(119 days)
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No
The summary describes a browser-based ECG viewer and annotation tool. It explicitly states it does not offer diagnosis or medical alarms and requires competent human intervention for interpretation. There is no mention of AI, ML, or any automated analysis beyond viewing and annotation.
No
The device is described as software used for viewing and annotating diagnostic ECG data, not for providing therapy or treatment. Its intended use explicitly states it "does not offer diagnosis, or medical alarms" and that "competent human intervention be involved before any impact on health occurs."
No
The device is a viewer and annotation tool for ECG data and explicitly states that it "does not offer diagnosis, or medical alarms." While it processes data from "diagnostic ECG sources," the software itself is not performing the diagnostic function.
Yes
The device description explicitly states it is "browser based ECG viewer software" and runs "locally in a browser," with data accessed via user credentials on the "hardware platform running the web browser." It does not include or require specific hardware components beyond a standard computer with a web browser.
Based on the provided information, Bioflux Software II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Bioflux Software II's Function: Bioflux Software II is a software viewer for ECG data. ECG data is a recording of the electrical activity of the heart, obtained externally from the body. It does not involve the analysis of biological specimens.
- Intended Use: The intended use clearly states it's for viewing and annotating data acquired from diagnostic ECG sources. It explicitly states it "does not offer diagnosis, or medical alarms" and relies on "competent human intervention" and "clinical judgement and experience" for interpretation.
Therefore, Bioflux Software II falls under the category of a medical device, specifically a software medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MWJ
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:
-
- It is a cardiology software product, running locally in a browser.
-
- Bioflux Software II operates on 2018 or later versions of Chrome and Firefox browsers.
-
- 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.
-
- Information can be displayed on the computer monitor or printed on paper using the web browser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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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
1
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
2
Indications for Use
510(k) Number (if known) K201040
Device Name Bioflux Software II
Indications for Use (Describe)
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.
| 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
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
4
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:
-
- It is a cardiology software product, running locally in a browser.
-
- Bioflux Software II operates on 2018 or later versions of Chrome and Firefox browsers.
-
- 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.
-
- 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.
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.
| Product/
510(k) # | BioFlux Software II/
K201040 (under review) | BioFlux Software/
K162571 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 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 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 | Bioflux software does not offer diagnosis, or
medical alarms. It is intended that
competent human intervention be involved |
Indications for Use Comparison Table:
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| that competent human intervention be
involved before any impact on health
occurs. Clinical judgement and experience
are used to check and interpret the data. | before any impact on health occurs. Clinical
judgement and experience are used to check
and interpret the data. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------- |
|---|
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 |
6
| lines and adjust
| beat calipers. | ||
|---|---|---|
| Horizontal | ||
| Caliper Heart | ||
| Rate Averaging, | ||
| Manual tool. | Yes | No - Bioflux software does not have |
| this 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.