(168 days)
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.
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.
The Mega Electronics Ltd eMotion ECG Mobile is a device designed for the ambulatory monitoring of chronic patients by collecting and transmitting health parameters from plug-in devices (e.g., ECG sensors, blood pressure monitors, weighing scales) to healthcare professionals. The device itself does not provide automatic analysis or diagnosis.
Here's an analysis of its acceptance criteria and the study that proves it meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ECG Sensor Performance: | ||
| System A/D Conversion | 14 bit | Passed (14 bit) |
| Sampling rate | 1000 Hz | Passed (1000 Hz) |
| IP Class | IP20 | Passed (IP20) |
| Signal frequency band | ECG: 1 Hz ... 30 Hz | Passed (ECG: 1 Hz ... 30 Hz) |
| System sensitivity | 1µV / bit (peak to peak) or 0.2µV / bit (peak to peak) switchable | Passed (ECG: 1.33 µV / bit (peak to peak)) |
| System noise | 1 µV RMS | Passed (1 µV RMS) |
| CMRR | 90 dB minimum | Passed (104 dB typical) |
| Signal range | 14 bit: +/- 8192µV (peak to peak) | Passed (14 bit: +/- 8192µV (peak to peak)) |
| Accelerometer | 10-bit +/- 8g mode, typical sensitivity 64 bits/g, Output data rate: 250 Hz, Accuracy: +/- 5% at 1g | Passed |
| ECG Waveform shape | ECG Complex - Recognizable; Ventricular Fibrillation - Recognizable; 30, 60, 120, 180 and 240 BPM +/- 2 %; Sine wave 10Hz and 40 Hz +/- 2 %, shape a clear sine wave | Passed |
| Sensor power | Re-chargeable Li-Po or Li-ion 140mAh, 3.7V | Passed |
| Battery life | 300 full re-charge cycles (80%) | Passed |
| Operating time | Online with Bluetooth: ca. 4h | Passed |
| Commercial OTS Plug-ins (Connectivity & Functionality) | Successful operation/connectivity with listed devices | Passed for all listed devices (K043217, K061822, K102350, UC-321 PBT C40, HBF-206IT) |
| Overall Design | PEMS and Software | Passed |
| Biocompatibility | Complies with ISO 10993-1 | Passed (Yes) |
| Electrical Safety | Complies with EN 60601-2-25:1999 (Basic Safety and Essential Performance of Electrocardiographs) | Passed (Yes, all tests successfully passed) |
| Software | Required software testing completed as part of verification and validation | Passed |
The Study Proving Acceptance Criteria are Met:
The device's performance was evaluated through non-clinical performance data (laboratory testing and verification/validation processes).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a distinct "test set" in terms of patient data or clinical cases. Instead, the testing appears to be based on a single device or a set of devices undergoing various laboratory-based performance and safety tests.
- Data Provenance: The data is generated from non-clinical performance testing conducted by the manufacturer, Mega Electronics Ltd., in Finland. This is prospective data generation from device testing, not retrospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided as the study is a non-clinical device performance and safety verification, not a clinical study involving expert interpretation of patient data. The "ground truth" here is adherence to engineering specifications and recognized consensus standards (e.g., EN 60601-2-25:1999).
4. Adjudication Method for the Test Set:
- This is not applicable as there was no clinical test set requiring expert adjudication. The "adjudication" in this context would be the pass/fail determination based on predefined engineering and safety specifications within the written test protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
- The device explicitly states: "The eMotion ECG Mobile does not provide any automatic analysis or diagnosis." Therefore, there is no AI component providing interpretations that would be compared with or assisting human readers. The device serves solely as a data collection and transmission tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Yes, in a sense, a standalone performance evaluation was conducted for the device's technical specifications. However, it's critical to reiterate that the "eMotion ECG Mobile does not provide any automatic analysis or diagnosis." Therefore, this standalone performance refers to the accuracy and reliability of its data acquisition and transmission capabilities, not the performance of an AI algorithm in interpreting medical data. The performance tests (e.g., A/D conversion, sampling rate, noise, CMRR, waveform shape) represent the standalone technical performance of the device's hardware and embedded software for data capture.
7. Type of Ground Truth Used:
- The ground truth used for the non-clinical performance data is based on engineering specifications, recognized consensus standards (e.g., EN 60601-2-25:1999), and pre-defined pass/fail criteria established in written test protocols. For the connectivity with plug-in devices, the ground truth was "proper functioning" and successful data transmission with those specific commercial devices.
8. Sample Size for the Training Set:
- This is not applicable. The eMotion ECG Mobile does not employ machine learning or AI algorithms that would require a training set for diagnostic or analytical purposes. It is a data collection and transmission device.
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable as there is no training set for an AI algorithm.
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EMERGO 9 GROUP
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Section 5 - 510(k) Summary
1. Submission Sponsor
Mega Electronics Ltd Pioneerinkatu 6 KUOPIO FI-70800 Finland Phone: +358 17 581 7700 Fax: +358 17 580 0978 Contact: Aki Tiihonen, Operations Director Email: aki.tiihonen@megaemg.com
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: André Kindsvater, Senior Consultant, QA/RA Email: project.management@emergogroup.com
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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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
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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 SCIENTIFICSURVIVAL, LTD |
|---|---|---|---|
| Trade Name | eMotion ECG | Heartrak Smart ECAT | Card Guard PMP4Medical Web Center |
| 510(k) Number | TBD | K083535 | K050940 |
| Product Code | DXH | DXH | DXH |
| RegulationNumber | 21 CFR 870.2920 | 21 CFR 870.2920 | 21 CFR 870.2920 |
| RegulationName | Transmitters AndReceivers,Electrocardiograph,Telephone | Transmitters AndReceivers,Electrocardiograph,Telephone | Transmitters AndReceivers,Electrocardiograph,Telephone |
| Indications forUse | The eMotion ECG sensor isa wearable, portable,externally applied,electrocardiographrecorder and transmitterfor the purpose of healthmonitoring, biofeedbackand scientific research.The eMotion ECG Mobile isintended for use in clinicaland non-clinical settings tocollect and transmit healthparameters to healthcareprofessionals formonitoring and evaluation.Health parameters arecollected from a variety ofcommercially available,external plug-in devicessuch as ECG sensors,Weight Scales, Blood | Heartrak Smart ECAT is awireless ambulatory,multi-channel, continuousECG event recorder withembedded arrhythmiadetection algorithms.Heartrak Smart ECATregisters symptomatic andasymptomatic cardiacevent triggered by apatient manually or auto-triggered by embeddedarrhythmia detectionalgorithms. Using wirelesstechnology, HeartrakSmart ECAT, when placedwith range of a compatibleRF receiver, uploadsrecorded ECG parameterdata to receiver. Whendata upload is complete | The PMP4 Medical WebCenter is a Softwareapplication intended forsupporting remotemonitoring ofElectrocardiographic(ECG), Spirometric,Fetal/Maternal, BloodPressure, Heart Rate,Blood Glucose, BloodOxygen Saturation, BodyWeight and optionallyother patients' vital signsand parameters.The data is received fromtransducers/monitors,which are external to thesystem. |
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 SCIENTIFICSURVIVAL, LTD |
|---|---|---|---|
| Trade Name | eMotion ECGPressure Meters and PulseOximeters.The eMotion ECG Mobiledoes not provide anyautomatic analysis ordiagnosis. | Heartrak Smart ECATdata can be reviewed andanalyzed at a physician'soffice, clinic or monitoringcenter. | Card Guard PMP4Medical Web Center |
| Overall Design | PEMS and Software | PEMS | Software |
| Sterile | non-sterile | non-sterile | N/A |
| Single-Use | no | no | No |
| BatteryOperated | Re-chargeable 3.7 V Li-ionbattery | Internal Li-Ionrechargeable battery 3.6V | N/A |
| DataTransmission | Bluetooth & Mobile Net | Bluetooth & Mobile Net | N/A |
| Sampling rate | Selectable 100, 125, 250,500 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 |
| Datatransmission | via mobile device | RF within 10 m | via PDA, Cellular Phone,iTV, PC |
| Web-basedMedical CenterPlatform | Yes | N/A | Yes |
| Complies withISO 10993-1 | Yes | Yes | N/A |
| Electrical SafetyTesting 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
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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/DConversion | 14 bit | Passed |
| 2 | Sampling rate | 1000 Hz | Passed |
| 3 | IP Class | IP20 | Passed |
| 4 | Signal frequencyband | ECG: 1 Hz ... 30 Hz | Passed |
| 5 | System sensitivity | 1µV / bit (peak to peak) or 0.2µV / bit(peak to peak) switchableECG: 1.33 µV / bit (peak to peak) | Passed |
| 6 | System noise | 1 µV RMS | Passed |
| 7 | CMRR | 90 dB minimum104 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/gOutput data rate: 250 HzAccuracy: +/- 5% at 1g | Passed |
| 10 | ECG Waveformshape | ECG Complex - RecognizableVentricular Fibrillation - Recognizable30, 60, 120, 180 and 240 BPM +/- 2 %Sine wave 10Hz and 40 Hz +/- 2 %, shape aclear 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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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'
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).