LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K970674
    Device Name
    G.E.M. WATER SYSTEMS, INTERNATIONAL
    Manufacturer
    G.E.M. WATER SYSTEMS
    Date Cleared
    1997-11-19

    (268 days)

    Product Code
    FIN
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    G.E.M. WATER SYSTEMS, INTERNATIONAL

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

    THE INTENDED USE OF THESE DEVICES IS ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PRUIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW THE MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a 510(k) clearance letter from the FDA and an Indication for Use statement for Sodium Bicarbonate Mixers/Delivery Systems. These documents declare substantial equivalence for the device based on its intended use, but they do not contain any information regarding performance metrics, acceptance criteria, or a study demonstrating that the device meets such criteria.

    Therefore, I cannot extract the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "effect size," "standalone performance," "ground truth type," "sample size for training set," or "how ground truth for training set was established" are not addressed in these regulatory documents.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1