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510(k) Data Aggregation
K Number
K142349Device Name
TM eCloud ECG Analysis System
Manufacturer
Telemed Solutions, Inc.
Date Cleared
2015-09-21
(395 days)
Product Code
DQK, DOK, DPS, DXH, KRE, MLO, OUG
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
Telemed Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TM eCloud ECG Analysis System, using proprietary algorithm, is intended for use in adults and children of any age from birth upwards. The Program makes significant use of the patient's age and gender and will provide a unique diagnosis if age differs only by a few days in the case of neonates. It is a program that is based on normal limits derived using the algorithm itself with this applying to criteria for subjects of all ages, including neonates.
TM eCloud ECG Analysis System is qualified to evaluate, detect, and aid in the physician diagnosis of the following cardiac arrhythmias and/or conduction defects:
- o Evaluation of symptoms that may be caused by cardiac arrhythmia and /or conduction disturbances
- Evaluation of symptoms that may be due to myocardial ischemia
- Detection of ECG events that alter prognosis in certain forms of heart disease
- Detection and analysis of indirect pacemaker function and failure
- Determination of cardiac response to lifestyle
- Evaluation of therapeutic interventions
- . Investigations in epidemiology and clinical trials
- Evaluation of heart rate variability in the assessment of heart disease
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. This software qualifies to be used in hospitals, physician offices, and scanning services. It is designed for acquisition, analysis, edit, review, report and storage of all ECG and multi-parameter data. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), acute MI, ventricular hypertrophy, abnormal ST-T changes, lethal arrhythmias, and common rhythm abnormalities.
TM eCloud ECG Analysis System can analyze recordings performed on newborns, children, and adults.
TM eCloud ECG Analysis System's interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG that may be detected. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.
Device Description
The TM eCloud ECG Analysis System consists of a (1) server-side, application Platform as a Service (PaaS) cloud based system, a (2) desktop client-side application, and (3) a web-based Physician Portal website.
The (1) server-side, application PaaS component collects, stores, performs arrhythmia analysis on ECG uploads, and transfers data to and from the client-side application.
The (2) desktop client-side application is a workstation system which allows technicians to review ECG, edit the analysis results produced by the (1) server-side, application PaaS component, and generate reports for the ECG study. The edited results and reports are uploaded to the (1) server-side, application PaaS component. It also allows notifications and updates to (3) Physician Portal website.
The TM eCloud ECG Analysis System is capable of processing and performing arrhythmia analysis on ten seconds to 60 days of recorded ECG from one to 12 channels. The system is designed to be compatible with any stationary or ambulatory ECG device having the ability to export ECG. Typical compatible devices interfaces include Cardiac Mobile Telemetry, Event recorders, and Holter recorders but is not limited to a particular ECG device. ECG interfaces from desperate devices are translated by Telemed Adapters which convert proprietary formats to the Physionet WFDB MIT format but vendors may choose to provide the Physionet WFDB directly and bypass the use of an adapter.
The purpose of the TM eCloud ECG Analysis System is to determine if any irregular rhythms, irregular beats, conduction defects, or ST depression occurred during the recording or monitoring. A qualified physician can then use the results of the analysis report to determine what action needs to be taken to help the patient reduce or prevent the occurrence of these abnormalities.
The users may upload ECG to the TM eCloud ECG Analysis System via a cellular network, REST web service, or FTP from any computer or cellular equipment. The system performs analysis on the uploaded ECG using the proprietary 12 Lead Diagnostic EKG Analysis Engine or proprietary algorithm Reduced Lead 1-7 lead Analysis Engine and downloads the results to the client.
If detected, the ECG engine will report on the following arrhythmias: ventricular ectopy, atrial ectopy, pauses, heart block, junctional rhythms, hemiblock, LBBB, RBBB, ST anomalies, and prolonged QT. It will display up to 900 statements including atrial fibrillation, ventricular fibrillation/flutter, and WPW.
The (2) client workstation software employs several screens to display the ECG data. These screens include: 5-Minute View, Hourly view, or Daily view, 8-Second View, Arrhythmias Only View, time and frequency domain HRV, ST changes, AF burden. All analyzed data is saved in a database. From there data can be organized into a report that can be printed on paper or distributed electronically.
Although the analysis engine reports arrhythmias and abnormalities with a high rate of accuracy, all results need to be reviewed and/or edited by a qualified medical professional.
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