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    K Number
    K961927
    Device Name
    RMI HEMOCONCENTRACTOR TUBING SET
    Manufacturer
    RESEARCH MEDICAL, INC.
    Date Cleared
    1996-08-13

    (88 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RMI HEMOCONCENTRACTOR TUBING SET

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

    The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container.

    Device Description

    The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container. The RMI Hemoconcentrator Tubing Set is provided sterile and non-pyrogenic.

    AI/ML Overview

    Here's an analysis of the provided text regarding the RMI Hemoconcentrator Tubing Set, structured to address your specific questions.

    Note: The provided text primarily focuses on biocompatibility and basic functional performance testing. It does not contain information related to AI/ML device performance, ground truth establishment, expert consensus, or multi-reader multi-case studies. Therefore, many of your requested points will be marked as "Not Applicable" or "Not Provided in Text."

    Acceptance Criteria and Device Performance for RMI Hemoconcentrator Tubing Set

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    BiocompatibilityNot cytotoxicThe test article is not cytotoxic (MEM Elution Test).
    Not a significant sensitizerUpon rechallenge, none of the test group or negative control animals exhibited scores higher than 1 (response of 1 is not considered significant sensitization) (Guinea Pig Maximization).
    Meets USP Intracutaneous Test requirementsThe test article met the requirements of the USP Intracutaneous Test.
    Meets USP Systemic Injection Test requirementsThe test article met the requirements of the USP Systemic Injection Test.
    Hemolysis ≤ Acceptable Limit (Implicitly 0% or very low)The test article had 0.00% Hemolysis.
    Functional / Performance Testing
    Flow vs. Pressure (Blood Flow)Deliver flows exceeding 1000 ml/min with line pressure
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