(135 days)
Not Found
Unknown
The document mentions a "proprietary algorithm" for automated ECG interpretation and analysis, including "multi-label classification" for abnormality labels. While these tasks are commonly performed by AI/ML algorithms, the document does not explicitly state that AI or ML is used. The lack of information on training/test sets and performance metrics typically associated with AI/ML models further contributes to the uncertainty.
No.
The device is strictly for analysis and assessment of ECG data, providing advisory information to healthcare professionals. It does not perform any direct treatment or intervention.
Yes
The device is intended for the "assessment of arrhythmias using ECG data" and aids physicians in "ECG analysis" and "rhythm analysis," which are diagnostic activities. It processes and analyzes ECG data from other diagnostic devices (Holter, event recorder, 12 lead ambulatory ECG devices).
Yes
The device description explicitly states "Cardiologs Holter Platform is a software only medical device".
Based on the provided information, the Cardiologs Platform is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The platform is intended for the "assessment of arrhythmias using ECG data". ECG data is biological data collected from a patient. The analysis of this data is performed in vitro (outside the body) to provide diagnostic information about the patient's heart rhythm.
- Device Description: The device is a software-only medical device that processes and analyzes uploaded digital ECG files. This processing and analysis of biological data for diagnostic purposes is a core function of IVDs.
- Input Data: The input is "ECG data", which is a type of biological sample data.
- Performance Standards: The performance studies mention compliance with standards like AAMI ANSI EC57:2012, which is specifically for "Testing and Reporting Performance Results of Cardiac Rhythm And ST-Segment Measurement Algorithms". This further reinforces its role in analyzing biological signals for diagnostic purposes.
- Predicate Device: The predicate device, K170568, is also named "Cardiologs ECG Analysis Platform", suggesting a consistent classification.
While the platform is not for use in life-supporting systems or as a sole means of diagnosis, its primary function is the in vitro analysis of biological data (ECG) to provide information for the diagnosis of arrhythmias. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cardiologs Platform (Also known as Cardiologs ECG Analysis Platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediation. 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 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 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 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 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 (comma separated list FDA assigned to the subject device)
DPS, DQK
Device Description
Cardiologs Holter Platform is a software only medical device with the following components 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 Holter Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).
Cardiologs Holter Platform works in the following sequence:
- . 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.
- II. Processing of the uploaded ECG file;
- III. 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":
- Abnormality labels: the algorithm provides probability scores on a predefined set of . abnormality labels (multi-label classification);
- IV. Cardiologs Holter 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
- V. Cardiologs Holter 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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric population
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 aqainst a gold standard. No residual anomalies 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 on the previously cleared version of the software and met all requirements. The minimal changes to the software implemented for the subject device have been confirmed to have no impact on usability. Consequently, the previous usability testing is representative of the current version of software and no additional usability testing is required. All software validation testing was completed successfully and met all requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2340 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 13, 2022
Cardiologs Technologies Arezou Azar VP, Regulatory Affairs and Quality Assurance 136 Rue Saint Denis Paris, ILE DE FRANCE 75002 France
Re: K212112
Trade/Device Name: Cardiologs Holter Platform Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK
Dear Arezou Azar:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 18, 2021. Specifically, FDA is updating this SE Letter as an administrative correction to the Indications for Use statement.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Shih Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, Jennifer.Shih(@fda.hhs.gov.
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 18, 2021
Cardiologs Technologies Arezou Azar VP, Regulatory Affairs and Quality Assurance 136 Rue Saint Denis Paris, ILE DE FRANCE 75002 France
Re: K212112
Trade/Device Name: Cardiologs Holter Platform Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DOK Dated: October 18, 2021 Received: October 18, 2021
Dear Arezou Azar:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Shruti N. Mistry -S
Jennifer Shih Kozen External Heart Rhythm and Rate Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K212112
Device Name Cardiologs Platform
Indications for Use (Describe)
The Cardiologs Platform (Also known as Cardiologs ECG Analysis Platform) is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediation. 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 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 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 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 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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
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4
Page 1 of 6
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.
Applicant Information:
| Date Prepared: | November 18, 2021 |
|---|---|
| Name: | Cardiologs Technologies |
| Address: | 136 Rue Saint Denis, 75001 PARIS |
| Primary Contact Person: | Arezou Azar, PhD. |
| arezou@cardiologs.com | |
| Telephone Number: | +1 650-804-0285 |
| Device Information: | |
| Device Trade Name: | Cardiologs Holter Platform |
| Common Name: | Cardiologs Holter Platform |
| Classification Name(s): | Electrocardiograph / Programmable Diagnostic Computer |
Predicate Device:
Classification:
Product Code/ Regulation:
Cardiologs ECG Analysis Platform (K170568)
l. Subject Device Description
Class II
Cardiologs Holter Platform is a software only medical device with the following components 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.
DQK, DPS 21 CFR 870.1425 / 21 CFR 870.2340
Cardiologs Holter Platform can be accessed through a network connection/wireless device when the electrocardiograph allows for digital ECG upload, or locally (stand-alone algorithm).
Cardiologs Holter Platform works in the following sequence:
- . 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.
5
- II. Processing of the uploaded ECG file;
- III. 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":
- Abnormality labels: the algorithm provides probability scores on a predefined set of . abnormality labels (multi-label classification);
- IV. Cardiologs Holter 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
- V. Cardiologs Holter 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.
. Subject Device Indications for Use
The Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. The product supports downloading and analyzing data recorded in compatible formats from any device used for 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 Holter 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 Holter 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 Holter 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 Holter 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.
6
III. Predicate and Subject Device Comparison
The table below compares the features of the Cardiologs Holter Platform to the predicate device.
| Feature | Cardiologs ECG Analysis
Platform (K170568) | Cardiologs Holter Platform
(Subject device) |
|-----------------------------------------------------------|-----------------------------------------------|------------------------------------------------|
| 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 & Pediatric |
Table 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 Holter Platform | Cardiologs ECG Analysis Platform | Same |
| Manufacturer | Cardiologs Technologies | Cardiologs Technologies | Same |
| 510(k) # | TBD | K170568 | 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 | DQK, DPS | Same |
| Level of Concern | Moderate | Moderate | Same |
| Intended Use | Assessment of ECG arrhythmias | Assessment of ECG arrhythmias | Same |
| Indications for Use | The Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia | 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 | The subject device is indicated for pediatric as well as adult patients. |
7
| diagnostics such as Holter,
event recorder, 12 lead
ambulatory ECG devices,
or other similar devices
when assessment of the
rhythm is necessary. The
Cardiologs Holter 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 Holter 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 Holter 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 Holter 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 | 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, 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 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
8
| | background, clinical history,
symptoms, and other
diagnostic information. | conjunction with the
physician's knowledge of
ECG patterns, patient
background, clinical history,
symptoms, and other
diagnostic information. | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Fundamental
scientific
technology | The Cardiologs Holter
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 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). | Same |
Table 2 - Comparison between subject and predicate device
IV. 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 aqainst a gold standard. No residual anomalies 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 on the previously cleared version of the software and met all requirements. The minimal changes to the software implemented for the subject device have been confirmed to have no impact on usability. Consequently, the previous usability testing is representative of the current version of software and no additional usability testing is required. All software validation testing was completed successfully and met all requirements.
V. Summary
Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Cardiologs Holter Platform has been shown to be substantially equivalent to the cited predicate.