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510(k) Data Aggregation

    K Number
    K103706
    Device Name
    THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
    Manufacturer
    APPLIED CARDIAC SYSTEMS, INC.
    Date Cleared
    2011-08-24

    (247 days)

    Product Code
    QYX, DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED CARDIAC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmia The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia occurs. - 2. Holter Mode: Use on adult patients experiencing palpitations, syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG. - 3. Multi-Lead (Resting EKG) Mode: Use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body.
    Device Description
    The ACS Cardiac Outpatient Real Time ECG (CORE™) monitor is a multipurpose device designed with the ability to perform: a 2-lead (2 or 3-electrode) Mobile Cardiac Outpatient Telemetry complete with Arrhythmia Detection and Alarm for up to 30 days; a 24-hour or longer 3-lead (5electrode) or a resting 12-lead (10-electrode) EKG. The ambulatory device may be used on an outpatient basis with remote clinician data analysis as well as use within the physician office setting by a medical professional. The CORE™ monitor is comprised of 1) a single component ECG monitor with an integrated cellular modem and 2) an interface to four independent cable configurations through a single connector. The CORE™ device automatically changes functionality when a specific cable with the same form factor is inserted with the following configurations: 3-wire, ambulatory, snap electrode cable invokes a 1, or 2-lead MCT mode (Lead I, II - no anterior views). 5-wire, ambulatory, snap electrode cable invokes the Holter 3-lead mode by default (up to 5-leads are available with anterior views). 10-wire, resting (lengthened for full body), alligator clip electrode cable invokes the Resting 12-lead EKG mode (8-channels; derived Leads III, aVF, aVR, aVL). A USB cable invokes the PC communication service mode. Cable is interchangeable with ECG lead sets requiring disconnection from the body before connection to an external device can be made. The built-in cellular modem technology pushes and pulls information to and from the device in a HIPAA compliant fashion using the cryptographic protocol; Transport Layer Security (TLS). Additional data integrity is performed by Error Correction Coding (ECC) and MD5 hash sums. The CORE™ device houses a microprocessor for running the algorithm and an Application Specific Integrated Circuit (ASIC) for controlling the CORE™ device, a rechargeable battery, real time ECG Arrhythmia Detection using built-in hardware DSP engine in any mode, ECG capture circuitry provided by the ASIC and the multiple components, GSM/GPRS/EGPRS/WCDMA/HSPA network transceivers for cellular communication, Cellular SIM card, high-capacity SD flash card (up to 1024 GB), internal EEPROM, GPS module, a Bluetooth transceiver and a Zigbee (IEEE 802.15.4) transceiver for bi-directional communication with external devices, a full-color LCD touch screen display, 5-button keyboard, Power and Event button, 3-axis accelerometer, RGB color LED indication module, speaker/microphone, external battery charger, and a USB device port. The CORE™ device utilizes an embedded algorithm developed by Applied Cardiac Systems, Inc. to analyze ECG signals in real-time. Upon detection of an arrhythmic or patient-activated event, the ECG signal is transmitted wirelessly via the cellular network to a remote Monitoring Center for additional analysis and intervention by a clinician. When cellular service is unavailable, the event will be stored until such time the cellular network becomes available or the patient transmits the data using a land telephone line. When in the resting 12-lead EKG mode, the device can capture and display 12 channels of ECG. The ECG can be streamed in real-time to a PC wirelessly via the 802.15.4 network transceiver to be displayed, printed, and stored. An embedded SQL database is used in the device for ECG storage and reporting in all modes - MCT, Holter, and resting 12-lead.
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