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510(k) Data Aggregation

    K Number
    K983559
    Device Name
    BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
    Manufacturer
    ICU MEDICAL, INC.
    Date Cleared
    1998-12-24

    (72 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 'Blood Tubing Accessory with CLAVE Connector' is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE Connector allows the clinician needle-free blood withdrawal.

    Device Description

    The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    AI/ML Overview

    This submission describes a medical device, the "Blood Tubing Accessory with CLAVE Connector," not an AI/ML powered device. As such, the information provided does not align with the requested categories for AI/ML device studies. I will provide the acceptance criteria and study information that is available in the provided text.

    Acceptance Criteria and Device Performance (based on non-AI/ML device information):

    Acceptance CriteriaReported Device Performance
    Hemolysis (no significant hemolysis)A hemolysis study conducted by an independent laboratory found no significant hemolysis occurs with the use of the CLAVE Connector.
    Sterile barrier maintenance (for 6 days/144 hours with 24 activations/day)A microbial challenge study showed that the CLAVE Connector maintained a sterile barrier for six days or 144 hours while administering 24 repeat activations per day with a standard disinfection protocol. These results indicate that the CLAVE Connector, when using a standard disinfection protocol, did not increase infection rates under worst-case clinical simulation.

    Study Details (based on non-AI/ML device information):

    1. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are non-clinical laboratory studies, not based on patient data in the context of an "AI/ML test set."
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical studies like hemolysis and microbial challenge is typically established by laboratory testing methodologies and standards, not expert consensus in the diagnostic sense.
    3. Adjudication method: Not applicable. This applies to diagnostic assessments, not non-clinical device performance studies.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a non-AI/ML device; an MRMC study is not relevant.
    5. If a standalone study was done: Yes, the described studies (hemolysis and microbial challenge) are standalone performance tests for the device's physical and biological properties.
    6. The type of ground truth used:
      • Hemolysis: The ground truth would be based on established laboratory methods and standards for quantifying hemolysis in blood samples.
      • Microbial challenge: The ground truth would be based on microbiological techniques to assess sterility and barrier integrity, likely quantifying microbial growth or penetration under controlled conditions.
    7. The sample size for the training set: Not applicable. This device does not involve AI/ML.
    8. How the ground truth for the training set was established: Not applicable. This device does not involve AI/ML.
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