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510(k) Data Aggregation

    K Number
    K071104
    Device Name
    ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
    Manufacturer
    FLIER'S QUALITY WATER SYSTEMS INC
    Date Cleared
    2008-01-14

    (270 days)

    Product Code
    FIP
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLIER'S QUALITY WATER SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flier's Quality Water Systems, Inc. systems are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001. They remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, in the reprocessing of hemodialyzers, and equipment rinse and disinfection. The Acute System #1 consists of two each carbon and mixed bed DI tanks with pre & post filtration. It is intended to be placed on the back of dialysis machine or on a handcart for single patient dialysis. Acute System #2 consists of just carbon tanks and is intended to be used as pretreatment to a single patient RO system. The Central System #1 and #2 consists of two or more carbon and mixed bed D1 tanks with pre & post filtration. They are used as either a temporary system to feed multiple dialysis machines in normal use, or for a system to feed a biomedical technician service station. For permanent, multiple station dialysis clinics Flier's recommends using central water treatment systems including reverse osmosis. The Back-up System #1 and #2 consists of two or more mixed bed DI tanks as a component in a "back up" condition when a RO system or major component on a water purification system for hemodialysis is in need of repair. It may also be used in DI polishing mode to remove ions from an RO stream to meet AAMI RD62:2001 requirements. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These systems are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Flier's systems are not to be used alone.
    Device Description
    The systems are primary or temporary devices used to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62:2001. The Flier's Quality Water Systems, Inc. systems purify potable feed water through deionization. Deionization is used to remove 99.9% of ions from water. Deionization alone does not remove particulates, organics, bacteria, viruses or endotoxins. The systems require pretreatment and post-treatment. Deionizers are designed in a hemodialysis application to treat RO water or carbon filtered potable water. Improper use can result in the formation of nitrosamines in the effluent of the deionizer. The purpose of the pretreatment section of the system is to condition that feed water supplying the deionizers. Conditioning the feed water will include: cartridge filters to reduce particulates and sediment and carbon filtration tarks to remove chlorine/chloramine residual. The purpose of the post-treatment section of the system is to remove bacteria and endotoxins or lower them to acceptable levels as required by AAMI standards. The post-treatment section of the system will include: submicron/ultrafilters after the deionizers, sample ports to check for microbial contamination and to test for comprehensive AAMI analysis, a 1 megohm quality control light at mid tank and a temperature compensated audible and visual resistivity alarm set at 1M ohm or greater for final water quality. A remote alarm will be installed if the deionization system is not located in the patient treatment area. A distribution section of the system is necessary to deliver product water that meets ANSI/AAMI standards to the points of use. During use, continual monitoring of the effluent through the use of the temperature compensated audible and visual resistivity alarm is required. Routine monitoring of the mid tank quality indicator is also required on intervals during the day, at least before and after each patient treatment. Should final water quality fall at or below 1 megohm, the alarm will sound and all patient treatments must be discontinued. The deionization tanks must be replaced per tank exchange procedure prior to resuming and patient treatment. Divert to drain option will be provided when necessary per AAMI quidelines. Divert to drain is not supplied for acute systems located in patient room. Monitor and divert to drain not supplied for back-up systems with existing monitor/alarm/divert.
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