Bioflux Software II is intended to be used to view and annotate data acquired from diagnostic ECG sources of 1 to 3leads. Bioflux Software II is operated in a web browser and data is accessed via the users' credentials on the hardware platform running the web browser. It will be used by cardiologists, general practitioners, cardiac, ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions.

Bioflux Software II will be used in independent clinical testing facilities. clinics, hospitals, physician's offices, or anywhere a physician or qualified practitioners deem appropriate.

Bioflux Software II 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 Description

Bioflux Software II is a browser based ECG viewer software that displays ECG records and provides tools for trained clinicians to annotate (store, retrieve and report) those ECG recordings. It is utilized by manually opening ECG files of supported formats or through an API that allows for third parties to integrate their devices and directly push ECG files into the viewer.

Bioflux Software II fulfills all of the following:

1. It is a cardiology software product, running locally in a browser.
1. Bioflux Software II operates on 2018 or later versions of Chrome and Firefox browsers.
1. The data can be opened manually or entered via keyboard, mouse or touchscreen where upon it gets opened in the browser for viewing and storage.
1. Information can be displayed on the computer monitor or printed on paper using the web browser.

AI/ML Overview

The Bioflux Software II is an ECG viewer intended to view and annotate data acquired from diagnostic ECG sources of 1 to 3-leads. It does not offer diagnosis or medical alarms, and competent human intervention is required.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with AAMI EC11 standard	Complies with AAMI EC11 standard
Compliance with AAMI EC38 standard	Complies with AAMI EC38 standard
Compliance with IEC60601-2-25 standard	Complies with IEC60601-2-25 standard
Compliance with IEC60601-2-47 standard	Complies with IEC60601-2-47 standard
Operates in Firefox browser	Verified in Firefox browser
Operates in Google Chrome browser	Verified in Google Chrome browser
Scenario validations meet pre-determined acceptance criteria	Met pre-determined acceptance criteria
Beat marker confirmation testing meets pre-determined acceptance criteria	Met pre-determined acceptance criteria
Device functional testing meets pre-determined acceptance criteria	Met pre-determined acceptance criteria

2. Sample Size for Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Verification activities related to the device modification were performed on the applicant device."

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. Given that the device is an ECG viewer for annotation and does not offer diagnosis or alarms, it's possible that the "ground truth" for functional testing related to viewing and annotation capabilities would be based on expected software behavior rather than expert clinical consensus on diagnoses.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a viewer and annotator, not a diagnostic aid that would assist human readers in interpretation. The goal of the study was to verify the software's functionality and compliance with standards, not to evaluate improvements in human reader performance with AI assistance.

6. Standalone Performance Study

A standalone performance study was done for the device in the sense that the listed performance criteria (compliance with standards, scenario validations, beat marker confirmation, device functional testing) were performed directly on the "applicant device" (Bioflux Software II) and its operating environments (Firefox and Chrome). This verifies the algorithm's functionality and compliance without human-in-the-loop performance evaluation in a diagnostic context.

7. Type of Ground Truth Used

The type of ground truth used appears to be expected software behavior and compliance with technical standards. The verification activities focused on functional aspects like "scenario validations," "beat marker confirmation testing," and "device functional testing" in the context of specified ECG viewing and annotation capabilities. This contrasts with diagnostic devices where ground truth might be established by expert consensus on clinical findings, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not mention a training set. This is consistent with the device being primarily an ECG viewer and annotation tool, rather than a machine learning model that requires a training set for algorithm development.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for this device, the method for establishing ground truth for a training set is not applicable.

Summary

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July 29, 2020

Biotricity Spencer Ladow VP of Engineering 275 Shoreline Drive, Suite 150 Redwood City, California 94065

Re: K201040

Trade/Device Name: Bioflux Software II Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: June 29, 2020 Received: July 2, 2020

Dear Spencer Ladow:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201040

Device Name Bioflux Software II

Indications for Use (Describe)

Bioflux Software II will be used in independent clinical testing facilities. clinics, hospitals, physician's offices, or anywhere a physician or qualified practitioners deem appropriate.

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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510(k) SUMMARY (as required by 807.92)

1. SUBMITTER

Biotricity

275 Shoreline Drive, Suite 150

Redwood City CA 94065

1-650-832-1626

Contact: Spencer LaDow

Date Prepared: June 28, 2020

2. DEVICE

Name of Device: Bioflux Software II Classification Name: Medical Magnetic Tape Recorder Classification Number: 21 CFR 870.2800 Device Panel: Cardiovascular Regulatory Class: Class II Product Code: MWJ

3. PREDICATE DEVICE

Name of Device: Bioflux Software Classification Name: Medical Magnetic Tape Recorder Classification Number: 21 CFR 870.2800 Device Panel: Cardiovascular Regulatory Class: Class II Product Code: DSH 510(k): K162571

4. DEVICE DESCRIPTION

Bioflux Software II is a browser based ECG viewer software that displays ECG records and provides tools for trained clinicians to annotate (store, retrieve and report) those ECG

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recordings. It is utilized by manually opening ECG files of supported formats or through an API that allows for third parties to integrate their devices and directly push ECG files into the viewer.

Bioflux Software II fulfills all of the following:

1. It is a cardiology software product, running locally in a browser.
1. Bioflux Software II operates on 2018 or later versions of Chrome and Firefox browsers.
1. The data can be opened manually or entered via keyboard, mouse or touchscreen where upon it gets opened in the browser for viewing and storage.
1. Information can be displayed on the computer monitor or printed on paper using the web browser.

5. Indications for USE

Bioflux Software II is intended to be used to view and annotate data acquired from diagnostic ECG sources of 1 to 3-leads. Bioflux Software II is operated in a web browser and data is accessed via the users' credentials on the hardware platform running the web browser. It will be used by cardiologists, general practitioners, cardiac, ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions.

Bioflux Software II will be used in independent clinical testing facilities, clinics, hospitals, physician's offices, or anywhere a physician or qualified practitioners deems appropriate.

Product/510(k) #	BioFlux Software II/K201040 (under review)	BioFlux Software/K162571
	Bioflux Software II is intended to be usedto view and annotate data acquired fromdiagnostic ECG sources of 1 to 3-leads.Bioflux Software II is operated in a webbrowser and data is accessed via the users'credentials on the hardware platformrunning the web browser. It will be usedby cardiologists, general practitioners,cardiac, ECG technicians, nurses,monitoring service technicians, and othercardiac related institutions.	Bioflux software is intended to be used toanalyze, view, and report ECG data acquiredfrom a variety of ECG sources includingsingle and 3-lead ECG devices. Biofluxsoftware is operated locally in a browser anddata is accessed via the users' credentials onthe hardware platform running the browser.It will be used by cardiologists, generalpractitioners, cardiac, or ECG technicians,nurses, monitoring service technicians, andother cardiac related institutions, or caregivers, in independent clinical testingfacilities, clinics, hospitals, physician'soffices, or anywhere a physician or qualifiednon-physician practitioners deemsappropriate.
	Bioflux Software II will be used inindependent clinical testing facilities,clinics, hospitals, physician's offices, oranywhere a physician or qualifiedpractitioners deem appropriate.
	Bioflux Software II does not offerdiagnosis, or medical alarms. It is intended	Bioflux software does not offer diagnosis, ormedical alarms. It is intended thatcompetent human intervention be involved

Indications for Use Comparison Table:

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that competent human intervention beinvolved before any impact on healthoccurs. Clinical judgement and experienceare used to check and interpret the data.	before any impact on health occurs. Clinicaljudgement and experience are used to checkand interpret the data.
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6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATED DEVICE

The Bioflux Software II is substantially equivalent in intended use and similar technological characteristics of Bioflux Software cleared under K162571.

Category	Bioflux Software II	Bioflux Software
510(k) Number	K201040	K162571
Classification Name	Medical Magnetic Tape Recorder	Medical Magnetic Tape Recorder
Classification Number	21 CFR 870.2800	21 CFR 870.2800
Product Code	MWJ	DSH
Intended Use	View and annotate data acquired from diagnostic ECG sources.	Analyze, view and report data acquired from a variety of ECG sources.
The ECG Viewer will meet the IEC60601-2-47.	Yes	Yes
The ECG Viewer will meet the IEC60601-2-25 Standard.	Yes	Yes
ECG viewer will view and annotate data acquired from diagnostic ECG sources of 1 to 3-leads.	Yes	Yes
ECG viewer will be compatible with web browsers	Yes– Google Chrome and FireFox 2018	Yes- Google Chrome and FireFox 2015
Software will support import of ECG data formats.	Yes- JSON	Yes- GVX, MIT, RES, SCP
Interval Measurement	Yes - manual	Yes - automated
Beat Caliper, Manual tool to place six vertical	Yes	Yes

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lines and adjustbeat calipers.
HorizontalCaliper HeartRate Averaging,Manual tool.	Yes	No - Bioflux software does not havethis manual horizontal caliper.

7. PERFORMANCE TESTING

The Bioflux Software II device was tested and complies with AAMI EC11, AAMI EC38, IEC60601-2-25 and IEC60601-2-47 standards. The Bioflux Software II was verified in both of its operating environments of Firefox and Google Chrome. Verification 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, beat marker confirmation testing, and device functional testing.

8. CONCLUSIONS

The conclusions drawn from the indications for use and testing demonstrates that Bioflux Software II exhibits comparable indications for use, technological, and design characteristics to the predicate (Bioflux Software). Based on this, the Bioflux Software II is as safe, and effective, and performs as well as the legally marketed device predicate. The Bioflux Software II is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).