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510(k) Data Aggregation

    K Number
    K171303
    Device Name
    Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
    Manufacturer
    University of Texas Medical School at Houston, Texas
    Date Cleared
    2017-09-22

    (142 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K171303,K143664
    Why did this record match?
    Device Name :

    Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

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

    HeartSee K171303 Software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images by quantification of their severity.

    HeartSee K171303 is intended for use by trained professionals, such as nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.

    Device Description

    HeartSee K171303 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/q, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected ot known coronary artery disease. HeartSee K171303 is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification.

    HeartSee contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the K171303 software quantifies absolute rest and stress myocardial perfusion per unit tissue (cc/min/g), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values. Archiving output data is supported for clinical diagnostics, quality control and research.

    AI/ML Overview

    Here's a breakdown of the requested information based on the provided document:

    Acceptance Criteria and Device Performance Study

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by demonstrating that K171303 performs "identically" to the predicate device (K143664) for certain metrics and "better" for others.

    Acceptance Criteria / Performance MetricPredicate Device (K143664) PerformanceDevice (K171303) PerformanceResult (K171303 vs. K143664)
    Quantitative Measurements:
    Rest Perfusion (cc/min/g)N/A (implicit)Values within two decimal places of K143664Identical
    Stress Perfusion (cc/min/g)N/A (implicit)Values within two decimal places of K143664Identical
    Coronary Flow Reserve (CFR)N/A (implicit)Values within two decimal places of K143664Identical
    Mean values and standard deviations for Rest Perfusion, Stress Perfusion, and CFRN/A (implicit)Identical to K143664Identical
    Correlation between K171303 and K143664 for Rest-Stress perfusion and CFRN/A (implicit)R = 1.0, P
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