ACCELERATED TRANSMISSION PROTOCOL

K955060 · Instromedix, Inc. · DXH · Apr 8, 1996 · Cardiovascular

Device Facts

• Record ID: K955060
• Device Name: ACCELERATED TRANSMISSION PROTOCOL
• Applicant: Instromedix, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Apr 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Indications for Use

These devices are intended for use by patients who need to record their ECG during daily activities 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.

Device Story

Non-invasive, external ambulatory ECG memory monitors (King Of Hearts Express ATP, King Of Hearts Prince ATP, HeartCard ATP) record ECG data during daily activities; patient-operated. Accelerated Transmission Protocol (ATP) feature activates only during transmission mode; converts stored ECG data to FM signal for telephonic transmission to LRC 2000 Receiver. Receiver demodulates FM signal; expands signal to original scale via 3x sampling rate and 3x chart drive speed. Output is analog ECG chart strip with edge print indicating accelerated transmission. Enables timely clinical review of transient cardiac symptoms; facilitates remote physician advice.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ambulatory ECG memory monitors; FM signal transmission; 3x accelerated transmission rate; compatible with LRC 2000 Receiver; non-invasive; Class II device.

Indications for Use

Indicated for patients requiring ambulatory ECG monitoring during daily activities to document transient symptoms (dizziness, palpitations, chest discomfort) suggestive of cardiac arrhythmia; used for rehabilitation or medical treatment follow-up. No contraindications.

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.

Reference Devices

• LRC 2000 Receiver

Submission Summary (Full Text)

{0}

Instromedix, Inc.
K955000 APR - 8 1996

# Summary Of Safety And Effectiveness for the Accelerated Transmission Protocol (ATP™)

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 activities 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 follow-up, where such symptoms may be present.

Features and functions are identical 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.

ATP™ 510(k) Safety and Effectiveness Summary
Summary - 1