LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992894
    Device Name
    MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Date Cleared
    1999-11-24

    (89 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K883111,K922757
    Why did this record match?
    Reference Devices :

    K883111,K922757

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

    The Baxter Meridian machine is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafitration controller to prevent excessive loss of water from the patient's blood, an extracomoreal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard nearchardialysis treatment capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acctate mode for concentrates .

    The Meridian Hemodialysis Machine is designed to operate in the chronic and acute dialysis environment.

    Device Description

    The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an extracorporeal circuit of blood tubing and hemodialyzer, and monitors the system for safe operating conditions. Its features include high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis capabilities, and patient prescription entry through a patient data card. Optional features include automated patient blood pressure monitoring, a heparin pump and a sodium administration button.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a 510(k) summary for the Baxter Meridian Hemodialysis Machine, which focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.

    No information is available regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number and qualifications of experts for ground truth establishment.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Training set sample size.
    9. Ground truth establishment for the training set.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1