(296 days)
A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity
TMJ Relax™ is durable medical equipment in the form of a mouthguard that is fitted to the teeth that temporarily provides traction on the mandible such that it repositions the mandible to reduce muscle tension. The device is a removeable home use product that a consumer may wear up to 22 hours per day, in other words except when eating or during sports activities. The TMJ Relax™ system is a single or series of appliances prescribed for patients with a history of a diagnosis of temporomandibular joint disorder and/or migraines/tension headaches. The device is a one-part removeable oral appliance fitted on the mandibular or maxillary teeth that repositions the mandible while sleeping or during sedentary daytime use. The appliance is patient fitted by using a computer aided manufacturing protocol.
The provided document is a 510(k) Premarket Notification from the FDA, specifically concerning the TMJ Relax device. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting the results of a standalone study with acceptance criteria and performance data in the format requested.
Therefore, this document does not contain the detailed information required to fully answer the request regarding acceptance criteria and a study proving the device meets them.
The document explicitly states:
- "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Page 8, Section 10. Clinical Performance Data)
- "The subject device is identical and/or substantially equivalent to the predicate devices, and introduces no new risks or concerns compared to the predicates." (Page 8, Section 10. Clinical Performance Data)
This means there wasn't a dedicated clinical study performed on the TMJ Relax device itself with defined acceptance criteria for its performance. Instead, the submission relies on the established safety and efficacy of the predicate devices.
However, I can extract information related to the device and its claimed equivalence:
Device Information:
- Device Name: TMJ Relax™
- Intended Use: Prophylactic treatment of medically diagnosed migraine pain and migraine-associated tension-type headaches, by reducing signs and symptoms through reduction of trigeminally innervated muscular activity; and for the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity.
- Mechanism of Action: Disocclusion and temporary repositioning of the mandible.
- Technology: Computer-aided design and manufacturing algorithm for custom fitting, 3D printed thermoplastic resin appliance.
Inferences based on the provided text (though not actual study data):
Since no specific study is described with acceptance criteria, the table below will reflect the claimed performance based on substantial equivalence to predicate devices rather than measured performance from a study of the TMJ Relax device itself.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric/Criterion (Implied via Predicate Equivalence) | Reported Device Performance (Implied via Predicate Equivalence) |
|---|---|---|
| Safety | Biocompatibility (ISO 10993-1 compliance) | Complies with ISO 10993-1 for surface contacting device with mucosal membrane for long-term use (>30 days). Uses biocompatible acrylic resin. |
| Absence of novel risks | Does not raise new questions of safety; at least as safe as predicate devices. | |
| Effectiveness | Prophylactic treatment of medically diagnosed migraine pain and migraine-associated tension-type headaches by reducing signs and symptoms (based on predicate) | Expected to reduce signs and symptoms for migraine pain and tension-type headaches, equivalent to predicate. |
| Prevention of bruxism (based on predicate) | Expected to prevent bruxism, equivalent to predicate. | |
| Prevention of TMJ syndrome (based on predicate) | Expected to prevent TMJ syndrome, equivalent to predicate. | |
| Reduction of trigeminally innervated muscular activity (based on predicate) | Expected to reduce trigeminally innervated muscular activity, equivalent to predicate. | |
| Usability/Usability | Ease of use by adult patients in a home setting | "Easy to use, reversible method." User manuals provided to healthcare providers and patients. |
| Method of disinfection | Disinfected with soap and water; air dry. |
Since no clinical study was performed for this 510(k) submission, the following sections cannot be populated with specific data for the TMJ Relax device. I will indicate this where appropriate.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable, as no dedicated test set from a clinical study was reported for the TMJ Relax device.
- Data Provenance: Not applicable. The "performance" is based on the established history and data of predicate devices (NTI-TSS NTI Tension Suppression System K010876 and Luco Hybrid OSA Appliance K160477), which have been on the market for many years.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical study with a test set requiring ground truth establishment was conducted for this submission.
4. Adjudication method for the test set:
- Not applicable, as no clinical study with a test set was conducted for this submission.
5. 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 applicable. This device is a physical mouthguard, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical mouthguard, not an algorithm, in the context of typical AI/software performance studies. The "proprietary computer aided design and manufacturing algorithm" is for fabrication, not for diagnostic or clinical performance assessment in the sense of a standalone algorithm study.
7. The type of ground truth used:
- Not applicable, as no direct clinical study with a ground truth was conducted for this submission. The "ground truth" for the substantial equivalence claim relies on the long-standing clinical experience and performance of the predicate devices for similar indications.
8. The sample size for the training set:
- Not applicable, as no machine learning model requiring a training set for clinical performance was described in the context of this submission's regulatory requirements. The mention of a "proprietary computer aided design and manufacturing algorithm" refers to device fabrication, not a clinical diagnostic algorithm.
9. How the ground truth for the training set was established:
- Not applicable, for the same reasons as in point 8.
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June 24, 2021
Charles Sutera, CEO, Officer of Development Moonwalker Innovations Inc 20 Roosevelt Rd Medford, Massachusetts 02155
Re: K202523
Trade/Device Name: TMJ Relax Regulatory Class: Unclassified Product Code: OCO, MQC Dated: May 24, 2021 Received: May 26, 2021
Dear Charles Sutera:
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/cdrh/cfdocs/cfpmp/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 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
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202523
Device Name TMJ Relax
Indications for Use (Describe)
A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and;
For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity
| 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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Moonwalker Innovations
Section 5 - 510(k) Summary
1. Submission Sponsor
Moonwalker Innovations Inc 20 Roosevelt Rd Medford, MA 02155 Phone: +781-487-1111 Contact: Charles Sutera DMD, FAGD, CEO, Officer of Development
2. Submission Correspondent
Moonwalker Innovations Inc 20 Roosevelt Rd Medford, MA 02155 Phone: +781-487-1111 Contact: Charles Sutera DMD, FAGD, CEO, Officer of Development Charles.sutera@aestheticsmilereconstruction.com
3. Date Prepared
06/23/2021
Device Identification 4.
Trade/Proprietary Name: TMJ Relax™ Common/Usual Name: Mouthguard Classification Name: Mouthquard, Migraine/Tension Headache: Mouthquard, prescription Classification Regulation: Unclassified Product Code: Product Code OCO, MQC Device Class: Unclassified Device Use: RX Classification Panel: Dental
Legally Marketed Predicate Device(s) 5.
Primary Predicate: NTI-TSS NTI Tension Suppression System (#K010876) Reference Device: The Luco Hybrid OSA Appliance (#K160477)
6. Device Description
TMJ Relax™ is durable medical equipment in the form of a mouthguard that is fitted to the teeth that temporarily provides traction on the mandible such that it repositions the mandible to reduce muscle tension. The device is a removeable home use product that a consumer may wear up to 22 hours per day, in other words except when eating or during sports activities.
The TMJ Relax™ system is a single or series of appliances prescribed for patients with a history of a diagnosis of temporomandibular joint disorder and/or migraines/tension headaches. The device is a one-part removeable oral appliance fitted on the mandibular
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Moonwalker Innovations
or maxillary teeth that repositions the mandible while sleeping or during sedentary daytime use. The appliance is patient fitted by using a computer aided manufacturing protocol.
TMJ Relax™ is available by prescription by a healthcare provider (MD, DQ, DMD, or DDS) and dispensed directly to the patient by the healthcare provider as durable medical equipment. Impressions and bite registration are required to be taken by a dental healthcare provider.
To fabricate the appliance, maxillary and mandibular impressions are taken by the treating healthcare provider using an additive silicone material of the provider's choice or via digitally scanned impressions. In addition, a bite registration is taken. The patient is instructed to deprogram their bite first, and then a bite registration is taken by the preference of the treating healthcare provider. We suggest taking the bite registration in centric occlusion using a bite fork such as the George Gauge® or via a digitally scanned method. It is preferable to take the bite registration in centric occlusion using a bite fork or another method of disocclusion to account for the resin thickness of the device for most accurate transfer of the bite position indicated by the provider.
The impression samples and bite registration are shipped with provided shipping packaging to our dental lab facility for evaluation, design, and fabrication.
The raw data is obtained using dental laboratory scanners and generated in a computer-aided design software. If raw data is incomplete, the treating healthcare provider is contacted to resubmit new impressions to address the data deficiencies.
When appropriate data is fully submitted, the device is fitted to the consumer's teeth using TMJ Relax's proprietary computer aided design and manufacturing algorithm. The algorithm is consistent for each device manufactured and includes criteria to design a device with the intended mode of action.
The appliance is manufactured via a 3D printer. The manufactured TMJ Relax™ appliance provides traction to the mandible such that it allows the mandible to passively reposition and reduces muscular activity.
The device is dispensed directly to the patient by the healthcare provider to be used according to the recommended indications and instructions for use. The patient wears the initial appliance for approximately 2 weeks which allows the mandible to relax and advance into an initial new mandibular position. A patient follow-up is recommended with the treating healthcare provider after wearing the initial appliance for approximately 2 weeks. The patient is instructed to wear the appliance for at least one hour prior to the followup appointment. The treating healthcare provider has the option to either adjust the device or replace the device with a fabricated device set to a new mandibular position by the treating healthcare provider. If a secondary device is selected, an additional bite registration is taken, mailed by the treating healthcare provider to a
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Moonwalker Innovations Inc. dental lab, and a secondary appliance is fabricated to the new mandibular position.
The system may continue in a plurality of adjustments and/or appliances over a period of time which must be directed by the treating healthcare provider. The final appliance in the series may be used long term as durable medical equipment at the direction of the treating healthcare provider.
TMJ Relax™ is an easy to use, reversible method for treatment of medically diagnosed tension-type headaches, and prevention of bruxism and TMJ syndrome by action of reducing of muscular activity.
Special conditions for use statement(s):
- a. For at home use.
- b. This device is not a substitute for visits to a healthcare provider for recommended screening or appropriate follow-up. It is recommended that users consult with a healthcare provider if there are any questions or concerns about symptoms, and to determine if further treatment is indicated.
- c. The etiology of symptoms should be evaluated and confirmed in a clinical setting.
- d. The device is intended for users ≥ 18 years old, or those able to be compliant with the protocol as determined by a healthcare provider.
- e. The device is intended for people without active caries or periodontal disease, without loose teeth, and with a minimum of 20 existing teeth in the mouth.
Indication for Use Statement 7.
A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and;
For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity
8. Substantial Equivalence Discussion
The comparison chart below provides evidence to facilitate the substantial equivalence determination between TMJ Relax™ to the primary predicate device (K010876) and reference device (K160477) with respect to intended use, technological characteristics, and mode of action.
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Moonwalker Innovations Inc.
TMJ Relax™ Traditional 510(k) K202523
Image /page/6/Picture/1 description: The image shows the text "Moonwalker Innovations" in a stylized font. The word "Moonwalker" is written in a bold, rounded, cursive-like font, with the letters connected to each other. The word "Innovations" is written in a smaller, more delicate cursive font and is placed to the right of "Moonwalker."
| Device | TMJ Relax™(Subject Device) | NTI-TSS NTI TensionSuppression System(K010876); PrimaryPredicate | Luco Hybrid OSAAppliance® (K160477);Reference Device |
|---|---|---|---|
| Product Code | OCO, MQC | OCO | OCO, MQC |
| Indications for Use | A device to be used in theprophylactic treatment ofmedically diagnosedmigraine pain as well asmigraine associatedtension-type headaches, byreducing their signs andsymptoms throughreduction of trigeminallyinnervated muscularactivity, and;For the prevention ofbruxism and TMJ syndromethrough reduction oftrigeminally innervatedmuscular activity | A device to be used in theprophylactic treatment ofmedically diagnosedmigraine pain as well asmigraine associatedtension-type headaches, byreducing their signs andsymptoms throughreduction of trigeminallyinnervated muscularactivity, and;For the prevention ofbruxism and TMJsyndrome throughreduction of trigeminallyinnervated muscularactivity | A device to be used for thetreatment of sleep bruxismAs an aid in the treatmentof associatedtension/migraine typeheadaches in adults |
| Intended User | Adult in Home Setting | Adult in Home Setting | Adult in Home Setting |
| Material | Thermoplastic resin | Thermoplastic resin | Thermoplastic resin fortooth bearing surfaces;dental alloy for theframework; stainless steelclasps, wires, andexpansion screws |
| Anatomical sites | Worn on maxillary ormandibular teeth | Worn on maxillary archinvolving the uppermaxillary central incisors | Worn on maxillary andmandibular teeth |
| Design | The TMJ Relax is a smallintraoral device, which isfitted to a single arch ofteeth and has an occlusalsurface which is balancedto the new mandibularposition and eliminatesprotrusive/lateral excursiveinterferences. A healthcareprovider monitorssymptoms accordingly. Thesurface is customized bythe healthcare provider bymanual adjustments or byfabricating a series ofappliances from a series ofbite registrations toreposition the mandible tothe new mandibular | The NTI-tss is a smallintraoral device, which isfitted over the two maxillarycentral incisors and has adome shaped protrusion,which extends lingually.The dome is customized bythe healthcare provider, toact as a single pointcontact at the incisalembrasure of the twomandibular central incisors,thereby preventingposterior or canine toothcontact. The device doesnot introduce anychemicals or substancesinto the patient's system. | Uses wings on a lowerappliance to engage blocksof an upper appliance totemporarily hold themandible forward anddisclude the teeth toreposition the mandible tothe new mandibularposition. |
| position as determined bythe treating healthcareprovider. | |||
| Mechanism of Action | Disocclusion | Disocclusion | Disocclusion |
| Removeable? | Yes | Yes | Yes |
| Location of Use | Used by adults at home | Used by adults at home | Used by adults at home |
| Biocompatibility | Uses a biocompatibleacrylic resin (unclassified);Does not use any dyes. | Uses a biocompatibleacrylic resin (unclassified);Does not use any dyes. | Uses a biocompatibleacrylic resin (unclassified);Does not use any dyes. |
| Hardness | Hard variation only | Hard variation only | Hard variation only |
| Sterility | The appliance is deliverednon-sterile | The appliance is deliverednon-sterile | The appliance is deliverednon-sterile |
| Method ofDisinfection | Soap and water; air dry | Soap and water; air dry | Soap and water; air dry |
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Image /page/7/Picture/1 description: The image contains the text "Moonwalker Innovations" in a stylized font. The word "Moonwalker" is written in a larger, bold, cursive font, while "Innovations" is in a smaller, more standard cursive font. The text is black against a white background.
The comparison chart above provides evidence to facilitate the substantial equivalence determination between TMJ Relax™ and our chosen primary predicate, NTI-TSS NTI Tension Suppression System, and the reference device, Luco Hybrid OSA Appliance®.
There is a direct correlation between the Indications for Use Statement/Intended Use of TMJ Relax™, the NTI-TSS NTI Tension Suppression System, and Luco Hybrid OSA Appliance®. Each of the devices are oral appliances used to disocclude the teeth to reposition the mandible. Each of the devices have similar composition and biocompatiability.
The design characteristics between TMJ Relax™, the NTI-TSS NTI Tension Suppression System, and Luco Hybrid OSA Appliance® are substantially equivalent as the primary mode of action is to disocclude the teeth and allow the mandible to reposition to the new mandibular position. The TMJ Relax™ incorporates all active features of the predicate devices related to the intended use.
The primary design difference between the proposed device and the predicate/reference device is where the device sits within the oral cavity. The Luco Hybrid OSA Appliance® sits on both the maxillary and the mandibular teeth, while the TMJ Relax™ sits either the maxillary or mandibular arch, and the primary predicate device, the NTI-TSS NTI Tension Suppression System, sit on the maxillary arch involving the maxillary central incisors. Although the positions of the device within the oral cavity are different, the intent in all of the devices is disocclusion, traction, and repositioning of the mandible to the new mandibular position.
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The proposed and predicate devices are patient specific and reuseable for the given patient. TMJ Relax™, the NTI-TSS NTI Tension Suppression System, and the Luco Hybrid OSA Appliance® are made available to patients when critical care is not required. Each of the devices are intended for patients who are willing and capable of managing its use in the home environment.
The TMJ Relax does not raise new questions of safety and effectiveness, and an internal risk analysis supports TMJ Relax is at least as safe and effective as both predicate devices.
All these facts provide evidence to facilitate the substantial equivalence determination between TMJ Relax™ and the primary predicate device, NTI-TSS NTI Tension Suppression System (K010876) and the reference device, the Luco Hybrid OSA Appliance® (K160477).
9. Non-Clinical Performance Data
During the development of TMJ Relax™ Standards ISO 20795-2, ANSI 139-2012, and ISO 10993-1 were carefully considered to ensure compliance. As per the 10993-1 quidance document, the TMJ Relax™ device is classified as a surface contacting device with the mucosal membrane for long term use > 30 days. The contact duration is based on ISO 10993-1, Clause 5.3: medical devices whose cumulative sum of single, multiple or repeated contact time exceeds 30 d.
The TMJ Relax device complies with all applicable standards.
Clinical Performance Data 10.
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for home use for many years with a proven safety and efficacy for the use of the device. The subject device is identical and/or substantially equivalent to the predicate devices, and introduces no new risks or concerns compared to the predicates.
Statement of Substantial Equivalence 11.
The TMJ Relax™ has the same or similar intended use as the primary predicate and the reference device and any technological differences between the TMJ Relax™ and the predicate/reference devices do not raise any questions regarding TMJ Relax™ safety and effectiveness.
The proposed labeling states intended uses, selection criteria, results of the product, directions for proper use, and warninqs in such terms that the prescribed product would be understood and used properly by the ordinary individual including individuals of low comprehension under customary conditions of purchase and use. A healthcare provider user manual will be provided to healthcare providers and a patient user manual will be
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provided within the product packaging, also will be available via downloadable PDF format which can be viewed, saved, or printed. Further information, instructions, and questions will be available from the prescribing healthcare provider. Information included details how dental healthcare providers should take impressions to fabricate the device and how to follow-up care. Patient user manual details how to properly use the device, how to clean the device, describes common expectations, and how to properly evaluate the need for follow up care with a healthcare provider.
The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators in the home setting.
N/A