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510(k) Data Aggregation

    K Number
    K993120
    Device Name
    MODIFIED BLOOD RECIPIENT SET
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    1999-11-17

    (58 days)

    Product Code
    BRZ
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFIED BLOOD RECIPIENT SET

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

    The modified Baxter blood sets have the same intended use as currently marketed Baxter blood sets. The intended use of these sets is the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.

    Device Description

    Baxter currently markets a line of intravascular administration sets containing 80 micron and 170 to 260 micron blood filters. These sets are used in blood transfusion procedures for the administration of blood, blood components and solutions. We plan to replace the current 80 micron and 170 to 260 micron filters in these blood sets with a modified filter design. The key differences between the current and proposed blood filters are in the material composition and design of the filter chamber. The current filters are polyester and nylon screen type filters housed in PVC chambers. The new filters will be polyester screen type filters but will be housed in chambers of a different material and design. The mesh size of the polyester screen filter will be standardized to 200 microns to meet ISO standard ISO 1135-4.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for "Modified Blood Administration Sets" and focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.

    The document discusses "functional performance" but does not provide details on specific acceptance criteria, reported performance, sample sizes, expert involvement, or comparative effectiveness with human readers.

    Therefore, I cannot populate the table or answer the questions based on the provided text. The only piece of information that hints at a standard is: "The mesh size of the polyester screen filter will be standardized to 200 microns to meet ISO standard ISO 1135-4." However, this is a design specification, not an acceptance criterion with a reported performance outcome.

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