EMA 3D

K232735 · Ema Sleep Incorporated · LRK · May 3, 2024 · Dental

Device Facts

• Record ID: K232735
• Device Name: EMA 3D
• Applicant: Ema Sleep Incorporated
• Product Code: LRK · Dental
• Decision Date: May 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMA 3D 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

EMA 3D is a custom-fitted, removable oral appliance for treating snoring and mild to moderate OSA. It consists of two 3D-printed trays (upper and lower) that fit over the dentition; trays are connected by elastic straps attached to integrated button hooks. The device functions as a mandibular repositioner, increasing pharyngeal space to reduce airway obstruction during sleep. It is fabricated by a dental laboratory based on a dentist's or physician's order. The dental professional selects from four elastic strap strengths (White-Soft, Yellow-Medium, Blue-Firm, Clear-Extra Firm) and nine lengths (13mm-21mm) to titrate mandibular advancement. The device is non-sterile and intended for night-time use by the patient. It does not reposition teeth but holds them in place. By advancing the mandible, the device improves the patient's ability to exchange air, potentially reducing snoring and OSA symptoms.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including flexural strength and modulus testing per ISO 20795-2 and ASTM D790-17, and biocompatibility testing per ISO 10993-1, -5, and -10 (cytotoxicity, irritation, and skin sensitization).

Technological Characteristics

Custom 3D-printed oral appliance; trays fabricated from biocompatible dental resins (KeySplint Hard/Soft); mandibular advancement via TPE elastic straps; button hook fastening system; non-sterile; patient-specific dimensions; manual titration by dental professional.

Indications for Use

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

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

• Serena Sleep Elastic Mandibular Advancement (K203606)
• Elastic Mandibular Advancement (K971794)

Reference Devices

• KeySplint Soft (K183598)
• KeySplint Hard (K203000)

Submission Summary (Full Text)

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May 3, 2024

EMA Sleep Incorporated % Cheryl Fisher Principal Consultant FisherMed Consulting LLC 820 Civic Center Drive Santa Clara, California 95050

Re: K232735

Trade/Device Name: EMA 3D 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. LOZ Dated: February 5, 2024 Received: February 5, 2024

Dear Cheryl Fisher:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and

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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

Submission Number (if known)

K232735

Device Name

EMA 3D (EMA 3D)

Indications for Use (Describe)

The EMA 3D 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

## EMA 3D

## K232735

#### 1. Submission Sponsor

EMA Sleep Incorporated

27005 Masters Parkway

Spicewood, TX

78669

United States

Contact: Joseph Frantz

Title: President

## 2. Submission Correspondent

FisherMed Consulting, LLC

820 Civic Center Drive

Santa Clara, CA 95050

Office Phone: [phone]

Contact: Cheryl Fisher

Title: Principal Consultant, RA/QA

## 3. Date Prepared

4/30/24

## 4. Device Identification

| Trade/Proprietary Name: | EMA 3D |
|-------------------------|----------------------------------------------------------------|
| Common/Usual Name: | Intraoral Devices for Snoring and / or Obstructive Sleep Apnea |
| Classification Name: | Intraoral Devices for Snoring and / or Obstructive Sleep Apnea |
| Regulation Number: | 872.5570 |

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Product Code: LRK, Device, Anti Snoring- Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

> LQZ, Device, Jaw Repositioning- Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea

Device Class: Class II

Classification Panel: Dental

#### 5. Legally Marketed Predicate Device(s)

Primary Predicate K203606 Serena Sleep Elastic Mandibular Advancement

Secondary Predicate K971794 Elastic Mandibular Advancement

Reference Devices K183598 KeySplint Soft K203000 KeySplint Hard

#### 6. Indication for Use Statement

The EMA 3D 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.

#### 7. Device Description

The EMA 3D device is a simple hardware device. It is an oral appliance and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.

The EMA 3D device is intra-oral device used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). It has a patented button hook design with variable elastic band for optimum titration with bitewing if needed. The device consists of two custom fitted trays which fit over the upper and lower dentition of a patient. The trays are standard biocompatible trays that do not reposition teeth. Each tray holds the teeth in their present location not allowing tooth movement. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air.

There are four button hooks utilized on the EMA 3D device (two hooks per tray, two trays top and bottom. The hooks must be placed at a distance of 21mm apart from the top tray hook to the bottom tray hook center to center. Though there is no requirement except the opitimum location for hook placement between the top and bottom trays is on the upper bicuspid and the lower first molar.

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lt is important to note the hooks are made of the same material as the trays and are integrated as a part of the fabrication process.

Button hooks and bite blocks for the EMA 3D utilize standard dimensions.

These button hooks serve as fastening anchors for Elastic Straps that come in four different color coded strengths:

- 1. White-Soft
- 2. Yellow-Medium
- 3. Blue-Firm and
- 4. Clear- Extra Firm

These straps also come in 9 different lengths such that the Dental Professional can ensure the patient specific correct amount of mandibular advancement the lengths are as follows:

- 1. 21mm
- 2. 20mm
- 3. 19mm
- 4. 18mm
- 5. 17mm
- 6. 16mm
- 7. 15mm
- 8. 14mm
- 9. 13mm

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#### 8. Substantial Equivalence Discussion

The following table compares the EMA 3D to the Secondary Predicate and reference device(s) and Primary Predicate with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the Secondary Predicate device.

| 9. Feature | EMA 3D | Secondary<br>Predicate<br>Elastic Mandibular<br>Advancement | Reference Device 1<br>KeySplint Soft | Reference Device 2<br>KeySplint Hard | Primary Predicate<br>Serena Sleep Elastic<br>Mandibular<br>Advancement | Comparison |
|----------------------------------------------------------------|---------------------|--------------------------------------------------------------------|--------------------------------------|--------------------------------------|------------------------------------------------------------------------|-------------|
| 510 (k) Number | K232735 | K971794 | K183598 | K203000 | K203606 | Same method |
| Manufacturer | EMA<br>Incorporated | Donald Frantz, DDS<br>(Patent Holder of<br>EMA system)<br>Meyerson | Keystone Industries | Keystone Industries | Serena Sleep Solutions | NA |
| Primary Device Similarities to support Substantial Equivalence | | | | | | |
| Classification # | 872-5570 | 872-5570 | Unclassified | Unclassified | 872-5570 | Same |
| Product Code | Primary LRK | Primary LRK | Primary MQC<br>Secondary KMY | Primary MQC<br>Secondary KMY/EBI | Primary LRK | Same |

#### Table 5A – Comparison of Characteristics

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| Intended<br>Use | Adults, Transitional<br>Adolescent (A&B), | Adults, Transitional<br>Adolescent (A&B),<br>and Adolescent | Not defined | Not defined | Adults and Transitional<br>Adolescent (A&B) | Same as Primary<br>Predicate | Mode of Action | These<br>devices<br>function<br>as<br>a<br>mandibular<br>repositioner, which<br>acts to increase the<br>patient's<br>pharyngeal space,<br>by<br>reducing<br>obstructions of the<br>airway<br>and<br>improving<br>their<br>ability to exchange<br>air during sleep. | These<br>devices<br>function<br>as<br>a<br>mandibular<br>repositioner, which<br>acts to increase the<br>patient's<br>pharyngeal space,<br>by<br>reducing<br>obstructions of the<br>airway<br>and<br>improving<br>their<br>ability to exchange<br>air during sleep. | Not Applicable<br>This is a dental resin<br>the mode of action is<br>determined by<br>the<br>type of device the<br>material is fabricated<br>to be | Not Applicable<br>This is a dental resin<br>the mode of action is<br>determined by<br>the<br>type of device the<br>material is fabricated<br>to be | Mandibular<br>advancement<br>achieved through the<br>twin-mated<br>positioning posts build<br>into the upper and<br>lower trays | Member of the<br>Primary Predicate<br>family.<br>Same mode of<br>action for both<br>the<br>PrimaryPredicate<br>Device<br>and<br>Secondary<br>Predicate<br>Reference<br>devices 1 and 2<br>are the dental<br>resins used to<br>make the EMA 3D<br>trays |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| population | | | Current Market Usage:<br>Adults,<br>Transitional<br>Adolescent (A&B), and<br>Adolescent | Current Market usage:<br>Adults,<br>Transitional<br>Adolescent (A&B), and<br>Adolescent | | Similar<br>to<br>Secondary<br>Predicate .<br>Reference<br>devices 1 and 2<br>are dental resins<br>the EMA 3D is<br>made<br>of<br>therefore the<br>intended<br>population<br>includes adults<br>and transitional<br>Adolescent (A&B)<br>but is also used in<br>Adolecents for<br>the use of<br>retainers made of<br>the resins | Functionality | Consists<br>of<br>an<br>upper and lower<br>appliance that are<br>2<br>separate<br>appliances<br>that<br>work<br>in<br>conjunction<br>with<br>each other – via an<br>embedded button<br>hook and variable | Consists<br>of<br>an<br>upper and lower<br>appliance that are 2<br>separate<br>appliances<br>that<br>work in conjunction<br>with each other -<br>via a an embedded<br>button hook and<br>variable size and | Not Applicable<br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Not Applicable<br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Consists of an upper<br>and lower appliance<br>that are 2 separate<br>appliances that work<br>in conjunction with<br>each other -via a an<br>embedded<br>button<br>hook and variable size<br>and strength elastic<br>bands that allows the | Functionality is<br>the same for the<br>EMA 3D, its<br>Primary Predicate<br>specifically the<br>Serena Sleep<br>Solutions Elastic<br>Family member<br>of the Primary<br>predicate and its |
| Indications for<br>use | The EMA 3D is a<br>removable medical<br>device that is fitted<br>in the patient's<br>mouth and is<br>intended to reduce<br>or alleviate snoring | Treatment of nasal<br>respiratory<br>dysfunction of<br>obstructive sleep<br>apnea and snoring<br>in those patients<br>where | The<br>KeyPrint®<br>KeySplint Soft™<br>device is indicated for<br>the fabrication of<br>orthodontic and dental<br>appliances | The<br>KeyPrint"<br>KeySplint HardTM<br>device is indicated for<br>the fabrication of<br>orthodontic and<br>dental appliances such<br>as mouthguards. | The Serena Sleep<br>Appliance is a<br>removable medical<br>device that is fitted in<br>the patient's mouth | Same as Primary<br>Predicate Serena<br>Sleep EMA<br>Similar to<br>Secondary | | | | | | | |
| | and mild to<br>moderate<br>obstructive sleep<br>apnea (OSA) in<br>adults. | repositioning of the<br>mandible can<br>increase the<br>patients air space. | such as mouthguards,<br>nightguards, splints<br>and repositioners | nightguards,<br>splints and<br>repositioners<br>retainers. | and is intended to<br>reduce or<br>alleviate snoring and<br>mild to moderate<br>obstructive sleep<br>apnea (OSA) in adults. | Predicate device<br>the original EMA<br><br>Reference<br>devices 1 and 2<br>are the resins<br>used by the EMA<br>Sleep Inc. to<br>make the trays<br>used in the EMA<br>3D therefore the<br>indications for<br>use are not the<br>same | | | | | | | |
| Target<br>Population | Adults diagnosed<br>with mild to<br>moderate sleep<br>apnea | Adults diagnosed<br>with mild to<br>moderate sleep<br>apnea | Patients diagnosed<br>with the need for<br>dental appliances for<br>multiple conditions | Patients diagnosed<br>with a need for dental<br>appliances for multiple<br>conditions | Adults diagnosed with<br>mild to moderate<br>sleep apnea<br>obstructive sleep<br>apnea (OSA) in adults | Same as Primary<br>Predicate and<br>Secondary<br>Predicate | | | | | | | |
| Single or Family<br>submission | Single | Single | Single | Single | Family | Same as Secondary<br>Predicate and<br>reference devices<br>1 and 2. | | | | | | | |

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| | size and strength | strength elastic | | | dental professional to | Secondary |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | elastic bands that | bands that allows | | | properly adjust the | Predicate . |
| | allows the dental | the dental | | | devices to patient | |
| | professional to | professional to | | | dentition and | |
| | properly adjust the | properly adjust the | | | physiological need | |
| | devices to patient | devices to patient | | | ultimately reducing | |
| | dentition and | dentition and | | | pharyngeal | |
| | physiological need | physiological need | | | obstruction through | |
| | ultimately reducing | ultimately reducing | | | mandibular | |
| | pharyngeal | pharyngeal | | | advancement | |
| | obstruction | obstruction | | | | |
| | through | through | | | | |
| | mandibular | mandibular | | | | |
| | advancement | advancement | | | | |
| Tray Material | Keystone | EMA | Same | Same | Serena Solutions | Sleep Similar in |
| | KeySplint Hard FDA<br>(K203000) | PETG | This is the dental resin | This is the dental resin | Nylon 12 | strength and<br>biocompatibility |
| | KeySplint Soft FDA<br>(K183593) | | used to fabricate the<br>trays for the EMA 3D<br>device | used to fabricate the<br>trays for the EMA 3D<br>device | | and performance<br>aspects of both<br>the |
| | | | | | | PrimaryPredicate<br>device and |
| | | | | | | Secondary<br>Predicate<br>different material |
| | | | | | | The EMA 3D<br>utilizes tray |
| | | | | | | material of the<br>fabricated dental<br>resins identified<br>as Reference<br>devices 1 and 2 |
| Material<br>Connecting<br>Mechanism | Thermoplastic<br>Elastomer (TPE)<br>and colorant for<br>White, Yellow and<br>Blue Elastic Straps<br><br>No colorant<br>utilized Clear<br>Elastic straps | Thermoplastic<br>Elastomer (TPE)<br>and colorant for<br>White, Yellow and<br>Blue Elastic Straps<br><br>No colorant utilized<br>for Clear Elastic<br>straps | Not Applicable<br><br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Not Applicable<br><br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Thermoplastic<br>Elastomer (TPE) and<br>colorant for White,<br>Yellow and Blue Elastic<br>Straps<br><br>No colorant utilized for<br>Clear Elastic straps | Same |
| Connecting<br>Mechanism | Button hook<br>system with Elastic<br>Straps | Button hook<br>system with Elastic<br>Straps | Not Applicable<br><br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Not Applicable<br><br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Button hook system<br>with Elastic Straps | Same |
| Range and<br>Precision of<br>adjustment | Front to back +/-<br>1mm | Front to back +/-<br>1mm | Not Applicable<br><br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Not Applicable<br><br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Front to back +/- 1mm | Same |

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| | | | trays for the EMA 3D<br>device | | | |
|--------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Maximum<br>Mandibular<br>Advancement | 14 mm | 14 mm | Not Applicable | Not Applicable | 14mm | Same as Primary<br>Predicate Device<br>and Secondary<br>Predicate |
| Mode of Care | Adjustable by<br>Dentist or<br>Physician during<br>the duration of use | Adjustable by<br>Dentist or Physician<br>during the duration<br>of use | Not Applicable<br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Not Applicable<br>This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Adjustable by Dentist<br>or Physician during the<br>duration of use | Same |
| Usage | Removable and<br>Reusable by the<br>same patient.<br>Night Time Usage<br>Only | Removable and<br>Reusable by the<br>same patient.<br>Night Time Usage<br>Only | In fabricated form<br>Removable and<br>Reusable by the same<br>patient.<br>Night Time Usage Only | In fabricated form<br>Removable and<br>Reusable by the same<br>patient.<br>Night Time Usage Only | Removable and<br>Reusable by the same<br>patient.<br>Night Time Usage Only | Same |
| Sterility | Non-sterile device<br>cleaned between | Non-sterile device<br>cleaned between | Not Applicable | Not Applicable | Non-sterile device<br>cleaned between uses | Non-sterile device<br>cleaned |
| | uses by the patient<br>following<br>instructions<br>provided by its<br>manufacturer | uses by the patient<br>following<br>instructions<br>provided by its<br>manufacturer | This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device<br><br>EMA 3D device is Non-<br>sterile device cleaned<br>between uses by the<br>patient following the<br>instructions for use<br>provided by the<br>fabricated device<br>manufacturer | This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device<br><br>EMA 3D device is Non-<br>sterile device cleaned<br>between uses by the<br>patient following the<br>instructions for use<br>provided by the<br>fabricated device<br>manufacturer | by the patient<br>following instructions<br>provided by its<br>manufacturer | between uses by<br>the patient<br>following<br>instructions<br>provided by its<br>manufacturer |
| Biocompatible | Yes | Yes | Yes | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Rx | Rx | Rx | Same |
| | | | Device Technological Differences Difference | | | |
| Tray Materials | EMA-3D- KeySplint<br>Hard<br>(K203000)<br><br>KeySplint Soft<br>(K183593) | EMA Custom-PETG | This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | This is the dental resin<br>used to fabricate the<br>trays for the EMA 3D<br>device | Serena Sleep Solutions<br>Nylon 12 | PETG/TPU, EVA<br>PETG/TPE, Nylon,<br>Keystone<br>KeySplint<br>materials have<br>different physica |

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| | | | properties. Each |
|--|--|--|--------------------|
| | | | material utilized |
| | | | has a long and |
| | | | successful history |
| | | | of use in the |
| | | | orthodontic and |
| | | | oral appliance |
| | | | devices. |
| | | | |
| | | | They are |
| | | | biocompatible, |
| | | | durable and have |
| | | | sufficient |
| | | | strength to |
| | | | perform the |
| | | | intended |
| | | | functions of the |
| | | | device in |
| | | | accordance with |
| | | | each patients |
| | | | specific clinical |
| | | | needs. Therefore |
| | | | there are no |
| | | | additional risks |
| | | | incurred by the |
| | | | patient |
| | | | |

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| Fabrication | 3D Printed | Thermoformed | 3D Printed | 3D Printed | Laser Sintering | The different fabrications utilized are all commonly used in the dental industry for dental and orthodontic appliances they are all capable of creating product that meets specified requirements with no additional risks to the patient. |
|-------------|------------|--------------|------------|------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | | |

The EMA 3D device shares the same or similar indications for use, device operation, overall technical and therefore is substantially equivalent to the Primary Predicate device(s). The EMA 3D is similar in design and function to the Primary and Secondary Predicate devices for the modes of operation and use.

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#### Performance Testing Summary

The EMA Sleep Incorporated utilized risk management techniques identified in ISO 14971 Application of Risk Management to medical devices.

Standard Physical Properties testing was completed on the EMA 3D device components using accepted standards including:

Strength Flexural Testing:

| # | Standard |
|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 20795-2 Ultimate Flexural Strength, Flexural Modulus, Sorption, Solubility, Free Monomer<br>Extraction, as applied by Keystone industries in the KeySplint Soft Material |
| 2 | ASTM, D790-17, Standard Test Methods for Flexure Properties of Unreinforced Plastics and<br>Electrical Insulating Materials, 2016 as applied by the Keystone Industries in KeySplint Hard<br>Material |

Additionally, Biocompatibility testing was completed on the individual components of this device in accordance with the recommendations of ISO, 10993-1, Biological Evaluation of Medical Devices, 06/30/2010, for this type of device.

Internal verification and validation testing confirms that product specifications are met which are equivalent in design and technological characteristics as the Primary and Secondary Predicate devices

All testing was considered successful and met identified acceptance criteria. Results demonstrate performance commensurate with the indications for use, in the intended use environment and supports the claims of substantial equivalence to the Primary and Secondary Predicate devices.

#### Comparison Discussion:

The differences between the EMA 3D and its predicate and reference devices are not significant and do not affect the substantial equivalence of the device. Most of the differences documented between the EMA 3D and its predicate and reference device(s), primarily the predicate devices are related to fabrication method and materials which have similar strengths and technical characteristics that satisfy the intended use of the devices cleared for similar indications for use. The reference devices 1 and 2 that are resins are the same resins used to fabricate the EMA 3D device.

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The EMA 3D device has similar intended uses and technological characteristics as compared to the predicate device and reference device(s) and therefore are substantially equivalent to the predicate and reference device(s).

#### 10. Non-Clinical Performance Data

As part of demonstrating the substantial equivalence of the EMA 3D to the Secondary Predicate/reference devices that are subject to this 510(k) submission, EMA Sleep Incorporated utilized Elastic straps that have been previously cleared by the FDA under K97194 and utilized FDA cleared materials under K203000 and K183598 that have undergone the following performance testing:

Strength and Flexural testing:

| # | Standard |
|---|-----------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 20795-2 Ultimate Flexural Strength, Flexural Modulus, Sorption, Solubility, Free Monomer<br>Extraction |
| 2 | ASTM, D790-17, Standard Test Methods for Flexure Properties of Unreinforced Plastics and<br>Electrical Insulating Materials, 2016 |

The EMA 3D passed all the testing in accordance with internal requirements, applied national standards, and applied international standards shown below to support substantial equivalence of the subject device:

Biocompatibility - The biological safety of the components of the EMA 3D were evaluated in accordance with ISO 10993-1 and guidance document entitled Use of International ISO-10993-1,"Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process". Under this, for the stated indications for use, each component of the device's biological safety was evaluated for in vitro cytotoxicity, skin sensitization, and irritation, and mutagenicity and chemical characterization.

- . Biocompatibility testing per ISO 10993-1 Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process: Assessed
- Biocompatibility testing per ISO 10993-5 Cytotoxicity: Passed
- . Biocompatibility testing per ISO 10993-10 Test for irritation and Skin Sensitization Passed

Risk Analysis - Formal Risk Assessment of the EMA 3D was performed in accordance with ISO 14971. With respect to perceivable conditions in which the device would be subjected to a worst-case environmental or human error scenario, EMA Sleep Incorporated believes the outcomes of these risks

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are considered acceptable within the context of ISO 14971, and that all potential risks have been mitigated to the lowest form.

## 11. Performance Testing Summary

As part of demonstrating the substantial equivalence of the EMA 3D and in showing substantial equivalence to the Secondary Predicate devices that are subject to this 510(k) submission, EMA Sleep Incorporated completed a number of tests. The EMA 3D met all the requirements for overall design, biocompatibility, and performance testing confirming that the output meets the design inputs and specifications. The EMA 3D passed all required testing stated above as shown by the acceptable results obtained.

The EMA 3D complies with the applicable voluntary standards for biocompatibility per materials used. The device passed all the testing in accordance with national standards relative to their intended use.

## 12. Statement of Substantial Equivalence

lt has been shown in this 510(k) submission that the differences between the EMA 3D and the Primary Predicate or Secondary Predicate device do not raise any different questions regarding its safety and effectiveness. The performance testing provided demonstrates that the subject device(s) are substantially equivalent to the Primary and Secondary Predicate device and reference devices. The EMA Sleep Incorporated , EMA 3D as designed and manufactured, are determined to be substantially equivalent to the Primary and Secondary Predicate devices and reference device(s).

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