HEART 400 ECG TRANSMITTER

K953762 · Aerotel, Ltd. · DXH · Jul 18, 1996 · Cardiovascular

Device Facts

• Record ID: K953762
• Device Name: HEART 400 ECG TRANSMITTER
• Applicant: Aerotel, Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

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.

Device Story

Battery-powered 3-lead ECG transmitter; captures patient ECG via electrodes and patient cable; transmits 3-channel ECG signal via telephone handset to central receiving station (e.g., Heartline 3000). Operated by patient; used for immediate transmission of ECG data. Device lacks internal memory; transmission occurs in real-time during signal acquisition. Receiving center staff edit and record ECG for clinical review. Facilitates remote cardiac assessment by physicians.

Clinical Evidence

Clinical testing involved three volunteers comparing ECG quality between Heart 400 and Heart 1001 via telephone lines. Results demonstrated equivalent signal quality in all cases.

Technological Characteristics

Battery-powered 3-lead ECG transmitter; FM transmission; analog circuitry; patient electrodes and cable interface. Bench tests performed: common mode rejection ratio, frequency response, audio signal sound level, temperature stress, electromagnetic immunity, shock, and vibration.

Indications for Use

Indicated for patients requiring transmission of ECG signals via telephone to a receiving center. Contraindicated for patients incapable of operating the device or telephone, and not intended for long-term monitoring.

Regulatory Classification

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.

Predicate Devices

• Aerotel Heart 1001 ECG Transmitter (K931020)

Reference Devices

• Aerotel Heartline 3000 (K930314)

Submission Summary (Full Text)

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201 438 3213 P.02

# K953762

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, 1995.

1. 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.

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.

3. Predicate Device
Aerotel Heart 1001 ECG Transmitter, K931020

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.

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201 438 3213
P.03

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 ratio, frequency response, sound level of the audio signal, temperature stress, 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

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1. 15, INC.
201 438 3213
P.04

The conclusion drawn from these tests is that the Heart 400 is equivalent in safety and efficacy to its predicate device