EMS-200

K153285 · Meta Systems Co., Ltd. · EKX · Aug 12, 2016 · Dental

Device Facts

• Record ID: K153285
• Device Name: EMS-200
• Applicant: Meta Systems Co., Ltd.
• Product Code: EKX · Dental
• Decision Date: Aug 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.

Device Story

EMS-200 is an integrated dental unit combining an endodontic motor, electronic apex locator, and obturation system (pack and fill) controlled via a 7-inch LCD touchscreen. The endo motor rotates Ni-Ti files to shape root canals. The apex locator uses dual-frequency impedance measurement (main unit to file to patient to lip holder) to determine root canal length. The obturation system uses heated tips for vertical compaction (pack) and injection of thermoplasticized gutta percha (fill). Used by dentists in clinical settings. The device provides real-time feedback on file position and system status on the display. Benefits include consolidated endodontic workflow, precise canal shaping, accurate length determination, and efficient obturation. The system is available as a standalone unit (EMS-200S) or cart-mounted (EMS-200C).

Clinical Evidence

Bench testing only. Comparative performance testing against predicate devices conducted per ISO 14457. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. Biocompatibility testing performed per ISO 10993-1. Usability testing validated the integrated user interface. Software validated as moderate level of concern.

Technological Characteristics

Integrated dental unit with 7" LCD touchscreen. Components: Endo-motor (16:1 gear ratio, 250-800rpm), Apex locator (dual-frequency impedance, accuracy ±0.5mm), Pack/Fill handpieces (140-300°C). Materials: Stainless steel, silicone rubber, PBT, brass/gold-plated needles. Power: AC/DC adapter. Sterilization: Validated per ISO 17665-1/2 (SAL 10^-6). Software: Moderate level of concern.

Indications for Use

Indicated for trained dental professionals to perform endodontic procedures, including root canal expansion via motor-driven files, root canal length measurement via electronic apex location, and root canal obturation via thermal compaction and backfilling of gutta percha.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• Endo-Smart ES-100 (K133298)

Reference Devices

• I-Root 100 Electronic Apex Locator (K112508)
• Endodontic Obturation Unit (K031664)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 12, 2016

Meta Systems Co., Ltd. c/o Ms. Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K153285

Trade/Device Name: EMS-200 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX, EKR, LQY Dated: July 12, 2016 Received: July 13, 2016

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K153285

Device Name EMS-200

#### Indications for Use (Describe)

The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.

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

#### SPONSOR

| Company Name: | Meta Systems Co., Ltd. |
|---------------------------|---------------------------------------------------------------------------------|
| Company Address | 55, Galmachi-ro 281beon-gil,<br>Jungwon-gu, Seongnam-si,<br>Gyeonggi-do, Korea, |
| Telephone: | [phone] |
| Contact Person: | Ray Jeon |
| Summary Preparation Date: | August 8, 2016 |

## DEVICE NAME

| Trade Name: | EMS-200 |
|----------------------|----------------------------------|
| Common/Usual Name: | Dental Handpiece and Accessories |
| Classification Name: | Dental Handpiece and Accessories |
| Regulation Number: | 21 CFR 878.4200 |
| Product Code: | EKX |
| Device Class: | Class 1 |

# PREDICATE DEVICE

| Primary Predicate: | | |
|--------------------|-------------------|----------------------|
| K Number | Device Name | Manufacturer |
| K133298 | Endo-Smart ES-100 | Metabiomed (S-Denti) |

#### Reference Predicates

| K Number | Device Name | Manufacturer |
|----------|------------------------------------|-----------------|
| K112508 | I-Root 100 Electronic Apex Locator | S-Denti Co, Ltd |
| K031664 | Endodontic Obturation Unit | Sybron Endo |

## DEVICE DESCRIPTION

The EMS -200 dental unit is device that combines the 1) Endo-motor Handpiece (K133298) which ablates the tooth to expand the root canal, a 2) Endodontic Obturation Unit which is used to fill and pressurize various shaped packing elements, and 3) Electronic apex locator (K112508) which is used to ensure the location of the front tip in root canal through changes of electric resistance value into one unit. The working of each of the components is displayed through a single touch screen.

| Model | EMS-200S | EMS-200C |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Stand Alone unit<br>for portability | Combined with a rolling cart |
| Components | Display panel- Control unit<br>Handpieces (Micro-motor, Pack and Fill)<br>Additional accessories:<br>File holder A/B, Lip holder, Contra-angle, | Display panel- Control unit<br>Handpieces (Micro-motor, Pack and Fill)<br>Additional accessories:<br>File holder A/B, Lip holder, Contra-angle, |

The EMS 200 unit is supplied as follow:

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| | Pack tip, Fill needle | Pack tip, Fill needle |
|--------------|-----------------------|-----------------------|
| | Stand for the unit | Cart |
| Power supply | Adapter & Power cord | Adapter & Power cord |
| | | Battery |

# EMS – 200 System Critical Components Description

Image /page/4/Figure/2 description: The image shows two different models of dental equipment, labeled EMS-200S and EMS-200C. Both models feature a screen labeled with the number 1 and a water line labeled with the number 2. The EMS-200S model has dental tools labeled 3, 4, and 5, while the EMS-200C model has dental tools labeled 3, 4, and 5 and a set of drawers labeled 6.

| Item | Description | K Number of previously<br>cleared Meta System<br>devices |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| 1. Touch Screen | 7″ LCD Touchscreen for display of working components | |
| 2. Apex | Electronic Apex Locator<br>Micro signals consisting of dual frequencies coming from the<br>main body return to where they are sent after traveling along<br>the electric circuit that is composed of " main body – probe<br>cord – file holder – hand file – patient – lip holder – probe<br>cord" | K100450 |
| 3. Motor | Endo motor (Endodontic motor)<br>Endo motor forms a root canal by rotating the rotary file | K133298 |
| 4. Pack | Gutta percha Obturator | |
| 5. Fill | Continuous wave is essentially a vertical compaction (Down-<br>packing) of core material and sealer in the apical portion of the<br>root canal using commercially available heating devices and<br>then back filling the remaining portion of the root canal with<br>thermoplasticized core material using injection device. | |
| 6. Cart | Movable cart for the EMS200C | |

# Critical Components Specifications

| 1. Control Unit with LED Touch Screen | |
|---------------------------------------|-------------------------------------------------------------------------------|
| Dimensions | Control box- 128 mm × 192 mm × 49 mm,<br>Stand type - 253.mm × 13mm × 212.7mm |
| Weight | < 2kg |
| 2. Apex Locator<br>(K112508) | |
| Accuracy of Apex Locating point | < ±0.5mm |
| Accessory | Lip holder, File holder A/B, Probe cord |

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| 3. Motor: Endo-Motor handpiece<br>(K133298) | Image: Handpiece diagram with dimensions |
|---------------------------------------------|------------------------------------------|
| Dimensions | ø20 x L108mm |
| Weight | 106 g (including tubing wire) |
| Torque range | 0.6 ~ 6.4Ncm (Gear 16:1 basis) |
| Mode of Operation | Auto Stop / Forward and reverse |
| Gear ratio | 16:1 |
| Contra Angle | ACL (B) – 42EP 16:1 |

| 4. Fill: Back Filling handpiece<br>1.Operation Button<br>2. Power buttons<br>3 Mode button<br>4. Hold switch<br>5. GP (Gutta Percha)<br>6.Cartridge | Image: handpiece | Image: cartridge |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------|
| Dimensions | ø27 x L212mm | |
| Weight | 200g | |
| Working temperature | 140°C, 160°C, 180°C, 200° | |
| 5. PACK:<br>1. Pack tip<br>2. Operation button<br>3. Power Button<br>4. Mode button<br>5. Operation lamp | Image: handpiece | |
| Dimensions | ø20 x L153mm | |
| Weight | 104g | |
| Working temperature | 140°C, 200°C, 300°C | |
| 6. Cart<br>(Optional) | Image: cart | |
| Dimensions | 310mm x 350mm x 80mm | |
| Weight | 26kg | |

# Accessories

| Name | Photo | Dimensions<br>& weight | Material |
|---------------|----------------------------------------------|------------------------------|-----------------------------------|
| Lip holder | Image: Lip holder diagram with dimensions | 64mm 2 mm<br>Weight - 2g | Stainless steel |
| File holder A | Image: File holder A diagram with dimensions | 120mm × 2.7mm<br>Weight - 3g | Silicone rubber & Stainless steel |

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| File holder B | Image: File holder B | $6mm \times 9.mm$<br>Weight - 4g | Silicone rubber & PBT |
|---------------|----------------------|-----------------------------------------------------------|-----------------------------------|
| Contra angle | Image: Contra angle | $\text{\O}16.7 x L6mm$<br>Weight-34.8g<br>Gear ratio 16:1 | Stainless steel |
| Pack tip | Image: Pack tip | $5mm \times 2mm$<br>Weight -3g | Stainless steel |
| Fill Needle | Image: Fill Needle | 56mm<br>Weight - 1g | Brass, Ag plating (or Au plating) |
| Probe Cord | Image: Probe Cord | 1,810mm ±3mm<br>Weight 26g | PVC |

## INDICATIONS FOR USE

The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the front tip in the root canal, for use by trained dental professionals.

#### COMPARISON OF TECHNICAL CHARACTERISTICS

| | New device<br>EMS - 200 | Primary<br>Predicate Device<br>K133298 | References<br>Predicate<br>K112508 | Reference Predicate<br>K031664 | Indications for Use | The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals. | The Endo Smart ES- 100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills. | The i-Root 100 is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures | The Elements Obturation Unit is intended to be used in Dentistry to:<br>1. Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus<br>2. For tissue cauterization and coagulation, and<br>3. TO backfill and downpack gutta percha during Endodontic root canal treatment.<br>4. When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation. |
|----------------|-------------------------------------------|----------------------------------------------------------------|------------------------------------------|--------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Meta Systems | S- Denti Co, Ltd<br>(=Meta Systems)<br>Applicant : Meta Biomed | S- Denti Co, Ltd<br>(=Meta Systems) | Sybron Endo | Principle of Operation<br>MOTOR | The Motor rotates the motor-operated file(Ni-Ti file) by pressing the operation button on the micro-motor handpiece which expands or shapes the root canal by using the rotating power of the electric file (Ni-Ti file). | The Motor rotates the motor-operated file(Ni-Ti file) by pressing the operation button on the micro-motor handpiece which expands or shapes the root canal by using the rotating power of the electric file (Ni-Ti file). | | |
| Trade Name | EMS-200<br>(model: EMS-200S,<br>EMS-200C) | Endo Smart, ES-100 | I-Root 100<br>Electronic<br>Apex Locator | Endodontic Obturation<br>Unit | APEX | Micro signals consisting of dual frequencies coming from the main unit return to where they are sent after travelling along the electric circuit that is composed of 'main unit - probe cord - file holder-file - patient - lip holder - probe cord'. | | Micro signals consisting of dual frequencies coming from the main unit return to where they are sent after travelling along the electric circuit that is composed of 'main unit – probe cord - file holder-file - patient - lip holder – probe cord'. | |
| Product Code | EKX | EKX | LQY | EKR | PACK | Pack handpiece provides instantaneous heating and cooling of the heat plugger with precisely controlled temperature and timing. | | | Pack handpiece provides instantaneous heating and cooling of the heat plugger with precisely controlled temperature and timing. |
| 510(k) no. | New device | K133298 | K112508 | K031664 | FILL | FILL handpiece is designed to inject warmed Gutta percha that is specially formulated into the root canal directly. | | | FILL handpiece is designed to inject warmed Gutta percha that is specially formulated into the root canal directly. |
| Classification | Class 1 | Class 1 | None | Class 1 | | | | | |
| Regulation No. | 872.4200 | 872.4200 | None | 872.4565 | | | | | |

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| Patient<br>Contacting<br>Materials | Lip holder<br>Pack tip<br>Fill needle | | Lip holder | Pack tip<br>Fill needle | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------|
| Functional<br>Specification | [MOTOR]<br>File Rotation Speed : 250-<br>800rpm<br>Torque limit value : 0.6-<br>5.0Ncm<br>Gear ration 16: 1 (contra<br>angle)<br>[APEX]<br>Accuracy (Working length) :<br>less than ±0.5 mm<br>[PACK] Pack tip :<br>140, 200, 300°C<br>[FILL] Heater bobbin : 140,<br>160, 180, 200°C | | [MOTOR]<br>File Rotation Speed :<br>250-800rpm<br>Torque limit value :<br>0.6-6.4Ncm<br>Gear ration 16: 1<br>(contra angle)<br>[APEX]<br>Accuracy (Working<br>length) : less than<br>±0.5 mm | [PACK] Pack tip:<br>30-600°C<br>[FILL] Heater bobbin:<br>200°C | |
| Display | LCD touchscreen | | LCD | LCD | |
| Power supply | AC100-240V, 50/60Hz<br>(AC/DC Adaptor)<br>DC 12V, 5.0A | | DC7.2V<br>(Li-ion battery) | DC4.5V<br>(Alkaline battery 3ea) | AC100-240V, 50/60Hz |
| Operating<br>Temperature<br>Humidity: | 10°C - 40°C<br>30%-75% | | 10°C — 40°C<br>30%-75% | 10°C - 40°C<br>30%-75% | 10°C - 35°C<br>30%-75% |
| Dimension<br>Main Body | 148.1mm x 187.6mm x<br>45mm | | 110mm x 100 mm x<br>117mm | 110mm x 134 mm x<br>116.5 mm | 158mm x 178 mm x<br>140mm |
| Weight | Less than 2kg<br>(Stand type) | | 320g | 443g | 1.3kg |

#### PERFORMANCE DATA

#### Safety Testing

- IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007 Medical electrical equipment Part1-1: General requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic compatibility
- ISO 10993-1:2009 Biological evaluation of medical devices-Part 1
- ISO10993-10:2010 Biological evaluation of medical devices-Test for irritation and sensitization
- EN 60601-1-6:2010 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
- EN 62304:2006 Medical device software. Software life-cycle processes

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- EN 60601-1-6:2010 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
- EN ISO 14971:2012 Medical devices Application of risk management to medical devices
- EN 1639:2009 Dentistry. Medical devices for dentistry. Instruments
- EN 62366:2008 Medical devices. Application of usability engineering to medical devices
- EN 1041: 2008 Information supplied by the manufacturer with medical devices
- EN 980:2008 Graphical symbols for use in the labeling of medical devices
- ISO 9001:2008 Quality management systems Requirements
- ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes
- ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the validation of a sterilization process
- Sterilization validation per ISO 17665-1 and ISO 17665-2 Sterilization was performed to demonstrate SAL of 10-6
- Software documentation and validation for software of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices
- Bench testing for conformance to ISO 14457
- Referenced literature articles regarding the temperature of gutta percha to include: Obturation of Root Canal Systems, American Association of Endodontists; and Dentistry-Thermoplasticized root canal obturating material

## CONCLUSION

The EMS-200 is a dental device that combines in a single device with a LCD touchscreen display an 1) endo motor which ablates the tooth to expand the root canal, 2) an electronic apex locator which assists the operator in the location of the front tip in the root canal for used by trained dental professionals, and 3) a dental obturator to fill and pressurize various shaped packing elements.

The Indications for Use for the EMS-200 has expanded to include the Indications for Use of the each predicate.

Similarities between the Motor Handpiece in EMS-200 and the ES-100 (K133298)

The subject device, EMS 200 is similar to the ES-100 (K133298)

- . Indications for use for the use of this designated handpiece in the combined units EMS-200
- . Operating Principle has not been altered or changed
- Performance Specifications has not altered ●

Differences

- . user interface

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Similarities between the Apex in EMS 200 and the predicate i-Root 100 (K112508)

- Indications for use for the use of this designated handpiece in the combined units EMS-200
- . Operating Principle has not been altered or changed
- Performance Specifications has not altered

Differences

- . user interface
Similarities between the Pack & Fill in EMS 200 and the predicate Elements Obturation Unit (K031664)

- . Indications for use for the use of this designated handpiece in the combined units EMS-200
- Operating Principle has not been altered or changed

Differences

- Most of functional uses are similar but the Pack in the EMS-200 is able to choose one of temperature of 140, 200, 300°Cand Elements Obturation Unit is able to choose 30°Cto 600°C
- . In case of Fill in the EMS-200 offers temperature selection of 140, 160, 180, 2000 Cbut Elements Obturation Unit offers only 200°C As noted above, EMS-200 and Elements Obturation Unit (EOU) have minor differences in terms of performance. However, in terms of safety EMS-200 has safer effects on human due to it operated in the low temperature range than Elements Obturation Unit.
- . User interface

The Indications for Use and intended use of the EMS-200 and the predicates has not been altered by the combination of the individual units into a single integrated unit. The technological characteristics for use and function are similar to the primary predicate and the reference predicates provided in this comparison table.

The EMS-200 performance was verified by a comparative bench test with the predicate devices according to ISO 14457. Usability testing by the intended user was performed to validate the user interface of the combined unit. Software documentation and validation for software of moderate level of concern was performed per the FDA Guidance Document for Software Contained in Medical Devices. Electrical Safety testing was performed according to IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2:2007 Medical electrical equipment Part1-1: General requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic compatibility to verify safe use. All testing was performed for mitigation of risk according to ISO 14971:2012 Medical devices -Application of risk management to medical devices. In addition biocompatibility testing according to ISO 10993-1 was performed on patient contacting materials.

It is the conclusion of Meta Systems, based on non-clinical testing that the EMS-200 introduces no new issues of safety and efficacy and is substantially equivalent to the primary predicate and reference predicate devices.