(161 days)
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 diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices indicated for recording heart rhythm.
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 physiological 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.
Cardiologs Holter Platform is comprised of:
- An interface, which provides tools to measure, analyze and review numerous ECGs;
- An automated proprietary ECG interpretation support algorithm using artificial intelligence (AI) to analyze ECGs to provide clinicians with supportive information for ECG diagnosis.
Cardiologs Holter Platform is an online portal that can be accessed through a network connection and allows the clinician to review and annotate the ECG signals. Alternatively, the Cardiologs Holter Platform can be accessed via an Application Programming Interface (API) connection. The API connection allows a digital ECG upload from a connected device and allows the connected device to receive the output of the Cardiologs ECG interpretation support algorithm and further process and display its output in their system.
Cardiologs Holter Platform is intended to analyze recordings from devices used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices for the assessment of heart rhythm in adult and pediatric populations.
Cardiologs Holter Platform works in the following way:
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Upload of a digital ECG file to Cardiologs' secure hosting databases;
- i. Manual upload: via the web-interface
- ii. Direct upload: no manual intervention required, upload occurs whenever the third-party hardware or software system is connected to the Cardiologs' Application Programming Interface (or API) and the ECG is automatically sent to the Cardiologs' servers.
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Processing of the uploaded ECG file;
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Analysis and annotation of the uploaded ECG performed by Cardiologs' proprietary algorithm;
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Display the analysis of the ECG, along with the original signal, to the clinician for review of patient data. The algorithm output may be accessed/displayed through the following interfaces:
- i. The clinician can access the algorithm output directly within Cardiologs using Cardiologs' user interface.
- ii. The clinician can access the algorithm output in their own downstream system. The downstream system receives the output of the algorithm via Cardiologs' Application Programming Interface (API).
- The Cardiologs Holter Platform allows for editing and/or validation of the measurements and parameters by the analyzing clinician.
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A PDF report is generated as the result of the analysis.
The provided FDA 510(k) clearance letter for the Cardiologs Holter Platform (K250569) does not contain the detailed information required to describe the acceptance criteria and the specific study proving the device meets these criteria.
The letter states:
- "Performance testing demonstrates that the proposed device is as safe and effective and performs as well as the predicate." (Page 6 & 7)
- "No clinical testing was performed in support of this premarket notification." (Page 7)
- "The modified device includes performance updates to enhance the accuracy of the currently cleared abnormalities and measurements and expanded pediatric indications." (Page 6)
This indicates that internal performance testing was conducted, likely against the predicate device's performance, but the details of these tests (acceptance criteria, performance results, sample sizes, ground truth establishment, etc.) are not included in this public facing letter. Such information would typically be found in the full 510(k) submission document, which is not provided here.
Therefore, I cannot fulfill your request with the given input. The document is a clearance letter, which summarizes the outcome of the FDA's review, but does not detail the technical studies and their results.
§ 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).