(205 days)
To reduce nighttime snoring and mild to moderate sleep apnea in adults.
The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.
The device is identical to the already-marketed mRNA appliance except the top and bottom trays interlock using the Herbst telescoping hinge instead of the mRNA flange. It is used in the predicate SomnoMed® device as well as many other devices in the market, e.g. Oasys Sleep (K181571) reference and Oasys Oral/Nasal Airway system (K030440). The mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device.
The provided document is a 510(k) summary for the mmRNA appliance, which is an intraoral device for snoring and mild to moderate sleep apnea. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Vivos Therapeutics mRNA Device, K130067).
However, the document does not contain a study that proves the device meets specific acceptance criteria. Instead, it relies on the argument of substantial equivalence to a predicate device, as permitted under the 510(k) pathway. This means that direct performance data from a clinical study for the subject device (mmRNA appliance) is generally not required if it can be demonstrated that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested details about acceptance criteria, clinical study results, expert involvement, and ground truth establishment are not available in this document for the subject device. The document focuses on demonstrating similarity to the predicate device.
Below is an attempt to address your request based on the information available in the document, highlighting what is not present.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and General Claims)
As this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device that is already deemed safe and effective for the indicated use. The document does not provide specific quantitative acceptance criteria or a study with direct performance metrics for the mmRNA appliance itself. Instead, it makes claims about its function and similarity to the predicate.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Claims based on Predicate) |
|---|---|
| Mechanism of Action: Open the airway during sleep via mandibular advancement. | Mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device. (page 3) |
| Intended Use: Reduce nighttime snoring and mild to moderate sleep apnea in adults. | "To reduce nighttime snoring and mild to moderate sleep apnea in adults." (page 5) - Identical to primary predicate device. |
| Material Safety (Biocompatibility): Materials are safe for intraoral use. | "No additional biocompatibility testing is necessary, as the materials are use are identical to those of the predicate device." (page 5) |
| Mechanical Integrity: Device components are durable and functional. | "Mechanical Testing: The Somnodent predicate device, K130558, provided mechanical testing on the hinge. All other components are the same as the predicate mRNA." (page 5) - Relies on predicate hinge testing and component similarity. |
| Risk Profile: Risks (soreness, obstruction, tooth movement, breakage) are equivalent to predicate. | "A risk analysis was performed, which considered soreness, obstruction of breathing, tooth movement, and breakage. The product was compared to predicate devices in each area to show the risks were equivalent to the predicate devices." (page 5) |
Missing Information (Not provided in the document):
The following information is not available in the provided 510(k) summary because the document focuses on substantial equivalence rather than presenting a new clinical study for the subject device:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for the subject device as no new clinical study data is presented for its performance. The document relies on the established performance of the predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a medical device, not an AI or imaging diagnostic tool that would involve human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new performance study is presented. The "ground truth" for the predicate device's efficacy would have been established through its own clinical trials or prior regulatory clearances. The current document asserts the subject device functions similarly.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of what is available regarding "the study that proves the device meets the acceptance criteria":
The document argues for substantial equivalence to the predicate device (Vivos Therapeutics mRNA Device, K130067), rather than presenting a new clinical study. The "proof" is based on:
- Similarity in Intended Use: Identical indications for use as the predicate device.
- Similarity in Mechanism of Action: Mandibular advancement, the same as the primary predicate device. The only difference is the specific hinge mechanism (Herbst hinge vs. flange).
- Similarity in Design and Materials: Customized acrylic trays with an expansion screw, optional extender, and standard dental materials (acrylic, stainless steel orthodontic wires).
- Reliance on Predicate Testing: Biocompatibility is assumed due to identical materials. Mechanical testing for the Herbst hinge is referenced from another predicate (SomnoMed® SomnoDent Herbst, K130558). A risk analysis concluded equivalence to predicates.
In conclusion, the document is a 510(k) submission that seeks clearance based on substantial equivalence to a predicate device, not on new clinical study data for the subject device itself. Therefore, detailed information about acceptance criteria met by a specific study is not provided for the mmRNA appliance but rather implied through its similarity to already cleared devices.
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August 19, 2021
Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I) % Colette Cozean Regulatory Consultant Colette Cozean, PhD 21581 Midcrest Dr. Lake Forest, California 92630
Re: K210203
Trade/Device Name: mmRNA appliance 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, LQZ Dated: January 20, 2021 Received: January 26, 2021
Dear Colette Cozean:
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/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.
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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 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/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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K201203
Device Name: mmRNA appliance™
Indications for Use: To reduce nighttime snoring and mild to moderate sleep apnea in adults.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use ___X (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Applicant
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510(k) Summary
mmRNA appliance™ VIVOS THERAPEUTICS, INC. 9137 S. RIDGELINE BLVD. SUITE 135 HIGHLANDS RANCH, CO 80129
| Date Prepared : | August 13, 2021 |
|---|---|
| Official Contact: | Colette Cozean, PhD(949) 855-2885; colettecozean@gmail.com) |
| Proprietary/Trade Name: | mmRNA appliance™ |
| 510(k) Number | K210203 |
| Common/Usual Name: | Dental Device – Anti Snoring/Obstructive Sleep Apnea Device |
| Classification Name: | Anti-Snoring/Obstructive Sleep Apnea Device |
| Proposed Product Code: | LRK, LQZ |
| Primary Predicate Device:Reference Device: | Vivos Therapeutics mRNA Device, K130067SomnoMed® SomnoDent Herbst, K130558 |
Device Description
The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.
The device is identical to the already-marketed mRNA appliance except the top and bottom trays interlock using the Herbst telescoping hinge instead of the mRNA flange. It is used in the predicate SomnoMed® device as well as many other devices in the market, e.g. Oasys Sleep (K181571) reference and Oasys Oral/Nasal Airway system (K030440). The mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device.
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Technical Features:
| Subject Device mmRNA | Primary Predicate mRNA device | |
|---|---|---|
| Upper and lower trays | Customized, acrylic | Customized, acrylic |
| Degrees of Freedom | 6 | 6 |
| Expansion mechanism | Expansion screw | Expansion screw |
| Mandibular advancementmechanism | Herbst hinge | Flange |
| Optional extender | Yes | Yes |
Scientific Principles
During sleep, the muscles in the tongue and back of the throat relax, which can cause them to sag and narrow the airway. Airflow through a narrow airway is the cause of snoring. When this narrowing of the airway is severe, it results in Obstructive Sleep Apnea (OSA), where the airway closes. This can happen up to hundreds of times during the night, lasting for a minute or longer. With these closures, the brain detects the lack of oxygen and disturbs sleep to draw breath. In many cases, the individual isn't completely aware of the stoppages, which don't fully awaken the sleeper.
Device Function
The mmRNA appliance is a customized oral device featuring a lower tray and upper tray. These trays put gentle pressure on the tissue at the back of the throat to prevent the airway from collapsing sleep.
Studies have shown that customized oral devices that function by increasing the patency of the airway show comparable efficacy to continuous positive airway pressure (CPAP) devices, considered the gold standard of treatment for OSA (Oral appliance therapy in Obstructive Sleep Appea syndrome - A clinical study on therupeutic outcomes Hoekema A PhD thesis, University Medical Centre Groningen Department of Oral and Maxillofacial Surgery. pp 110, 2007). On the basis of these studies, use of oral devices has been recommended by the American Academy of Sleep Medicine for patients with mild or moderate OSA, or for those with severe OSA who are unable to tolerate the CPAP device.
The mmRNA appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The mmRNA appliance allows for six degrees of freedom in customization, including antero-posterior (AP) adjustment, transverse (TV) adjustment, as well as permitting adjustments of the vertical dimension of occlusion (VDO).
The addition of an optional extender on the back of the device further prevents the patient's airway from collapsing during sleep.
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Intended Use
To reduce nighttime snoring and mild to moderate sleep apnea in adults. These are the same indications as the primary predicate device (mRNA).
Target Population: Patients, over 18 years of age, with snoring or mild to moderate obstructive sleep apnea.
Environment of Use: Fitting of the mmRNA appliance in the dental office for patient use at home.
Comparison to Predicate Devices: The mmRNA appliance with the extender is identical in both mechanism of action and design to the predicate mRNA device, except that it advances the mandible via a telescoping hinge instead of a flange. The device allows the airway to remain open during sleep. The device is made of the same materials (standard dental acrylic, stainless steel orthodontic wires, and orthodontic adjustment screws).
The cleaning instructions for use, and labeling are identical to the already-marketed predicate device.
Shelf Life: The device is provided non-sterile. Shelf life will be identical to the predicate device. No shelf life is required as the device is custom-manufactured and immediately fitted to the patient by the dentist.
Non-clinical Testing: No additional biocompatibility testing is necessary, as the materials are use are identical to those of the predicate device. A risk analysis was performed, which considered soreness, obstruction of breathing, tooth movement, and breakage. The product was compared to predicate devices in each area to show the risks were equivalent to the predicate devices.
Mechanical Testing: The Somnodent predicate device, K130558, provided mechanical testing on the hinge. All other components are the same as the predicate mRNA.
Labeling: The labeling has been changed to reflect the hinge.
Conclusion: The subject device, mmRNA, is substantially equivalent to the primary predicate device, mRNA in its design, mechanism of action, intended use, target population, materials, testing, and labeling. The only difference between the two devices is the mmRNA advances the mandible via a telescoping hinge instead of the flange used in the mRNA.
§ 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.”