate - SnoreRx - K170825 - 18 years and older."
Contraindications/Warnings	Contraindications and warnings are similar to the predicate device. Conclusion: "The contraindications are similar for both devices." Changes were made to labeling deemed "applicable and appropriate."
OTC Designation	Over-The-Counter (OTC) designation. Conclusion: "Both are OTC designation and thus similar" to the predicate, which was also cleared for OTC.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of a clinical test set for AI performance. The studies performed were non-clinical (durability, mechanical, biocompatibility). For these tests, sample sizes would refer to the number of devices or material samples tested, but these specific numbers are not provided in the summary.
Data Provenance: Not applicable for non-clinical testing. The tests would have been performed in a lab setting, likely by the manufacturer or a contracted testing facility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is a medical device for snoring, and the submission is based on substantial equivalence demonstrated through non-clinical performance and biocompatibility testing, not on a clinical AI performance study requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described as part of non-clinical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on non-clinical performance and similarity in design and indications to a predicate device. This type of study would typically be conducted for diagnostic AI devices, not for a physical intraoral device for snoring.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical intraoral appliance, not an algorithm or AI system.

7. The Type of Ground Truth Used

For Non-Clinical Testing: The "ground truth" for the non-clinical tests (durability, strength, biocompatibility) is established by adherence to industry standards (e.g., ISO 10993-1 for biocompatibility) and engineering specifications. The "truth" is whether the device materials and construction meet the predefined physical, chemical, and biological safety parameters.
For Efficacy (Snoring Reduction): The document does not present a clinical study for efficacy with ground truth data (e.g., from polysomnography or snore monitors). The efficacy claim is based on the substantial equivalence to the predicate device, which itself is cleared as "an aid for the reduction of snoring," implying a known mechanism of action.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 RegulatoryAirway Management3418 Midcourt Road, #114Carrollton, TX 75006866.264.7667 x 354
Proprietary or Trade Name:	myTAP2
Common/Usual Name:	Intra-oral appliance
Classification Name:	LRK - Device, anti-snoring, Intraoral devices for snoringand intraoral devices for snoring and obstructive sleep apnea21 CFR 872.5570, Class 2
Predicate Devices:	K170825 – Apnea Sciences – SnoreRx

Device Description

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	SnoreRxK170825
	Attributes
Indications for Use	The myTAP2 is intended for use on adultpatients 18 years of age or older as an aid forthe reduction of snoring.	The SnoreRx is intended for use on adultpatients 18 years of age or older as an aid forthe 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• 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 oris undergoing orthodontic treatment• Has loose teeth, abscesses, or severe gumdisease• Have a history of chronic asthma,emphysema, or any respiratory disorder,unless approved by their physician	• Has central sleep apnea• Is under the age of 18• Has a history of TMD, temporomandibulardisorder• Has received dental implants within thepast year• Has dentures or is undergoing orthodontictreatment• Has loose teeth, abscesses, or severe gumdisease• Have a history of chronic asthma,emphysema, or any respiratory disorder,unless approved by their physician
Warnings	• Tooth movement or changes in dentalocclusion• Dental sensitiveness after removing themyTAP2• Gingival (gum) or dental soreness• Pain or soreness of the jaw• Obstruction of oral breathing• Excessive salivation	• Tooth movement or changes in dentalocclusion• Gingival or dental soreness• Pain or soreness to thetemporomandibular joint• Obstruction of oral breathing• Excessive salivation
OTC	Yes	Yes
Duration of Use	Single patient, multi-use	Single patient, multi-use
Principle of operation /means of mandibularadvancement	Adjustment of the relative position of thetrays by the use of screw adjustment.	Adjustment of the relative position of thetrays using fixed advancement on the side ofthe trays.
Design
Tray Design	Pre-formed and fixed	Pre-formed and fixed
Allows lateral andvertical movement	Allows for lateral and vertical movement	Does not allow for lateral and verticalmovement
Maximum adjustmentby 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 DevicemyTAP2	Predicate DeviceSnoreRxK170825
30-Aug-18
Performance Testing
Biocompatibility and	CytotoxicitySensitizationIrritationSurface Contacting, Mucosal membrane,with duration of use prolonged> 24 hours ≤ 30 days	CytotoxicitySensitizationIrritationSurface Contacting, Mucosal membrane,with duration of use prolonged> 24 hours ≤ 30 days
Patient contact
Durability testing	1 year	N/A
Performance testing	• Functional testing for durability aftermultiple cleanings equivalent to 365 daysuse• Flexural strength• Mechanical / Tensile testing• 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.

Regulation Number and Section

§ 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.”