Faros Mobile

K182030 · Bittium Biosignals , Ltd. · MLO · Nov 8, 2018 · Cardiovascular

Device Facts

• Record ID: K182030
• Device Name: Faros Mobile
• Applicant: Bittium Biosignals , Ltd.
• Product Code: MLO · Cardiovascular
• Decision Date: Nov 8, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Intended 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

Device Story

Faros Mobile is a wearable, ambulatory ECG recorder/transmitter; captures heart electrical activity via snap electrodes; stores data on internal memory; transmits data via USB or Bluetooth to companion devices/systems (Cardiac Navigator/Explorer). Used in clinical/home environments by patients; managed by healthcare professionals via Faros Manager application. Device provides computer-generated analysis of cardiac abnormalities; requires physician confirmation. Enables long-term monitoring, arrhythmia detection, and remote data transmission; supports clinical decision-making by providing diagnostic-quality ECG data for rhythm and ST-segment evaluation.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by bench testing, including electrical/mechanical safety, electromagnetic compatibility, usability, and algorithm performance verification in accordance with FDA guidance for arrhythmia detectors.

Technological Characteristics

Ambulatory ECG recorder; 1- or 3-channel configuration; Li-Ion battery; USB and Bluetooth connectivity. Materials: commercially available snap ECG electrodes. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-47, ISO 10993-1, IEC 62304, IEC 62366-1. Software: Cardiac Navigator/Explorer for analysis; Faros Manager for configuration.

Indications for Use

Indicated for adult and pediatric patients (≥10 kg) requiring long-term ambulatory ECG monitoring in or outside clinical settings. Used for evaluating rhythm disturbances, arrhythmias, ST segment changes, pacemaker function, rest/stress ECG, and heart rate variability. Contraindicated for patients requiring attended in-hospital monitoring for life-threatening arrhythmias or pediatric patients <10 kg.

Regulatory Classification

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.

Predicate Devices

• CARDIO SPY ECG Holter Systems (K140847)

Reference Devices

• eMotion Faros ECG Mobile (K143032)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) |
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| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <input type="checkbox"/> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# Section 005 - Abbreviated 510k Summary

## 1. Submitter

| Bittium Biosignals Ltd. | Bittium Biosignals Ltd.<br>Pioneerinkatu 6<br>Kuopio, Finland FI-70800 |
|-------------------------|------------------------------------------------------------------------|
| Phone | [phone] |
| Fax: | [phone] |
| Registration number | 1000425315 |
| Contact | Taneli Vääräniemi ([e-mail])<br>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 |

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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

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#### 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

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# 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<br>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<br>(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…