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510(k) Data Aggregation

    K Number
    K151245
    Device Name
    Rhythm View Workstation (non-streaming, steaming option)
    Manufacturer
    TOPERA, INC.
    Date Cleared
    2015-09-15

    (127 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPERA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    The RhythmView Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Radio-Frequency Identification (RFID) Reader/Writer, Solid State Hard Drive (optional component), Keyboard, Mouse, Two Port USB Switch, Video Splitter (new component - streaming option only), *Panel box required, Software. RhythmView takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The Rhythm View computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
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    K Number
    K142901
    Device Name
    RhythmView Workstation
    Manufacturer
    Topera, Inc.
    Date Cleared
    2014-12-19

    (66 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Topera, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    The RhythmView™ Workstation is comprised of the following components: Cart, Keyboard, Monitor/Display, Mouse, Computer Software, Radio-Frequency Identification (RFID) Reader/Writer (new component), Two Port USB Switch (new component), Solid State Hard Drive (new optional component). RhythmView™ takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The RhythmView™ computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView™ then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
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    K Number
    K142182
    Device Name
    FRIMAP ADAPTER CONNECTOR (MAC)
    Manufacturer
    TOPERA, INC.
    Date Cleared
    2014-09-09

    (32 days)

    Product Code
    MTD
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPERA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Topera FIRMap™ Mapping Adapter Connector (MAC) is indicated for use with Topera's FIRMap™ Catheters in cardiac electrophysiology procedures. Refer to the individual Instructions for Use of the associated FIRMap Catheter. It is important to carefully review the specific indications included with the associated catheters prior to use.
    Device Description
    The FIRMapTM MAC is a re-usable, non-sterile, non-patient contact device that is intended to be used in conjunction with the FIRMapTM catheter. The MAC acts as an interface between the catheter and electrophysiology recording system by connecting the extension cable to the EP system fan out cable.
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    K Number
    K133305
    Device Name
    RHYTHM VIEW WORKSTATION
    Manufacturer
    TOPERA, INC.
    Date Cleared
    2013-12-16

    (49 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPERA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rhythm View™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™ Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    The RhythmView™ Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Keyboard, Mouse, Software. RhythmView™ takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The RhythmView™ computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The Rhythm View™ then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
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    K Number
    K130827
    Device Name
    FIRMAP CATHETER
    Manufacturer
    TOPERA, INC.
    Date Cleared
    2013-10-31

    (219 days)

    Product Code
    MTD
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPERA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Topera FIRMap™ Catheter may also be used for delivery of externally generated pacing stimuli.
    Device Description
    The FIRMap™ Catheter is comprised of these major components, • Handle • Handle Strain Relief • Introducer Tool • Catheter Shaft • Basket The FIRMap™ Catheter is a sterile, single use device used to detect and record intracardiac electrical potentials and to deliver externally generated pacing stimuli. The distal, expandable basket assembly is, in essence, eight miniature octapolar catheters that are arranged into a three dimensional "basket" shape.. The basket assembly contains an array of 64 electrodes mounted onto eight support structures called splines.
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    K Number
    K123295
    Device Name
    RHYTHM VIEW
    Manufacturer
    TOPERA, INC.
    Date Cleared
    2013-04-24

    (184 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPERA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™M Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    The RhythmView is comprised of these major components, 1. RhythmView hardware - Cart, Computer, monitor, keyboard, and mouse 2. RhythmView software - Software pre-installed The RhythmView Workstation takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias.
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    K Number
    K110878
    Device Name
    RHYTHMVIEW (TM)
    Manufacturer
    TOPERA, INC.
    Date Cleared
    2011-09-23

    (177 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPERA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™M Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
    Device Description
    The RhythmView is comprised of these major components, 1. RhythmView hardware – Computer, monitor, keyboard, and mouse 2. RhythmView Software – Software pre-installed The RhythmView Workstation takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias.
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