(239 days)
No
The device description focuses on the physical components and mechanical function of the oral appliance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults, which are therapeutic actions.
No
Explanation: The device is described as 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." Its function is as a mandibular repositioner to increase pharyngeal space, which is a therapeutic action, not a diagnostic one. There is no mention of the device being used to identify, detect, or characterize a condition.
No
The device description explicitly states it is a "simple hardware device" and details its physical components and manufacturing process.
Based on the provided information, the EMA 3D device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults by being fitted in the patient's mouth. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical oral appliance that mechanically repositions the mandible to open the airway. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose OSA or any other condition. Its function is purely to treat the symptoms of snoring and OSA.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EMA 3D device does not perform any such function.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LRK, LQZ
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth, pharyngeal space
Indicated Patient Age Range
Adults, Transitional Adolescent (A&B)
Intended User / Care Setting
Dentist, Physician or licensed practitioner.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 Electrical Insulating Materials, 2016 as applied by the Keystone Industries in KeySplint Hard 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.
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 Extraction
2 | ASTM, D790-17, Standard Test Methods for Flexure Properties of Unreinforced Plastics and 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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.
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"
1
(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
2
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
3
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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4
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 |
5
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.
6
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
7
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
Predicate
Elastic Mandibular
Advancement | Reference Device 1
KeySplint Soft | Reference Device 2
KeySplint Hard | Primary Predicate
Serena Sleep Elastic
Mandibular
Advancement | Comparison |
|----------------------------------------------------------------|---------------------|--------------------------------------------------------------------|--------------------------------------|--------------------------------------|------------------------------------------------------------------------|-------------|
| 510 (k) Number | K232735 | K971794 | K183598 | K203000 | K203606 | Same method |
| Manufacturer | EMA
Incorporated | Donald Frantz, DDS
(Patent Holder of
EMA 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 MQC
Secondary KMY | Primary MQC
Secondary KMY/EBI | Primary LRK | Same |
Table 5A – Comparison of Characteristics
8
| Intended
Use | Adults, Transitional
Adolescent (A&B), | Adults, Transitional
Adolescent (A&B),
and Adolescent | Not defined | Not defined | Adults and Transitional
Adolescent (A&B) | Same as Primary
Predicate | Mode of Action | These
devices
function
as
a
mandibular
repositioner, which
acts to increase the
patient's
pharyngeal space,
by
reducing
obstructions of the
airway
and
improving
their
ability to exchange
air during sleep. | These
devices
function
as
a
mandibular
repositioner, which
acts to increase the
patient's
pharyngeal space,
by
reducing
obstructions of the
airway
and
improving
their
ability to exchange
air during sleep. | Not Applicable
This is a dental resin
the mode of action is
determined by
the
type of device the
material is fabricated
to be | Not Applicable
This is a dental resin
the mode of action is
determined by
the
type of device the
material is fabricated
to be | Mandibular
advancement
achieved through the
twin-mated
positioning posts build
into the upper and
lower trays | Member of the
Primary Predicate
family.
Same mode of
action for both
the
PrimaryPredicate
Device
and
Secondary
Predicate
Reference
devices 1 and 2
are the dental
resins used to
make the EMA 3D
trays |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| population | | | Current Market Usage:
Adults,
Transitional
Adolescent (A&B), and
Adolescent | Current Market usage:
Adults,
Transitional
Adolescent (A&B), and
Adolescent | | Similar
to
Secondary
Predicate .
Reference
devices 1 and 2
are dental resins
the EMA 3D is
made
of
therefore the
intended
population
includes adults
and transitional
Adolescent (A&B)
but is also used in
Adolecents for
the use of
retainers made of
the resins | Functionality | Consists
of
an
upper and lower
appliance that are
2
separate
appliances
that
work
in
conjunction
with
each other – via an
embedded button
hook and variable | Consists
of
an
upper and lower
appliance that are 2
separate
appliances
that
work in conjunction
with each other -
via a an embedded
button hook and
variable size and | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Consists of an upper
and lower appliance
that are 2 separate
appliances that work
in conjunction with
each other -via a an
embedded
button
hook and variable size
and strength elastic
bands that allows the | Functionality is
the same for the
EMA 3D, its
Primary Predicate
specifically the
Serena Sleep
Solutions Elastic
Family member
of the Primary
predicate and its |
| Indications for
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 | Treatment of nasal
respiratory
dysfunction of
obstructive sleep
apnea and snoring
in those patients
where | The
KeyPrint®
KeySplint Soft™
device is indicated for
the fabrication of
orthodontic and dental
appliances | The
KeyPrint"
KeySplint HardTM
device is indicated for
the fabrication of
orthodontic and
dental appliances such
as mouthguards. | The Serena Sleep
Appliance is a
removable medical
device that is fitted in
the patient's mouth | Same as Primary
Predicate Serena
Sleep EMA
Similar to
Secondary | | | | | | | |
| | and mild to
moderate
obstructive sleep
apnea (OSA) in
adults. | repositioning of the
mandible can
increase the
patients air space. | such as mouthguards,
nightguards, splints
and repositioners | nightguards,
splints and
repositioners
retainers. | and is intended to
reduce or
alleviate snoring and
mild to moderate
obstructive sleep
apnea (OSA) in adults. | Predicate device
the original EMA
Reference
devices 1 and 2
are the resins
used by the EMA
Sleep Inc. to
make the trays
used in the EMA
3D therefore the
indications for
use are not the
same | | | | | | | |
| Target
Population | Adults diagnosed
with mild to
moderate sleep
apnea | Adults diagnosed
with mild to
moderate sleep
apnea | Patients diagnosed
with the need for
dental appliances for
multiple conditions | Patients diagnosed
with a need for dental
appliances for multiple
conditions | Adults diagnosed with
mild to moderate
sleep apnea
obstructive sleep
apnea (OSA) in adults | Same as Primary
Predicate and
Secondary
Predicate | | | | | | | |
| Single or Family
submission | Single | Single | Single | Single | Family | Same as Secondary
Predicate and
reference devices
1 and 2. | | | | | | | |
9
10
11
| 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 and | |
| biocompatibility | ||||||
| KeySplint Soft FDA | ||||||
| (K183593) | used to fabricate the | |||||
| trays for the EMA 3D | ||||||
| device | used to fabricate the | |||||
| trays for the EMA 3D | ||||||
| device | and performance | |||||
| aspects of both | ||||||
| the | ||||||
| PrimaryPredicate | ||||||
| device and | ||||||
| Secondary | ||||||
| Predicate | ||||||
| different material | ||||||
| The EMA 3D | ||||||
| utilizes tray | ||||||
| material of the | ||||||
| fabricated dental | ||||||
| resins identified | ||||||
| as Reference | ||||||
| devices 1 and 2 | ||||||
| Material | ||||||
| Connecting | ||||||
| Mechanism | Thermoplastic | |||||
| Elastomer (TPE) | ||||||
| and colorant for | ||||||
| White, Yellow and | ||||||
| Blue Elastic Straps |
No colorant
utilized Clear
Elastic straps | Thermoplastic
Elastomer (TPE)
and colorant for
White, Yellow and
Blue Elastic Straps
No colorant utilized
for Clear Elastic
straps | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Thermoplastic
Elastomer (TPE) and
colorant for White,
Yellow and Blue Elastic
Straps
No colorant utilized for
Clear Elastic straps | Same |
| Connecting
Mechanism | Button hook
system with Elastic
Straps | Button hook
system with Elastic
Straps | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Button hook system
with Elastic Straps | Same |
| Range and
Precision of
adjustment | Front to back +/-
1mm | Front to back +/-
1mm | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Front to back +/- 1mm | Same |
12
13
| | | | trays for the EMA 3D
device | | | |
|--------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Maximum
Mandibular
Advancement | 14 mm | 14 mm | Not Applicable | Not Applicable | 14mm | Same as Primary
Predicate Device
and Secondary
Predicate |
| Mode of Care | Adjustable by
Dentist or
Physician during
the duration of use | Adjustable by
Dentist or Physician
during the duration
of use | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Not Applicable
This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Adjustable by Dentist
or Physician during the
duration of use | Same |
| Usage | Removable and
Reusable by the
same patient.
Night Time Usage
Only | Removable and
Reusable by the
same patient.
Night Time Usage
Only | In fabricated form
Removable and
Reusable by the same
patient.
Night Time Usage Only | In fabricated form
Removable and
Reusable by the same
patient.
Night Time Usage Only | Removable and
Reusable by the same
patient.
Night Time Usage Only | Same |
| Sterility | Non-sterile device
cleaned between | Non-sterile device
cleaned between | Not Applicable | Not Applicable | Non-sterile device
cleaned between uses | Non-sterile device
cleaned |
| | uses by the patient
following
instructions
provided by its
manufacturer | uses by the patient
following
instructions
provided by its
manufacturer | This is the dental resin
used to fabricate the
trays for the EMA 3D
device
EMA 3D device is Non-
sterile device cleaned
between uses by the
patient following the
instructions for use
provided by the
fabricated device
manufacturer | This is the dental resin
used to fabricate the
trays for the EMA 3D
device
EMA 3D device is Non-
sterile device cleaned
between uses by the
patient following the
instructions for use
provided by the
fabricated device
manufacturer | by the patient
following instructions
provided by its
manufacturer | between uses by
the patient
following
instructions
provided by its
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
Hard
(K203000)
KeySplint Soft
(K183593) | EMA Custom-PETG | This is the dental resin
used to fabricate the
trays for the EMA 3D
device | This is the dental resin
used to fabricate the
trays for the EMA 3D
device | Serena Sleep Solutions
Nylon 12 | PETG/TPU, EVA
PETG/TPE, Nylon,
Keystone
KeySplint
materials have
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 |
| 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 |
| Electrical Insulating Materials, 2016 as applied by the Keystone Industries in KeySplint Hard | |
| 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 |
| Extraction | |
| 2 | ASTM, D790-17, Standard Test Methods for Flexure Properties of Unreinforced Plastics and |
| 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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