(342 days)
No
The description focuses on the device's function as a transmitter of ECG data via telephone, with no mention of AI or ML processing of the data.
No
The device is a transmitter for ECG signals, intended for diagnostic purposes (transmitting patient ECGs to a receiving center for recording and editing), not for treating any condition.
No
The H400 is an ECG transmitter that sends a patient's ECG to a receiving center for editing and recording. It does not perform analysis or diagnosis itself, rather it facilitates the transmission of data to a diagnostic center.
No
The device description explicitly states it is a "battery powered 3-lead Transtelephonic ECG Transmitter" and mentions physical components like electrodes, a patient cable, and an On/Off button, indicating it is a hardware device.
No, 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 for diagnosis, monitoring, or screening.
- H400 function: The H400 is a device that transmits an electrocardiogram (ECG), which is a recording of the electrical activity of the heart. This is a measurement taken directly from the patient's body, not from a specimen taken from the body.
The H400 is a medical device used for diagnostic purposes, but it falls under the category of devices that measure physiological signals directly from the patient, not IVDs.
N/A
Intended Use / Indications for Use
The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The device is not intended to be used for long-term monitoring or when the patient is not capable of actuating the device or the telephone.
Product codes
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Device Description
The Heart 400 is a battery-powered ECG transmitter that is capable of transmitting a 3-channel ECG signal by means of a telephone to a central receiving station.
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
patient
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
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Summary of Performance Studies
Non-clinical tests provided include bench tests of common mode rejection frequency response, sound level of the audio signal, temperature stress, ratio, electromagnetic immunity, and shock and vibration. There is no safety question, since the Heart 400 is battery operated.
Electrocardiograms were taken from three volunteers using the Heart 400 and the Heart 1001, and transmitting the electrocardiograms over telephone lines. The quality of the electrocardiograms in every case is equivalent.
Key Metrics
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Predicate Device(s)
Aerotel Heart 1001 ECG Transmitter, K931020
Reference Device(s)
Aerotel's Heartline 3000 (FDA # K930314)
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
JUL 18 1996
Aerotel Ltd. Heart 400 ECG Transmitter K953762 Request for Additional Information K953762 July 15, 1996 revised 510(k) Summary
AEROTEL LTD.
510(k) Submission
Heart 400 ECG Transmitter (H400)
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements Regulation par 807.92, effective March 14, 1 ପିଟିର୍ତ୍
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- Submitter
Name: Aerotel Ltd Address: 5 Hazoref St., Holon 58856, Israel Telephone Number: 972-3-5596111 Contact person: Dr. George Myers, 201-438-2310 Date prepared: July 13, 1995.
- Submitter
2. Device
Proprietary name: Heart 400 Common Name: Electrocardiograph Telephonic Transmitter Classification Name: Transmitters and Receivers, electrocardiograph, telephone
The Heart 400 is a battery-powered ECG transmitter that is capable of transmitting a 3-channel ECG signal by means of a telephone to a central receiving station.
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- Predicate Device
Aerotel Heart 1001 ECG Transmitter, K931020
- Predicate Device
4. Description
The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent.
1
The Heart 400 transmits each of leads I, II, III as selected by the patient. Patient connection is done by means of electrodes and a patient cable. The electrodes are attached by the physician.
To transmit the electrocardiogram, the telephone handset transmitter is placed over the device and the On/Off button of the H400 is released. At the receiving center, the ECG will be edited and recorded.
5. Intended Use
The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The device is not intended to be used for long-term monitoring or when the patient is not capable of actuating the device or the telephone.
6. Comparison
The Heart 400 has basically the same physical characteristics as the predicate device, except that the Heart 400 does not have a memory. Thus, when the Heart 400 is used, the electrocardiogram is transmitted on the telephone at the same time it is taken, while with the Heart 1001 there can be a time lag. Apart from that, both use FM transmission, similar circuitry, and similar patient electrodes. This difference is not critical to the use of the device, because the Heart 400 is used when the electrocardiogram is to be transmitted immediately.
b. Performance Data
(1) Non-clinical tests
Non-clinical tests provided include bench tests of common mode rejection frequency response, sound level of the audio signal, temperature stress, ratio, electromagnetic immunity, and shock and vibration. There is no safety question, since the Heart 400 is battery operated.
(2) Clinical Tests
Electrocardiograms were taken from three volunteers using the Heart 400 and the Heart 1001, and transmitting the electrocardiograms over telephone lines. The quality of the electrocardiograms in every case is equivalent.
(3) Conclusion
2
The conclusion drawn from these tests is that the Heart 400 is equivalent in safety and efficacy to its predicate device