(158 days)
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.
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).
The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets such criteria in the format typically found for AI/ML device evaluations. This submission primarily focuses on establishing substantial equivalence to a predicate device, as opposed to demonstrating specific performance metrics for an AI component.
However, based on the Performance Data Summary section and general principles of device clearance, we can infer some aspects and highlight what information is not present that would typically be in an AI/ML device submission.
Inferred Acceptance Criteria and Reported Device Performance (Based on "Performance Data Summary"):
| Acceptance Criteria Category | Reported Device Performance (or implied) |
|---|---|
| Safety and Essential Performance | Meets requirements of EN 60601-1:2006 (General Requirements for Basic Safety and Essential Performance). |
| Electromagnetic Compatibility (EMC) | Meets requirements of EN 60601-1-2:2007 (Collateral Standard: Electromagnetic Compatibility - Requirements and Tests). |
| Biocompatibility | Meets requirements of ISO 10993-1:2003 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing). |
| Electrocardiograph Specific Standards | Meets requirements of EN 60601-2-25:1999 (Particular requirements for the basic safety and essential performance of electrocardiographs). |
| Design and Intended Use Performance | "Fully verified and validated against written test protocols to demonstrate that the design meets the requirements and performs as intended." (General Statement) |
| Substantial Equivalence (Overall) | Demonstrated substantial equivalence to K131699 "eMotion ECG Mobile" based on identical intended use, and similar technological characteristics and principles of operation, with performance testing showing no new safety/effectiveness questions. |
Information NOT available in the provided text (and why it's typically relevant for AI/ML devices but not explicitly discussed here):
The provided 510(k) submission is for an ECG recorder and transmitter device that does not provide any automatic analysis or diagnosis. Therefore, it does not involve an AI/ML algorithm that requires performance metrics against ground truth for diagnostic or analytical capabilities. The "study" mentioned here refers to non-clinical testing to ensure the device's technical specifications and safety standards are met, particularly in comparison to a predicate device.
1. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm's test set. The "test set" here refers to the device itself being tested for compliance with technical standards. If this were an AI/ML device, details about the number of cases/patients, their demographic breakdown, and where the data originated (e.g., specific hospitals, countries, retrospective/prospective collection) would be crucial.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Since the device does not perform analysis or diagnosis, there's no "ground truth" to establish for its output. If this were an AI/ML device, this section would detail the number of clinicians (e.g., cardiologists), their experience levels, and their role in labeling the data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication is mentioned as the device's function is data collection and transmission, not interpretation. For an AI/ML diagnostic device, this would describe how expert disagreements in ground truth labeling were resolved.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device does not assist human readers in diagnosis. An MRMC study would be critical for an AI/ML device that provides interpretative assistance.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no standalone algorithm for analysis or diagnosis.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. There is no ground truth needed for diagnostic accuracy as the device merely records and transmits.
7. The sample size for the training set: Not applicable. There is no AI/ML algorithm being trained by the device.
8. How the ground truth for the training set was established: Not applicable. As there is no training set for an AI/ML algorithm.
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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
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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
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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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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 90b) eMotion Faros 180c) 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
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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.
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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 ECGsensor (K131699) | eMotion Faros 90(modified device) | eMotion Faros 180(modified device) | eMotion Faros 360(modified device) | |
|---|---|---|---|---|
| ECGChannel(s) | Online: 1-channel | Offline:1-channel | Online and offline:1-channel | Online: 1-channelOffline:3-channels |
| SensorDimensions | 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 Datalogger | no | Yes | yes | yes |
| MemoryCapacity | no | 512Mb | 1 GB | 1 GB or more |
| ECG SamplingRate | Selectable: 100,125, 250, 500, 1000Hz | Selectable: 100,125, 250 Hz | Selectable: 100,125, 250, 500, 1000Hz | Selectable: 100,125, 250, 500, 1000Hz |
| 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 withnotifications | No | Yes |
| Administration Management | Yes | Yes |
Table 3: Comparison Between UI Interfaces features
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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.
§ 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).