(158 days)
K/DEN number: Not Found
There are no K/DEN numbers for reference devices in the provided text.
No
The summary focuses on the device's function as an ECG memory monitor and its accelerated data transmission protocol. There is no mention of AI or ML being used for analysis, interpretation, or any other function.
No
The device is described as an ECG memory monitor used for evaluation and recording, not for active treatment or therapy. Its purpose is diagnosis and monitoring, as indicated by phrases like "documenting transient symptoms," "evaluation of transient symptoms," and "may be incorporated as part of rehabilitation, or medical treatment followup."
Yes
The device records ECG data for the purpose of documenting transient symptoms that may suggest cardiac arrhythmia and allows patients to receive advice based on their ECG and symptoms, which are all indicative of a diagnostic function.
No
The device description explicitly states "These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors." and describes hardware components like transmitters and receivers that convert and transmit data as an FM signal.
Based on the provided text, 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 Function: The description clearly states that this device is a "non-invasive, external ambulatory electrocardiographic (ECG) memory monitor." It records electrical activity of the heart from the surface of the body.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly measures a physiological signal (ECG).
Therefore, the function and intended use of this device fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
"These devices are intended for use by patients who need to record their ECG during daily activites for subsequent transmission to a clinic, service, or hospital. These patients may have been instructed by their physician to record their ECG for the purpose of documenting transient symptoms which may suggest cardiac arrhythmia. The telephonic use of these devices allows the patient to receive advice based on their ECG and symptoms in a timely manner.
These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment followup, where such symptoms may be present."
Product codes
Not Found
Device Description
"The accelerated transmission protocol may be used by transtelephonic ECG transmitters. This protocol allows the stored ECG data to be sent more rapidly over the communications link to the receiver. Three devices that incorporate the Advanced Transmission Protocol (ATP) are presented in this summary statement. They are the King Of Hearts, Express ATP. the King Of Hearts, Prince ATP, and the HeartCard ATP.
Features and functions are identified to the identified predicate devices with the addition of the ATP feature. The Accelerated Transmission Protocol feature does not play any part in the recording of ECGs. It is only active in the transmit mode. The ATP feature accelerates the transmission rate to 3 times the rate the data was acquired. The transmitters convert the data to an FM signal, which is sent to a receiver (LRC 2000 Receiver) designed to receive the ATP protocol. The receiver demodulates the FM signal back to the analog ECG waveform, and expands the received signal to the original scale by using an increased sampling rate (3x) and operating the chart drive at a 3x rate. The result is a chart strip showing the time scale of the original signal acquisition. The edge print on the ECG strip indicates that an accelerated transmission has been received from an Instromedix transmitter."
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
Not Found
Intended User / Care Setting
"clinic, service, or hospital"
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Instromedix, Inc.
K955060 APR - 8 1996
Summary Of Safety And Effectiveness for the Accelerated Transmission Protocol (ATPTM )
The accelerated transmission protocol may be used by transtelephonic ECG transmitters. This protocol allows the stored ECG data to be sent more rapidly over the communications link to the receiver. Three devices that incorporate the Advanced Transmission Protocol (ATP) are presented in this summary statement. They are the King Of Hearts, Express ATP. the King Of Hearts, Prince ATP, and the HeartCard ATP.
These devices are intended for use by patients who need to record their ECG during daily activites for subsequent transmission to a clinic, service, or hospital. These patients may have been instructed by their physician to record their ECG for the purpose of documenting transient symptoms which may suggest cardiac arrhythmia. The telephonic use of these devices allows the patient to receive advice based on their ECG and symptoms in a timely manner.
These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment followup, where such symptoms may be present.
Features and functions are identified to the identified predicate devices with the addition of the ATP feature. The Accelerated Transmission Protocol feature does not play any part in the recording of ECGs. It is only active in the transmit mode. The ATP feature accelerates the transmission rate to 3 times the rate the data was acquired. The transmitters convert the data to an FM signal, which is sent to a receiver (LRC 2000 Receiver) designed to receive the ATP protocol. The receiver demodulates the FM signal back to the analog ECG waveform, and expands the received signal to the original scale by using an increased sampling rate (3x) and operating the chart drive at a 3x rate. The result is a chart strip showing the time scale of the original signal acquisition. The edge print on the ECG strip indicates that an accelerated transmission has been received from an Instromedix transmitter.
The safety and effectiveness of these devices using ATP is substantially equivalent to the predicate devices. There are no known contraindications for use of this type of device. In our opinion, the ATP in these device provides a non-significant risk to the host, which are Class II, non-significant risk devices.