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510(k) Data Aggregation

    K Number
    K241156
    Device Name
    Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401
    Manufacturer
    Surgical Instrument Service and Savings Inc.
    Date Cleared
    2024-09-14

    (141 days)

    Product Code
    NLH
    Regulation Number
    870.1220
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K221067,K151622
    Why did this record match?
    Reference Devices :

    K221067

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

    The Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheters and Supreme Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmia from endocardial and intravascular sites.

    Device Description

    Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are fixed electrode catheters constructed of a polyurethane insulation/shaft and incorporate platinum electrodes. Each device is marked and tracked and will be taken out of service once the maximum number of cycles has been reached.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for reprocessed electrophysiology catheters, specifically the Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter and Supreme Electrophysiology Catheter.

    However, the document does not contain the detailed information necessary to complete the requested table and answer questions 2 through 9 regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for a medical device that uses an algorithm or AI.

    The document is a regulatory submission for reprocessed physical medical devices (catheters), not a study of an algorithmic or AI-based diagnostic/detection device. The "Non-clinical Testing Summary" section discusses functional performance, mechanical characteristics, corrosion resistance, cleaning, biocompatibility, packaging, shelf-life, and sterilization validation, which are typical for reprocessed physical medical devices.

    Therefore, I cannot extract the requested information as the context of the document does not align with the type of study and acceptance criteria you are asking about (i.e., for an AI/algorithm-based device).

    To summarize, the relevant information you requested is not present in the provided text because the document is about reprocessed physical medical devices, not an AI or algorithm-driven device.

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