(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the software as an API-based viewer with tools for manual analysis by trained clinicians. There is no mention of automated analysis or learning algorithms.
No
The device is described as software for analyzing and viewing ECG data. It explicitly states it does not offer diagnosis or medical alarms and requires human intervention for health impacts, indicating it is an analytical tool rather than a therapeutic one.
No
The Bioflux software is explicitly stated to "not offer diagnosis" and requires competent human intervention and clinical judgment to interpret the data, functioning as a viewing and analysis tool rather than a diagnostic one.
Yes
The device is described as "Bioflux software" and its description focuses solely on its software functionalities (API-based viewer, data analysis tools, browser operation). It explicitly states it is "delivered on disk" and operates within existing browser environments, indicating no dedicated hardware component is part of the device itself.
Based on the provided information, Bioflux software 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's Function: Bioflux software analyzes, views, and reports ECG data. ECG data is electrical activity from the heart, not a specimen derived from the human body in the sense of an IVD.
- Intended Use: The intended use clearly states it's for analyzing, viewing, and reporting ECG data acquired from ECG devices. It does not mention analyzing biological specimens.
- Device Description: The description focuses on displaying and providing tools for analyzing ECG recordings, not on testing biological samples.
Therefore, Bioflux software falls under the category of a medical device, specifically a cardiology software product, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DSH
Device Description
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.
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
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
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 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.
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.
Not Found
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| ☑ 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 21CFR 807.92)
SUBMITTER I.
Biotricity Inc. 75 International Blvd. Suite 300 Toronto ON M9W 6L9 Canada Contact Person: Tom Elias telias@biotricity.com Phone: 416.931.9001 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/
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
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 | Guava II is intended to be used by
cardiologists, general practitioners,
cardiac or ECG technicians, nurses,
monitoring service technicians, and
other cardiac related institutions or
care givers to store, retrieve,
communicate and report ECG and
ECG data acquired from a variety of
ECG sources including single and
multi-lead ECG devices. Guava II is
intended to be electronically
interfaced, and perform analysis
with data transferred from other
computer based ECG systems.
Guava II includes an algorithm that
will analyze the 12 Lead ECG and
produce measurements of the ECG
recording as well as textual
interpretation. The product also
includes an automatic analysis and
interpretation software library that
provides ECG signal processing and
analysis on a beat by beat basis,
QRS and Ventricular Ectopic Beat
detection, QRS feature extraction,
interval measurement, heart rate
measurement, and rhythm analysis |
| Category | Identical/ | Bioflux | Guava II |
| | Different | | |
| | | 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. | for up to twelve (12) leads of
captured data. Guava II is intended
for use in clinics, hospitals,
physician's offices, or anywhere a
medical doctor deems appropriate.
It is intended that competent
human intervention be involved
before any impact on health
occurs. Clinical judgment and
experience are used to check and
interpret the data. Guava II may be
licensed to other software
developers as an ECG viewer for
their |
| The ECG Viewer
will meet the EC-
11 Standard. | Identical | Yes | Yes |
| The ECG Viewer
will meet the EC-
38 Standard. | Identical | Yes | Yes |
| The ECG Viewer
will meet the
IEC60601-2-47. | Similar | Yes | Not required at time of submission |
| The ECG Viewer
will meet the
IEC60601-2-25
Standard. | Similar | Yes | Not required at time of submission |
| ECG Viewer will
include Beat
Caliper
measurements in
standard ECG
intervals (RR, PR,
QRS, QT, QTc) | Identical | Yes | Yes |
| ECG viewer will
display ECG
traces, as well as
speed, gain, and | Identical | Yes | Yes |
| Category | Identical/
Different | Bioflux | Guava II |
| filter values. | | | |
| ECG viewer will
be compatible
with web
browsers | Similar | Google Chrome and Firefox | Internet Explorer |
| Software will
decode ECGs
from a wide
range of acoustic
devices (using
demodulators
and FSK
analyzers). | Different | Bioflux software does not
process ECGs from acoustic
devices | Yes |
| Software will
decode ECGs
from a wide
range of digital
devices (using
servers). | Different | Bioflux software does not
process ECG's from locally
connected
devices using USB connections | Yes |
| Software will
support import of
common ECG
data formats
(GVX, MIT, RES,
SCP) | Similar | Yes | Guava II also accepts data in
formats: DAT, CEV, DTX, GVZ, TEL,
TMS |
| Software will
provide analysis
of ECGs from
some specific
devices.
• Heartbeat
• Beat
Complex | Different | No | Guava II provides analysis of ECGs
from Louvain, and Monebo. |
| Heart Rate
Determination
Non-paced | Different | No | Yes |
| QRS Detection | Different | No | Yes |
| Non-Paced
Arrhythmia
Interpretation | Different | No | Yes |
| Category | Identical/
Different | Bioflux | Guava II |
| Non-Paced
Ventricular
Arrhythmia | Different | No | Yes |
| Interval
Measurement | Similar | Yes | Yes |
| Ventricular
Ectopic Beat
detection | Different | No | Yes |
| Beat Caliper,
Manual tool to
place six vertical
lines and adjust
beat calipers to
mark main points
of the QRS
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.