EMOTION ECG MOBILE

K131699 · Mega Electronics , Ltd. · DXH · Nov 26, 2013 · Cardiovascular

Device Facts

• Record ID: K131699
• Device Name: EMOTION ECG MOBILE
• Applicant: Mega Electronics , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The eMotion ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research. The eMotion ECG Mobile is intended for use in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug-in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The eMotion ECG Mobile does not provide any automatic analysis or diagnosis.

Device Story

eMotion ECG Mobile is a telemetry system for remote monitoring of chronic patients. Input: physiological data (ECG, blood pressure, weight, pulse oximetry) from external plug-in devices via Bluetooth. Transformation: mobile application transmits data over mobile networks to a central Health Gateway server using a secured connection. Output: data visualization via Web Monitor on a PC for healthcare professionals. Usage: clinical and non-clinical settings; operated by patients (data collection) and clinicians (data review). Benefit: enables remote monitoring and evaluation of patient health parameters by healthcare providers. Device performs no automatic analysis or diagnosis.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including system A/D conversion, sampling rate, signal frequency, sensitivity, noise, CMRR, and signal range verification. Performance of commercial off-the-shelf (OTS) plug-in devices was also verified.

Technological Characteristics

Wearable, portable, battery-operated (3.7V Li-ion) ECG recorder/transmitter. Connectivity: Bluetooth (to plug-ins) and mobile network (to server). Sampling rates: 100-1000 Hz. 3-lead patient cable. Materials: Latex-free. Standards: ISO 10993-1 (biocompatibility), EN 60601-2-25 (safety/performance). Software: PEMS and web-based platform. Non-sterile, reusable.

Indications for Use

Indicated for chronic patients requiring remote monitoring of health parameters including ECG, blood pressure, weight, and pulse oximetry in clinical or non-clinical settings. No specific age or gender restrictions. Contraindications not specified.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Heartrak Smart ECAT (K083535)
• Card Guard PMP4 Medical Web Center (K050940)

Submission Summary (Full Text)

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### EMERGO 9 GROUP

### K131699 b 1/6

### Section 5 - 510(k) Summary

#### 1. Submission Sponsor

Mega Electronics Ltd Pioneerinkatu 6 KUOPIO FI-70800 Finland Phone: [phone] Fax: [phone] Contact: Aki Tiihonen, Operations Director Email: [e-mail]

#### 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Phone: [phone] Fax: [phone] Contact: André Kindsvater, Senior Consultant, QA/RA Email: [e-mail]

#### 3. Date Prepared

May 20th, 2013

### 4. Device Identification

| Trade/Proprietary Name: | eMotion ECG Mobile |
|----------------------------|-----------------------------------------------------------|
| Common/Usual Name: | Digital Ambulatory Monitor |
| Classification Name: | Transmitters And Receivers, Electrocardiograph, Telephone |
| Classification Regulation: | 21 CFR 870.2920 |
| Product Code: | DXH |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |

#### 5. Predicate Devices

Heartrak Smart ECAT, 510(k) Number: K083535 Card Guard PMP4 Medical Web Center, 510(k) Number: K050940

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## EMERGO GROUP

KI31699 P 2/6

#### Device Description 6.

The eMotion ECG Mobile is a mobile device, PC and Internet based telemetry solution for the ambulant monitoring of the plug-in device data of chronic patients via a mobile network. Plug-in devices can be ECG devices, blood pressure monitors, weighing scales, etc. The device reads data from the plug-in device via a Bluetooth connection. The application in the mobile device sends the data to a server (Health Gateway) over mobile networks using the secured connection.

Data can be viewed from the Health Gateway server using the Web Monitor. Monitoring is performed using PC application that reads data from the server over the internet using the secured connection.

Figure 5-1. eMotion ECG Mobile concept

#### 7. Intended Use

The eMotion ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.

The eMotion ECG Mobile is intended for use in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug-in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters.

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·

# EMERGO GEROUP

KI31699 b 3/6

The eMotion ECG Mobile does not provide any automatic analysis or diagnosis.

#### 8. Comparison of Technological Characteristics

The following table compares the eMotion ECG Mobile to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| Manufacturer | Mega Electronics Ltd | Universal Medical Inc. | CARD GUARD SCIENTIFIC<br>SURVIVAL, LTD |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | eMotion ECG | Heartrak Smart ECAT | Card Guard PMP4<br>Medical Web Center |
| 510(k) Number | TBD | K083535 | K050940 |
| Product Code | DXH | DXH | DXH |
| Regulation<br>Number | 21 CFR 870.2920 | 21 CFR 870.2920 | 21 CFR 870.2920 |
| Regulation<br>Name | Transmitters And<br>Receivers,<br>Electrocardiograph,<br>Telephone | Transmitters And<br>Receivers,<br>Electrocardiograph,<br>Telephone | Transmitters And<br>Receivers,<br>Electrocardiograph,<br>Telephone |
| Indications for<br>Use | The eMotion ECG sensor is<br>a wearable, portable,<br>externally applied,<br>electrocardiograph<br>recorder and transmitter<br>for the purpose of health<br>monitoring, biofeedback<br>and scientific research.<br>The eMotion ECG Mobile is<br>intended for use in clinical<br>and non-clinical settings to<br>collect and transmit health<br>parameters to healthcare<br>professionals for<br>monitoring and evaluation.<br>Health parameters are<br>collected from a variety of<br>commercially available,<br>external plug-in devices<br>such as ECG sensors,<br>Weight Scales, Blood | Heartrak Smart ECAT is a<br>wireless ambulatory,<br>multi-channel, continuous<br>ECG event recorder with<br>embedded arrhythmia<br>detection algorithms.<br>Heartrak Smart ECAT<br>registers symptomatic and<br>asymptomatic cardiac<br>event triggered by a<br>patient manually or auto-<br>triggered by embedded<br>arrhythmia detection<br>algorithms. Using wireless<br>technology, Heartrak<br>Smart ECAT, when placed<br>with range of a compatible<br>RF receiver, uploads<br>recorded ECG parameter<br>data to receiver. When<br>data upload is complete | The PMP4 Medical Web<br>Center is a Software<br>application intended for<br>supporting remote<br>monitoring of<br>Electrocardiographic<br>(ECG), Spirometric,<br>Fetal/Maternal, Blood<br>Pressure, Heart Rate,<br>Blood Glucose, Blood<br>Oxygen Saturation, Body<br>Weight and optionally<br>other patients' vital signs<br>and parameters.<br>The data is received from<br>transducers/monitors,<br>which are external to the<br>system. |

#### Table SA - Comparison of Characteristics

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#### Mega Electronics LTD Traditional 510(k) Premarket Submission eMotion ECG Mobile

# EMERGO GROUP

| Manufacturer | Mega Electronics Ltd | Universal Medical Inc. | CARD GUARD SCIENTIFIC<br>SURVIVAL, LTD |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Trade Name | eMotion ECG<br>Pressure Meters and Pulse<br>Oximeters.<br>The eMotion ECG Mobile<br>does not provide any<br>automatic analysis or<br>diagnosis. | Heartrak Smart ECAT<br>data can be reviewed and<br>analyzed at a physician's<br>office, clinic or monitoring<br>center. | Card Guard PMP4<br>Medical Web Center |
| Overall Design | PEMS and Software | PEMS | Software |
| Sterile | non-sterile | non-sterile | N/A |
| Single-Use | no | no | No |
| Battery<br>Operated | Re-chargeable 3.7 V Li-ion<br>battery | Internal Li-Ion<br>rechargeable battery 3.6V | N/A |
| Data<br>Transmission | Bluetooth & Mobile Net | Bluetooth & Mobile Net | N/A |
| Sampling rate | Selectable 100, 125, 250,<br>500 or 1000 Hz | 205 Hz | N/A |
| AC Powered | no | no | N/A |
| Patient Cable | 3-lead | 3-lead | N/A |
| Latex Free | yes | yes | N/A |
| Data<br>transmission | via mobile device | RF within 10 m | via PDA, Cellular Phone,<br>iTV, PC |
| Web-based<br>Medical Center<br>Platform | Yes | N/A | Yes |
| Complies with<br>ISO 10993-1 | Yes | Yes | N/A |
| Electrical Safety<br>Testing Passed | Yes | Yes | N/A |

#### 9. Non-Clinical Performance Data

The eMotion ECG Mobile has been fully verified and validated following written test protocols to demonstrate that the design meets the requirements and performs as intended. The test results including pass/fail determination are documented in the corresponding test reports.

The device was also tested against the recognized consensus standard EN 60601-2-25:1999 Basic Safety and Essential Performance of Electrocardiographs.

The proper functioning of the applicable plug in devices was also verified.

The device and the applicable plug-in's passed all tests successfully.

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EMERGO 9 GROUP

K131699 b 5/6

All required software testing was completed as part of the software verification and validation. Please refer to Section 016 Software.

#### Summary of Performance Testing Result

All the specified performance tests have been passed successfully.

| Test | Pass / fail criteria | Results | |
|------|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 1 | System A/D<br>Conversion | 14 bit | Passed |
| 2 | Sampling rate | 1000 Hz | Passed |
| 3 | IP Class | IP20 | Passed |
| 4 | Signal frequency<br>band | ECG: 1 Hz ... 30 Hz | Passed |
| 5 | System sensitivity | 1µV / bit (peak to peak) or 0.2µV / bit<br>(peak to peak) switchable<br>ECG: 1.33 µV / bit (peak to peak) | Passed |
| 6 | System noise | 1 µV RMS | Passed |
| 7 | CMRR | 90 dB minimum<br>104 dB typical (type tested) | Passed |
| 8 | Signal range | 14 bit: +/- 8192µV (peak to peak) | Passed |
| 9 | Accelerometer | 10-bit +/- 8g mode, typical sensitivity 64 bits/g<br>Output data rate: 250 Hz<br>Accuracy: +/- 5% at 1g | Passed |
| 10 | ECG Waveform<br>shape | ECG Complex - Recognizable<br>Ventricular Fibrillation - Recognizable<br>30, 60, 120, 180 and 240 BPM +/- 2 %<br>Sine wave 10Hz and 40 Hz +/- 2 %, shape a<br>clear sine wave | Passed |
| 11 | Sensor power | Re-chargeable Li-Po or Li-ion 140mAh, 3.7V | Passed |
| 12 | Battery life | 300 full re-charge cycles (80%) | Passed |
| 13 | Operating time | Online with Bluetooth: ca. 4h | Passed |

#### Table 5B – Performance Testing Summary - ECG Sensor

The performance of the commercial OTS plug-ins has been tested and all tests passed successfully.

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Mega Electronics LTD Traditional 510(k) Premarket Submission eMotion ECG Mobile

# EMERGO GROUP

K131699 P 6/6

| K-Number | Device | Results |
|----------|--------------------------------------------|---------|
| K043217 | UA-767PBT Digital Blood Pressure Monitor | Passed |
| K061822 | HEM-780N3 Automatic Blood Pressure Monitor | Passed |
| K102350 | 3150 WristOX2 | Passed |
| none | UC-321 PBT C40 Weight Scale | Passed |
| none | HBF-206IT Weight Scale | Passed |

#### Table 5C - Performance Testing - OTS Plug-ins

The eMotion ECG Mobile meets all the requirements for overall design, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The eMotion ECG Mobile passed all testing and supports the claims of substantial equivalence and safe operation.

The eMotion ECG Mobile complicable voluntary standards for biocompatibility. The device passed all the testing in accordance with national and international standards.

#### 10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

#### 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the eMotion ECG Mobile and the predicate devices do not raise any questions regarding its safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the eMotion ECG Mobile is substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use.

The eMotion ECG Mobile, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized representation of an eagle with its wings spread. The eagle is facing to the right and has three wavy lines emanating from its body.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 26, 2013

Mega Electronics Ltd. c/o Mr. Andre Kindsvater Senior Consultant QA/RA Prinsessegracht 20 2514 AP, The Hague Netherlands

Re: K 13 l 699

> Trade/Device Name: Emotion ECG Mobile Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter & Receiver Regulatory Class: II (two) Product Code: DXH Dated: October 22, 2013 Received: October 24, 2013

Dear Mr. Andre Kindsvater:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.goy/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

OwenP.Faris -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K131699

### Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: eMotion ECG Mobile •

Indications for Use:

The eMotion ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.

The eMotion ECG Mobile is intended for use in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug-in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters.

The eMotion ECG Mobile does not provide any automatic analysis or diagnosis.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -S
Date: 2013.11.26
13:18:19-05'00'