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510(k) Data Aggregation

    K Number
    K962547
    Device Name
    CARDIOSERV P
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Date Cleared
    1997-03-06

    (251 days)

    Product Code
    DRO
    Regulation Number
    870.5550
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARDIOSERV P

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

    CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia.
    CardioServ is intended to be used by trained operators
    CardioServ is designed for external and internal defibrillation (including cardioversion)
    CardioServ is capable of monitoring the heart rate with adjustable alarm limits.
    CardioServ is designed for external pacing with adjustable current and frequency.
    The intended use of CardioServ is identical to the intended use of the predicate devices.

    Device Description

    CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency.

    AI/ML Overview

    The provided text describes a medical device, the CardioServ P, and its equivalence to predicate devices, but it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met for AI/algorithm performance.

    The document is a 510(k) summary from 1997, focusing on the safety and effectiveness of a defibrillator/pacemaker. The "Technology" section mentions compliance with voluntary standards (e.g., ANSI/AAMI, IEC) and quality assurance measures like "software and hardware testing," "safety testing," and "final validation testing by an independent test group." However, these are general development and testing processes for a hardware medical device, not a study evaluating an AI algorithm's performance against specific acceptance criteria.

    Therefore, I cannot provide the requested information. The document focuses on the equivalence of the CardioServ P to predicate devices based on its intended use, technological similarity, and adherence to established electrical and medical device standards. There is no mention of an AI component, performance metrics like sensitivity/specificity, or a study design suitable for evaluating such a component.

    To fulfill your request, I would need a document detailing the performance evaluation of an AI or algorithm, including specific acceptance criteria and the results of a study designed to demonstrate compliance.

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