(101 days)
No
The document mentions a "computer-generated analysis of potential patient cardiac abnormalities" and an "Interpretation algorithm," but there is no explicit mention of AI, ML, or related terms like neural networks or deep learning. The description focuses on standard signal processing and analysis techniques for ECG data.
No.
The device is used for monitoring, data transfer, and analysis of ECG, and does not provide therapy.
Yes
The "Intended Use / Indications for Use" section states: "Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias" and "Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information." This indicates its use for identifying medical conditions.
No
The device description explicitly states that the system consists of a "Faros ECG sensor" which is a hardware component connected to the patient via electrode leads. While the system includes software applications for data analysis and management, it is not solely software.
No, the Faros Mobile system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Faros Mobile Function: The Faros Mobile system directly measures electrical activity of the heart (ECG) from the patient's body using electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "long term ambulatory ECG monitoring, data transfer and analysis," which is a direct measurement of a physiological signal from the patient.
Therefore, based on the provided information, the Faros Mobile system falls under the category of a medical device that performs direct physiological measurements, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments.
Faros Mobile provides the detection and reporting features appropriate for the indications below
- · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias.
- · Evaluation of patients for ST segment changes
- · Evaluation patients with pacemaker
- · Evaluating patient rest and stress ECG
- · Reporting heart rate variability analysis
- · Wireless transmission of patient ECG data and arrhythmia events for further analysis.
Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements.
Faros Mobile is contraindicated for
- · Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias
- · Pediatric patients weighting less than 10 kg
Product codes (comma separated list FDA assigned to the subject device)
MLO, DSI, DXH
Device Description
Faros Mobile is used for long term registration of a patient's heart electrocardiogram (ECG) and the wireless or wired transmission of the registered electrocardiogram arrhythmia events to a receiver or analysis system running on computer. The device is connected to a patient via electrode leads and the patient wears the device during the recording period and/or while he or she performs normal daily activities. The device is used with commercially available snap ECG electrodes.
Data is transferred to computer via USB. The ECG recording is analyzed at a medical facility using a Cardiac Navigator or Cardiac Explorer software.
In wireless transmission mode, Bluetooth communication protocol enables use of the Faros sensor as a part of a Mobile Cardiac Telemetry (MCT) or Cardiac Event Monitor (CEM) system. Data is transferred from device to companion device. For clarity, all the data is stored on sensor memory when the device operates via Bluetooth. The communication protocol is provided for 30° party integration purposes.
Device measurement configurations are managed via Faros Device Manager. The application operator can manage measurement configurations which include: ECG and motion data sampling frequencies, ECG channel count, heart rate variability, temperature, auto start and measurement auto stop features. Values for cardiac arrhythmia event detections are handled via Faros Manager application.
Faros Mobile system consists of:
- . Faros ECG sensor
- o Bluetooth communication protocol and documentation for implementing interface for data collection from Faros sensor
- channel and 3-channel cable sets o
- general micro-USB cable for recharging device O
- Faros Manager application
- Cardiac Explorer application
- Cardiac Navigator application
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
adult and pediatric patients, but contraindicated for pediatric patients weighting less than 10 kg
Intended User / Care Setting
clinical long term ambulatory ECG monitoring, data transfer and analysis. inside or outside hospital or healthcare facility environments.
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 Faros Mobile submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" released on October 2003. The test reports in the submission demonstrate the Faros Mobile meets its intended use and design requirements. The verification, validation, and testing activities establish the performance and functionality characteristics of the Faros Mobile. Testing comprised electrical and mechanical safety tests, environmental tests, ECG and algorithm performance tests, usability and functional tests. Performance data demonstrated that Faros Mobile is effective, secure, safe and suitable for its indication for use, and data has shown conformance to voluntary FDA recognized standards.
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.
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
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2018
Bittium Biosignals Ltd. Taneli Vaaraniemi Quality Manager Pioneerinkatu 6 Kuopio. Finland FI-70800
Re: K182030
Trade/Device Name: Faros Mobile Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MLO, DSI, DXH Dated: October 5, 2018 Received: October 9, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182030
Device Name Faros Mobile
Indications for Use (Describe)
The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments.
Faros Mobile provides the detection and reporting features appropriate for the indications below
- · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias.
- · Evaluation of patients for ST segment changes
- · Evaluation patients with pacemaker
- · Evaluating patient rest and stress ECG
- · Reporting heart rate variability analysis
- · Wireless transmission of patient ECG data and arrhythmia events for further analysis.
Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements.
Faros Mobile is contraindicated for
- · Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias
- · Pediatric patients weighting less than 10 kg
| 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
Section 005 - Abbreviated 510k Summary
1. Submitter
| Bittium Biosignals Ltd. | Bittium Biosignals Ltd.
Pioneerinkatu 6
Kuopio, Finland FI-70800 |
|-------------------------|------------------------------------------------------------------------|
| Phone | +358 17 581 7700 |
| Fax: | +358 17 580 0978 |
| Registration number | 1000425315 |
| Contact | Taneli Vääräniemi (taneli.vaaraniemi@bittium.com)
Quality Manager |
2. Date
November 7, 2018
3. Device identification
| Device name | Faros Mobile |
|---|---|
| Trade/Proprietary Name: | Faros ambulatory ECG recorder, telemetric |
| Common/Usual Name: | Digital Ambulatory ECG recorder, transmitter |
| Classification Product Code: | MLO - Electrocardiograph, Ambulatory, with Analysis Algorithm |
| Regulation Classification | 870.2800 |
| Subsequent Product Code | DSI - Arrhythmia detector and alarm |
| Regulation Classification | 870.1025 |
| Subsequent Product Code | DXH - Transmitters and Receivers, Electrocardiograph, Telephone |
| Regulation Classification | 870.2920 |
| Class of Device: | Class II |
| Panel: | Cardiovascular |
| Device Classification EU: | Class II |
| Medical Device Directive: | 93/42EEC as an amended by 2007/47/EC |
| Certificate issued by VTT Expert services Ov. NB0537 |
4
Abbreviated 510(k) Premarket Submission
4. Substantial equivalence, predicate device
K140847, CARDIO SPY ECG Holter Systems by LABTECH KFT.
Reference device: technology, design functionality
K143032, eMotion Faros ECG Mobile by Mega Electronics Ltd.
5. Indications for Use Statement
The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments.
Faros Mobile provides the detection and reporting features appropriate for the indications below
- . Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias.
- Evaluation of patients for ST segment changes
- Evaluation patients with pacemaker
- Evaluating patient rest and stress ECG
- Reporting heart rate variability analysis
- Wireless transmission of patient ECG data and arrhythmia events for further analysis.
Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements.
Faros Mobile is contraindicated for
- . Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias
- Pediatric patients weighting less than 10 kg
5
6. Device Description
Faros Mobile is used for long term registration of a patient's heart electrocardiogram (ECG) and the wireless or wired transmission of the registered electrocardiogram arrhythmia events to a receiver or analysis system running on computer. The device is connected to a patient via electrode leads and the patient wears the device during the recording period and/or while he or she performs normal daily activities. The device is used with commercially available snap ECG electrodes.
Data is transferred to computer via USB. The ECG recording is analyzed at a medical facility using a Cardiac Navigator or Cardiac Explorer software.
In wireless transmission mode, Bluetooth communication protocol enables use of the Faros sensor as a part of a Mobile Cardiac Telemetry (MCT) or Cardiac Event Monitor (CEM) system. Data is transferred from device to companion device. For clarity, all the data is stored on sensor memory when the device operates via Bluetooth. The communication protocol is provided for 30° party integration purposes.
Device measurement configurations are managed via Faros Device Manager. The application operator can manage measurement configurations which include: ECG and motion data sampling frequencies, ECG channel count, heart rate variability, temperature, auto start and measurement auto stop features. Values for cardiac arrhythmia event detections are handled via Faros Manager application.
Faros Mobile system consists of:
- . Faros ECG sensor
- o Bluetooth communication protocol and documentation for implementing interface for data collection from Faros sensor
- channel and 3-channel cable sets o
- general micro-USB cable for recharging device O
- Faros Manager application
- Cardiac Explorer application
- Cardiac Navigator application
6
7. Comparison of technological characteristics
The following table compares the Faros Mobile to the predicate device with respect to indications for use, technological characteristics and principles of operation providing more information regarding the basis for the determination of substantial equivalence.
The technological characteristics and principles of operation of the Faros Mobile are the same as the predicate device.
| Manufacturer | Bittium Biosignals Ltd | LABTECH KFT. | Mega Electronics Ltd |
|---|---|---|---|
| Trade name | Faros Mobile | CARDIOSPY ECG Holter Systems | eMotion Faros ECG Mobile |
| Subject device | Predicate device | Reference device | |
| 510(k) number | K182030 | K140847 | K143032 |
| Product code and regulation number | DSI - 21 CFR 870.1025 | MLO - 21 CFR 870.2800 | DXH - 21 CFR 870.2920 |
| Subsequent Product Code and regulation number | DXH - 21 CFR 870.2920 | ||
| MLO 21 CFR 870.2800 | n/a | n/a | |
| ECG channels | 1- or 3-channels | 1, 2, 3, 12 -channels | 1- or 3-channels |
| ECG performance standard | IEC 60601-2-47 | IEC 60601-2-47 | IEC 60601-2-25 |
| RR Algorithm | Yes | Yes | Yes |
| Cardiac arrhythmia detection | Yes | Yes | No |
| Event marker | Yes | Yes | Yes |
| Data transfer | Yes | Yes | Yes |
| Battery type | Li Ion battery | 1x1.2 V AAA NiMH battery | |
| (or 1x1.5 V AAA alkaline battery) | Li Ion battery | ||
| Software | Cardiac Navigator, Cardiac Explorer | Cardiospy software | LiveECG and Virtual Clinic |
| Simple, user friendly software with multiple functions | Yes | Yes | Yes |
| Full disclosure ECG review tool | Yes | Yes | Yes |
| Precise QRS classification and rhythm analysis | Yes | Yes | No |
| Arrhythmia analysis, arrhythmia overview | Yes | Yes | No |
| Atrial Fibrillation analysis | Yes | Yes | No |
| Manufacturer | Bittium Biosignals Ltd | LABTECH KFT. | Mega Electronics Ltd |
| Trade name | Faros Mobile | CARDIOSPY ECG Holter Systems | eMotion Faros ECG Mobile |
| Indications for use | The Faros Mobile system is | ||
| intended for use in clinical | |||
| long term ambulatory ECG | |||
| monitoring, data transfer | |||
| and analysis. Faros Mobile is | |||
| indicated for adult and | |||
| pediatric patients who | |||
| require ECG monitoring | |||
| inside or outside hospital or | |||
| healthcare facility | |||
| environments. |
Faros Mobile provides the
detection and reporting
features appropriate for the
indications below
• Evaluation of patients with
symptoms related to rhythm
disturbances or symptoms
suggesting arrhythmias.
• Evaluation of patients for
ST segment changes
• Evaluation patients with
pacemaker
• Evaluating patient rest and
stress ECG
• Reporting heart rate
variability analysis
• Wireless transmission of
patient ECG data and
arrhythmia events for
further analysis.
Interpretation algorithm
provides a computer-
generated analysis of
potential patient cardiac
abnormalities, which must
be confirmed by a physician
with other relevant clinical
information. The Faros
Mobile does not provide
interpretive statements.
Faros Mobile is | The Cardiospy ECG Holter
System is intended for use in
a clinical, by qualified
professionals, for patients
requiring ambulatory
(Holter) monitoring 24, 48,
72, 168 h hours. Such
monitoring is most
frequently used for purpose
of prospective and
retrospective cardiac data
and arrhythmia analysis. The
System, among others,
provides the detection and
reporting features
appropriate to the
indications below for
children and adults of all
ages (up to 2 years):
• Evaluation of patients with
symptoms related to rhythm
disturbances or symptoms
suggesting arrhythmia.
• Evaluation of patients for
ST segment changes
• Evaluation of patients with
pacemakers
• Reporting of time domain
heart rate variability
• Evaluation of a patient's
response after resuming
occupational or recreational
activities (e.g., after MI. or
cardiac surgery.)
• Evaluation of ECG
documenting therapeutic
interventions in individual
patients or
groups of patients
• Clinical and
epidemiological research
studies | The eMotion Faros ECG
sensor is a wearable,
portable, 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 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
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. |
| contraindicated for | | | |
| • Those patients requiring
attended, in-hospital
monitoring for life
threatening arrhythmias | | | |
| • Pediatric patients
weighing less than 10 kg | | | |
Table 1: Comparison of characteristics
7
Table 2: Comparison of indications for use
8
Abbreviated 510(k) Premarket Submission
9
Abbreviated 510(k) Premarket Submission
8. Performance Data Summary
Faros Mobile submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" released on October 2003. The test reports in the submission demonstrate the Faros Mobile meets its intended use and design requirements.
The verification, validation, and testing activities establish the performance and functionality characteristics of the Faros Mobile. Testing comprised electrical and mechanical safety tests, environmental tests, ECG and algorithm performance tests, usability and functional tests.
Performance data demonstrated that Faros Mobile is effective, secure, safe and suitable for its indication for use, and data has shown conformance to following voluntary FDA recognized standards:
- . IEC 60601-1:2005+AMD1:2012, Medical Electrical Equipment - Part 1 General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2: 2014, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- . IEC 60601-2-47:2012, Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- ISO 10993-1: 2015, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
- IEC 60601-1-11:2015, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62366-1:2015, Medical devices -- Application of usability engineering to medical devices
- IEC 62304:2006, Medical device software -- Software life cycle processes
- IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
10
9. 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 nonclinical testing performed supports the substantial equivalence of the device.
10. Statement of Substantial Equivalence
Faros Mobile device is substantially equivalent to a predicate device when 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 Abbreviated 510(k) submission that the difference between the Faros Mobile and the predicate devices do not raise any new questions regarding its safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the Faros Mobile is substantially equivalent to the relevant aspects of the predicate devices in terms of design, principle of operation, performance characteristics, and intended use.