(92 days)
No
The device description and performance studies focus on signal transfer and conversion, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device acts as an interface to transfer an ECG signal for recording; it does not directly treat or diagnose a medical condition.
No.
The Telelink is an interface device that transfers an ECG signal received over the telephone to a conventional ECG recorder. It does not perform any diagnostic analysis itself; it merely facilitates the display of diagnostic data (ECG signals) on another device.
No
The device description explicitly states it is a "battery powered device" and a "battery powered ECG telephone receiving interface," indicating it is a hardware device with electrical components.
Based on the provided information, the Telelink device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Telelink's intended use and device description clearly state that it receives an ECG signal over the telephone and transfers it to an ECG recorder. The patient has no contact with the device, and it does not analyze any biological samples (like blood, urine, tissue, etc.).
- The device processes an electrical signal (ECG), not a biological sample. The input is an electrical representation of the heart's activity, not a physical specimen from the patient.
The Telelink is a medical device, specifically an ECG telephone receiving interface, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Telelink is a battery powered device intended to be used by the physician in his office, for the transfer of an ECG signal received over the telephone from a compatible transmitter, to a conventional single trace ECG recorder in the physician's office . The patient has no contact with the Telelink, and it does not affect him in any way.
Product codes
Not Found
Device Description
The Telelink is a battery powered ECG telephone receiving interface that is capable of transferring the transtelephonic ECG, received over the telephone, to a conventional single trace ECG recorder.
The Telelink is a battery powered interface which is intended to be used by a physician or an ECG technician to convert an ECG signal received via the telephone to an analog ECG signal recordable on the physician's conventional single trace ECG recorder.
The Telelink has two connections; one of these is connected to the telephone's handset via an acoustic coupler (included) which is placed on the speaker of the handset; the other connection is attached to the single-trace ECG recorder in the physician's office via the recorder's patient cable by using only 3 wires of the patient cable.
After activating the recorder, all received ECG leads from the telephone, will be routed to the recorder will print them out, one after the other, in the sequence in which they have been transmitted.
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
Physician in his office
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
Electrocardiograms were taken from three volunteers transmitting over the phone 3 and 12 lead ECG (by Aerotel HeartView recorder / transmitter 510(K) # K950004) and printing them out on an ECG recorder model MICRORULER, CARDIETTE, Elettronica Trentina. The electrocardiograms were compared to those received on Aerotel's Heartline receiving console (510(K) # K930314) - the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests: Bench tests of frequency response, temperature stress, electromagnetic immunity and shock tests.
Clinical tests: Electrocardiograms were taken from three volunteers transmitting over the phone 3 and 12 lead ECG (by Aerotel HeartView recorder / transmitter 510(K) # K950004) and printing them out on an ECG recorder model MICRORULER, CARDIETTE, Elettronica Trentina. The electrocardiograms were compared to those received on Aerotel's Heartline receiving console (510(K) # K930314) - the predicate device.
Key results: The electrocardiograms from the two systems are equivalent in quality and diagnostic utility. The Telelink is equivalent in safety and efficacy to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Aerotel
JUL 1 0 1996
510 (K) Submission Telelink telephonic ECG receiving interface
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, I dddri
| 1. | Submitter | |
|---|---|---|
| Name: | Aerotel Ltd. | |
| Address: | 5, Hazoref St., Holon 58856, Israel. | |
| Telephone No .: | +972-3-559-3222 | |
| Contact Person: | Dr. George Myers, 201-438-2310 | |
| Date prepared: | January 25, 1996 |
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- Device Telelink Proprietary name: Common name: ECG telephonic receiving interface. Classification name: Transmitters and receivers electrocardiograph, telephone.
The Telelink is a battery powered ECG telephone receiving interface that is capable of transferring the transtelephonic ECG, received over the telephone, to a conventional single trace ECG recorder.
- Device Telelink Proprietary name: Common name: ECG telephonic receiving interface. Classification name: Transmitters and receivers electrocardiograph, telephone.
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- Predicate device
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- Predicate device
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Aerotel H3000 transtelephonic ECG receiving console, 510(K): #K930314
1
Telelink
4. Description:
The Telelink is a battery powered interface which is intended to be used by a physician or an ECG technician to convert an ECG signal received via the telephone to an analog ECG signal recordable on the physician's conventional single trace ECG recorder.
| The ECG signal can be sent over the phone by any of Aerotel's transtelephonic | |
|---|---|
| recorders / transmitters such as: | HeartView (510(K) # K950004) |
| H1001 (510(K) # K931020) | |
| H2002 (510(K) # K915624) |
or equivalent. These units have been cleared for sale in the United States by the FDA.
The Telelink has two connections; one of these is connected to the telephone's handset via an acoustic coupler (included) which is placed on the speaker of the handset; the other connection is attached to the single-trace ECG recorder in the physician's office via the recorder's patient cable by using only 3 wires of the patient cable.
After activating the recorder, all received ECG leads from the telephone, will be routed to the recorder will print them out, one after the other, in the sequence in which they have been transmitted.
ഗ് Intended use
The Telelink is a battery powered device intended to be used by the physician in his office, for the transfer of an ECG signal received over the telephone from a compatible transmitter, to a conventional single trace ECG recorder in the physician's office . The patient has no contact with the Telelink, and it does not affect him in any way.
6. Comparison
The Telelink has the same intended use as Aerotel's Heartline Receiving Console (510(K) # K930314). Its realization differs in that the Telelink does not have memory, is not PC - based, records on a conventional electrocardiograph, and is not software operated.
2
Telelink
Performance Data
(a) Non clinical tests
Non clinical tests provided include bench tests of frequency response, temperature stress, electromagnetic immunity and shock tests. There is no leakage current issue because the device is battery operated, and not connected to a patient.
(b) Clinical tests
Electrocardiograms were taken from three volunteers transmitting over the phone 3 and 12 lead ECG (by Aerotel HeartView recorder / transmitter 510(K) # K950004) and printing them out on an ECG recorder model MICRORULER, CARDIETTE, Elettronica Trentina. The electrocardiograms were compared to those received on Aerotel's Heartline receiving console (510(K) # K930314) - the predicate device. The electrocardiograms from the two systems are equivalent in quality and diagnostic utility.
(c) Conclusion
The conclusion drawn from these tests is that the Telelink is equivalent in safety and efficacy to its predicate device.
3
7
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Photograph
Image /page/3/Picture/4 description: The image shows a Telelink device with a cord and a sensor. The device has a power on and low battery indicator. There are also indicators labeled R and N. The device is white and has the Telelink logo on the bottom.