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.
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.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria in a format that allows for the extraction of all requested data points. While it mentions performance evaluation and compliance with standards, and that "All clinical input requirements were validated against a gold standard," it does not specify the numerical acceptance criteria or the specifics of the study design, sample sizes, expert qualifications, or adjudication methods for that validation.

Therefore, I can only provide limited information based on the text.

Here's a summary of what can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document mentions that the device performs:

Heart rate determination for non-paced adult
QRS Detection
Non-paced arrhythmia interpretation for adult patients
Non-paced ventricular arrhythmia calls
Intervals measurements
Ventricular ectopic beat detection

It also states, "All clinical input requirements were validated against a gold standard," implying that the device's performance for these functionalities met certain (unspecified) acceptance criteria as compared to a gold standard. However, the specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and the reported device performance metrics are not provided in the text.

2. Sample sized used for the test set and the data provenance:

Sample size for the test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not specified.
Qualifications of experts: Not specified. The term "gold standard" is used without elaborating on how it was established or by whom.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication method: Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is described as providing "supportive information for ECG analysis" and its "interpretation results are not intended to be the sole means of diagnosis," suggesting an assistive role, but no study details for this are given.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document describes the device as having "An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis." It also states, "CardioLogs ECG Analysis Platform then allows for editing and/or confirmation of the measurements and parameters by the analyzing physician." This implies a standalone capability for analysis before physician review, but no specific study reporting standalone performance metrics is detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The text states, "All clinical input requirements were validated against a gold standard." The specific nature of this "gold standard" (e.g., expert consensus, pathology, follow-up outcomes) is not specified.

8. The sample size for the training set:

Sample size for the training set: Not specified.

9. How the ground truth for the training set was established:

How ground truth was established: Not specified, as details about the training set or its ground truth establishment are absent.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

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)

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

{3}------------------------------------------------

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}------------------------------------------------

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 ECGAnalysis Platform	Monebo Automated ECG Analysisand Interpretation SoftwareLibrary
Heart rate determination fornon-paced adult	Yes	Yes
QRS Detection	Yes	Yes
Non-paced arrhythmiainterpretation for adultpatients	Yes	Yes
Non-paced ventriculararrhythmia calls	Yes	Yes
Intervals measurements	Yes	Yes
Ventricular ectopic beatdetection	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 topredicate device
Device Name	CardioLogs ECGAnalysis Platform	Monebo Automated ECGAnalysis and InterpretationSoftware Library	N/A
Manufacturer	Cardiologs Technologies	Monebo Technologies, Inc.	N/A
510(k) #	TBD	K062282	N/A
RegulationNumber	21 CFR 870.2340	21 CFR 870.2340	Same
Class	II	II	Same
DeviceClass/Name	Electrocardiograph	Electrocardiograph	Same
Product Code	DQK, DPS	DPS	DPS is the same
Level ofConcern	Moderate	Moderate	Same
Indication forUse	Refer to Section 7.2	Refer to predicate device labeling.	Both devices areintended for the sameuse.
	Subject Device	Predicate Device	Comparison topredicate device
Fundamentalscientifictechnology	The CardioLogs ECGAnalysis Platformconsists of:- An interface whichprovides tools tomeasure, analyze andreview numerousECGs coded in javalanguage under theAngular and D3.jsframeworks;- An automatedproprietary ECGinterpretation supportalgorithm whichmeasures and analyzesECGs to providesupportive informationfor ECG diagnosis,written in Pythonlanguage.This application can beaccessed through anInternet connection and aweb browser, or isdirectly connected to theCardioLogs' ApplicationProgramming Interface(API)	The predicate device is acollection of callable functionsthat have been complied intomachine code or IDL code of thecomputer on which they execute.The predicate device consists of abasic application for viewing,analyzing and annotating ECGdata, and a callable object librarybuilt on the Microsoft .Netframework. An applicationsoftware can be written to invokesome or all the functions in anobject library.The library can be accessedthrough an Application programInterface (API) as a callablefunction. This allows the libraryto be used as an accessory to anECG management application oras a stand-alone product.	The CardioLogs ECGAnalysis Interface andthe predicate device bothconsists of:- a user's interface forviewing, analyzing andannotating ECG data- an algorithm- an API to access to thealgorithmAn object library is atype of algorithmarchitecture, they arecoded in the 2000's.The languages andframeworks used todevelop the software aredifferent. TheCardioLogs ECGAnalysis Platform iscoded with the moderntools.The subject device isaccessible through theInternet, while thepredicate device isinstalled on the user'shardware.CardioLogs ECGAnalysis Platformtherefore does notpresent any majortechnologicalinnovations compared topredicate device.However, to furtherdemonstrate the non-innovative technologyused by the predicatedevices, its technology iscompared to a referencedevice.

{6}------------------------------------------------

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 toReference device
Device Name	CardioLogs ECG AnalysisPlatform	TM eCloud ECG AnalysisSystem	N/A
Manufacturer	Cardiologs Technologies	Telemed Solutions, Inc.	N/A
510(k) #	TBD	K142349	N/A
RegulationNumber	21 CFR 870.1425	21 CFR 870.1425	Same
Class	II	II	Same
DeviceClass/Name	Programmable DiagnosticComputer	Programmable DiagnosticComputer	Same
Product Code	DQK	DQK, KRE, MLO, DPS,DXH, OUG	DQK is the same

Comparison to Reference Device:

{8}------------------------------------------------

	Subject Device	Reference Device	Comparison toReference device
Fundamentalscientifictechnology	The Cardiologs ECGAnalysis Platform consistsof a (1) server-side,application Platform as aService(PaaS) cloud based system,and (2) a client-sideapplication website.The (1) server-side,application PaaScomponent collects, stores,performs arrhythmiaanalysis on ECG uploads,and transfers data to andfrom the client-sideapplication.The (2) client-sideapplication allows the usersto review ECG, edit theanalysis results producedby the (1) server-side,application PaaScomponent.The users may upload ECGto the ECG AnalysisPlatform via the API(REST web service) fromany computer equipment,or, in the specific caseswhere the user's hardwareis already connected to theCardioLogs' ApplicationProgramming Interface (orAPI), the ECG isautomatically sent toCardioLogs' servers.	The TM eCloud ECG AnalysisSystem consists of a (1)server-side, applicationPlatform as a Service (PaaS)cloud based system, a (2)desktop client-sideapplication, and (3) a web-based Physician Portalwebsite.The (1) server-side,application PaaS componentcollects, stores, performsarrhythmia analysis on ECGuploads, and transfers data toand from the client-sideapplication.The (2) desktop client-sideapplication is a workstationsystem which allowstechnicians to review ECG,edit the analysis resultsproduced by the (1) server-side, application PaaScomponent, and generatereports for the ECG study. Theedited results and reports areuploaded to the (1) server-side, application PaaScomponent. It also allowsnotifications and updates to (3)Physician Portal website.The users may upload ECG tothe TM eCloud ECG AnalysisSystem via a cellular network,REST web service, or FTPfrom any computer or cellularequipment	Both the devices consistsof a server-side,application Platform as aService (PaaS) cloudbased system, and aclient-side applicationwebsite, that works thesame way. The onlydifference is that thereference device userinterface is installed onthe user's hardware whilethe subject device userinterface is also online.CardioLogs ECGAnalysis Platformtherefore does not presentany major technologicalinnovations compared tothe 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.

Regulation Number and Section

§ 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).