(239 days)
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.
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. 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: White-Soft, Yellow-Medium, Blue-Firm and 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: 21mm, 20mm, 19mm, 18mm, 17mm, 16mm, 15mm, 14mm, 13mm.
Based on the provided text, the device in question is the EMA 3D, an intraoral device for snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The substance of the application is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy through a comparative effectiveness study or standalone algorithm performance. Therefore, the information provided focuses on non-clinical performance data and comparison to predicates rather than a clinical study with human readers or AI.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds for "Pass" or "Fail" for all tests. Instead, it states that "All testing was considered successful and met identified acceptance criteria" and "The EMA 3D passed all the testing in accordance with internal requirements, applied national standards, and applied international standards." The performance data is primarily qualitative and comparative to predicate devices concerning materials, design, and functionality.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical/Physical Properties | |
| Strength Flexural Testing (ISO 20795-2 & ASTM D790-17 as applied to reference materials) | Passed; confirmed material properties of Keystone KeySplint Soft/Hard (used for EMA 3D trays). |
| Biocompatibility | |
| ISO 10993-1 (Biological Evaluation of Medical Devices) | Assessed; all components evaluated for biological safety. |
| ISO 10993-5 (Cytotoxicity) | Passed. |
| ISO 10993-10 (Irritation & Skin Sensitization) | Passed. |
| Risk Management (ISO 14971) | |
| Acceptance of outcomes of risks within the context of ISO 14971 and mitigation to the lowest form. | All potential risks considered acceptable and mitigated to the lowest form. |
| Overall Design & Performance | |
| Meeting overall design, biocompatibility, and performance testing requirements; output meets design inputs/specifications. | Met all requirements, confirming substantial equivalence to Primary and Secondary Predicate devices. Performance commensurate with indications for use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "testing" of the device components and materials. It does not specify sample sizes for these tests in terms of number of devices or patients. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective nature. The tests mentioned are laboratory-based material and component performance tests, not clinical studies on patient populations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The "ground truth" concept usually applies to clinical efficacy or diagnostic accuracy studies (e.g., for AI/image analysis devices). For a hardware device seeking 510(k) clearance based on substantial equivalence, the "ground truth" refers to the adherence to engineering standards and biocompatibility requirements rather than clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which is not the primary focus of this 510(k) submission as described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance. This device is a physical intraoral appliance, not an AI or imaging device where such a study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone algorithm performance. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" is established through adherence to recognized material and performance standards (e.g., ISO, ASTM for mechanical properties; ISO 10993 for biocompatibility) and demonstrable equivalence to predicate devices in terms of indications for use, technological characteristics, and safety profiles. It is not based on direct clinical outcomes data from new patient studies for this 510(k) submission.
8. The sample size for the training set
This information is not applicable and not provided. This is not a machine learning or AI device that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no training set for this type of device.
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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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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: (408) 410-5920
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:
-
- White-Soft
-
- Yellow-Medium
-
- Blue-Firm and
-
- 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:
-
- 21mm
-
- 20mm
-
- 19mm
-
- 18mm
-
- 17mm
-
- 16mm
-
- 15mm
-
- 14mm
-
- 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 | SecondaryPredicateElastic MandibularAdvancement | Reference Device 1KeySplint Soft | Reference Device 2KeySplint Hard | Primary PredicateSerena Sleep ElasticMandibularAdvancement | Comparison |
|---|---|---|---|---|---|---|
| 510 (k) Number | K232735 | K971794 | K183598 | K203000 | K203606 | Same method |
| Manufacturer | EMAIncorporated | Donald Frantz, DDS(Patent Holder ofEMA system)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 MQCSecondary KMY | Primary MQCSecondary KMY/EBI | Primary LRK | Same |
Table 5A – Comparison of Characteristics
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| IntendedUse | Adults, TransitionalAdolescent (A&B), | Adults, TransitionalAdolescent (A&B),and Adolescent | Not defined | Not defined | Adults and TransitionalAdolescent (A&B) | Same as PrimaryPredicate | Mode of Action | Thesedevicesfunctionasamandibularrepositioner, whichacts to increase thepatient'spharyngeal space,byreducingobstructions of theairwayandimprovingtheirability to exchangeair during sleep. | Thesedevicesfunctionasamandibularrepositioner, whichacts to increase thepatient'spharyngeal space,byreducingobstructions of theairwayandimprovingtheirability to exchangeair during sleep. | Not ApplicableThis is a dental resinthe mode of action isdetermined bythetype of device thematerial is fabricatedto be | Not ApplicableThis is a dental resinthe mode of action isdetermined bythetype of device thematerial is fabricatedto be | Mandibularadvancementachieved through thetwin-matedpositioning posts buildinto the upper andlower trays | Member of thePrimary Predicatefamily.Same mode ofaction for boththePrimaryPredicateDeviceandSecondaryPredicateReferencedevices 1 and 2are the dentalresins used tomake the EMA 3Dtrays |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| population | Current Market Usage:Adults,TransitionalAdolescent (A&B), andAdolescent | Current Market usage:Adults,TransitionalAdolescent (A&B), andAdolescent | SimilartoSecondaryPredicate .Referencedevices 1 and 2are dental resinsthe EMA 3D ismadeoftherefore theintendedpopulationincludes adultsand transitionalAdolescent (A&B)but is also used inAdolecents forthe use ofretainers made ofthe resins | Functionality | Consistsofanupper and lowerappliance that are2separateappliancesthatworkinconjunctionwitheach other – via anembedded buttonhook and variable | Consistsofanupper and lowerappliance that are 2separateappliancesthatwork in conjunctionwith each other -via a an embeddedbutton hook andvariable size and | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Consists of an upperand lower appliancethat are 2 separateappliances that workin conjunction witheach other -via a anembeddedbuttonhook and variable sizeand strength elasticbands that allows the | Functionality isthe same for theEMA 3D, itsPrimary Predicatespecifically theSerena SleepSolutions ElasticFamily memberof the Primarypredicate and its | |||
| Indications foruse | The EMA 3D is aremovable medicaldevice that is fittedin the patient'smouth and isintended to reduceor alleviate snoring | Treatment of nasalrespiratorydysfunction ofobstructive sleepapnea and snoringin those patientswhere | TheKeyPrint®KeySplint Soft™device is indicated forthe fabrication oforthodontic and dentalappliances | TheKeyPrint"KeySplint HardTMdevice is indicated forthe fabrication oforthodontic anddental appliances suchas mouthguards. | The Serena SleepAppliance is aremovable medicaldevice that is fitted inthe patient's mouth | Same as PrimaryPredicate SerenaSleep EMASimilar toSecondary | |||||||
| and mild tomoderateobstructive sleepapnea (OSA) inadults. | repositioning of themandible canincrease thepatients air space. | such as mouthguards,nightguards, splintsand repositioners | nightguards,splints andrepositionersretainers. | and is intended toreduce oralleviate snoring andmild to moderateobstructive sleepapnea (OSA) in adults. | Predicate devicethe original EMAReferencedevices 1 and 2are the resinsused by the EMASleep Inc. tomake the traysused in the EMA3D therefore theindications foruse are not thesame | ||||||||
| TargetPopulation | Adults diagnosedwith mild tomoderate sleepapnea | Adults diagnosedwith mild tomoderate sleepapnea | Patients diagnosedwith the need fordental appliances formultiple conditions | Patients diagnosedwith a need for dentalappliances for multipleconditions | Adults diagnosed withmild to moderatesleep apneaobstructive sleepapnea (OSA) in adults | Same as PrimaryPredicate andSecondaryPredicate | |||||||
| Single or Familysubmission | Single | Single | Single | Single | Family | Same as SecondaryPredicate andreference devices1 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(K203000) | PETG | This is the dental resin | This is the dental resin | Nylon 12 | strength andbiocompatibility | |
| KeySplint Soft FDA(K183593) | used to fabricate thetrays for the EMA 3Ddevice | used to fabricate thetrays for the EMA 3Ddevice | and performanceaspects of boththe | |||
| PrimaryPredicatedevice and | ||||||
| SecondaryPredicatedifferent material | ||||||
| The EMA 3Dutilizes tray | ||||||
| material of thefabricated dentalresins identifiedas Referencedevices 1 and 2 | ||||||
| MaterialConnectingMechanism | ThermoplasticElastomer (TPE)and colorant forWhite, Yellow andBlue Elastic StrapsNo colorantutilized ClearElastic straps | ThermoplasticElastomer (TPE)and colorant forWhite, Yellow andBlue Elastic StrapsNo colorant utilizedfor Clear Elasticstraps | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | ThermoplasticElastomer (TPE) andcolorant for White,Yellow and Blue ElasticStrapsNo colorant utilized forClear Elastic straps | Same |
| ConnectingMechanism | Button hooksystem with ElasticStraps | Button hooksystem with ElasticStraps | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Button hook systemwith Elastic Straps | Same |
| Range andPrecision ofadjustment | Front to back +/-1mm | Front to back +/-1mm | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Front to back +/- 1mm | Same |
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| trays for the EMA 3Ddevice | ||||||
|---|---|---|---|---|---|---|
| MaximumMandibularAdvancement | 14 mm | 14 mm | Not Applicable | Not Applicable | 14mm | Same as PrimaryPredicate Deviceand SecondaryPredicate |
| Mode of Care | Adjustable byDentist orPhysician duringthe duration of use | Adjustable byDentist or Physicianduring the durationof use | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Not ApplicableThis is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Adjustable by Dentistor Physician during theduration of use | Same |
| Usage | Removable andReusable by thesame patient.Night Time UsageOnly | Removable andReusable by thesame patient.Night Time UsageOnly | In fabricated formRemovable andReusable by the samepatient.Night Time Usage Only | In fabricated formRemovable andReusable by the samepatient.Night Time Usage Only | Removable andReusable by the samepatient.Night Time Usage Only | Same |
| Sterility | Non-sterile devicecleaned between | Non-sterile devicecleaned between | Not Applicable | Not Applicable | Non-sterile devicecleaned between uses | Non-sterile devicecleaned |
| uses by the patientfollowinginstructionsprovided by itsmanufacturer | uses by the patientfollowinginstructionsprovided by itsmanufacturer | This is the dental resinused to fabricate thetrays for the EMA 3DdeviceEMA 3D device is Non-sterile device cleanedbetween uses by thepatient following theinstructions for useprovided by thefabricated devicemanufacturer | This is the dental resinused to fabricate thetrays for the EMA 3DdeviceEMA 3D device is Non-sterile device cleanedbetween uses by thepatient following theinstructions for useprovided by thefabricated devicemanufacturer | by the patientfollowing instructionsprovided by itsmanufacturer | between uses bythe patientfollowinginstructionsprovided by itsmanufacturer | |
| Biocompatible | Yes | Yes | Yes | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Rx | Rx | Rx | Same |
| Device Technological Differences Difference | ||||||
| Tray Materials | EMA-3D- KeySplintHard(K203000)KeySplint Soft(K183593) | EMA Custom-PETG | This is the dental resinused to fabricate thetrays for the EMA 3Ddevice | This is the dental resinused to fabricate thetrays for the EMA 3Ddevice | Serena Sleep SolutionsNylon 12 | PETG/TPU, EVAPETG/TPE, Nylon,KeystoneKeySplintmaterials havedifferent 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 MonomerExtraction, as applied by Keystone industries in the KeySplint Soft Material |
| 2 | ASTM, D790-17, Standard Test Methods for Flexure Properties of Unreinforced Plastics andElectrical Insulating Materials, 2016 as applied by the Keystone Industries in KeySplint HardMaterial |
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 MonomerExtraction |
| 2 | ASTM, D790-17, Standard Test Methods for Flexure Properties of Unreinforced Plastics andElectrical 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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§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”