(238 days)
DNA (K222872)
No
The summary describes a physical oral appliance with mechanical adjustment mechanisms. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on clinical outcomes related to the physical device's effect on AHI.
Yes
The device is described as intended to "treat mild and moderate obstructive sleep apnea" and "treat moderate and severe obstructive sleep apnea (OSA)," indicating a therapeutic purpose to improve a medical condition.
No
Explanation: The device is intended to treat snoring and obstructive sleep apnea by opening the airway during sleep. It measures treatment effectiveness via AHI reduction but does not perform the initial diagnosis of the condition.
No
The device description explicitly states that the device consists of physical components: an upper tray and a lower tray, which are customized and feature an adjustment mechanism. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce snoring and treat obstructive sleep apnea by physically opening the airway. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a physical appliance (upper and lower trays) designed to be worn in the mouth. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to in vitro diagnostics, such as reagents, calibrators, controls, or the analysis of biological specimens (blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on clinical outcomes related to sleep apnea (AHI reduction, snoring reduction) and physical changes (Transpalatal Width), not on the accuracy of a diagnostic test.
In summary, the C.A.R.E. Appliances are a therapeutic medical device used to treat a condition, not a diagnostic device used to test samples from the body.
N/A
Intended Use / Indications for Use
The C.A.R.E. Appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. Appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed.
Product codes (comma separated list FDA assigned to the subject device)
LRK, LQZ
Device Description
The C.A.R.E. appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed. They consist of an upper tray and a lower tray and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient.
The DNA appliance does not connect the upper and lower trays, while the mRNA and mmRNA appliances connect the trays with a flange and hinge respectively.
The devices are identical to the already-marketed predicates of the same name.
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 and older
Intended User / Care Setting
Fitting of the C.A.R.E. appliances in the dental office for patient use at home.
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)
Non-clinical Testing: 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. No biocompatibility testing was done as all the components are the same as the predicate device.
Clinical Testing: This submittal relies on peer-reviewed literature and clinical data (RWD) demonstrating that C.A.R.E. Appliances can treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older and treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed. The C.A.R.E. appliances raise no new questions of safety and efficacy as compared to the predicate device.
A peer-reviewed, blinded, controlled, randomized study evaluated the reduction in AHI in 15 consecutive patients randomly assigned to a DNA or a mRNA treatment group. The sleep studies were conducted pre- and post-treatment (the average treatment period was 9.7 months) without an appliance in the mouth. AHI reduction in DNA patients was 70.2%, mRNA patients was 50.6% and C.A.R.E. appliances combined was 64.0%.
Real Word Clinical Data obtained from a research database over a period of 5 years (2018-2023) was filtered to include i) patients 18 years of age and older, ii) treated with a C.A.R.E. appliance, iii) pre-and post-sleep studies at least six months apart and iv) diagnosed with moderate (15≤AHI
§ 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.”
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November 28, 2023
Vivos Therapeutics, Inc % Colette Cozean Regulatory Consultant Eyedeas Company 21581 Midcrest Dr Lake Forest, California 92630
Re: K230947
Trade/Device Name: C.A.R.E. Appliance (DNA, mRNA, mmRNA) 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: November 26, 2023 Received: November 27, 2023
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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) K230947
Device Name
C.A.R.E. Appliances (DNA, mRNA, mmRNA)
Indications for Use (Describe)
The C.A.R.E. Appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. Appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed.
| 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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5. 510(k) Summary - K230947
| Applicant: | Vivos Therapeutics
300 S. 5th Street
Murray, KY, 42017, USA
(270)-226-9237 |
|---------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colette Cozean, PhD
21581 Midcrest Drive
Lake Forest, CA
92630 (949) 855-2885
colettecozean@gmail.com |
| Date Prepared | November 18, 2023 |
| Proprietary Name | C.A.R.E. Appliances (DNA, mRNA, mmRNA) |
| Common Name | Dental Device - Anti Snoring /Obstructive Sleep Apnea Device |
| Classification Name | Anti Snoring/ Obstructive Sleep Apnea Device |
| Product Code | LRK, LQZ |
| Primary Predicate | DNA (K222872) |
| Reference Device | mRNA (K130067) |
| Reference Devices | mmRNA (K210203) |
Device Description
The C.A.R.E. appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed. They consist of an upper tray and a lower tray and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient.
The DNA appliance does not connect the upper and lower trays, while the mRNA and mmRNA appliances connect the trays with a flange and hinge respectively.
The devices are identical to the already-marketed predicates of the same name.
5
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. Sleep apnea has been linked to major medical conditions, including hypertension, headaches, heart disease, diabetes, depression, and more.
Device Function
The C.A.R.E. appliances are customized oral devices featuring a lower tray and an upper trav. These trays put gentle pressure on the back of the throat to prevent the airway from collapsing during 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 Olstructive Sleep Aprea-Hypopnea syndrome - A clinical study on therapeutic 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 C.A.R.E. Appliances aim to expand the nasal airway through jaw expansion and mid-facial redevelopment. In doing so, an oral device may be able to permanently improve the oropharyngeal airway. Studies have shown that the C.A.R.E. appliances can increase nasal cavity volume and reduce the incidence of apnea-hypopnea episodes. The mRNA and mmRNA also increase air cavity volume by mandibular advancement.
The C.A.R.E. appliances are customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The C.A.R.E. appliances allow 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.
Intended Use
The C.A.R.E. appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed.
Target Population: Patients 18 years of age and older with obstructive sleep apnea.
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Environment of Use: Fitting of the C.A.R.E. appliances in the dental office for patient use at home.
Comparison to Predicate Devices: Each of the C.A.R.E. appliances (DNA, mRNA and mmRNA) are identical to the previously cleared predicate devices of the same name. This is a request for an expanded Indication of Use only.
The cleaning instructions, instructions for use, and labeling are those currently used for the already-marketed predicate device. The have been reworded, but the indications for use, contraindications, warnings and cautions are the same. The precautions, warnings, risk analysis and other critical statements have been changed only slightly to allow for simultaneous treatment with other modalities as was done with the DNA appliance in K222872) according to the Vivos Method.
Shelf Life: The devices are provided non-sterile. Shelf life will be identical to the predicate devices. No shelf life is required as the device is custom-manufactured and immediately fitted to the patient by the dentist.
Non-clinical Testing: 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. No biocompatibility testing was done as all the components are the same as the predicate device.
Clinical Testing: This submittal relies on peer-reviewed literature and clinical data (RWD) demonstrating that C.A.R.E. Appliances can treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older and treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed. The C.A.R.E. appliances raise no new questions of safety and efficacy as compared to the predicate device.
A peer-reviewed, blinded, controlled, randomized study evaluated the reduction in AHI in 15 consecutive patients randomly assigned to a DNA or a mRNA treatment group. The sleep studies were conducted pre- and post-treatment (the average treatment period was 9.7 months) without an appliance in the mouth. AHI reduction in DNA patients was 70.2%, mRNA patients was 50.6% and C.A.R.E. appliances combined was 64.0%.
Real Word Clinical Data obtained from a research database over a period of 5 years (2018-2023) was filtered to include i) patients 18 years of age and older, ii) treated with a C.A.R.E. appliance, iii) pre-and post-sleep studies at least six months apart and iv) diagnosed with moderate (15≤AHI