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510(k) Data Aggregation

    K Number
    K964539
    Device Name
    PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST
    Manufacturer
    ZYZATECH WATER SYSTEMS, INC.
    Date Cleared
    1997-11-26

    (379 days)

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

    ZYZATECH WATER SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A ZyzaTech Portable, V, Z or T Series Reverse Osmosis System and its pretreatment and product water distribution components is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
    Device Description
    The ZyzaTech series RO systems purify feed water through reverse osmosis which is the opposite of osmosis. Osmosis is the natural process wherein concentrated and dilute solutions, separated by a semipermeable membrane, flow to equalize concentrations. Solvent will flow from the dilute to the concentrated side of the membrane creating equal levels of concentration. Reverse osmosis is the application of high hydrostatic pressure on the concentrated solution; the direction of flow is reversed so that high solute concentrations flow across a semi-permeable membrane and become dilute concentrations. This results in two streams of water; one that is purer than the feed water, and the other that is higher in concentrates than the feed water. The pure flow is product water. The high concentrate flow is waste water. The purpose of a pretreatment section of the system is to remove chlorine/chloramines and to condition the feed water supplying the RO unit. Conditioning the feed water can include: boosting the pressure, tempering, removal of particulates and, often, membrane scaling factors, along with volatile inorganic and organic solutes. The pretreatment section can include: feed water booster pumps, a temperature blend valve, chemical feed unit, cartidge filters, multi-media (sediment) filters, water softeners, dealkalizers and carbon filtration tanks. The RO unit removes dissolved inorganic solutes with a molecular weight greater than 300, bacteria, viruses, endotoxins and particles. The primary elements of a RO unit are: a prefilter, RO pump and RO membranes housed in pressure vessels. The purpose of a product water distribution section of a system is to deliver product water that meets AAMI standards to the points of use. Additional post-treatment measures are intended to control or eliminate bacteria prior to the points of use, especially in an indirect feed type of system. The product water distribution section can include: a storage tank, distribution repressurization pumps, distribution loop, UV irradiators, ultra and sub-micron filters. Depending upon the series and model, ZyzaTech water purification systems produce typically from 250 gpd to 42,000 gpd of product water with a range of 17-75 percent recovery rate. Rejection of total dissolved solids (TDS) and monovalent and polyvalent ions is in the range of 95-99% depending upon feed water characteristics. Bacteria and pyrogens are rejected 99%. Organic size cut-off is a molecular weight greater than 300 Dalton. ZyzaTech's water purification systems produce product water that meets the requirements of the voluntary standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD5-1992, Hemodialysis Systems.
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