ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

K221889 · Prosomnus Sleep Technologies · LRK · Oct 6, 2022 · Dental

Device Facts

• Record ID: K221889
• Device Name: ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
• Applicant: Prosomnus Sleep Technologies
• Product Code: LRK · Dental
• Decision Date: Oct 6, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ProSomnus® EVO™ [PH] 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™ [PH] Sleep and Snore Device, the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.

Device Story

ProSomnus EVO [PH] is a custom-fabricated, CAD/CAM-milled mandibular advancement device (MAD) consisting of upper and lower arches connected by a Herbst-style telescopic advancement mechanism. Used by patients at home or in sleep labs to treat snoring and mild-to-moderate OSA by holding the mandible forward, increasing pharyngeal space. The device allows for jaw movement (side-to-side, opening/closing). Physicians prescribe the device; advancements are adjusted by the patient via a hex nut or pinhole mechanism. Optionally, a DentiTrac micro-recorder can be embedded to monitor patient compliance with therapy. The device is non-sterile and made of medical-grade polymer and stainless steel.

Clinical Evidence

Bench testing only. Performance testing included mechanical strength (button hook, shear, pull tests), biocompatibility (ISO 10993-1, -5, -10, -11, -12, -23), and physical property testing (ASTM D638, D790, D695, D256, D785, D648, D570). Packaging distribution testing followed ASTM D4169.

Technological Characteristics

Materials: Medical-grade polymer, stainless steel Herbst arms, biocompatible adhesive. Principle: Mandibular advancement via telescopic Herbst mechanism. Form factor: Custom-milled, two-arch intraoral splint. Connectivity: Optional embedded DentiTrac micro-recorder for compliance monitoring. Sterilization: Supplied non-sterile. Software: None (mechanical device).

Indications for Use

Indicated for adults with mild to moderate obstructive sleep apnea (OSA) and snoring. Optional use of embedded DentiTrac micro-recorder for measuring patient compliance with oral appliance therapy.

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

• Kava and Kava with Herbst (K182661)

Reference Devices

• Respire Pink Series with DentiTrac (K170692)

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, there 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 6, 2022

ProSomnus Sleep Technologies Divya Mavalli Director of Regulatory & Quality 5860 W Las Positas Blvd. Suite 25 Pleasanton, California 94588

Re: K221889

Trade/Device Name: ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring Regulation Number: 21 CFR 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: August 26, 2022 Received: August 29, 2022

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 Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221889

#### Device Name

ProSomnus® EVO™ [PH] Sleep and Snore Device ProSomnus® EVO™ [PH] Sleep and Snore Device with Patient Monitoring

#### Indications for Use (Describe)

The ProSomnus® EVO™ [PH] 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™ [PH] 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) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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Image /page/3/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular graphic 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, suggesting a focus on sleep-related technology and solutions.

# 510(K) SUMMARY - K221889

### 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 |

- Email: [e-mail] Phone: [phone]
- Date Prepared: August 30, 2022

#### 2. Device Name and Classification

| Trade/Proprietary Name: | ProSomnus® EVO™ [PH] Sleep and Snore Device |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|
| | ProSomnus® EVO™ [PH] Sleep and Snore Device with Patient<br>Monitoring |
| Common Name: | Mandibular Advancement Device |
| Classification Name:<br>and | Intraoral devices for snoring and intraoral devices for snoring<br>obstructive sleep apnea. |
| Regulatory Class: | II (special controls) |
| Regulatory Number: | 21 CFR 872.5570 |
| Product Code: | LRK (Device, Anti-snoring), LQZ (Device, Jaw Repositioning), and<br>PLC (Sleep Appliances with Patient Monitoring) |
| Panel: | Dental |

### 3. Predicate and Reference Devices

| Device Names: | Kava and Kava with Herbst<br>Respire Pink Series with DentiTrac |
|-----------------|-----------------------------------------------------------------|
| 510(k) Numbers: | K182661<br>K170692 |

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Image /page/4/Picture/0 description: The image contains the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular graphic 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, suggesting a focus on technology and sleep-related products or services.

#### 4. Device Description

The ProSomnus® EVO™ [PH] Sleep and Snore Device consists of maxillary and mandibular device arches 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 connected with the herbst advancer. The device is designed and manufactured using Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) dental technologies, which allows the delivery of a well-fitting, aesthetic, and durable intraoral device for the patient. These devices are digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply rotating the telescopic advancer hex nut or pinhole mechanism in an upward direction to increase the forward positioning of the mandible by smaller increments and according to the physician schedule. Advancements up to 12 mm past the initial bite position may be achieved with additional arches as prescribed by the physician The patient will be able to move the lower jaw forward, side-to-side, and open and close the mouth while wearing the device. The proposed device materials include medical grade polymer, stainless steel herbst arms, and biocompatible adhesive. The device is supplied nonsterile.

#### 5. Intended Use/Indication for Use

The ProSomnus® EVO™ [PH] 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™ [PH] 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. Non-Clinical Performance Data

Product performance testing was performed to support the above indications for use as well as the claim of Substantial Equivalence.

Bench testing of the ProSomnus® EVO™ [PH] Sleep and Snore Device was conducted in accordance with ProSomnus Sleep Technologies' risk analysis and all applicable FDA guidance documents and international standards, including:

ISO 10993-1, Biological evaluation of medical device – Part 1 Evaluation and testing within a risk management process

ISO 10993-5 - Biological evaluation of medical device - Part 5 Tests for in vitro cytoxicity

ISO 10993-10 – Biological evaluation of medical device – Part 10 Tests irritation and skin sensitization

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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 and the company name on the right. The circular design is made up of curved lines that create a sense of movement. The text "ProSomnus" is in a larger, bolder font, while "Sleep Technologies" is in a smaller font below it.

ISO 10993-11 – Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

ISO 10993-12 – Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

ISO 10993- 23 Biological evaluation of medical devices – Part 23: Tests for irritation

ISO 14971 Medical devices - Application of risk management to medical devices

Guidance for industry and FDA Staff: Class II Special Controls Intraoral Devices for Snoring and/or Obstructive Sleep Apnea

Bench testing was conducted on finished devices, unless otherwise specified. The following testing was completed:

- . Metal-Free Button Hook Strength Testing
- . Shear Testing
- . Loctite 3922 Cure Time Test
- . Polymer Adhesive Pull Test

### Packaging

Packaging distribution testing was performed following ASTM D4169 procedure, following Distribution Cycle 13 at Assurance Level II.

#### Biocompatibility

Biocompatibility testing, per ISO 10993-1 was performed, which included the following tests: Cytotoxicity, Sensitization, and Irritation

#### Physical Properties Testing

| Modulus of elasticity (tensile test) | ASTM D 638 |
|---------------------------------------|------------|
| Tensile strength at yield | ASTM D 638 |
| Elongation at break (tensile test) | ASTM D 638 |
| Flexural strength | ASTM D 790 |
| Modulus of elasticity (flexural test) | ASTM D 790 |
| Compression strength | ASTM D 695 |
| Compression modulus | ASTM D 790 |
| Notched impact strength (Izod) | ASTM D 256 |
| Rockwell hardness | ASTM D 785 |
| Deflection temperature | ASTM D 648 |
| Moisture absorption | ASTM D 570 |

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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 graphic on the left and the company name on the right. The words "SLEEP TECHNOLOGIES" are written in a smaller font size below the company name.

## 7. Comparison of Technological Characteristics

The ProSomnus® EVO™ [PH] Sleep and Snore Device has the same intended use as the predicate and reference devices. The materials, design, and performance characteristics are similar to the predicate and reference devices.

The below table provides a comparison of technological characteristics to predicate and reference devices.

| Characteristics | ProSomnus®<br>EVOTM [PH] Sleep<br>and Snore Device<br>(Subject Device) | Kava and Kava with<br>Herbst<br>(Predicate Device) | Respire Pink Series<br>with DentiTrac<br>(Reference Device) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Body Material | 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 |
| Splint | Comprised of two<br>customizable<br>splints (upper and<br>lower) | Comprised of two<br>splints (upper and<br>lower) | Comprised of two<br>splints (upper and<br>lower) |
| Splints Jointure | Herbst style<br>adjustable medical<br>grade stainless<br>steel advancement<br>mechanism | Adjustable metal<br>screws or lugs | Surgical grade<br>stainless steel<br>herbst hardware |
| Technical Method | Advances the<br>patient's mandible<br>in a forward<br>position to increase<br>airway space.<br>Optionally,<br>monitors patient's<br>compliance to the<br>oral appliance<br>therapy. | Advances the<br>patient's mandible<br>in a forward position<br>to maintain an open<br>airway. | Advances the<br>patient's mandible<br>in a forward<br>position to<br>maintain an open<br>airway. Optionally,<br>monitors the<br>patient compliance<br>to oral appliance<br>therapy. |
| Embed Micro-<br>Recorder | Optional | No | Optional |

- 8. Substantial Equivalence

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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 and the words "ProSomnus" and "SLEEP TECHNOLOGIES" on the right. The word "ProSomnus" is in a larger font than the words "SLEEP TECHNOLOGIES". The logo is simple and modern.

| Substantially | ProSomnus® EVO™<br>[PH] Sleep and Snore<br>Device (Subject Device) | Kava and Kava with<br>Herbst<br>(Predicate Device) | Respire Pink Series<br>with DentiTrac<br>(Reference Device) | Indications for<br>Use | The ProSomnus®<br>EVOTM [PH] Sleep and<br>Snore Device is<br>intended to reduce<br>night time snoring and<br>mild to moderate<br>obstructive sleep apnea<br>(OSA) in adults.<br><br>Optionally, if the<br>DentiTrac micro-<br>recorder is completely<br>embedded in the<br>ProSomnus® EVOTM<br>[PH] Sleep and Snore<br>Device, the micro-<br>recorder is intended to<br>measure patient<br>compliance to oral<br>device/appliance<br>therapy in combination<br>with the DentiTrac<br>System. | The Kava and Kava<br>with Herbst device(s)<br>are intended to reduce<br>nighttime snoring and<br>mild to moderate<br>obstructive sleep<br>apnea (OSA) in adults. | The Respire Pink<br>Series intraoral<br>appliances are<br>intended to treat<br>snoring and mild to<br>moderate<br>Obstructive Sleep<br>Apnea (OSA) in<br>adult patients 18<br>years of age or<br>older.<br><br>Optionally, the<br>DentiTrac micro-<br>recorder may be<br>incorporated into a<br>Respire Pink Series<br>device. The micro-<br>recorder is<br>intended to<br>measure patient<br>compliance to oral<br>appliance therapy<br>in combination<br>with the DentiTrac<br>system. |
|--------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalent<br>Connection | | | | Usability | Single patient, multiple<br>use | Single patient, multiple<br>use | Single patient,<br>multiple use |
| 510(k) Number | K221889 | K182661 | K170692 | Target<br>Population | Adult patients | Adult patients | Adult patients |
| Manufacturer | ProSomnus Sleep<br>Technologies | Sketchpad Innovations<br>LLC | Respire Medical<br>Holding | Where Used | For personal nighttime<br>use at home or in sleep<br>laboratories | For personal use | For personal use |
| Relation | Subject Device | Predicate Device | Reference Device<br>with Patient<br>Monitoring | Biocompatible | Yes | Yes | Yes |
| Device | • Device, Anti-Snoring<br>• Device, Jaw<br>Repositioning<br>• Sleep Appliances<br>with Patient<br>Monitoring | • Device, Anti-<br>Snoring<br>• Device, Jaw<br>Repositioning | Sleep Appliances<br>with Patient<br>Monitoring | Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Product Code | LRK<br>LQZ<br>PLC | LRK<br>LQZ | PLC | Prescription | Yes | Yes | Yes |
| Device<br>Classification | Class II | Class II | Class II | Principle of<br>Operation | Mandibular<br>Repositioners | Mandibular<br>Repositioners | Mandibular<br>Repositioners |
| Regulation<br>Number | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | Non-Sterile | Yes | Yes | Yes |
| Design | Allows mandibular<br>movement and to open<br>and close mouth during<br>wear | Allows mandibular<br>movement and to open<br>and close mouth<br>during wear | Allows mandibular<br>movement and to<br>open and close<br>mouth during wear | | | | |

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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 words "ProSomnus" and "SLEEP TECHNOLOGIES" on the right. The word "ProSomnus" is in a larger font than "SLEEP TECHNOLOGIES". The color of the text is also blue.

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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 and the company name on the right. The words "ProSomnus" are in a larger font than the words "Sleep Technologies", which are stacked below the first word.

| Adjustment<br>Mechanism | Herbst style<br>advancement | Herbst style<br>advancement | Herbst style<br>advancement |
|-------------------------|-----------------------------|-----------------------------|-----------------------------|
| Clean | Daily | Daily | Daily |

### 9. Conclusion

The ProSomnus® EVO™ [PH] Sleep and Snore Device is substantially equivalent to the predicate device with respect to safety and effectiveness.