(80 days)
The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device. the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.
The ProSomnus® EVO Sleep and Snore Device is an oral device, which improves the flow of air through the patient's pharyngeal space during sleep by repositioning the mandible. The ProSomnus® EVO Sleep and Snore Device and the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower device arches are CAD/CAM designed with twin-mated posts and are digitally milled to be patient-specific according to physician prescription. Customizable ergonomic features are available to improve patient comfort. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.
A micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring. The micro-recorder is a compliance sensor, which logs the time the device is worn.
The provided text describes the acceptance criteria and performance data for the ProSomnus® EVO Sleep and Snore Device. This information is derived from a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance (bench testing) rather than clinical studies involving human patients or AI performance.
Therefore, many of the requested details regarding clinical study design (sample size of test/training sets, data provenance, expert adjudication, MRMC studies, ground truth establishment) are not applicable (N/A) because this submission relies on bench testing to demonstrate performance and substantial equivalence.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Specification | ProSomnus® EVO Sleep and Snore Device (Subject Device) | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|
| Anterior-Posterior (AP) Shear Strength (lbf) | 235.4 | Must be greater than 200 lbf | Pass |
| Stroke (in) | 0.17 | Must be greater than 0.1 | Pass |
| Anterior-Posterior Directional Torque (lbf-in) | $235.4 \text{ lbf } * 0.17 \text{ in } = 40.0 \text{ lbf-in}$ | Must be equal or better than predicate device | Pass |
| Lateral Direction Shear Strength (lbf) | 71.5 | Must be greater than 50 lbf | Pass |
| Stroke (in) | 0.17 | Must be greater than 0.1 | Pass |
| Lateral Directional Torque (lbf-in) | $71.5 \text{ lbf } * 0.17 \text{ in } = 12.2 \text{ lbf-in}$ | Must be equal or better than predicate device | Pass |
| Durability when elastic bands pull on hooks at peak force (mm & lbs.) | 135.55 mm stretch length with an average peak force of 5.06 lbs. With no visible damage to the device and its metal-free hooks. | Must be equal or more durable than predicate device | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of a "test set" as this was bench testing on physical devices, not a dataset for an algorithm. The reported numbers (e.g., 235.4 lbf for AP Shear Strength) are likely averages or representative values from multiple tests, but the exact number of units tested is not stated.
- Data Provenance: This refers to non-clinical bench testing. There is no information about country of origin, or whether it was retrospective or prospective, as these terms usually apply to clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A: Ground truth based on expert consensus is not relevant for this type of bench testing. The "ground truth" for the performance specifications is determined by the physical properties and engineering measurements of the device as tested in a laboratory setting. No human experts are used for this type of "ground truth" establishment in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A: No adjudication method specified or implied as this was bench testing on device performance, not interpretation of data by multiple readers.
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
- N/A: No MRMC study was conducted. This device is a physical intraoral device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A: No standalone algorithm performance was assessed as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Testing/Engineering Specifications: The "ground truth" for the device's performance relies on objective measurements from mechanical testing (e.g., force, torque, length, durability) against pre-defined engineering specifications and comparison to the predicate device's measured performance.
8. The sample size for the training set
- N/A: There is no "training set" as this device is not an AI/machine learning model.
9. How the ground truth for the training set was established
- N/A: Not applicable since there is no AI training set.
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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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2020
ProSomnus Sleep Technologies, Inc. Divya Mavalli Ouality and Regulatory Manager 5860 West Las Positas Blvd. Pleasanton, California 94588
Re: K202529
Trade/Device Name: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring 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, PLC Dated: October 23, 2020 Received: October 26, 2020
Dear Divya Mavalli:
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.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202529
Device Name
ProSomnus® EVO Sleep and Snore Device ProSomnus® EVO Sleep and Snore Device with Patient Monitoring
Indications for Use (Describe)
The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device. the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.
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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Image /page/3/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo features a blue circular design on the left, followed by the company name "ProSomnus" in a larger, bolder blue font. Below "ProSomnus" is the text "SLEEP TECHNOLOGIES" in a smaller, lighter blue font. The logo is clean and professional, suggesting a focus on sleep-related technology.
K202529 510(K) SUMMARY
1. Manufacturer and Submitter
| Company Name: | ProSomnus® Sleep Technology, Inc |
|---|---|
| Company Address: | 5860 West Las Positas Blvd.Suite 25Pleasanton, CA 94588 |
| Contact Person: | Divya MavalliEmail: dmavalli@prosomnus.comPhone: 925.307.5337 |
| Date Prepared: | October 23, 2020 |
2. Device Name and Classification
| Trade/Proprietary Name: | ProSomnus® EVO Sleep and Snore DeviceProSomnus® EVO Sleep and Snore Device with PatientMonitoring |
|---|---|
| Common Name: | Mandibular Advancement Device |
| Classification Name: | Intraoral devices for snoring and intraoral devices for snoringand obstructive sleep apnea. |
| Regulatory Class: | II |
| Regulatory Number: | 21 CFR 872.5570 |
| Product Code: | LRK (Device, Anti-snoring), LQZ (Device, Jaw Repositioning)PLC (Sleep Appliances with Patient Monitoring) |
| Panel: | Dental |
| Predicate Device | |
| Device Name: | ProSomnus® MicrO2 Obstructive Sleep Apnea Device |
| 510(k) Number: | K133683 |
| Reference Device | |
| Device Name: | ProSomnus® MicrO2 Obstructive Sleep Apnea Device withMicro-Recorder |
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Image /page/4/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, with the text "ProSomnus" in blue to the right of the circle. Below "ProSomnus" is the text "Sleep Technologies" in a smaller font, also in blue. The logo is clean and modern, with a focus on the company's name and its area of expertise.
510(k) Number: K161624
4. Device Description
The ProSomnus® EVO Sleep and Snore Device is an oral device, which improves the flow of air through the patient's pharyngeal space during sleep by repositioning the mandible. The ProSomnus® EVO Sleep and Snore Device and the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower device arches are CAD/CAM designed with twin-mated posts and are digitally milled to be patient-specific according to physician prescription. Customizable ergonomic features are available to improve patient comfort. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.
A micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring. The micro-recorder is a compliance sensor, which logs the time the device is worn.
5. Intended Use/Indication for Use
The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac System.
6. Technological Characteristics
Both the predicate and subject devices use upper and lower device arches to reposition the mandible.
The below table provides a comparison of technological characteristics to models of the predicate and reference devices.
| Characteristics | ProSomnus®EVO Sleep andSnore Device(SubjectDevice) | ProSomnus®EVO Sleep andSnore Devicewith PatientMonitoring | ProSomnusMicrO2ObstructiveSleep ApneaDevice | ProSomnusMicrO2ObstructiveSleep Apnea |
|---|---|---|---|---|
| (Subject Devicewith Micro-Recorder) | (PredicateDevice) | Device withMicro-Recorder(ReferenceDevice) | ||
| Body Material | Medical GradePolymer | Medical GradePolymer | Polymethylmethacrylate(PMMA) | Polymethylmethacrylate(PMMA) |
| Usability | Single-patient,multiple use | Single-patient,multiple use | Single-patient,multiple use | Single-patient,multiple use |
| Splint | Comprised oftwo or morecustomizablesplints (upperand lower) | Comprised oftwo or morecustomizablesplints (upperand lower) | Comprised oftwo or morecustomizablesplints (upperand lower) | Comprised oftwo or morecustomizablesplints (upperand lower) |
| Technical Method | Advances thepatient'smandible in aforwardposition toincreaseairway space | Advances thepatient'smandible in aforwardposition toincrease airwayspace andadditionallymonitors thepatientcompliance tooral appliancetherapy | Advances thepatient'smandible in aforwardposition toincrease airwayspace | Advances thepatient'smandible in aforwardposition toincrease airwayspace andadditionallymonitors thepatientcompliance tooral appliancetherapy |
| ErgonomicFeatures - SplintDesign | The scallopedand contourededge allows forpatientcomfort | The scallopedand contourededge allows forpatientcomfort | Straight-lineplane at theedge of thesplint aroundthe front of theteeth | Straight-lineplane at theedge of thesplint aroundthe front of theteeth |
| ErgonomicFeatures - PostStyle | The dual radiusposts to allowfor patientcomfort | The dual radiusposts to allowfor patientcomfort | The post angleto the splint is astandard 90degrees | The post angleto the splint is astandard 90degrees |
| ErgonomicFeatures -Anterior Airway | Anteriorairway opening | Anterior airwayopening | No anteriorairway opening | No anteriorairway opening |
| ErgonomicFeatures -AnteriorDiscluder | The prescribingprovider canrequest theaddition of averticalelement | The prescribingprovider canrequest theaddition of averticalelement | No discluderoption isprovided | No discluderoption isprovided |
| ErgonomicFeatures -Lingual Coverage | Prescriber mayrequestposterior orfull lingualcoverage | Prescriber mayrequestposterior or fulllingualcoverage | No posterior orfull lingualcoverageprovided | No posterior orfull lingualcoverageprovided |
| ErgonomicFeatures - PlasticHooks | Plastic hooksincorporatedinto the design | Plastic hooksincorporatedinto the design | Uses stainlesssteel balls orhooks to securerubber bands inthoseprescriptionswhere they areindicated | Uses stainlesssteel balls orhooks to securerubber bands inthoseprescriptionswhere they areindicated |
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Image /page/5/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, followed by the text "ProSomnus" in a larger, bolder blue font. Below "ProSomnus" is the text "SLEEP TECHNOLOGIES" in a smaller, lighter blue font. The logo is clean and modern, suggesting a focus on technology and sleep solutions.
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Image /page/6/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, followed by the text "ProSomnus" in a larger, bolder blue font. Below "ProSomnus" is the text "SLEEP TECHNOLOGIES" in a smaller, lighter blue font. The overall design is clean and professional, conveying a sense of innovation and expertise in the field of sleep technology.
7. Performance Data
Product bench testing was performed to support the above indications for use as well as the claim of Substantial Equivalence.
| PerformanceSpecification | Subject DeviceProSomnus®EVO Sleep andSnore Device | Predicate DeviceProSomnusMicrO2 OSADevice | AcceptanceCriteria | Results(Pass/Fail) |
|---|---|---|---|---|
| Anterior-Posterior (AP)Shear Strength(lbf) | 235.4 | 239.8 | Must be greaterthan 200 lbf | Pass |
| Stroke (in) | 0.17 | 0.11 | Must be greaterthan 0.1 | Pass |
| Anterior-PosteriorDirectionalTorque (lbf-in) | $235.4 \text{ lbf } * 0.17 \text{ in } = 40.0 \text{ lbf-in}$ | $239.8 \text{ lbf } * 0.11 \text{ in } = 26.4 \text{ lbf-in}$ | Must be equalor better thanpredicatedevice | Pass |
| LateralDirection ShearStrength (lbf) | 71.5 | 94.2 | Must be greaterthan 50 lbf | Pass |
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Image /page/7/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, followed by the company name "ProSomnus" in a larger, bolder blue font. Below "ProSomnus", the words "SLEEP TECHNOLOGIES" are written in a smaller, lighter blue font. The overall design is clean and professional, conveying a sense of innovation and expertise in the field of sleep technology.
| Stroke (in) | 0.17 | 0.11 | Must be greaterthan 0.1 | Pass |
|---|---|---|---|---|
| LateralDirectionalTorque (Ibf-in) | $71.5 \text{ lbf } * 0.17 \text{ in } = 12.2 \text{ lbf-in}$ | $94.2 \text{ lbf } * 0.11 \text{ in } = 10.4 \text{ lbf-in}$ | Must be equalor better thanpredicatedevice | Pass |
| Durability whenelastic bandspull on hooks atpeak force (mm& lbs.) | 135.55 mmstretch lengthwith an averagepeak force of5.06 lbs. Withno visibledamage to thedevice and itsmetal-freehooks. | 135.55 mm stretchlength with anaverage peak forceof 4.74 lbs. Withno visible damageto the device andits metal-freehooks. | Must be equalor more durablethen predicatedevice | Pass |
Non-Clinical Performance Testing
Product biocompatibility testing and risk analysis were performed, and the following standards were utilized:
-
ISO 10993-1: 2018 Biological Evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- A ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices -Part 2: Animal welfare requirements
-
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
-
ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
-
ISO 7405: 2018 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
-
ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices
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Image /page/8/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left and the company name on the right. The circular design is made up of three curved lines that form a circle. The text "ProSomnus" is in a larger, bolder font, while the text "Sleep Technologies" is in a smaller font below it.
8. Substantial Equivalence
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Image /page/9/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, followed by the text "ProSomnus" in a larger, bolder blue font. Below "ProSomnus" is the text "SLEEP TECHNOLOGIES" in a smaller, lighter blue font. The logo is clean and modern, suggesting a focus on technology and sleep solutions.
| SubstantiallyEquivalentConnection | ProSomnus®EVO Sleep andSnore Device | ProSomnus®EVO Sleep andSnore Devicewith PatientMonitoring | ProSomnusMicro2ObstructiveSleep ApneaDevice | ProSomnusMicro2ObstructiveSleep ApneaDevice withMicro-Recorder |
|---|---|---|---|---|
| 510(k) Number | K202529 | K202529 | K133683 | K161624 |
| Manufacturer | ProSomnusSleepTechnologies | ProSomnusSleepTechnologies | ProSomnusSleepTechnologies | ProSomnusSleepTechnologies |
| Relation | Subject Device | Subject Devicewith PatientMonitoring | PredicateDevice | PredicateDevice withMicro-Recorder |
| Device | Device, Anti-SnoringDevice, JawRepositioning | SleepAppliances withPatientMonitoring | Device, Anti-Snoring | SleepAppliances withPatientMonitoring |
| Product Code | LRKLQZ | PLC | LRK | PLC |
| Indications forUse | The device isintended toreduce nighttime snoringand mild tomoderateobstructivesleep apnea(OSA) in adults. | The device isintended toreduce nighttime snoringand mild tomoderateobstructivesleep apnea(OSA) in adults. | The device isintended toreduce nighttime snoringand mild tomoderateobstructivesleep apnea(OSA) in adults. | The device isintended toreduce nighttime snoringand mild tomoderateobstructivesleep apnea(OSA) in adults. |
| Usability | Single patient,multiple use | Single patient,multiple use | Single patient,multiple use | Single patient,multiple use |
| TargetPopulation | Adult patients | Adult patients | Adult patients | Adult patients |
| Where Used | For personaluse at home orin sleeplaboratories | For personaluse at home orin sleeplaboratories | For personaluse at home orin sleeplaboratories | For personaluse at home orin sleeplaboratories |
| Prescription | Yes | Yes | Yes | Yes |
| Principle ofOperation | MandibularRepositioners | MandibularRepositioners | MandibularRepositioners | MandibularRepositioners |
| Non-Sterile | Yes | Yes | Yes | Yes |
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Image /page/10/Picture/0 description: The image contains the logo for ProSomnus Sleep Technologies. The logo features a blue circular graphic on the left, followed by the text "ProSomnus" in a larger, bolder blue font. Below "ProSomnus", the words "SLEEP TECHNOLOGIES" are written in a smaller, lighter blue font. The overall design is clean and professional, suggesting a focus on sleep-related technology and solutions.
| Design | Allows spacefor tongue andmandibularmovement ofmouth openingand closingduring wear | Allows spacefor tongue andmandibularmovement ofmouth openingand closingduring wear | Allows spacefor tongue andmandibularmovement ofmouth openingand closingduring wear | Allows spacefor tongue andmandibularmovement ofmouth openingand closingduring wear |
|---|---|---|---|---|
| AdjustmentMechanism | No adjustmentmechanismssuch as pistons,screws, straps,or repositioningelastics areused to modifyor maintain themandibularposition | No adjustmentmechanismssuch as pistons,screws, straps,or repositioningelastics areused to modifyor maintain themandibularposition | No adjustmentmechanismssuch as pistons,screws, straps,or repositioningelastics areused to modifyor maintain themandibularposition | No adjustmentmechanismssuch as pistons,screws, straps,or repositioningelastics areused to modifyor maintain themandibularposition |
9. Conclusion
Based on the comparison of technology and the indications for use, we find that ProSomnus® EVO Sleep and Snore Device is substantially equivalent to ProSomnus® MicrO2 Obstructive Sleep Apnea Device.
§ 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.”