(15 days)
No
The description focuses on recording, storing, and transmitting ECG data for human interpretation, with no mention of automated analysis or algorithms that would typically involve AI/ML. The performance study describes human interpretation of the ECGs.
No
Explanation: This device records, stores, and transmits ECG data for diagnostic purposes, it does not directly treat or provide therapy for the cardiac rhythm disturbances.
Yes
The device is described as a "Tele-ECG device" that records, stores, and transmits ECG data for "further processing" and interpretation to detect "basic rhythm (sinus rhythm, atrial fibrillation, atrial flutter, supraventricular (heart atrium) tachycardia, or nodal rhythm)". This process is used to diagnose "symptomatic disturbances of cardiac rhythm".
No
The device description clearly states it includes a hardware component, the "patient activated Tele-ECG device SM100 / vitaphone 100IR," which records and transmits ECG data. While it also includes receiving software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The "sensor mobile" system records and transmits electrical signals from the heart (ECG), which are measured directly from the patient's body surface. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to detect and record symptomatic disturbances of cardiac rhythm, which is a physiological measurement, not an in vitro analysis.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The telemedical system "sensor mobile" comprises the patient activated Tele-ECG device SM100 / vitaphone 100IR and the REMOS Receiving Software. The SM100 / vitaphone 100IR records and stores one-channel ECG episodes and transmits these data by means of a telephone or a mobile phone to a receiving station equipped with the REMOS Receiving Software for further processing.
Symptomatic disturbances of cardiac rhythm such as palpitations, fatigue, heart racing, fluttering, chest discomfort or pain.
Product codes
DXH
Device Description
The Tele ECG device "sensor mobile" SM 100 / vitaphone 100IR, manufactured by TMS, is capable of recording, storing and transmitting up to three ECG episodes of 3C seconds each. The "sensor mobile" SM 100 is placed on the chest for post-event recording. The device is patient activated by pressing the record button. The 30-second ECG is stored in the device memory for later acoustic transmission via telephone or mobile phone in form of digital data (FSK) or via infrared (IrDA) and IrDA-enabled mobile phone to a telemedical central station equipped with the "sensor mobile" Receiving Software REMOS. The transmission is activated by pressing the send button. The device does not impair internal pacemakers and implantable cardioverters / defibrillators.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
chest
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: The system was tested with 80 patients suffering from different cardiac dysrhythmia or patients that are suspected of having cardiac dysrhythmia. One hundred ECG examples of the eighty patients have been transmitted and interpreted. 98 percent of the received ECGs could be interpreted. The basic rhythm (sinus rhythm, atrial fibrillation, atrial flutter, supraventricular (heart atrium) tachycardia, or nodal rhythm) could be detected with all the ECGs. The function of pacemakers could be checked, and the pacemaker spikes imaging and reply of these spikes in the atrium or in the ventricle is good. Determination of wide QRS complexes (in the sense of a bundle-branch block pattern) in ECG examples was also possible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0