ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

K202529 · Prosomnus Sleep Technologies, Inc. · LRK · Nov 20, 2020 · Dental

Device Facts

• Record ID: K202529
• Device Name: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
• Applicant: Prosomnus Sleep Technologies, Inc.
• Product Code: LRK · Dental
• Decision Date: Nov 20, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 therapy in combination with the DentiTrac System.

Device Story

Oral appliance for snoring and mild-to-moderate OSA; repositions mandible forward to increase pharyngeal airway space. CAD/CAM designed; digitally milled medical-grade polymer arches; twin-mated posts; no mechanical adjustment components (pistons, screws, straps). Patient-specific; prescribed by physician; used at home or sleep labs. Optional embedded DentiTrac micro-recorder logs wear time for compliance monitoring. Provider uses device to manage airway; patient wears device during sleep. Benefits include reduced snoring and improved sleep apnea symptoms.

Clinical Evidence

Bench testing only. Evaluated anterior-posterior shear strength, stroke, directional torque, lateral shear strength, and durability of hooks. All tests passed against acceptance criteria and compared favorably to predicate device performance.

Technological Characteristics

Medical grade polymer construction; CAD/CAM design; digitally milled; twin-mated posts; non-sterile. Sensing: optional embedded DentiTrac micro-recorder for compliance monitoring. Standards: ISO 10993-1, -2, -5, -10, -11, -12; ISO 7405; ISO 14971.

Indications for Use

Indicated for adult patients with mild to moderate obstructive sleep apnea (OSA) and snoring. Used to reduce snoring and OSA by repositioning the mandible.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• ProSomnus® MicrO2 Obstructive Sleep Apnea Device (K133683)

Reference Devices

• ProSomnus® MicrO2 Obstructive Sleep Apnea Device with Micro-Recorder (K161624)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>Suite 25<br>Pleasanton, CA 94588 |
| Contact Person: | Divya Mavalli<br>Email: [e-mail]<br>Phone: [phone] |
| Date Prepared: | October 23, 2020 |

# 2. Device Name and Classification

3.

| Trade/Proprietary Name: | ProSomnus® EVO Sleep and Snore Device<br>ProSomnus® EVO Sleep and Snore Device with Patient<br>Monitoring |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Mandibular Advancement Device |
| Classification Name: | Intraoral devices for snoring and intraoral devices for snoring<br>and obstructive sleep apnea. |
| Regulatory Class: | II |
| Regulatory Number: | 21 CFR 872.5570 |
| Product Code: | LRK (Device, Anti-snoring), LQZ (Device, Jaw Repositioning)<br>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 with<br>Micro-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®<br>EVO Sleep and<br>Snore Device<br>(Subject<br>Device) | ProSomnus®<br>EVO Sleep and<br>Snore Device<br>with Patient<br>Monitoring | ProSomnus<br>MicrO2<br>Obstructive<br>Sleep Apnea<br>Device | ProSomnus<br>MicrO2<br>Obstructive<br>Sleep Apnea |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | (Subject Device<br>with Micro-Recorder) | (Predicate<br>Device) | Device with<br>Micro-Recorder<br>(Reference<br>Device) |
| Body Material | Medical Grade<br>Polymer | Medical Grade<br>Polymer | Polymethyl<br>methacrylate<br>(PMMA) | Polymethyl<br>methacrylate<br>(PMMA) |
| Usability | Single-patient,<br>multiple use | Single-patient,<br>multiple use | Single-patient,<br>multiple use | Single-patient,<br>multiple use |
| Splint | Comprised of<br>two or more<br>customizable<br>splints (upper<br>and lower) | Comprised of<br>two or more<br>customizable<br>splints (upper<br>and lower) | Comprised of<br>two or more<br>customizable<br>splints (upper<br>and lower) | Comprised of<br>two or more<br>customizable<br>splints (upper<br>and lower) |
| Technical Method | Advances the<br>patient's<br>mandible in a<br>forward<br>position to<br>increase<br>airway space | Advances the<br>patient's<br>mandible in a<br>forward<br>position to<br>increase airway<br>space and<br>additionally<br>monitors the<br>patient<br>compliance to<br>oral appliance<br>therapy | Advances the<br>patient's<br>mandible in a<br>forward<br>position to<br>increase airway<br>space | Advances the<br>patient's<br>mandible in a<br>forward<br>position to<br>increase airway<br>space and<br>additionally<br>monitors the<br>patient<br>compliance to<br>oral appliance<br>therapy |
| Ergonomic<br>Features - Splint<br>Design | The scalloped<br>and contoured<br>edge allows for<br>patient<br>comfort | The scalloped<br>and contoured<br>edge allows for<br>patient<br>comfort | Straight-line<br>plane at the<br>edge of the<br>splint around<br>the front of the<br>teeth | Straight-line<br>plane at the<br>edge of the<br>splint around<br>the front of the<br>teeth |
| Ergonomic<br>Features - Post<br>Style | The dual radius<br>posts to allow<br>for patient<br>comfort | The dual radius<br>posts to allow<br>for patient<br>comfort | The post angle<br>to the splint is a<br>standard 90<br>degrees | The post angle<br>to the splint is a<br>standard 90<br>degrees |
| Ergonomic<br>Features -<br>Anterior Airway | Anterior<br>airway opening | Anterior airway<br>opening | No anterior<br>airway opening | No anterior<br>airway opening |
| Ergonomic<br>Features -<br>Anterior<br>Discluder | The prescribing<br>provider can<br>request the<br>addition of a<br>vertical<br>element | The prescribing<br>provider can<br>request the<br>addition of a<br>vertical<br>element | No discluder<br>option is<br>provided | No discluder<br>option is<br>provided |
| Ergonomic<br>Features -<br>Lingual Coverage | Prescriber may<br>request<br>posterior or<br>full lingual<br>coverage | Prescriber may<br>request<br>posterior or full<br>lingual<br>coverage | No posterior or<br>full lingual<br>coverage<br>provided | No posterior or<br>full lingual<br>coverage<br>provided |
| Ergonomic<br>Features - Plastic<br>Hooks | Plastic hooks<br>incorporated<br>into the design | Plastic hooks<br>incorporated<br>into the design | Uses stainless<br>steel balls or<br>hooks to secure<br>rubber bands in<br>those<br>prescriptions<br>where they are<br>indicated | Uses stainless<br>steel balls or<br>hooks to secure<br>rubber bands in<br>those<br>prescriptions<br>where they are<br>indicated |

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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.

| Performance<br>Specification | Subject Device<br>ProSomnus®<br>EVO Sleep and<br>Snore Device | Predicate Device<br>ProSomnus<br>MicrO2 OSA<br>Device | Acceptance<br>Criteria | Results<br>(Pass/Fail) |
|----------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------|------------------------|
| Anterior-<br>Posterior (AP)<br>Shear Strength<br>(lbf) | 235.4 | 239.8 | Must be greater<br>than 200 lbf | Pass |
| Stroke (in) | 0.17 | 0.11 | Must be greater<br>than 0.1 | Pass |
| Anterior-<br>Posterior<br>Directional<br>Torque (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 equal<br>or better than<br>predicate<br>device | Pass |
| Lateral<br>Direction Shear<br>Strength (lbf) | 71.5 | 94.2 | Must be greater<br>than 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 greater<br>than 0.1 | Pass |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------|
| Lateral<br>Directional<br>Torque (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 equal<br>or better than<br>predicate<br>device | Pass |
| Durability when<br>elastic bands<br>pull on hooks at<br>peak force (mm<br>& lbs.) | 135.55 mm<br>stretch length<br>with an average<br>peak force of<br>5.06 lbs. With<br>no visible<br>damage to the<br>device and its<br>metal-free<br>hooks. | 135.55 mm stretch<br>length with an<br>average peak force<br>of 4.74 lbs. With<br>no visible damage<br>to the device and<br>its metal-free<br>hooks. | Must be equal<br>or more durable<br>then predicate<br>device | 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.

| Substantially<br>Equivalent<br>Connection | ProSomnus®<br>EVO Sleep and<br>Snore Device | ProSomnus®<br>EVO Sleep and<br>Snore Device<br>with Patient<br>Monitoring | ProSomnus<br>Micro2<br>Obstructive<br>Sleep Apnea<br>Device | ProSomnus<br>Micro2<br>Obstructive<br>Sleep Apnea<br>Device with<br>Micro-Recorder |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K202529 | K202529 | K133683 | K161624 |
| Manufacturer | ProSomnus<br>Sleep<br>Technologies | ProSomnus<br>Sleep<br>Technologies | ProSomnus<br>Sleep<br>Technologies | ProSomnus<br>Sleep<br>Technologies |
| Relation | Subject Device | Subject Device<br>with Patient<br>Monitoring | Predicate<br>Device | Predicate<br>Device with<br>Micro-Recorder |
| Device | Device, Anti-<br>Snoring<br>Device, Jaw<br>Repositioning | Sleep<br>Appliances with<br>Patient<br>Monitoring | Device, Anti-<br>Snoring | Sleep<br>Appliances with<br>Patient<br>Monitoring |
| Product Code | LRK<br>LQZ | PLC | LRK | PLC |
| Indications for<br>Use | The device is<br>intended to<br>reduce night<br>time snoring<br>and mild to<br>moderate<br>obstructive<br>sleep apnea<br>(OSA) in adults. | The device is<br>intended to<br>reduce night<br>time snoring<br>and mild to<br>moderate<br>obstructive<br>sleep apnea<br>(OSA) in adults. | The device is<br>intended to<br>reduce night<br>time snoring<br>and mild to<br>moderate<br>obstructive<br>sleep apnea<br>(OSA) in adults. | The device is<br>intended to<br>reduce night<br>time snoring<br>and mild to<br>moderate<br>obstructive<br>sleep apnea<br>(OSA) in adults. |
| Usability | Single patient,<br>multiple use | Single patient,<br>multiple use | Single patient,<br>multiple use | Single patient,<br>multiple use |
| Target<br>Population | Adult patients | Adult patients | Adult patients | Adult patients |
| Where Used | For personal<br>use at home or<br>in sleep<br>laboratories | For personal<br>use at home or<br>in sleep<br>laboratories | For personal<br>use at home or<br>in sleep<br>laboratories | For personal<br>use at home or<br>in sleep<br>laboratories |
| Prescription | Yes | Yes | Yes | Yes |
| Principle of<br>Operation | Mandibular<br>Repositioners | Mandibular<br>Repositioners | Mandibular<br>Repositioners | Mandibular<br>Repositioners |
| 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 space<br>for tongue and<br>mandibular<br>movement of<br>mouth opening<br>and closing<br>during wear | Allows space<br>for tongue and<br>mandibular<br>movement of<br>mouth opening<br>and closing<br>during wear | Allows space<br>for tongue and<br>mandibular<br>movement of<br>mouth opening<br>and closing<br>during wear | Allows space<br>for tongue and<br>mandibular<br>movement of<br>mouth opening<br>and closing<br>during wear |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Adjustment<br>Mechanism | No adjustment<br>mechanisms<br>such as pistons,<br>screws, straps,<br>or repositioning<br>elastics are<br>used to modify<br>or maintain the<br>mandibular<br>position | No adjustment<br>mechanisms<br>such as pistons,<br>screws, straps,<br>or repositioning<br>elastics are<br>used to modify<br>or maintain the<br>mandibular<br>position | No adjustment<br>mechanisms<br>such as pistons,<br>screws, straps,<br>or repositioning<br>elastics are<br>used to modify<br>or maintain the<br>mandibular<br>position | No adjustment<br>mechanisms<br>such as pistons,<br>screws, straps,<br>or repositioning<br>elastics are<br>used to modify<br>or maintain the<br>mandibular<br>position |

# 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.