Bioflux Software

K162571 · Biotricity, Inc. · DSH · Oct 13, 2016 · Cardiovascular

Device Facts

• Record ID: K162571
• Device Name: Bioflux Software
• Applicant: Biotricity, Inc.
• Product Code: DSH · Cardiovascular
• Decision Date: Oct 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Bioflux software is intended to be used to analyze, view, and report ECG data acquired from a variety of ECG sources including single and 3-lead ECG devices. Bioflux software is operated locally in a browser and data is accessed via the users' credentials on the hardware platform running the browser. It will be used by cardiologists, general practitioners, cardiac, or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions, or care givers, in independent clinical testing facilities, clinics, hospitals, physician's offices, or anywhere a physician or qualified non-physician practitioners deems appropriate Bioflux software does not offer diagnosis, or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgement and experience are used to check and interpret the data.

Device Story

API-based ECG viewer software; displays ECG records; provides manual analysis tools for trained clinicians. Input: ECG files (supported formats) opened manually or via keyboard/mouse/touchscreen. Operation: Single Page Application running locally in Chrome or Firefox browsers. Output: Visual display or printed ECG traces/measurements. Usage: Clinics, hospitals, physician offices; operated by clinicians/technicians. Function: Manual measurement of ECG intervals (RR, PR, QRS, QT, QTc) using beat calipers; display of traces, speed, gain, and filter values. No automated diagnosis or medical alarms. Benefit: Facilitates clinical review and interpretation of ECG data by qualified personnel.

Clinical Evidence

Bench testing only. Verification and validation activities included scenario validations, algorithm confirmation testing, and functional testing. Device complies with AAMI EC11, AAMI EC38, IEC60601-2-25, and IEC60601-2-47 standards. Testing confirmed performance in Firefox and Google Chrome environments; all predetermined acceptance criteria were met.

Technological Characteristics

API-based ECG viewer software; Single Page Application model. Operates on Chrome and Firefox browsers. Supports manual ECG file import. Includes manual beat caliper tools for interval measurement (RR, PR, QRS, QT, QTc). Complies with AAMI EC11, AAMI EC38, IEC60601-2-25, and IEC60601-2-47. No automated diagnostic algorithms.

Indications for Use

Indicated for analysis, viewing, and reporting of ECG data from single and 3-lead ECG sources. Intended for use by cardiologists, GPs, cardiac/ECG technicians, nurses, and monitoring staff in clinical settings. No diagnosis or medical alarms provided; requires human intervention.

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

• Guava II (K122632)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13, 2016

Biotricity Inc. % Mr. Mark Job Third Party Reviewer Regulatory Technology Services LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K162571

> Trade/Device Name: Bioflux Software Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: September 14, 2016 Received: September 15, 2016

Dear Mr. Mark Job,

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mude Jellm
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 know n)

## K162571

Device Name Bioflux software

## Indications for Use (Describe)

Bloflux software is intended to be used to analyze, view, and report ECG data acquired from a variety of ECG sources including single and 3-lead ECG devices. Bioflux software is operated locally in a browser and data is accessed via the users' credentials on the hardware platform running the browser.

It will be used by cardiologists, general practitioners, cardiac, or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions, or care givers, in incel testing facilities, clinics, hospitals, physician's offices, or anywhere a physician or qualified non-physician practitioners deems appropriate

Bioflux, software does not offer diagnosis, or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgement and experience are used to check and interpret the data.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|--------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) SUMMARY

(as required by 21CFR 807.92)

#### SUBMITTER I.

Biotricity Inc. 75 International Blvd. Suite 300 Toronto ON M9W 6L9 Canada Contact Person: Tom Elias [e-mail] Phone: [phone] Date Prepared: October 13, 2016

#### II. DEVICE

Name of Device: Bioflux Software Classification Name: Recorder, Magnetic Tape, Medical Common or Usual Name: Medical Magnetic Tape Recorder Device Panel: Cardiovascular Regulatory Class: Class II Product Code: DSH

## III. PREDICATE DEVICE

The Bioflux Software is substantially equivalent in intended use and similar technological characteristics the following device, CardioComm Solutions, Inc. Guava II which was cleared under K122632.

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#### DEVICE DESCRIPTION IV.

Bioflux software is an API based ECG viewer software that can display ECG records and provide tools for trained clinicians to analyze those ECG recordings. It is utilized by manually opening up ECG files of supported formats into the viewer.

Bioflux software fulfills all of the following:

- It is a cardiology software product, delivered on disk using the Single Page Application model.
- It operates on 2015 or later versions of Chrome and Firefox browsers.
- The data can be opened manually or entered via keyboard, mouse or ● touchscreen whereupon it gets sent to the browser for viewing analysis and storage.
- Information can be displayed on the display or printed via the . browser.

Bioflux software is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

#### V. INDICATIONS FOR USE

Bioflux software is intended to be used to analyze, view, and report ECG data acquired from a variety of ECG sources including single and 3-lead ECG devices. Bioflux software is operated locally in a browser and data is accessed via the users' credentials on the hardware platform running the browser.

It will be used by cardiologists, general practitioners, cardiac, or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions, or care givers. in independent clinical testing facilities, clinics, physician's offices. or anywhere a physician or qualified non- physician practitioners deems appropriate

Bioflux software does not offer diagnosis, or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgement and experience are used to check and interpret the data.

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## SUMMARY OF TECHNOLIGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The Bioflux software is substantially equivalent in intended use and similar technological characteristics of Guava II cleared under K122632.

| Category | Identical/<br>Different | Bioflux | Guava II |
|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K162571 | K122632 |
| Classification | Identical | Medical | Medical |
| Name | | Magnetic Tape Recorder | Magnetic Tape Recorder |
| Product Code | Similar | DSH | DSH, DPS |
| Intended Use | Similar | Bioflux software is intended to<br>be used to analyze, view, and<br>report ECG data acquired from<br>a variety of ECG sources<br>including single and 3-lead<br>ECG devices. Bioflux software<br>is operated locally in a<br>browser and data is accessed<br>via the users' credentials on<br>the hardware platform<br>running the browser.<br>It will be used by cardiologists,<br>general practitioners, cardiac,<br>or ECG technicians, nurses,<br>monitoring service<br>technicians, and other cardiac<br>related institutions, or care<br>givers, in independent clinical<br>testing facilities, clinics,<br>hospitals, physician's offices,<br>or anywhere a physician or<br>qualified non-physician<br>practitioners deems<br>appropriate<br>Bioflux software does not | Guava II is intended to be used by<br>cardiologists, general practitioners,<br>cardiac or ECG technicians, nurses,<br>monitoring service technicians, and<br>other cardiac related institutions or<br>care givers to store, retrieve,<br>communicate and report ECG and<br>ECG data acquired from a variety of<br>ECG sources including single and<br>multi-lead ECG devices. Guava II is<br>intended to be electronically<br>interfaced, and perform analysis<br>with data transferred from other<br>computer based ECG systems.<br>Guava II includes an algorithm that<br>will analyze the 12 Lead ECG and<br>produce measurements of the ECG<br>recording as well as textual<br>interpretation. The product also<br>includes an automatic analysis and<br>interpretation software library that<br>provides ECG signal processing and<br>analysis on a beat by beat basis,<br>QRS and Ventricular Ectopic Beat<br>detection, QRS feature extraction,<br>interval measurement, heart rate<br>measurement, and rhythm analysis |
| Category | Identical/ | Bioflux | Guava II |
| | Different | | |
| | | offer diagnosis, or medical<br>alarms. It is intended that<br>competent human<br>intervention be involved<br>before any impact on health<br>occurs. Clinical judgement<br>and experience are used to<br>check and interpret the data. | for up to twelve (12) leads of<br>captured data. Guava II is intended<br>for use in clinics, hospitals,<br>physician's offices, or anywhere a<br>medical doctor deems appropriate.<br>It is intended that competent<br>human intervention be involved<br>before any impact on health<br>occurs. Clinical judgment and<br>experience are used to check and<br>interpret the data. Guava II may be<br>licensed to other software<br>developers as an ECG viewer for<br>their |
| The ECG Viewer<br>will meet the EC-<br>11 Standard. | Identical | Yes | Yes |
| The ECG Viewer<br>will meet the EC-<br>38 Standard. | Identical | Yes | Yes |
| The ECG Viewer<br>will meet the<br>IEC60601-2-47. | Similar | Yes | Not required at time of submission |
| The ECG Viewer<br>will meet the<br>IEC60601-2-25<br>Standard. | Similar | Yes | Not required at time of submission |
| ECG Viewer will<br>include Beat<br>Caliper<br>measurements in<br>standard ECG<br>intervals (RR, PR,<br>QRS, QT, QTc) | Identical | Yes | Yes |
| ECG viewer will<br>display ECG<br>traces, as well as<br>speed, gain, and | Identical | Yes | Yes |
| Category | Identical/<br>Different | Bioflux | Guava II |
| filter values. | | | |
| ECG viewer will<br>be compatible<br>with web<br>browsers | Similar | Google Chrome and Firefox | Internet Explorer |
| Software will<br>decode ECGs<br>from a wide<br>range of acoustic<br>devices (using<br>demodulators<br>and FSK<br>analyzers). | Different | Bioflux software does not<br>process ECGs from acoustic<br>devices | Yes |
| Software will<br>decode ECGs<br>from a wide<br>range of digital<br>devices (using<br>servers). | Different | Bioflux software does not<br>process ECG's from locally<br>connected<br>devices using USB connections | Yes |
| Software will<br>support import of<br>common ECG<br>data formats<br>(GVX, MIT, RES,<br>SCP) | Similar | Yes | Guava II also accepts data in<br>formats: DAT, CEV, DTX, GVZ, TEL,<br>TMS |
| Software will<br>provide analysis<br>of ECGs from<br>some specific<br>devices.<br>• Heartbeat<br>• Beat<br>Complex | Different | No | Guava II provides analysis of ECGs<br>from Louvain, and Monebo. |
| Heart Rate<br>Determination<br>Non-paced | Different | No | Yes |
| QRS Detection | Different | No | Yes |
| Non-Paced<br>Arrhythmia<br>Interpretation | Different | No | Yes |
| Category | Identical/<br>Different | Bioflux | Guava II |
| Non-Paced<br>Ventricular<br>Arrhythmia | Different | No | Yes |
| Interval<br>Measurement | Similar | Yes | Yes |
| Ventricular<br>Ectopic Beat<br>detection | Different | No | Yes |
| Beat Caliper,<br>Manual tool to<br>place six vertical<br>lines and adjust<br>beat calipers to<br>mark main points<br>of the QRS<br>complex | Similar | Yes | Yes |

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### VII. PERFORMANCE TESTING

The Bioflux device was tested and complies with AAMIEC11, AAMI EC38, IEC60601-2-25 and IEC60601-2-47 standards. The Bioflux software was verified in both of its operating environments of Firefox and Google Chrome. Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases. The activities included scenario validations, algorithm confirmation testing, and device functional testing.

## VIII. CONCLUSIONS

The testing completed demonstrates that Bioflux Software exhibits comparable technological, and design characteristics to the predicate. Based on those characteristics, the Bioflux Software is substantially equivalent to the predicate device in safety and effectiveness in addition to being intended for the same uses.