CardioLogs ECG Analysis Platform

K170568 · Cardiologs Technologies · DPS · Jun 26, 2017 · Cardiovascular

Device Facts

• Record ID: K170568
• Device Name: CardioLogs ECG Analysis Platform
• Applicant: Cardiologs Technologies
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Arrhythmia detection	—	—	—	—	—	—	—
QRS and Ventricular Ectopic Beat detection	—	—	—	—	—	—	—
ECG interval and heart rate measurement	—	—	—	—	—	—	—

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.

Device Story

CardioLogs ECG Analysis Platform is a cloud-based software system for arrhythmia assessment. It accepts digital ECG files via manual web-interface upload or direct API integration from compatible ECG hardware. The proprietary algorithm performs signal processing, delineates P-waves, QRS complexes, and T-waves, and provides multi-label classification with probability scores for abnormalities. The system outputs analyzed ECG data, including measurements (heart rate, intervals) and rhythm labels, to a web-based interface. Physicians review, edit, and confirm these automated findings. Used in clinical settings by healthcare professionals, the platform serves as an advisory tool to support clinical decision-making, diagnosis, and patient management. It benefits patients by providing automated, standardized analysis of ambulatory ECG recordings, facilitating faster and more consistent arrhythmia detection.

Clinical Evidence

Bench testing only. Verification of design inputs and product specifications was performed. Clinical input requirements were validated against a gold standard. Usability testing confirmed the ability to import, display, store, analyze, and manage ECG data. No residual anomalies were identified during software validation.

Technological Characteristics

Cloud-based software platform (PaaS) with web-based client interface. Developed using Java (Angular/D3.js) and Python. Connectivity via REST API or web upload. Complies with AAMI ANSI IEC 62304 (software lifecycle), IEC 60601-2-25 (ECG safety), IEC 62366-1 (usability), AAMI ANSI EC57 (algorithm performance), and AAMI ANSI IEC 60601-2-47 (ambulatory ECG).

Indications for Use

Indicated for assessment of arrhythmias in adults (>18 years) using ECG data from Holter, event recorders, 12-lead ambulatory ECG, or other compatible ECG management systems. Not for life-supporting/sustaining systems or real-time monitoring/alarms.

Regulatory Classification

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.

Predicate Devices

• Monebo Automated ECG Analysis and Interpretation Software Library (K062282)

Reference Devices

• TM eCloud ECG Analysis System (K142349)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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 [phone] 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 |
|-------------------|------------------------------|
| | [e-mail] |
| Mobile Number: | [phone] |
| Office Number: | [phone] |
| Facsimile Number: | [phone] |

#### 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).

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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.
- 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.

## 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.

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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<br>Analysis Platform | Monebo Automated ECG Analysis<br>and Interpretation Software<br>Library |
|--------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------------------|
| Heart rate determination for<br>non-paced adult | Yes | Yes |
| QRS Detection | Yes | Yes |
| Non-paced arrhythmia<br>interpretation for adult<br>patients | Yes | Yes |
| Non-paced ventricular<br>arrhythmia calls | Yes | Yes |
| Intervals measurements | Yes | Yes |
| Ventricular ectopic beat<br>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<br>predicate device |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CardioLogs ECG<br>Analysis Platform | Monebo Automated ECG<br>Analysis and Interpretation<br>Software Library | N/A |
| Manufacturer | Cardiologs Technologies | Monebo Technologies, Inc. | N/A |
| 510(k) # | TBD | K062282 | N/A |
| Regulation<br>Number | 21 CFR 870.2340 | 21 CFR 870.2340 | Same |
| Class | II | II | Same |
| Device<br>Class/Name | Electrocardiograph | Electrocardiograph | Same |
| Product Code | DQK, DPS | DPS | DPS is the same |
| Level of<br>Concern | Moderate | Moderate | Same |
| Indication for<br>Use | Refer to Section 7.2 | Refer to predicate device labeling. | Both devices are<br>intended for the same<br>use. |
| | Subject Device | Predicate Device | Comparison to<br>predicate device |
| Fundamental<br>scientific<br>technology | The CardioLogs ECG<br>Analysis Platform<br>consists of:<br>- An interface which<br>provides tools to<br>measure, analyze and<br>review numerous<br>ECGs coded in java<br>language under the<br>Angular and D3.js<br>frameworks;<br>- An automated<br>proprietary ECG<br>interpretation support<br>algorithm which<br>measures and analyzes<br>ECGs to provide<br>supportive information<br>for ECG diagnosis,<br>written in Python<br>language.<br>This application can be<br>accessed through an<br>Internet connection and a<br>web browser, or is<br>directly connected to the<br>CardioLogs' Application<br>Programming Interface<br>(API) | The predicate device is a<br>collection of callable functions<br>that have been complied into<br>machine code or IDL code of the<br>computer on which they execute.<br>The predicate device consists of a<br>basic application for viewing,<br>analyzing and annotating ECG<br>data, and a callable object library<br>built on the Microsoft .Net<br>framework. An application<br>software can be written to invoke<br>some or all the functions in an<br>object library.<br>The library can be accessed<br>through an Application program<br>Interface (API) as a callable<br>function. This allows the library<br>to be used as an accessory to an<br>ECG management application or<br>as a stand-alone product. | The CardioLogs ECG<br>Analysis Interface and<br>the predicate device both<br>consists of:<br>- a user's interface for<br>viewing, analyzing and<br>annotating ECG data<br>- an algorithm<br>- an API to access to the<br>algorithm<br>An object library is a<br>type of algorithm<br>architecture, they are<br>coded in the 2000's.<br>The languages and<br>frameworks used to<br>develop the software are<br>different. The<br>CardioLogs ECG<br>Analysis Platform is<br>coded with the modern<br>tools.<br>The subject device is<br>accessible through the<br>Internet, while the<br>predicate device is<br>installed on the user's<br>hardware.<br>CardioLogs ECG<br>Analysis Platform<br>therefore does not<br>present any major<br>technological<br>innovations compared to<br>predicate device.<br>However, to further<br>demonstrate the non-<br>innovative technology<br>used by the predicate<br>devices, its technology is<br>compared to a reference<br>device. |

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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

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

#### Comparison to Reference Device:

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| | Subject Device | Reference Device | Comparison to<br>Reference device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental<br>scientific<br>technology | The Cardiologs ECG<br>Analysis Platform consists<br>of a (1) server-side,<br>application Platform as a<br>Service<br>(PaaS) cloud based system,<br>and (2) a client-side<br>application website.<br>The (1) server-side,<br>application PaaS<br>component collects, stores,<br>performs arrhythmia<br>analysis on ECG uploads,<br>and transfers data to and<br>from the client-side<br>application.<br>The (2) client-side<br>application allows the users<br>to review ECG, edit the<br>analysis results produced<br>by the (1) server-side,<br>application PaaS<br>component.<br>The users may upload ECG<br>to the ECG Analysis<br>Platform via the API<br>(REST web service) from<br>any computer equipment,<br>or, in the specific cases<br>where the user's hardware<br>is already connected to the<br>CardioLogs' Application<br>Programming Interface (or<br>API), the ECG is<br>automatically sent to<br>CardioLogs' servers. | The TM eCloud ECG Analysis<br>System consists of a (1)<br>server-side, application<br>Platform as a Service (PaaS)<br>cloud based system, a (2)<br>desktop client-side<br>application, and (3) a web-<br>based Physician Portal<br>website.<br>The (1) server-side,<br>application PaaS component<br>collects, stores, performs<br>arrhythmia analysis on ECG<br>uploads, and transfers data to<br>and from the client-side<br>application.<br>The (2) desktop client-side<br>application is a workstation<br>system which allows<br>technicians to review ECG,<br>edit the analysis results<br>produced by the (1) server-<br>side, application PaaS<br>component, and generate<br>reports for the ECG study. The<br>edited results and reports are<br>uploaded to the (1) server-<br>side, application PaaS<br>component. It also allows<br>notifications and updates to (3)<br>Physician Portal website.<br>The users may upload ECG to<br>the TM eCloud ECG Analysis<br>System via a cellular network,<br>REST web service, or FTP<br>from any computer or cellular<br>equipment | Both the devices consists<br>of a server-side,<br>application Platform as a<br>Service (PaaS) cloud<br>based system, and a<br>client-side application<br>website, that works the<br>same way. The only<br>difference is that the<br>reference device user<br>interface is installed on<br>the user's hardware while<br>the subject device user<br>interface is also online.<br><br>CardioLogs ECG<br>Analysis Platform<br>therefore does not present<br>any major technological<br>innovations compared to<br>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

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- 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.