(87 days)
Not Found
No
The summary describes a mechanical oral appliance with no mention of AI or ML technology.
No.
The device is intended for the reduction of snoring, which is not typically classified as a therapeutic purpose for a medical condition.
No
The device description states its purpose as an "aid for the reduction of snoring" by advancing the lower tray, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is an "oral appliance" and describes physical components like "upper and lower trays," "impression material," and a "screw." It also mentions "Boil and Bite" and "Mandibular Repositioning Device (MRD)" concepts, all of which are hardware-based. The performance studies also focus on physical properties like durability, strength, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid for the reduction of snoring." This is a therapeutic or symptomatic treatment, not a diagnostic test performed on samples from the human body.
- Device Description: The device is an oral appliance designed to reposition the mandible. This is a physical intervention, not a test that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on laboratory results.
The device is clearly a medical device, specifically a Mandibular Repositioning Device (MRD), but it falls under the category of therapeutic or symptomatic treatment devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LRK
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).
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 of age or older
Intended User / Care Setting
Home and clinical settings
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 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
§ 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/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.
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
1
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
2
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 |
| Airway Management | |
| 3418 Midcourt Road, #114 | |
| Carrollton, TX 75006 | |
| 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 |
| and intraoral devices for snoring and obstructive sleep apnea | |
| 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.
4
510(k) Summary Page 2 of 4 30-Aug-18
Table 5.1 – Comparison to Predicate
| Proposed Device | Predicate Device | |
|---|---|---|
| myTAP2 | SnoreRx | |
| K170825 | ||
| Attributes | ||
| 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. | The SnoreRx is intended for use on adult | |
| patients 18 years of age or older as an aid for | ||
| 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 | |
| • 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 | • Has central sleep apnea | |
| • Is under the age of 18 | ||
| • Has a history of TMD, temporomandibular | ||
| disorder | ||
| • Has received dental implants within the | ||
| past year | ||
| • Has 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 | ||
| Warnings | • Tooth movement or changes in dental | |
| occlusion | ||
| • Dental sensitiveness after removing the | ||
| myTAP2 | ||
| • Gingival (gum) or dental soreness | ||
| • Pain or soreness of the jaw | ||
| • Obstruction of oral breathing | ||
| • Excessive salivation | • Tooth movement or changes in dental | |
| occlusion | ||
| • Gingival or dental soreness | ||
| • Pain or soreness to the | ||
| temporomandibular 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 mandibular | ||
| advancement | Adjustment of the relative position of the | |
| trays by the use of screw adjustment. | Adjustment of the relative position of the | |
| trays using fixed advancement on the side of | ||
| the trays. | ||
| Design | ||
| Tray Design | Pre-formed and fixed | Pre-formed and fixed |
| Allows lateral and | ||
| vertical movement | Allows for lateral and vertical movement | Does not allow for lateral and vertical |
| movement | ||
| Maximum adjustment | ||
| 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 | ||
| myTAP2 | Predicate Device | |
| SnoreRx | ||
| K170825 | ||
| 30-Aug-18 | ||
| Performance Testing | ||
| Biocompatibility and | Cytotoxicity | |
| Sensitization | ||
| Irritation | ||
| Surface Contacting, Mucosal membrane, | ||
| with duration of use prolonged |
24 hours ≤ 30 days | Cytotoxicity
Sensitization
Irritation
Surface 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 after
multiple cleanings equivalent to 365 days
use
• Flexural strength
• Mechanical / Tensile testing
• Drop test | Testing not available |
5
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.
6
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