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510(k) Data Aggregation

    K Number
    K082400
    Device Name
    DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
    Manufacturer
    CULLIGAN SOFT WATER SERVICE CO.
    Date Cleared
    2009-02-03

    (167 days)

    Product Code
    FIP
    Regulation Number
    876.5665
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K991519
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62. These tanks remove chlorine, chloramines, total organic carbons and total dissolved solids from water used to dilute dialysis concentrate to form dialysate, in reprocessing of hemodialyzers, as supply water to the dialysis machines and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These tanks are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Culligan's tanks are not to be used alone.

    Device Description

    The Culligan Soft Water Service Company, Deionizer and Carbon Exchange Service for Hemodialysis includes carbon filtration for the removal of chlorine and chloramines and deionizer (DI) exchange tanks for the removal of contaminants from the water through an ion exchange process to provide AAMI quality water for hemodialysis applications.

    AI/ML Overview

    This document is a 510(k) summary for the Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks for hemodialysis, not a study report. It states that the device is substantially equivalent to a predicate device (Ameriwater Dialysis Deionizer Exchange Service, K991519) and defines its intended use and general specifications.

    Therefore, the requested information regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not available within the provided text. This document focuses on the regulatory submission process and establishing substantial equivalence rather than presenting performance study results.

    To fulfill the request, a hypothetical example based on the type of device (water purification for hemodialysis) would typically involve:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance MetricAcceptance Criteria (e.g., based on ANSI/AAMI RD62)Reported Device Performance
    Chlorine Removal
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