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K Number
K170568
Device Name
CardioLogs ECG Analysis Platform
Manufacturer
Cardiologs Technologies
Date Cleared
2017-06-26

(119 days)

Product Code
DPSDOK
Regulation Number
870.2340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs ECG Analysis Platform can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Cardiologs ECG Analysis Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, ORS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs ECG Analysis Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. Cardiologs ECG Analysis Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
Device Description
CardioLogs ECG Analysis Platform is made up of: - An interface which provides tools to measure, analyze and review numerous ECGs; - An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis. CardioLogs ECG Analysis Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm). CardioLogs ECG Analysis Platform works in the following sequence: - 1. Upload of digital ECG file to CardioLogs' secured hosting databases (for health data i.e. HIPAA compliant); - Manual upload: via the web-interface which allows the selection of files to upload on the evaluating user's computer - Direct upload: with no manual intervention, in the specific cases where the user's hardware is already connected to the CardioLogs' Application Programming Interface (or API): the ECG is automatically sent to CardioLogs' servers. - 2. Processing of the uploaded ECG file; - 3. Analysis of the uploaded ECG performed by CardioLogs' proprietary algorithm, which labels the ECG; - Delineation (detection of at least P waves, QRS complexes and T waves on the ECG signal). The output format is a sequence of elements "wave type/start time/ end time"; - Abnormality labels: the algorithm provides probability scores on a predefined set of abnormality labels (multi-label classification); - 4. CardioLogs ECG Analysis Platform displays the resulting analysis, along with the original ECG signal and a variety of tools (ruler, zoom, etc.). Results are made available either on the CardioLogs interface if the user's hardware allows for digital ECG upload, or on an API in cases where the service is available as part of a package with an ECG machine; - 5. CardioLogs ECG Analysis Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician. The resulting information is stored on a secured database.
More Information

K062282

TM eCloud ECG Analysis System (K142349)

Yes
The device description mentions a "proprietary algorithm" that performs "multi-label classification" with "probability scores" on abnormality labels, which is characteristic of machine learning techniques applied to ECG analysis.

No
The CardioLogs ECG Analysis Platform is an analysis platform that provides supportive information for ECG analysis. It is described as an "advisory basis only" and specifically states it is "not for use in life supporting or sustaining systems or ECG monitor and Alarm devices." This indicates it does not directly treat or prevent a condition.

Yes

The device is intended for use by qualified healthcare professionals for assessing arrhythmias using ECG data and provides signal processing, analysis, and interpretation support for ECGs, which are diagnostic functions. While it states its results are not the sole means of diagnosis, it is offered in conjunction with other diagnostic information and aids in the overall diagnostic process.

Yes

The device description explicitly states it is a "CardioLogs ECG Analysis Platform" which is accessed through a network connection/wireless device or locally (stand-alone algorithm). It processes and analyzes digital ECG files. While it can interface with hardware, the device itself is the software platform performing the analysis, not the hardware that acquires the ECG data.

Based on the provided information, the CardioLogs ECG Analysis Platform is an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states that the platform is used for the "assessment of arrhythmias using ECG data". This involves analyzing biological data (ECG signals) obtained from a human subject to provide information for diagnosis or monitoring.
  • Device Description: The device processes and analyzes ECG data, providing "supportive information for ECG analysis" and "probability scores on a predefined set of abnormality labels". This analysis of biological data for diagnostic purposes is a core function of IVD devices.
  • Input Data: The input is "ECG data", which is a physiological signal derived from the electrical activity of the heart, a biological process.
  • Regulatory Context: The submission references predicate and reference devices (K numbers), which are typically associated with medical device regulatory submissions, including those for IVDs. The testing performed also aligns with standards relevant to medical devices and ECG analysis.

While the device is not for life support and the interpretation results are advisory, the fundamental purpose of analyzing biological data (ECG) to provide information for the assessment of a medical condition (arrhythmias) falls squarely within the definition of an In Vitro Diagnostic device. The "In Vitro" aspect comes from the analysis of data derived from the body, even though the data itself is not a biological sample in the traditional sense (like blood or urine). The regulatory definition of IVD often includes devices that analyze data derived from the body for diagnostic purposes.

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Intended Use / Indications for Use

The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs ECG Analysis Platform can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Cardiologs ECG Analysis Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, ORS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs ECG Analysis Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

Cardiologs ECG Analysis Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Product codes

DOK, DPS

Device Description

CardioLogs ECG Analysis Platform is made up of:

  • . An interface which provides tools to measure, analyze and review numerous ECGs;
  • An automated proprietary ECG interpretation support algorithm which measures and . analyzes ECGs to provide physicians supportive information for ECG analysis.

CardioLogs ECG Analysis Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).

CardioLogs ECG Analysis Platform works in the following sequence:

    1. Upload of digital ECG file to CardioLogs' secured hosting databases (for health data i.e. HIPAA compliant);
    • Manual upload: via the web-interface which allows the selection of files to ● upload on the evaluating user's computer
    • . Direct upload: with no manual intervention, in the specific cases where the user's hardware is already connected to the CardioLogs' Application Programming Interface (or API): the ECG is automatically sent to CardioLogs' servers.
    1. Processing of the uploaded ECG file;
    1. Analysis of the uploaded ECG performed by CardioLogs' proprietary algorithm, which labels the ECG;
    • Delineation (detection of at least P waves, QRS complexes and T waves on ● the ECG signal). The output format is a sequence of elements "wave type/start time/ end time";
    • . Abnormality labels: the algorithm provides probability scores on a predefined set of abnormality labels (multi-label classification);
    1. CardioLogs ECG Analysis Platform displays the resulting analysis, along with the original ECG signal and a variety of tools (ruler, zoom, etc.). Results are made available either on the CardioLogs interface if the user's hardware allows for digital ECG upload, or on an API in cases where the service is available as part of a package with an ECG machine;
    1. CardioLogs ECG Analysis Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician.

The resulting information is stored on a secured database.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ECG data

Anatomical Site

Not Found

Indicated Patient Age Range

subjects over 18 years of age.

Intended User / Care Setting

qualified healthcare professionals

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

Tests have been performed in compliance with the following recognized consensus standards:

  • AAMI ANSI IEC 62304 2006 Medical device software Software life-cycle ● processes
  • IEC EN 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment Part 2-25: . Particular requirements for the safety of electrocardiographs-
  • IEC 62366-1 Edition 1.0 2015-02 Medical devices Application of usability ● engineering to medical devices.
  • AAMI ANSI EC57:2012 Testing and Reporting Performance Results of Cardiac ● Rhythm And ST-Segment Measurement Algorithms
  • AAMI ANSI IEC60601-2-47:2012 Medical Electrical Equipment -- Part 2-47: ● Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems

Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated against a gold standard.

No residual anomaly appeared during verification and software validation tests.

General usability tests, analyzing the users' ability to import, display, store, analysis, distribute, and manage ECG data, were performed and met all requirements. All software validation testing was completed successfully and met all requirements.

Key Metrics

Not Found

Predicate Device(s)

Monebo Automated ECG Analysis and Interpretation Software Library (K062282)

Reference Device(s)

TM eCloud ECG Analysis System (K142349)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 26, 2017

CardioLogs Technologies % Michael Daniel President Daniel & Daniel Consulting, LLC 34 Jones Lane Gardnerville, Nevada 89460

Re: K170568

Trade/Device Name: CardioLogs ECG Analysis Platform Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS Dated: March 10. 2017 Received: March 13, 2017

Dear Michael Daniel:

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

1

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

M.A. Wilhelm

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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6. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(K) Number: K170568

Device Name

CardioLogs ECG Analysis Platform

o Indications for Use (Describe)

The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs ECG Analysis Platform can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Cardiologs ECG Analysis Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, ORS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs ECG Analysis Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

Cardiologs ECG Analysis Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 443-6740 EB

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7. Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K170568

Applicant Information:

Date Prepared:February 24, 2017
Name:Cardiologs Technologies
Address:Campus des Cordeliers, 15 rue de l'École de Médecine, 75006 Paris, France
Contact Person:Michael A Daniel, Consultant
madaniel@clinregconsult.com
Mobile Number:(415) 407-0223
Office Number:(775) 392-2970
Facsimile Number:(610) 545-0799

Device Information:

Device Trade Name:CardioLogs ECG Analysis Platform
Common Name:CardioLogs ECG Analysis Platform
Classification Name(s):Electrocardiograph / Programmable Diagnostic Computer
Product Code/Regulation:DQK, DPS 21 CFR 870.1425 / 21 CFR 870.2340
Classification:Class II

Predicate Device:

Monebo Automated ECG Analysis and Interpretation Software Library (K062282)

In compliance with FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" we are including the following as reference devices:

Reference Devices:

TM eCloud ECG Analysis System (K142349)

7.1. Subject Device Description

CardioLogs ECG Analysis Platform is made up of:

  • . An interface which provides tools to measure, analyze and review numerous ECGs;
  • An automated proprietary ECG interpretation support algorithm which measures and . analyzes ECGs to provide physicians supportive information for ECG analysis.

CardioLogs ECG Analysis Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).

4

CardioLogs ECG Analysis Platform is only intended to analyze recordings performed on adults (over the age of seventeen).

CardioLogs ECG Analysis Platform works in the following sequence:

    1. Upload of digital ECG file to CardioLogs' secured hosting databases (for health data i.e. HIPAA compliant);
    • Manual upload: via the web-interface which allows the selection of files to ● upload on the evaluating user's computer
    • . Direct upload: with no manual intervention, in the specific cases where the user's hardware is already connected to the CardioLogs' Application Programming Interface (or API): the ECG is automatically sent to CardioLogs' servers.
    1. Processing of the uploaded ECG file;
    1. Analysis of the uploaded ECG performed by CardioLogs' proprietary algorithm, which labels the ECG;
    • Delineation (detection of at least P waves, QRS complexes and T waves on ● the ECG signal). The output format is a sequence of elements "wave type/start time/ end time";
    • . Abnormality labels: the algorithm provides probability scores on a predefined set of abnormality labels (multi-label classification);
    1. CardioLogs ECG Analysis Platform displays the resulting analysis, along with the original ECG signal and a variety of tools (ruler, zoom, etc.). Results are made available either on the CardioLogs interface if the user's hardware allows for digital ECG upload, or on an API in cases where the service is available as part of a package with an ECG machine;
    1. CardioLogs ECG Analysis Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician.

The resulting information is stored on a secured database.

7.2. Subject Device Indications for Use

The CardioLogs ECG Analysis Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in subjects over 18 years of age. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices when assessment of the rhythm is necessary. The Cardiologs ECG Analysis Platform can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Cardiologs ECG Analysis Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs ECG Analysis Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

5

The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

Cardiologs ECG Analysis Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

7.3. Predicate and Reference Device and Subject Device Comparison

Table 7.3.1 compares the features of the CardioLogs ECG Analysis Platform to the predicate device.

| Feature | Cardiologs ECG
Analysis Platform | Monebo Automated ECG Analysis
and Interpretation Software
Library |
|--------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------------|
| Heart rate determination for
non-paced adult | Yes | Yes |
| QRS Detection | Yes | Yes |
| Non-paced arrhythmia
interpretation for adult
patients | Yes | Yes |
| Non-paced ventricular
arrhythmia calls | Yes | Yes |
| Intervals measurements | Yes | Yes |
| Ventricular ectopic beat
detection | Yes | Yes |
| Patient Population | Adult | Adult |

Table 7.3-1. Comparison between predicate and subject device features.

Comparison of Subject Device to Predicate Device:

| | Subject Device | Predicate Device | Comparison to
predicate device |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CardioLogs ECG
Analysis Platform | Monebo Automated ECG
Analysis and Interpretation
Software Library | N/A |
| Manufacturer | Cardiologs Technologies | Monebo Technologies, Inc. | N/A |
| 510(k) # | TBD | K062282 | N/A |
| Regulation
Number | 21 CFR 870.2340 | 21 CFR 870.2340 | Same |
| Class | II | II | Same |
| Device
Class/Name | Electrocardiograph | Electrocardiograph | Same |
| Product Code | DQK, DPS | DPS | DPS is the same |
| Level of
Concern | Moderate | Moderate | Same |
| Indication for
Use | Refer to Section 7.2 | Refer to predicate device labeling. | Both devices are
intended for the same
use. |
| | Subject Device | Predicate Device | Comparison to
predicate device |
| Fundamental
scientific
technology | The CardioLogs ECG
Analysis Platform
consists of:

  • An interface which
    provides tools to
    measure, analyze and
    review numerous
    ECGs coded in java
    language under the
    Angular and D3.js
    frameworks;
  • An automated
    proprietary ECG
    interpretation support
    algorithm which
    measures and analyzes
    ECGs to provide
    supportive information
    for ECG diagnosis,
    written in Python
    language.
    This application can be
    accessed through an
    Internet connection and a
    web browser, or is
    directly connected to the
    CardioLogs' Application
    Programming Interface
    (API) | The predicate device is a
    collection of callable functions
    that have been complied into
    machine code or IDL code of the
    computer on which they execute.
    The predicate device consists of a
    basic application for viewing,
    analyzing and annotating ECG
    data, and a callable object library
    built on the Microsoft .Net
    framework. An application
    software can be written to invoke
    some or all the functions in an
    object library.
    The library can be accessed
    through an Application program
    Interface (API) as a callable
    function. This allows the library
    to be used as an accessory to an
    ECG management application or
    as a stand-alone product. | The CardioLogs ECG
    Analysis Interface and
    the predicate device both
    consists of:
  • a user's interface for
    viewing, analyzing and
    annotating ECG data
  • an algorithm
  • an API to access to the
    algorithm
    An object library is a
    type of algorithm
    architecture, they are
    coded in the 2000's.
    The languages and
    frameworks used to
    develop the software are
    different. The
    CardioLogs ECG
    Analysis Platform is
    coded with the modern
    tools.
    The subject device is
    accessible through the
    Internet, while the
    predicate device is
    installed on the user's
    hardware.
    CardioLogs ECG
    Analysis Platform
    therefore does not
    present any major
    technological
    innovations compared to
    predicate device.
    However, to further
    demonstrate the non-
    innovative technology
    used by the predicate
    devices, its technology is
    compared to a reference
    device. |

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K170568 Page 4 of 7

Table 7.3-2. Comparison between subject and predicate device.

Difference in Fundamental Scientific Technology:

The Predicate device was designed for technology that was available in the early 2000's, i.e. software program running on a hardware-based platform. With the advancement of cloud

7

computing, the Subject device incorporates a logical update to that technology as a software program running on a cloud-based software platform. Indeed, the Subject devise is cloudbased and available online, implying different cybersecurity, safety and effectiveness question. Therefore, the Subject device is also compared to a Reference device (the previous Predicate device): the TM eCloud ECG Analysis System. The TM eCloud ECG Analysis System is intended to provide an interpretation of up to 12-channel ECG in all situations including resting and ambulatory ECG including Holter, cardiac event, and mobile cardiac telemetry. It is designed for acquisition, analysis, edit, review, report and storage of all ECG and multi-parameter data.

Although the Predicate device slightly differs from the Subject device related to the operating technology platform, there are several examples, one being the Reference device, that use cloud based computing for ECG data analysis. This fact, in combination with identification of hazards and appropriate risk controls related to this difference, we conclude that this difference in technology platform has no impact on the safety or efficacy of the Subject device.

| | Subject Device | Reference Device | Comparison to
Reference device |
|----------------------|-------------------------------------|-------------------------------------|-----------------------------------|
| Device Name | CardioLogs ECG Analysis
Platform | TM eCloud ECG Analysis
System | N/A |
| Manufacturer | Cardiologs Technologies | Telemed Solutions, Inc. | N/A |
| 510(k) # | TBD | K142349 | N/A |
| Regulation
Number | 21 CFR 870.1425 | 21 CFR 870.1425 | Same |
| Class | II | II | Same |
| Device
Class/Name | Programmable Diagnostic
Computer | Programmable Diagnostic
Computer | Same |
| Product Code | DQK | DQK, KRE, MLO, DPS,
DXH, OUG | DQK is the same |

Comparison to Reference Device:

8

| | Subject Device | Reference Device | Comparison to
Reference device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental
scientific
technology | The Cardiologs ECG
Analysis Platform consists
of a (1) server-side,
application Platform as a
Service
(PaaS) cloud based system,
and (2) a client-side
application website.
The (1) server-side,
application PaaS
component collects, stores,
performs arrhythmia
analysis on ECG uploads,
and transfers data to and
from the client-side
application.
The (2) client-side
application allows the users
to review ECG, edit the
analysis results produced
by the (1) server-side,
application PaaS
component.
The users may upload ECG
to the ECG Analysis
Platform via the API
(REST web service) from
any computer equipment,
or, in the specific cases
where the user's hardware
is already connected to the
CardioLogs' Application
Programming Interface (or
API), the ECG is
automatically sent to
CardioLogs' servers. | The TM eCloud ECG Analysis
System consists of a (1)
server-side, application
Platform as a Service (PaaS)
cloud based system, a (2)
desktop client-side
application, and (3) a web-
based Physician Portal
website.
The (1) server-side,
application PaaS component
collects, stores, performs
arrhythmia analysis on ECG
uploads, and transfers data to
and from the client-side
application.
The (2) desktop client-side
application is a workstation
system which allows
technicians to review ECG,
edit the analysis results
produced by the (1) server-
side, application PaaS
component, and generate
reports for the ECG study. The
edited results and reports are
uploaded to the (1) server-
side, application PaaS
component. It also allows
notifications and updates to (3)
Physician Portal website.
The users may upload ECG to
the TM eCloud ECG Analysis
System via a cellular network,
REST web service, or FTP
from any computer or cellular
equipment | Both the devices consists
of a server-side,
application Platform as a
Service (PaaS) cloud
based system, and a
client-side application
website, that works the
same way. The only
difference is that the
reference device user
interface is installed on
the user's hardware while
the subject device user
interface is also online.

CardioLogs ECG
Analysis Platform
therefore does not present
any major technological
innovations compared to
the reference device |

Table 7.3-3. Comparison between subject and reference device

7.4. Testing Completed

Tests have been performed in compliance with the following recognized consensus standards:

  • AAMI ANSI IEC 62304 2006 Medical device software Software life-cycle ● processes
  • IEC EN 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment Part 2-25: . Particular requirements for the safety of electrocardiographs-
  • IEC 62366-1 Edition 1.0 2015-02 Medical devices Application of usability ● engineering to medical devices.
  • AAMI ANSI EC57:2012 Testing and Reporting Performance Results of Cardiac ● Rhythm And ST-Segment Measurement Algorithms

9

  • AAMI ANSI IEC60601-2-47:2012 Medical Electrical Equipment -- Part 2-47: ● Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems
    Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. All clinical input requirements were validated against a gold standard.

No residual anomaly appeared during verification and software validation tests.

General usability tests, analyzing the users' ability to import, display, store, analysis, distribute, and manage ECG data, were performed and met all requirements. All software validation testing was completed successfully and met all requirements.

7.5. Summary

Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the CardioLogs ECG Analysis Platform has been shown to be substantially equivalent to the cited predicate and very similar to the cited reference devices.