Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

K203606 · Meris Investment Group · LRK · Mar 10, 2021 · Dental

Device Facts

• Record ID: K203606
• Device Name: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
• Applicant: Meris Investment Group
• Product Code: LRK · Dental
• Decision Date: Mar 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Serena Sleep Appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Device Story

Serena Sleep BMA and EMA are custom-fitted, removable intraoral devices for snoring and mild-to-moderate OSA. Input: digital dental scans provided by a treating dental physician. Transformation: CAD/CAM design based on physician-prescribed mandibular advancement; 3D printing using Nylon 12 (PA 2200). BMA uses integrated positioning blocks; EMA uses exterior pins and rubber bands for jaw repositioning. Output: custom trays that reposition the mandible forward, increasing pharyngeal space to improve airflow. Used in home setting by patient; prescribed and fitted by dental professionals. Benefits: reduced snoring and improved airway patency during sleep. Clinical decision-making: clinician selects advancement setting based on patient needs; device provides range of motion and lateral movement.

Clinical Evidence

No clinical testing was required. Evidence consists of bench testing comparing device performance to literature-based maximum jaw strengths, including compression, shear, and bruxism force testing, and one-year durability simulation.

Technological Characteristics

Custom-fitted intraoral trays; material: Nylon 12 (PA 2200); manufacturing: 3D printing (additive manufacturing); EMA straps: thermoplastic polyurethane/cured elastomer; non-sterile; biocompatibility: ISO 10993-5 compliant; adjustment: clinician-adjustable blocks (BMA) or clinician/patient-adjustable connectors (EMA).

Indications for Use

Indicated for adults with snoring and mild to moderate obstructive sleep apnea (OSA).

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 (K133683)
• O2Vent Optima (K190236)

Reference Devices

• Somnomed MAS RXA (K050592)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

March 10, 2021

Meris Investment Group % Sarah Moss Regulatory Affairs Consultant Medavice, Inc 11218 Zest Ct NE Blaine, Minnesota 55449

Re: K203606

Trade/Device Name: Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) 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 Dated: December 10, 2020 Received: December 10, 2020

Dear Sarah Moss:

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.

{1}------------------------------------------------

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael E. Adjodha, M.ChE. Assistant 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K203606

#### Device Name

Serena Sleep Block Mandibular Advancement (BMA) Serena Sleep Elastic Mandibular Advancement (EMA)

Indications for Use (Describe)

The Serena Sleep Appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Section 5. 510(k) Summary - K203606

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| Submitter: | Serena Sleep | |
|------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person: | Phone:<br>Email: | Gary Maas, President<br>[phone]<br>[e-mail] |
| Submission<br>Correspondent: | Address:<br>Phone:<br>Email: | Sarah Moss, Regulatory Affairs Consultant<br>11218 Zest Ct. NE, Blaine, MN 55449<br>[phone]<br>[e-mail] |
| Date Prepared: | December 2020 | |
| Proprietary Name: | Serena Sleep Block Mandibular Advancement and Elastic Mandibular<br>Advancement Devices | |
| Common Name: | Device, Anti-snoring | |
| Product Code: | LRK | |
| Device Classification: | Class 2 | |
| Predicate Devices: | Block Mandibular Advancement: Prosomnus MicrO2 (Primary<br>Predicate - K133683) | |
| Device Description: | Elastic Mandibular Advancement: O2Vent Optima (Reference Device<br>(K190236)) | |

The Serena Sleep Block Mandibular Advancement is an intraoral device that treats snoring and sleep apnea through mandibular repositioning the lower jaw forward from its normal location, the patient's pharyngeal space is increased and their ability to exchange air during sleep is improved. This device consists of custom fitted trays which fit over the upper and lower teeth. Based on the physician's prescription, positioning blocks are built into the upper and lower trays The mandibular advancement is achieved through the physician's selection of a specific upper and lower tray that when fitted, sets the optimal mandibular advancement. The separate two-piece construction is desirable for patients that want greater range of motion and lateral movement.

{4}------------------------------------------------

The Elastic Mandibular Advancement model is similar to the Block Mandibular Advancement but has exterior pins that allow for the use of rubber bands rather than the blocks. These bands provide additional treatment options and forces for repositioning the bottom jaw.

## Indications for Use:

The Serena Sleep appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

{5}------------------------------------------------

| Specification | Serena Sleep<br>Block Mandibular Advancement | Prosomnus MicrO2<br>(Predicate Device) | Comparison<br>Result |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| 510(k) Number | | K133683 | |
| Device Photo | Image: Serena Sleep Device | Image: Prosomnus MicrO2 Device | |
| Indication for<br>Use | The Serena Sleep Appliance is<br>a removable medical device<br>that is fitted in the patient's<br>mouth and is intended to<br>reduce or alleviate snoring and<br>mild to moderate obstructive<br>sleep apnea (OSA) in adults. | The MICRODENTAL, Inc. MicrO2<br>device is intended to reduce night<br>time snoring and mild to moderate<br>obstructive sleep apnea (OSA) in<br>adults. | Equivalent |
| Product Code | LRK | LRK | Equivalent |
| Regulations | 21CFR 872.5570 | 21CFR 872.5570 | Equivalent |
| Class | 2 | 2 | Equivalent |
| Use of<br>Device | Removable intraoral device. Single<br>patient multiple use. Prescription<br>use only. | Removable intraoral device. Single<br>patient multiple use. Prescription<br>use only. | Equivalent |
| Target<br>Population | People over 18 of age to<br>reduce or alleviate snoring<br>and mild to moderate<br>obstructive sleep apnea (OSA)<br>in adults. | Intended to reduce night time<br>snoring and mild to moderate<br>obstructive sleep apnea (OSA) in<br>adults | Equivalent |
| Device | Repositions the lower jaw<br>forward. | Repositions the lower jaw<br>forward. | Equivalent |
| Functionality | Acts by increasing the | Acts by increasing the pharyngeal | Equivalent |
| Specification | Serena Sleep<br>Block Mandibular Advancement | Prosomnus MicrO2<br>(Predicate Device) | Comparison<br>Result |
| | pharyngeal space to improve<br>the patient's ability to<br>exchange air. | space to improve the patient's<br>ability to exchange air. | |
| | Retains the top and bottom<br>teeth using rigid trays (PA<br>2200). | Retains the top and bottom teeth<br>using rigid trays (PMMA). | Similar – Different<br>Material |
| | Upper and lower trays are<br>separate | Upper and lower trays are<br>separate | Equivalent |
| Device Design<br>and Principle or<br>Operation | Mandibular advancement is<br>achieved through positioning<br>blocks that are built into the<br>upper and lower trays. | Mandibular advancement<br>achieved through twin-mated<br>positioning posts built into the<br>upper and lower trays | Similar – The BMA<br>uses blocks and the<br>MicrO2 uses posts |
| Means of<br>advancing the<br>mandible | Mandibular advancement<br>achieved via the use of<br>interlocking blocks placed on<br>the trays that are in line with<br>the teeth. The amount of<br>mandibular advancement is<br>based on the location of the<br>"step" relative to the<br>centerline of the block. | Mandibular advancement<br>achieved through twin-mated<br>positioning posts built into the<br>upper and lower trays | Equivalent |
| Adjustment | Can be adjusted by the<br>clinician. | Can be adjusted by the clinician. | Equivalent |
| Design | Serena Sleep devices will be<br>designed from digital scans of<br>a patient's dentition. This<br>baseline model of the<br>dentition is provided by the<br>treating dental physician.<br>Using the 3D image of the<br>patient's dentition and the<br>treating physician's indicated<br>mandibular advancement, the<br>patient's custom device is<br>designed by adding blocks.<br>The device is then 3D printed<br>using the material Nylon 12<br>(PA 2200). | CAD/CAM generated specifically<br>for each prescription and made<br>with a hard PMMA material | Similar – different<br>material |
| Specification | Serena Sleep<br>Block Mandibular Advancement | Prosomnus MicrO2<br>(Predicate Device) | Comparison<br>Result |
| Supplied<br>Sterile/Non-<br>Sterile | Non-sterile | Non-sterile | Equivalent |
| Materials:<br>Upper and<br>Lower Trays | Nylon 12 (PA 2200) | Hard PMMA | Similar — different<br>material |
| Cleaning<br>Instructions | Clean the device after use in<br>water with a soft<br>toothbrush. Rinse, dry, and<br>store in the case provided. | Cleaned daily. | Similar |
| Biocompatibility<br>: ISO 10993-5 | Passed | Not performed as the materials<br>are identical as in the<br>Somnomed MAS RXA (K050592). | Equivalent |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

| Comparison to Predicate Devices: Elastic Mandibular Advancement Device | | | |
|------------------------------------------------------------------------|--|--|--|
|------------------------------------------------------------------------|--|--|--|

| Specification | Serena Sleep<br>Elastic Mandibular Advancement | O2Vent Optima<br>(Predicate Device) | Comparison<br>Result |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | | K190236 | |
| Device Photo | Image: Serena Sleep Device | Image: O2Vent Optima Device | |
| Indication for<br>Use | The Serena Sleep Appliance is<br>a removable medical device<br>that is fitted in the patient's<br>mouth and is intended to<br>reduce or alleviate snoring and<br>mild to moderate obstructive<br>sleep apnea (OSA) in adults. | The O2Vent Optima is a<br>removable medical device that is<br>fitted in the patient's mouth and<br>is intended to reduce or alleviate<br>snoring and mild to moderate<br>obstructive sleep apnea (OSA).<br>The device is indicated for use<br>during sleep to aid in the<br>treatment of these conditions. | Equivalent |
| Product Code | LRK | LRK | Equivalent |
| Regulations | 21CFR 872.5570 | 21CFR 872.5570 | Equivalent |
| Class | 2 | 2 | Equivalent |
| Use of<br>Device | Removable intraoral device. Single<br>patient multiple use. Prescription<br>use only. | Removable intraoral device. Single<br>patient multiple use. Prescription<br>use only. | Equivalent |
| Target<br>Population | People over 18 of age to<br>reduce or alleviate snoring<br>and mild to moderate<br>obstructive sleep apnea (OSA)<br>in adults. | People over 18 years of age who<br>snore and/or have sleep apnea. | Equivalent |
| Device<br>Functionality | Repositions the lower jaw<br>forward. | Repositions the lower jaw forward. | Equivalent |
| | Acts by increasing the<br>pharyngeal space to improve<br>the patient's ability to<br>exchange air. | Acts by increasing the pharyngeal<br>space to improve the patient's<br>ability to exchange air. | Equivalent |
| Specification | Serena Sleep | O2Vent Optima | Comparison<br>Result |
| | Elastic Mandibular Advancement | (Predicate Device) | |
| | Retains the top and bottom<br>teeth using rigid trays (PA<br>2200). | Retains the top and bottom teeth<br>using rigid trays (PA 2200). | Equivalent |
| | Upper and lower trays are<br>separate | Upper and lower trays are separate | Equivalent |
| Device Design<br>and Principle or<br>Operation | Mandibular advancement<br>using exterior pins that allow<br>for the use of rubber bands<br>rather than the blocks. These<br>bands provide additional<br>treatment options and forces<br>for repositioning the bottom<br>jaw. | The trays have protrusions (lugs) at<br>the side of the upper and lower<br>parts with a connector between the<br>upper and lower parts to stabilize<br>and/or advance the lower jaw. | Equivalent |
| Means of<br>advancing the<br>mandible | Lower jaw adjusted by<br>attaching connectors of<br>varying lengths | Lower jaw adjusted by attaching<br>connectors of varying lengths | Equivalent |
| Adjustment | Can be adjusted by the<br>clinician and patient | Can be adjusted by the clinician and<br>patient | Equivalent |
| Design | Serena Sleep devices will be<br>designed from digital scans of<br>a patient's dentition. This<br>baseline model of the<br>dentition is provided by the<br>treating dental physician.<br>Using the 3D image of the<br>patient's dentition and the<br>treating physician's indicated<br>mandibular advancement, the<br>patient's custom device is<br>designed by adding pins. The<br>device is then 3D printed<br>using the material Nylon 12 | Customized for each patient in a<br>dental laboratory located at the<br>manufacturing site based on the<br>dentist prescription Use of computer<br>aided design (CAD) and computer<br>aided manufacturing (CAM) and is<br>made through additive<br>manufacturing using laser sintering<br>of Nylon 12 (PA2200) material. The<br>use of these technologies provides<br>for customization according to the<br>unique characteristics of the patient<br>oral anatomy based on the<br>prescription provided by the clinician | Equivalent |
| Adjustment<br>Accessory | Replacement/Re-supply<br>connectors (13-21 mm) | Replacement/re-supply connectors<br>(13-21 mm) | Equivalent |
| Supplied<br>Sterile/Non-<br>Sterile | Non-sterile | Non-sterile | Equivalent |
| Materials: Upper<br>and Lower Trays | Nylon 12 (PA2200) | Nylon 12 (PA2200) | Equivalent |
| Specification | Serena Sleep<br>Elastic Mandibular Advancement | 02Vent Optima<br>(Predicate Device) | Comparison<br>Result |
| Materials:<br>Straps | 100% thermoplastic<br>Polyurethane/cured<br>elastomer | 100% thermoplastic<br>Polyurethane/cured elastomer | Equivalent |
| Cleaning<br>Instructions | Clean the device after use in<br>water with a soft<br>toothbrush. Rinse, dry, and<br>store in the case provided. | Clean the device daily in lukewarm<br>water with a soft toothbrush. Rinse,<br>dry, and store in the case provided. | Equivalent |
| Biocompatibility<br>: ISO 10993-5 | Passed | Passed | Equivalent |

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

## Performance Testing (Bench)

Testing was conducted to compare the Serena Sleep Block Mandibular Advancement device and Elastic Mandibular Advancement device to mechanical forces found through a literature search of maximum jaw strengths. Compression, Shear, and Bruxism forces were tested, as well as a product durability test for one year of use. The bench testing proved that they devices were able to withstand forces greater than expected jaw forces during nighttime jaw clenching and bruxing.

A key design advantage of the Serena Sleep products are its ability to customize the amount of mandibular advancement for each patient. This feature allows the doctor the ability to find a setting that is right for each patient.

Therefore, the performance of the Serena Sleep device were shown to be at least equivalent to the predicate devices.

## Clinical Testing

No Clinical Testing was required for this product.

### Statement of Equivalence

### Block Mandibular Advancement

As summarized above, the main differences between the subject (Serena Sleep BMA) and predicate (Prosomnus MicrO2) devices are:

- Predicate device does not use PA2200 in the additive manufacturing process
- Predicate device uses positioning pins instead of positioning blocks

Based on comparison of indications for use, user population, performance testing, mechanical and technological features, the Block Mandibular Advancement device has been shown to be substantially equivalent to the legally marketed predicate device. This device does not raise any new safety or effectiveness questions as compared to the predicate device.

## Elastic Mandibular Advancement

As summarized above, there are no functional differences between the subject (Elastic Mandibular Advancement Device) and predicate (O2Vent Optima) devices.

Based on comparison of indications for use, user population, performance testing, mechanical and technological features, the Elastic Mandibular Advancement device has been shown to be substantially equivalent to the legally marketed predicate device. This device does not raise any new safety or effectiveness questions as compared to the predicate device.