(158 days)
Not Found
No
The summary explicitly states, "The eMotion Faros ECG Mobile does not provide any automatic analysis or diagnosis." and there are no mentions of AI, DNN, or ML.
No
The device is described as an electrocardiograph recorder and transmitter used for health monitoring, biofeedback, and scientific research, specifically for collecting and transmitting health parameters from various external plug-in devices to healthcare professionals for monitoring and evaluation. It explicitly states, "The eMotion Faros ECG Mobile does not provide any automatic analysis or diagnosis," and there is no mention of it administering treatment or therapy.
No
The device explicitly states, "The eMotion Faros ECG Mobile does not provide any automatic analysis or diagnosis." Its purpose is for data collection and transmission.
No
The device description explicitly states that the system includes "eMotion Faros ECG sensors" which are described as "wearable, externally applied, electrocardiograph recorder and transmitter". It also mentions "applicable plug-in devices" like blood pressure monitors and weighing scales. While there is a software component (the mobile application, server, and viewing interface), the system relies on and includes hardware components for data acquisition.
Based on the provided text, the eMotion Faros ECG sensor and the eMotion Faros ECG Mobile are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the eMotion Faros system focuses on collecting and transmitting physiological data directly from the patient (ECG, weight, blood pressure, pulse oximetry) using external sensors and devices.
- The intended use and device description clearly state that the system collects health parameters from externally applied or plug-in devices. There is no mention of analyzing biological specimens.
- The system transmits data to healthcare professionals for monitoring and evaluation. While this data can be used in a clinical context, the device itself is not performing the in vitro diagnostic test.
Therefore, the eMotion Faros ECG system falls under the category of medical devices that collect and transmit physiological data, rather than IVD devices.
N/A
Intended Use / Indications for Use
The eMotion Faros ECG sensor is a wearable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.
The eMotion Faros ECG Mobile is intended for use in 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.
Indicated for adult patients who require clinical ECG monitoring in healthcare facility environment under supervision of a physician or prescript by the supervising physician to supplement data acquisition in home environment.
The eMotion Faros ECG Mobile does not provide any automatic analysis or diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The eMotion Faros ECG Mobile is a mobile device. PC and Internet based telemetry solution for the ambulant monitoring of the pluq-in device data of chronic patients via a mobile network. Pluq-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 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 Virtual Clinic interface. Monitoring is performed using PC application that reads data from the server over the internet using the secured connection. ECG data is possible to record on eMotion Faros ECG sensors internal memory. Data from ECG sensors can be reviewed with eMotion EDF Viewer or uploaded via USB connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. healthcare facility environment under supervision of a physician or prescript by the supervising physician to supplement data acquisition in home environment.
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)
The eMotion Faros ECG Mobile has been fully verified and validated against written test protocols to demonstrate that the design meets the requirements and performs as intended. The test results including product release information summary is documented as a part of the section 011 Summary of Design Control Activities.
Performance is tested and evaluated according to the applicable sections of the following standards:
- EN 60601-1:2006, Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance
- EN 60601-1-2: 2007, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- ISO 10993-1: 2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- EN 60601-2-25:1999 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
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.
Not Found
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
§ 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).
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2015
Mega Electronics Ltd. Taneli Vaaraniemi Quality Engineer Pioneerinkatu 6 Kuopio, 70800 FI
Re: K143032
Trade/Device Name: Emotion Faros ECG Mobile Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: February 6, 2015 Received: February 9, 2015
Dear Taneli Vaaraniemi,
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
1
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 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 Industry and Consumer Education 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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K143032
Device Name eMotion Faros ECG Mobile
Indications for Use (Describe)
The eMotion Faros ECG sensor is a wearable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.
The eMotion Faros ECG Mobile is intended for use in 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.
Indicated for adult patients who require clinical ECG monitoring in healthcare facility environment under supervision of a physician or prescript by the supervising physician to supplement data acquisition in home environment.
The eMotion Faros ECG Mobile does not provide any automatic analysis or diagnosis.
| 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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3
Mega Electronics Ltd. 510(k) Premarket Submission eMotion Faros ECG Mobile
Image /page/3/Picture/1 description: The image shows the logo for Mega. The logo consists of a square with rounded corners that is pink. Inside the square is a white silhouette of an archer aiming an arrow. To the right of the square is the word "mega" in black, lowercase letters.
007 – 510(k) Summary
1. Submitter
Mega Electronics Ltd Pioneerinkatu 6 KUOPIO FI-70800 Finland Phone: +358 17 581 7700 Fax: +358 17 580 0978 Contact: Taneli Vääräniemi, Quality Engineer Email: taneli.vaaraniemi@megaemg.com
Registration Number: 1000425315
2. Date
March 25, 2015
3. Device Identification
| Modified ECG Module Names: | a) eMotion Faros 90
b) eMotion Faros 180
c) eMotion Faros 360 |
|-----------------------------------|---------------------------------------------------------------------|
| Modified Health Gateway Interface | Virtual Clinic |
| Trade/Proprietary Name: | eMotion Faros 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 |
| Device Classification EU: | Class IIa |
| Medical Device Directive: | 93/42EEC as a amended by 2007/47/EC |
4. Substantial Equivalence, Predicate Device
eMotion ECG Mobile, 510(k) Number: K131699
4
Image /page/4/Picture/1 description: The image contains a logo with a pink square on the left side and the word "mega" in black on the right side. The pink square contains a white silhouette of an archer aiming an arrow. The word "mega" is written in a bold, sans-serif font.
5. Device Description
The eMotion Faros ECG Mobile is a mobile device. PC and Internet based telemetry solution for the ambulant monitoring of the pluq-in device data of chronic patients via a mobile network. Pluq-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 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 Virtual Clinic interface. Monitoring is performed using PC application that reads data from the server over the internet using the secured connection. ECG data is possible to record on eMotion Faros ECG sensors internal memory. Data from ECG sensors can be reviewed with eMotion EDF Viewer or uploaded via USB connection.
Data acquisition is performed using eMotion Faros ECG sensors and applicable plug-in devices. Faros ECG sensors are modified versions of eMotion ECG sensor which the FDA granted clearance on November 26, 2013 (K131699).
Intended Use
The eMotion Faros ECG sensor is a wearable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research.
The eMotion Faros ECG Mobile is intended for use in 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.
Indicated for adult patients who require clinical or non-clinical ECG monitoring in healthcare facility environment under supervision of a physician or prescript by the supervising physician to supplement data acquisition in home environment.
The eMotion Faros ECG Mobile does not provide any automatic analysis or diagnosis.
5
Image /page/5/Picture/1 description: The image shows a logo with a pink square on the left and the word "mega" in black on the right. The pink square contains a white silhouette of an archer aiming an arrow. The word "mega" is written in a simple, sans-serif font and is positioned to the right of the square.
6. Comparison of Technological Characteristics
The eMotion Faros ECG Mobile is modified device of the predicate device. With respect to intended use, technological characteristics and principles of operation are identical with Predicate device, eMotion ECG Mobile K131699. Comparison to Legally Marketed Device in section 009 provides more detailed information regarding the basis for the determination of substantial equivalence.
The technological characteristics and principles of operation of the modified device are the same as the predicate device.
| | eMotion ECG
sensor (K131699) | eMotion Faros 90
(modified device) | eMotion Faros 180
(modified device) | eMotion Faros 360
(modified device) |
|-------------------------|-----------------------------------------------|---------------------------------------|-----------------------------------------------|-----------------------------------------------|
| ECG
Channel(s) | Online: 1-channel | Offline:
1-channel | Online and offline:
1-channel | Online: 1-channel
Offline:3-channels |
| Sensor
Dimensions | 35 x 35 x 15 (mm) | 48 x 29 x 12 (mm) | 48 x 29 x 12 (mm) | 48 x 29 x 12 (mm) |
| Sensor Weight | 16g | 13g | 13g | 13g |
| Internal Data
logger | no | Yes | yes | yes |
| Memory
Capacity | no | 512Mb | 1 GB | 1 GB or more |
| ECG Sampling
Rate | Selectable: 100,
125, 250, 500, 1000
Hz | Selectable: 100,
125, 250 Hz | Selectable: 100,
125, 250, 500, 1000
Hz | Selectable: 100,
125, 250, 500, 1000
Hz |
| Resolution | 14-bit | 14-bit | 14-bit | 24-bit |
| Bluetooth | yes | no | yes | yes |
| Battery | 3,7 V Li-ion battery | 3,7 V Li-ion battery | 3,7 V Li-ion battery | 3,7 V Li-ion battery |
Table 2: Technological Characteristics comparison Between ECG Sensors
| | Web Monitor
(Predicate Device) | Virtual Clinic
(Subject Device) |
|-------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------|
| Login screen | Yes | Yes |
| Patient list | Yes | Yes |
| Document list | Yes | Yes |
| Doctor info view | Yes | Yes |
| Doctor list | Yes | Yes |
| Measurement views
- ECG
- ECG Report and listing
- Blood pressure
- Body weight
- SpO2 | Yes | Yes |
| Patient management | Yes | Yes |
| Measurement value limits with
notifications | No | Yes |
| Administration Management | Yes | Yes |
Table 3: Comparison Between UI Interfaces features
6
Image /page/6/Picture/1 description: The image contains the logo for Mega Limited. On the left side of the image is a pink square with rounded corners. Inside the square is a white silhouette of an archer holding a bow and arrow. To the right of the square is the word "mega" in black, lowercase letters.
7. Performance Data Summary
The eMotion Faros ECG Mobile has been fully verified and validated against written test protocols to demonstrate that the design meets the requirements and performs as intended. The test results including product release information summary is documented as a part of the section 011 Summary of Design Control Activities.
Performance is tested and evaluated according to the applicable sections of the following standards:
- EN 60601-1:2006, Medical Electrical Equipment Part 1 General Requirements for Basic ● Safety and Essential Performance
- EN 60601-1-2: 2007, Medical Electrical Equipment Part 1-2: General Requirements for ● Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- ISO 10993-1: 2003, Biological Evaluation of Medical Devices Part 1: Evaluation and ● Testing
- . EN 60601-2-25:1999 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
8. 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 performed supports the substantial equivalence of the device.
9. 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 modified 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 Faros 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 Faros ECG Mobile is substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.