Who is the manufacturer of CARDIACMONITOR?

Vision Electronics filed the 510(k) submission for CARDIACMONITOR (K963375).

What is the FDA product code for CARDIACMONITOR?

DXH. It is classified under 21 CFR 870.2920 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CARDIACMONITOR?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CARDIACMONITOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CARDIACMONITOR

K963375 · Vision Electronics · DXH · Feb 28, 1997 · Cardiovascular

Device Facts

Record ID	K963375
Device Name	CARDIACMONITOR
Applicant	Vision Electronics
Product Code	DXH · Cardiovascular
Decision Date	Feb 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2920
Device Class	Class 2

Intended Use

The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace.

Device Story

External ambulatory ECG looping memory monitor; credit-card size (0.31" thick). Patient-activated during transient symptoms; records 90s ECG (continuous or 30s pre-/60s post-symptom). Data stored in looping memory; transferred via acoustic signal through standard telephone lines to receiving center. Used in home/workplace; operated by patient. Physician reviews transmitted ECG to diagnose cardiac events. Benefits: enables remote capture of transient arrhythmias without continuous clinical monitoring.

Clinical Evidence

Bench testing only. Compliance with AAMI EC-13 and EC-38 standards for ECG monitoring equipment confirmed; results within allowable limits.

Technological Characteristics

Non-invasive ambulatory ECG looping memory monitor. Dimensions: credit-card size, 0.31" thick. Connectivity: acoustic transmission via standard telephone lines. Power: internal battery (implied). Standards: AAMI EC-13, AAMI EC-38. Interface: slide switch for mode selection (P/P.P.), record button, erase button, internal speaker for acoustic data transmission.

Indications for Use

Indicated for patients experiencing transient cardiac symptoms requiring ambulatory ECG monitoring. Intended for use in home or workplace settings by patients to record and transmit ECG data for physician review.

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

HeartCard (K963375)

Related Devices

K072385 — HEARTEVENT, MODEL AT · Diagnostic Devices Pty, Ltd. · Jan 11, 2008
K972649 — CARDIOCALL CARDIAC EVENT RECORDER · Reynolds Medical , Ltd. · Dec 4, 1997
K100383 — VITAPHONE. MODEL 100 BT · Vitasystems GmbH · Apr 20, 2010
K032736 — HEART 2006 · Aerotel Medical Systems (1998) , Ltd. · Oct 3, 2003
K033451 — HEARTRAK SMART AT/HEARTRAK SMART2 · Universal Medical, Inc. · Feb 5, 2004

Submission Summary (Full Text)

{0} Page 6a. K963375 FEB 28 1997 # SUMMARY OF STATEMENT OF SAFETY AND EFFECTIVENESS CardiacMonitor - Cardiac Event Recorder L. A. Wood Electronics, Inc. Ref: K963375 The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace. The recorded ECG is sent by an acoustic signal from an internal speaker, using standard telephone lines to a telephonic receiver. The CardiacMonitor is the size of a Credit-card by about 0.31" thick. The device records either a 90 second ECG when Physician set in the (P.) mode or a 30 second pre-symptom and a 60 second post-symptom for a 90 second total ECG when Physician set in the (P.P.) mode. The function of the (P.) or (P.P.) mode have no impact on the quality of the ECG data obtained. The CardiacMonitor Shares much of the same operating features as the predicate device, HeartCard and the technical specifications comparison reveal no substantial differences and no differences which would effect safety and effectiveness. The indications for use are the same. A leadset provides means for attachment to standard ECG electrodes. Moving the slide switch to the (P.P.) mode activates the ECG scanning operation, during which ECG data is being stored in a looping memory. The memory loop continues to fill with the most recent ECG data. When the RECORD button is activated, the looping memory content is in non-looping memory. The data stored in memory may be sent by the patient to a receiving center. The patient calls the center and when instructed places the mouthpiece of the telephone over the yellow circle on the monitor and presses and releases the telephone mouthpiece. The ECG data is sent over the phone lines via an acoustic signal. The data may be sent again if requested. The stored data is retained until the "Erase" button is pressed. AAMI EC-13 and EC-38 test data results are all within the minimum and maximum allowable standards and no impact on safety and effectiveness is shown.