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510(k) Data Aggregation

    K Number
    K971114
    Device Name
    BIOACCESS MARROW HARVEST SYSTEM
    Manufacturer
    BIOACCESS, INC.
    Date Cleared
    1997-06-03

    (69 days)

    Product Code
    GDM
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K953064,K843830,K895198
    Why did this record match?
    Reference Devices :

    K953064, K843830, K895198

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

    The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.

    Device Description

    The device is a hand-held battery powered device that penetrates the bone and allows aspiration through a hole in the bit for bone marrow harvest. The device is made from medical grade components and sold as a disposable procedure kit and a reusable motor unit.

    AI/ML Overview

    This document is a 510(k) summary for the BioAccess Marrow Harvest System, submitted in 1997. It describes a medical device and its substantial equivalence to previously marketed devices. The document does not contain information about acceptance criteria or a study proving a device meets acceptance criteria, as it pertains to a physical medical device (a marrow harvest system) and not an AI/ML powered device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically associated with AI/ML device submissions, which are much more recent than a 1997 510(k) for a physical surgical instrument.

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