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510(k) Data Aggregation

    K Number
    K961219
    Device Name
    PERCUTANEOUS INTRODUCER SYSTEM
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    1996-06-21

    (85 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The proposed kit is indicated for suprapubic bladder drainage and percutancous access for the placement of theminsensor probes in patients undergoing ultrasound-guided urological cryosurgery procedures in accordance with the indications of legally marketed cryosurgery systems.

    Device Description

    The kit is comprised of guidewire(s), access needles(s), dilator(s), divinage catheter with connecting tube, scalpel and syringe.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for a medical device (Percutaneous Introducer System) from 1996. It does not contain the type of detailed study information, acceptance criteria, or performance data that would be relevant to evaluating an AI/ML powered device. The document predates the widespread use of AI/ML in medical devices by decades.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to this 1996 device submission.

    The document primarily focuses on establishing "substantial equivalence" of the device and its components to already legally marketed devices.

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