(136 days)
Not Found
No
The summary mentions an "ECG analysis algorithm" and an "embedded arrhythmia detection algorithm," but there is no mention of AI, ML, deep learning, or any related terms. The description of performance studies focuses on standard medical device testing and algorithm performance metrics, not AI/ML specific validation.
No
The "Intended Use / Indications for Use" section explicitly states, "The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support." This indicates it is a diagnostic/monitoring device, not a therapeutic one.
No.
The device continuously records ECG data and delivers it to a server for review by a medical professional. The "Intended Use" explicitly states that the device "does not provide interpretive or diagnostic statements." While the data can be used by another device for arrhythmia analysis, the bioflux device itself is a data collection and transmission tool, not a diagnostic one.
No
The device description explicitly states that the bioflux device is a "portable, battery-powered, wireless cardiac monitor," indicating it is a hardware component. The performance studies also include testing against hardware standards like IEC 60601 series.
Based on the provided information, the bioflux Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body). The bioflux device directly records electrical activity from the patient's body (ECG data) in vivo (within the body).
- The intended use describes monitoring cardiac activity directly from the patient. It doesn't mention collecting or analyzing biological samples.
- The device description focuses on recording and transmitting ECG data. There's no mention of handling or analyzing biological specimens.
The bioflux device is a medical device used for cardiac monitoring, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The bioflux Device is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis for up to 30 days. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.
The data received from the bioflux device can be used by another device for arrhythmia analysis, reporting and signal measurements. The bioflux device is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support.
bioflux is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The bioflux system consists of the bioflux device and the server. The bioflux device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and auto-triggered events such as Bradycardia, pause and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is designed to automatically deliver the data to the server. The data is delivered to the server wirelessly via mobile cellular dedicated network connection. A medical professional, using the server, can adjust and program the device configuration and autotriggering parameters.
bioflux device 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
medical professional / Not Found
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 following performance and safety tests have been passed successfully:
- . IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
- IEC 60601-1:2012 3rd Edition with amendment 1, Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 4th Edition, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-11:2015 Edition 1.1, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- ANSI/AAMI-EC 57:2012, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms.
- IEC 62366-1:2015 Edition 1.0, Medical devices Part 1: Application of usability engineering to medical devices
- Biocompatibility testing of patient contacting materials according to ISO 10993-1.
- . Bench test results verify that Bioflux Monitor system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto activated event recordings to the server via mobile network connection for evaluation by a medical professional. Test results verify that all requirements were met and that the Bioflux Monitor performs as designed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bench test results verify that all requirements were met and that the Bioflux Monitor performs as designed.
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
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo. On the right is the FDA logo, which is a blue square with the letters FDA in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2017
Biotricity Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K172311
Trade/Device Name: BioFlux Device Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: November 14, 2017 Received: November 21, 2017
Dear 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MS. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Food and Drug Administration
Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name BioFlux Device
Indications for Use (Describe)
The bioflux Device is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis for up to 30 days. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.
The data received from the bioflux device can be used by another device for arrhythmia analysis, reporting and signal measurements. The bioflux device is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support.
bioflux is for prescription use only.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) SUMMARY
(as required by 21CFR 807.92)
SUBMITTER l.
Biotricity - Measuring Vitals 275 Shoreline Drive, Suite 150 Redwood City CA 94065 Contact Person: Spencer LaDow sladow@biotricity.com Phone: 585-414-7407 Date Prepared: November 14, 2017
DEVICE II.
Name of Device: BioFlux Device Classification Name: 870.2920 Telephone electrocardiograph transmitter and receiver. Common or Usual Name: Mobile Cardiac Monitor Device Panel: Cardiovascular Regulatory Class: Class 2 Product Code: DXH
III. PREDICATE DEVICE
The bioflux System is substantially equivalent in intended use and similar technological characteristics the following device, Rhythmedix, LLC. RhythmStar System which was cleared under K141813.
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DEVICE DESCRIPTION IV.
The bioflux system consists of the bioflux device and the server. The bioflux device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and auto-triggered events such as Bradycardia, pause and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is designed to automatically deliver the data to the server. The data is delivered to the server wirelessly via mobile cellular dedicated network connection. A medical professional, using the server, can adjust and program the device configuration and autotriggering parameters.
bioflux device 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
The bioflux Device is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis for up to 30 days. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.
The data received from the bioflux device can be used by another device for arrhythmia analysis, reporting and signal measurements. The Bioflux device is not intended to sound any alarms. The device does not deliver any therapy, administer
any drugs, provide interpretive or diagnostic statements or provide for any life support. bioflux is for prescription use only.
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SUMMARY OF TECHNOLIGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE
The bioflux system is substantially equivalent in intended use and similar technological characteristics of RhythmStar System cleared under K141813.
| Category | Identical/
Different | bioflux | RhythmStar |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K172311 | K141813 |
| Classification | Identical | Medical | Medical |
| Name | Identical | Mobile Cardiac Monitor | Mobile Cardiac Monitor |
| Product Code | Similar | DXH | DXH |
| Intended Use | Similar | The bioflux Device is intended for
use by patients who either have or
are at risk of having cardiac disease
and those that demonstrate
intermittent symptoms indicative of
cardiac disease and require cardiac
monitoring on a continuing basis for
up to 30 days. The device
continuously records ECG data and
upon detection by an ECG analysis
algorithm or manually initiated by the
patient, automatically delivers the
recorded cardiac activity to the server
where it is presented and can be
reviewed by a medical professional.
The data received from the bioflux
device can be used by another device
for arrhythmia analysis, reporting and
signal measurements. The bioflux
device is not intended to sound any
alarms. The device does not deliver
any therapy, administer any drugs,
provide interpretive or diagnostic
statements or provide for any life
support. Bioflux is for prescription use
only. | The RhythmStar system is intended
for use by patients who either have
or are at risk of having cardiac
disease and those that demonstrate
intermittent symptoms indicative of
cardiac disease and require cardiac
monitoring on a continuing basis. The
device continuously records ECG data
and upon detection by an ECG
analysis algorithm or manually
initiated by the patient, automatically
delivers the recorded cardiac activity
to the server where it is presented
and can be reviewed by a medical
professional.
The data received from the
RhythmStar device can be used by
another device for arrhythmia
analysis, reporting and signal
measurements. The RhythmStar
system is not intended to sound any
alarms. The device does not deliver
any therapy, administer any drugs,
provide interpretive or diagnostic
statements or provide for any life
support. RhythmStar is for
prescription use only. |
| Delivered device
includes | Similar | bioflux device
-patient 3 lead ECG cable | RhythmStar monitor
- Patient 3 lead ECG lead cable |
| Category | Identical/Different | bioflux | RhythmStar |
| | | -internal rechargeable battery
-Wall Battery charger
-Carry pouch | - 2 externally re-chargeable batteries - Wall battery charger |
| Monitor functional blocks | Similar | analog ECG front end,
MCU,
flash data storage,
RF modem for
data transmission,
LCD screen, and
Record button | analog ECG front end,
accelerometer,
MCU,
flash data storage,
RF modem for
data transmission,
LCD screen, and
Record button |
| The server: | identical | facilitate data communication with the bioflux device, provide data storage, and present the data for evaluation by a medical professional | facilitate data communication with the RhythmStar device, provide data storage, and present the data for evaluation by a medical professional |
| Device form factor | Similar | small, lightweight
ambulatory cardiac monitors. | small, lightweight
ambulatory cardiac monitors. |
| Wireless technology used to transmit data to server | Identical | Yes | Yes |
| Device is battery powered by a rechargeable Li-Ion battery | Identical | Yes | Yes |
| using a server, can adjust device programming parameters such as pre-post recording times and auto-triggering configuration. | Identical | Yes | Yes |
| Category | Identical/
Different | bioflux | RhythmStar |
| Devices incorporate an
accelerometer to
capture activity level
data related to patient
motion and device
orientation. | Different | No | Yes |
| devices have Record
button for manual
event recordings and a
user interface to
indicate device status
and mode of operation. | similar | Yes | Yes |
| Device incorporate
embedded ECG analysis
algorithm to auto-
capture Bradycardia,
Tachycardia and Atrial
Fibrillation and
arrhythmia events
between the signal
acquisition point and
the server. | Similar | Yes | Yes |
| device has at least 2
ECG channels and 3-
lead electrodes | Similar | Yes | Yes |
| Functional,
Environmental and
Electrical
characteristics | Similar | Yes | Yes |
| USB connection | different | Yes, used to charge the battery,
marks ECG data during recording in
case noise is introduced, not used for
data download. | Yes, used only for data download and
secondary communication, cannot be
connected during ECG recording |
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PERFORMANCE TESTING VII.
The following performance and safety tests have been passed successfully:
- . IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
- IEC 60601-1:2012 3rd Edition with amendment 1, Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 4th Edition, Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-11:2015 Edition 1.1, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- ANSI/AAMI-EC 57:2012, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms.
- IEC 62366-1:2015 Edition 1.0, Medical devices Part 1: Application of usability ● engineering to medical devices
- Biocompatibility testing of patient contacting materials according to ISO 10993-1.
- . Bench test results verify that Bioflux Monitor system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto activated event recordings to the server via mobile network connection for evaluation by a medical professional. Test results verify that all requirements were met and that the Bioflux Monitor performs as designed.
SUBSTANTIAL EQUIVALENCE RATIONALE VIII.
The intended use, performance and technological characteristics of the bioflux Monitor system compared to the named predicate device demonstrates that the bioflux Monitor is substantially equivalent to the predicate.
CONCLUSIONS IX.
The analysis of the differences between bioflux Monitor and the predicate deice does not raise new questions of safety and effectiveness. Based on device performance test results, Biotricity determines that the bioflux Monitor system performs within its design specifications, and is substantially equivalent to the predicate devices.
The information in this 510(k) submission demonstrates that the bioflux Monitor system is substantially equivalent to the predicate device.