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510(k) Data Aggregation

    K Number
    K063277
    Device Name
    MAPMATE
    Manufacturer
    EP MEDSYSTEMS, INC.
    Date Cleared
    2006-11-30

    (30 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K994011,K042681,K042999,K020863,K013083,K000248,K000190,K993729,K992968
    Why did this record match?
    Device Name :

    MAPMATE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EP-WorkMate® system with an EP-4 stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping.

    MapMate™ is indicated for use during clinical electrophysiology procedures.

    Device Description

    This application describes a modification to the EP-WorkMate® system that will be offered as an option to customers under the name MapMate™. MapMate™ is comprised of a software module and an electronic interconnection between the EPMedSystems EP-WorkMate® and the BioSense Webster CARTO™ XP Navigation System computer. When the MapMate™ option is utilized, clinicians enter patient data in one system instead of two. A procedure log is created containing the list of map points along with the EP signals. Therefore, valuable time and attention are conserved in the busy EP lab enabling clinicians to focus on the EP case.

    AI/ML Overview

    The provided text is a 510(k) Summary for the EP-WorkMate® with MapMate™ device. It describes the device, its intended use, and indications for use, but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested table and study details from the input text. The document focuses on establishing substantial equivalence to predicate devices, which is common for 510(k) submissions, rather than presenting detailed performance study results against specific criteria.

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