(185 days)
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No
The description focuses on basic ECG recording and transmission via telephone lines, with no mention of AI/ML terms or functionalities like automated analysis or interpretation.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a monitor that records ECG data to be sent to a receiver, indicating it is for diagnostic purposes, not therapeutic.
Yes
Explanation: The device is a CardiacMonitor that records ECG, which is then sent to a telephonic receiver for analysis. This process of recording and sending physiological data for analysis to identify transient symptoms indicates a diagnostic purpose.
No
The device description explicitly states it is a "non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor" and describes its physical characteristics ("size of a Credit-card by about 0.31" thick"), indicating it is a hardware device that records and transmits ECG data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The CardiacMonitor is described as a "non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor." It records electrical activity of the heart from the body surface.
- Method of Operation: The device records ECG data directly from the patient's body and transmits it. It does not analyze samples taken from the body.
Therefore, the CardiacMonitor falls under the category of a medical device that monitors physiological signals in vivo (within the living body), rather than an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace.
Product codes
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Device Description
The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace. The recorded ECG is sent by an acoustic signal from an internal speaker, using standard telephone lines to a telephonic receiver. The CardiacMonitor is the size of a Credit-card by about 0.31" thick.
The device records either a 90 second ECG when Physician set in the (P.) mode or a 30 second pre-symptom and a 60 second post-symptom for a 90 second total ECG when Physician set in the (P.P.) mode. The function of the (P.) or (P.P.) mode have no impact on the quality of the ECG data obtained. A leadset provides means for attachment to standard ECG electrodes. Moving the slide switch to the (P.P.) mode activates the ECG scanning operation, during which ECG data is being stored in a looping memory. The memory loop continues to fill with the most recent ECG data. When the RECORD button is activated, the looping memory content is in non-looping memory. The data stored in memory may be sent by the patient to a receiving center. The patient calls the center and uhen instructed places the mouthpiece of the telephone over the yellow circle on the monitor and presses and releases the telephone mouthpiece. The ECG data is sent over the phone lines via an acoustic signal. The data may be sent again if The stored data is retained until the "Erase" requested. button is pressed.
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
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Indicated Patient Age Range
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Intended User / Care Setting
patient who experiences transient symptoms and is intended for human use, in the home or workplace.
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
AAMI EC-13 and EC-38 test data results are all within the minimum and maximum allowable standards and no impact on safety and effectiveness is shown.
Key Metrics
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Predicate Device(s)
HeartCard
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
FEB 2 8 1997
SUMMARY OF STATEMENT OF SAFETY AND EFFECTIVENESS
CardiacMonitor - Cardiac Event Recorder
L. A. Wood Electronics, Inc.
K963375 Ref:
The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace. The recorded ECG is sent by an acoustic signal from an internal speaker, using standard telephone lines to a telephonic receiver. The CardiacMonitor is the size of a Credit-card by about 0.31" thick.
The device records either a 90 second ECG when Physician set in the (P.) mode or a 30 second pre-symptom and a 60 second post-symptom for a 90 second total ECG when Physician set in the (P.P.) mode. The function of the (P.) or (P.P.) mode have no impact on the quality of the ECG data obtained. The CardiacMonitor Shares much of the same operating features as the predicate device, HeartCard and the technical specifications comparison reveal no substantial differences and no differences which would effect safety and effectiveness. The indications for use are the same.
A leadset provides means for attachment to standard ECG electrodes. Moving the slide switch to the (P.P.) mode activates the ECG scanning operation, during which ECG data is being stored in a looping memory. The memory loop continues to fill with the most recent ECG data. When the RECORD button is activated, the looping memory content is in non-looping memory.
The data stored in memory may be sent by the patient to a receiving center. The patient calls the center and uhen instructed places the mouthpiece of the telephone over the yellow circle on the monitor and presses and releases the telephone mouthpiece. The ECG data is sent over the phone lines via an acoustic signal. The data may be sent again if The stored data is retained until the "Erase" requested. button is pressed.
AAMI EC-13 and EC-38 test data results are all within the minimum and maximum allowable standards and no impact on safety and effectiveness is shown.