(28 days)
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.
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.
The provided text does not contain detailed information about specific acceptance criteria related to a device performance study. Instead, it focuses on the Bioflux software's compliance with general standards and its substantial equivalence to a predicate device.
However, based on the information describing the performance testing and compliance with standards, we can infer some general acceptance criteria for the functions the Bioflux software is intended to perform.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:
Acceptance Criteria and Study for Bioflux Software
The Bioflux software is an API-based ECG viewer software intended to analyze, view, and report ECG data. The study primarily focused on demonstrating compliance with relevant industry standards and ensuring the software performed its intended functions in its specified operating environments.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from Standards & Description) | Reported Device Performance |
|---|---|---|
| ECG Data Handling & Display | Compliance with AAMI EC11 (Diagnostic Electrocardiographic Devices) | The Bioflux device was tested and complies with AAMI EC11. This suggests accurate display of ECG traces, appropriate speed/gain/filter values, and perhaps other display characteristics for diagnostic ECGs. |
| Ambulatory ECG Data Handling | Compliance with AAMI EC38 (Ambulatory Electrocardiographs) | The Bioflux device was tested and complies with AAMI EC38. This indicates its capability to handle and display data specifically related to ambulatory ECGs. |
| ECG Measurement & Analysis | Compliance with IEC 60601-2-25 (Particular requirements for the basic safety and essential performance of electrocardiographs) | The Bioflux device was tested and complies with IEC 60601-2-25. This implies the system meets safety and performance requirements for basic electrocardiographs, potentially including accurate interval measurements (RR, PR, QRS, QT, QTc) and general signal processing. |
| Ambulatory ECG Safety & Performance | Compliance with IEC 60601-2-47 (Requirements for the basic safety and essential performance of ambulatory electrocardiographic systems) | The Bioflux device was tested and complies with IEC 60601-2-47. This indicates compliance with safety and essential performance standards specifically for ambulatory ECG systems, supporting its ability to reliably process and present such data. |
| Beat Caliper Measurements | ECG Viewer will include Beat Caliper measurements in standard ECG intervals (RR, PR, QRS, QT, QTc) | Yes. The software supports beat caliper measurements for standard ECG intervals. |
| ECG Trace Display & Controls | ECG viewer will display ECG traces, as well as speed, gain, and filter values. | Yes. The software displays ECG traces and relevant parameters. |
| Software Functionality & Reliability | Verification and validation activities related to device modification | "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." This indicates successful functional testing, scenario validations, and algorithm confirmation testing within the software. |
| Browser Compatibility | Operate on targeted web browsers (Chrome, Firefox) | The software was verified in both Firefox and Google Chrome operating environments, confirming its compatibility and functionality within these browsers. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set. It mentions "scenario validations, algorithm confirmation testing, and device functional testing," which implies that various test cases and data were used, but the quantity is not provided.
The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of a software viewer that processes existing ECG data, it is likely that existing (retrospective) ECG datasets were utilized for testing, but this is not confirmed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any details regarding the number of experts used or their qualifications for establishing ground truth for the test set. The Bioflux software is described as not offering diagnosis or medical alarms, and that "competent human intervention be involved before any impact on health occurs" and "Clinical judgement and experience are used to check and interpret the data." This suggests that human expert interpretation is crucial in the real-world use of the device, but it doesn't detail how ground truth was established during testing for its performance. The testing primarily focused on compliance with technical standards for ECG data processing and display, not on diagnostic accuracy against expert ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. The performance testing section mentions "predetermined acceptance criteria were met," which implies that the outcomes of the tests were evaluated against these criteria, but not necessarily through an adjudication process by multiple experts for diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. The summary focuses on the device's technical compliance and substantial equivalence to a predicate, not on improvements in human reader performance with or without AI assistance. The Bioflux software is described as a viewer and analysis tool that "does not offer diagnosis, or medical alarms," emphasizing human intervention for interpretation.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not describe a standalone study in the context of diagnostic accuracy or a specific algorithm's performance without human-in-the-loop. The "algorithm confirmation testing" mentioned in the performance section suggests internal testing of software algorithms, but this is distinct from a standalone diagnostic performance study. The device's primary function is to display and analyze data for human interpretation.
7. The Type of Ground Truth Used
Given that the performance testing focused on compliance with technical standards for ECG data handling, display, and measurement (AAMI EC11, AAMI EC38, IEC 60601-2-25, IEC 60601-2-47), the "ground truth" for the software's technical performance would likely have been established through:
- Reference standards and specifications: Each standard defines specific technical requirements for ECG devices.
- Known input data: During "algorithm confirmation testing" and "scenario validations," the software would be fed with known ECG data (e.g., simulated, annotated) to verify correct processing and output.
- Manual verification: For display accuracy and measurement tools, human verification against the known input would likely serve as the ground truth.
There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the performance testing described.
8. The Sample Size for the Training Set
The document does not specify a training set size. As the Bioflux software is described as an "ECG viewer software" that provides "tools for trained clinicians to analyze those ECG recordings" and "does not offer diagnosis, or medical alarms," it implies that it's not an AI/ML diagnostic algorithm that would typically have a distinct "training set" in the conventional sense. Its functionality is to display and provide measurement tools for existing ECG data based on predefined standards and algorithms, rather than learning from data to make predictions or classifications.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/ML model, the concept of establishing ground truth for a training set is not applicable based on the provided information. The device functions as a data display and analysis tool guided by established medical device standards.
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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 (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
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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)
| ☑ 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 tobe used to analyze, view, andreport ECG data acquired froma variety of ECG sourcesincluding single and 3-leadECG devices. Bioflux softwareis operated locally in abrowser and data is accessedvia the users' credentials onthe hardware platformrunning the browser.It will be used by cardiologists,general practitioners, cardiac,or ECG technicians, nurses,monitoring servicetechnicians, and other cardiacrelated institutions, or caregivers, in independent clinicaltesting facilities, clinics,hospitals, physician's offices,or anywhere a physician orqualified non-physicianpractitioners deemsappropriateBioflux software does not | Guava II is intended to be used bycardiologists, general practitioners,cardiac or ECG technicians, nurses,monitoring service technicians, andother cardiac related institutions orcare givers to store, retrieve,communicate and report ECG andECG data acquired from a variety ofECG sources including single andmulti-lead ECG devices. Guava II isintended to be electronicallyinterfaced, and perform analysiswith data transferred from othercomputer based ECG systems.Guava II includes an algorithm thatwill analyze the 12 Lead ECG andproduce measurements of the ECGrecording as well as textualinterpretation. The product alsoincludes an automatic analysis andinterpretation software library thatprovides ECG signal processing andanalysis on a beat by beat basis,QRS and Ventricular Ectopic Beatdetection, QRS feature extraction,interval measurement, heart ratemeasurement, and rhythm analysis |
| Category | Identical/ | Bioflux | Guava II |
| Different | |||
| offer diagnosis, or medicalalarms. It is intended thatcompetent humanintervention be involvedbefore any impact on healthoccurs. Clinical judgementand experience are used tocheck and interpret the data. | for up to twelve (12) leads ofcaptured data. Guava II is intendedfor use in clinics, hospitals,physician's offices, or anywhere amedical doctor deems appropriate.It is intended that competenthuman intervention be involvedbefore any impact on healthoccurs. Clinical judgment andexperience are used to check andinterpret the data. Guava II may belicensed to other softwaredevelopers as an ECG viewer fortheir | ||
| The ECG Viewerwill meet the EC-11 Standard. | Identical | Yes | Yes |
| The ECG Viewerwill meet the EC-38 Standard. | Identical | Yes | Yes |
| The ECG Viewerwill meet theIEC60601-2-47. | Similar | Yes | Not required at time of submission |
| The ECG Viewerwill meet theIEC60601-2-25Standard. | Similar | Yes | Not required at time of submission |
| ECG Viewer willinclude BeatCalipermeasurements instandard ECGintervals (RR, PR,QRS, QT, QTc) | Identical | Yes | Yes |
| ECG viewer willdisplay ECGtraces, as well asspeed, gain, and | Identical | Yes | Yes |
| Category | Identical/Different | Bioflux | Guava II |
| filter values. | |||
| ECG viewer willbe compatiblewith webbrowsers | Similar | Google Chrome and Firefox | Internet Explorer |
| Software willdecode ECGsfrom a widerange of acousticdevices (usingdemodulatorsand FSKanalyzers). | Different | Bioflux software does notprocess ECGs from acousticdevices | Yes |
| Software willdecode ECGsfrom a widerange of digitaldevices (usingservers). | Different | Bioflux software does notprocess ECG's from locallyconnecteddevices using USB connections | Yes |
| Software willsupport import ofcommon ECGdata formats(GVX, MIT, RES,SCP) | Similar | Yes | Guava II also accepts data informats: DAT, CEV, DTX, GVZ, TEL,TMS |
| Software willprovide analysisof ECGs fromsome specificdevices.• Heartbeat• BeatComplex | Different | No | Guava II provides analysis of ECGsfrom Louvain, and Monebo. |
| Heart RateDeterminationNon-paced | Different | No | Yes |
| QRS Detection | Different | No | Yes |
| Non-PacedArrhythmiaInterpretation | Different | No | Yes |
| Category | Identical/Different | Bioflux | Guava II |
| Non-PacedVentricularArrhythmia | Different | No | Yes |
| IntervalMeasurement | Similar | Yes | Yes |
| VentricularEctopic Beatdetection | Different | No | Yes |
| Beat Caliper,Manual tool toplace six verticallines and adjustbeat calipers tomark main pointsof the QRScomplex | 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.
§ 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).