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510(k) Data Aggregation

    K Number
    K000190
    Device Name
    MODIFICATION TO CARTO EP NAVIGATION SYSTEM
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Date Cleared
    2000-05-05

    (113 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO CARTO EP NAVIGATION SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K993729
    Device Name
    MODIFICATION TO CARTO EP NAVIGATION SYSTEM
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Date Cleared
    1999-12-03

    (29 days)

    Product Code
    DQK,DOK
    Regulation Number
    870.1425
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K992968
    Why did this record match?
    Device Name :

    MODIFICATION TO CARTO EP NAVIGATION SYSTEM

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

    The intended use of the CARTO EP Navigation System is catheter-based cardiac mapping. The CARTO EP Navigation System allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

    Device Description

    The CARTO EP Navigation System is designed to acquire, analyze, and display electroanatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. In the CARTO EP Navigation System the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a magnetic location sensor.

    AI/ML Overview

    The provided text is a 510(k) summary for the CARTO™ EP Navigation System. It describes the device, its intended use, and states that non-clinical bench and animal testing show it is as safe and effective as the previously marketed device (CARTO mapping system, 510(k) No. K992968).

    However, the document is a regulatory submission summary and does not contain the detailed study information required to fully answer your request. Specifically, it lacks:

    • Explicit acceptance criteria, reported performance values, sample sizes for test sets (human or animal), details on ground truth establishment for test and training sets, expert qualifications, adjudication methods, or results of MRMC or standalone studies.

    The key takeaway is that the device's substantial equivalence and performance are based on non-clinical bench and animal testing, comparing it to a predicate device, rather than human clinical studies with specific performance metrics against defined acceptance criteria.

    Therefore, most of the information requested in your prompt cannot be extracted from the provided text.

    Here is what can be inferred or explicitly stated from the document:

    AspectInformation from Document
    1. Acceptance Criteria & Reported Device PerformanceNot explicitly stated. The document states: "The non-clinical bench and animal testing show that the device is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness." This implies the acceptance criterion was "equivalent safety and effectiveness to the predicate device" based on non-clinical data, but no specific performance metrics or thresholds are provided.
    2. Sample Size (Test Set) & Data ProvenanceNot specified. "Non-clinical bench and animal testing." No information on the number of animals or specific bench tests.
    3. Number & Qualifications of Experts (Ground Truth - Test)Not applicable/Not specified. As the testing was non-clinical (bench and animal), human experts establishing ground truth for a test set in the conventional sense is not described.
    4. Adjudication Method (Test Set)Not applicable.
    5. MRMC Comparative Effectiveness StudyNo. The document describes non-clinical testing.
    6. Standalone (Algorithm Only) Performance StudyImplied by non-clinical testing, but no specific study details are provided. The device's performance was assessed without human-in-the-loop given it's bench and animal testing for equivalence to a predicate.
    7. Type of Ground Truth UsedNot explicitly stated. For bench testing, "truth" would likely be engineering specifications or known electrical/spatial properties. For animal testing, it would involve direct anatomical/physiological measurements.
    8. Sample Size (Training Set)Not applicable/Not specified. The document does not describe an AI/ML algorithm that would undergo a training phase. It describes a system for acquiring, analyzing, and displaying electroanatomical maps using magnetic location technology.
    9. Ground Truth Establishment (Training Set)Not applicable/Not specified.
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