(338 days)
No
The summary describes a mechanical intraoral device and mentions a micro-recorder for compliance monitoring, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the "treatment of snoring and mild to moderate obstructive sleep apnea," which classifies it as a therapeutic device.
No
The device is an intraoral appliance for treating snoring and sleep apnea by repositioning the mandible. It records and monitors patient compliance, but its primary function is therapeutic, not diagnostic.
No
The device description explicitly states it is an "intraoral device" and describes its physical function as a "mandibular repositioner." It also mentions "appliances" and "adjustable coupling mechanism," all of which are hardware components. While there is mention of software testing, the core device is a physical appliance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of snoring and mild to moderate obstructive sleep apnea by repositioning the mandible. It also monitors patient compliance. This is a therapeutic and monitoring function, not a diagnostic one performed on in vitro samples.
- Device Description: The device is an intraoral appliance that physically alters the patient's anatomy during sleep. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing samples outside of the body, which is the defining characteristic of an IVD.
The device is clearly a medical device used for treatment and monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and monitor patient compliance to oral device/appliance therapy.
Product codes
PLC, LRK, LQZ
Device Description
The SomnoDent intraoral devices functions as a mandibular repositioner, which acts to increase the patient's pharvngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to breather during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the sleep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.
This Rest Assure System consists of two appliances, namely the Rest Assure Elite Appliance with (formerly the SomnoDent Herbst commercially distributed under K150369) and the Rest Assure Avant. Both hold current 510(k) clearances from FDA, K150369 for the SomnoDent Herbst Advanced with embedded micro-recorder and K183443 for the SomnoDent Avant.
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
patients over 18.
Intended User / Care Setting
Not Found
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
To demonstrate the performance of the Rest Assure System, the following performance testing was completed:
- A. Software Testing per IEC 62304
- B. Safety Testing by UL per 60601-1 series
- C. EMC Testing per 60601-1-2
- D. Risk Analysis per ISO 14971
- E. Cybersecurity Evaluation and Assessment
- Co-existence Testing and Assessment
- G. Biocompatibility Assessment per the specific guidance "Intraoral Devices for Snoring and/or Obstructive Sleep Apnea - Class II Special Controls Guidance Document for Industry" and "FDA Biocompatibility Guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process"
- H. Usability Testing per IEC 62366
Further, functional and systems testing was performed to demonstrate requirements were successfully completed to demonstrate compliance with the device requirements and specifications. Since the device characteristics and features, intended use, instructions for use, and materials of the Rest Assure System were consistent with the identified predicate, clinical testing was not required or performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 3, 2024
Somnomed, Inc. Timothy Cowart Regulatory Affairs Contractor 6513 Windcrest Drive, Suite 100 Plano, Texas 75024
Re: K233497
Trade/Device Name: Rest Assure System 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: PLC, LRK, LQZ Dated: October 29, 2023 Received: January 10, 2024
Dear Timothy Cowart:
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/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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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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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).
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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
3
Indications for Use
510(k) Number (if known)
K233497
Device Name Rest Assure System
Indications for Use (Describe)
Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and montor patient compliance to oral device/ appliance therapy.
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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K233497
510(k) Summary
Rest Assure System
1.0 Submitter SomnoMed, Inc. 6513 Windcrest Drive, Suite 100 Plano, TX 75024 Telephone: 888-447-6673
Official Contact Timothy Cowart Regulatory Contractor Telephone: 678-481-9246 Email: tcowart@somnomed.com
- 2.0 Date Prepared October 3, 2024
- 3.0 Device Identification
| Proprietary Names: | Rest Assure System |
|---|---|
| Common Name: | Device, Anti-Snoring |
| Classification Name: | Intraoral device for snoring and Intraoral devices |
| for snoring and obstructive sleep apnea | |
| Device Classification: | Class II Product Code: LRK, LQZ, PLC |
| Regulation Number: | 21 CFR 872.5570 |
4.0 Legally Marketed Predicate Device
| Candidate(s) | Primary
Predicates | Manufacturer | Document
Number |
|----------------------------------------------------------------|----------------------------------------------------------------|-------------------|--------------------|
| Rest Assure
System
SomnoDent®
with Micro-
Recorder | SomnoDent® Herbst Advance
Appliance with Micro-
Recorder | SomnoMed,
Inc. | K150369 |
| | SomnoDent® Avant | | K183443 |
The Rest Assure System is substantially equivalent to the SomnoDent® Herbst Advance Appliance with the Micro-Recorder (K140278) and the SomnoDent® Avant (K183443).
5
5.0 Device Description
The SomnoDent intraoral devices functions as a mandibular repositioner, which acts to increase the patient's pharvngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to breather during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the sleep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.
This Rest Assure System consists of two appliances, namely the Rest Assure Elite Appliance with (formerly the SomnoDent Herbst commercially distributed under K150369) and the Rest Assure Avant. Both hold current 510(k) clearances from FDA, K150369 for the SomnoDent Herbst Advanced with embedded micro-recorder and K183443 for the SomnoDent Avant.
6.0 Intended Use
Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and monitor patient compliance to oral device/appliance therapy.
| Technological Characteristics | Predicate Devices | | Proposed
Device |
|----------------------------------------------------------|-------------------------------|----------------------------------------------------|--------------------|
| | SomnoDent® Avant
(K183443) | Herbst Advance with
Micro-Recorder
((150369) | Rest Assure |
| Intended Use | | | |
| Intended as an intraoral device | Yes | Yes | Yes |
| Intended to reduce snoring or help
alleviate snoring | Yes | Yes | Yes |
| Treatment of mild to moderate
obstructive sleep apnea | Yes | Yes | Yes |
| Intended for nighttime use | Yes | Yes | Yes |
| Indicated for single patient multiuse | Yes | Yes | Yes |
| Indicated for use at home or sleep
laboratories | Yes | Yes | Yes |
| Target population: adults | Yes | Yes | Yes |
| Prescription device | Yes | Yes | Yes |
| Design | | | |
| Customized fit for each patient | Yes | Yes | Yes |
| Separate upper and lower tray
pieces | Yes | Yes | Yes |
7.0 Comparison to the Predicate Devives
6
| Works by mandibular advancement | Yes | Yes | Yes |
|---|---|---|---|
| Can be adjusted or refit | Yes | Yes | Yes |
| Lower jaw adjustment using supplied | |||
| components | Yes | Yes | Yes |
| Permits patient to breathe through | |||
| mouth | Yes | Yes | Yes |
| Cleaned and inspected daily by | |||
| patient | Yes | Yes | Yes |
| Material | |||
| Trays constructed from a soft lining | |||
| material adhered to a hard surface | |||
| acrylic | Yes (Flex retention Avant and | ||
| Herbst) | |||
| No (Classic retention – with Herbst | |||
| only) | Yes (Flex | ||
| retention) | |||
| Advancement mechanism constructed | |||
| of surgical grade stainless steel | Yes | Yes |
Like the Micro-Recorder embedded within the Somnomed Herbst appliance, the sensors and embedded pcba within the Rest Assure Appliances do not change the intended use of the SomnoDent device for the treatment of night-time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. Also, the Micro-Recorder embedded within the Somnomed Herbst appliance are self-contained, and the sensors and embedded pcba within the Rest Assure appliances are encapsulated, so there is isolation resulting in no physical or electrical exposure to the sensor or embedded pcba. Furthermore, the size, position, and location of the embedded Micro-Recorder in the SomnoDent appliances does not increase any risk to patient safety as there is ample space in the patient's oral cavity to accommodate the appliances.
8.0 Performance Testing
To demonstrate the performance of the Rest Assure System, the following performance testing was completed:
- A. Software Testing per IEC 62304
- B. Safety Testing by UL per 60601-1 series
- C. EMC Testing per 60601-1-2
- D. Risk Analysis per ISO 14971
- E. Cybersecurity Evaluation and Assessment
- Co-existence Testing and Assessment ட்
- G. Biocompatibility Assessment per the specific guidance "Intraoral Devices for Snoring and/or Obstructive Sleep Apnea - Class II Special Controls Guidance Document for Industry" and "FDA Biocompatibility Guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process"
- H. Usability Testing per IEC 62366
Further, functional and systems testing was performed to demonstrate requirements were successfully completed to demonstrate compliance with the device requirements and specifications. Since the device characteristics and features,
7
intended use, instructions for use, and materials of the Rest Assure System were consistent with the identified predicate, clinical testing was not required or performed.
9.0 Conclusion
Based on the similarities in the intended use, principles of operation, functional design, established materials used, and testing performed combined with the test results, the Rest Assure System is safe and effective for its intended purpose and the submitted supports a substantial equivalence decision.