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510(k) Data Aggregation

    K Number
    K173075
    Device Name
    ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
    Manufacturer
    DxNow, Inc.
    Date Cleared
    2018-03-08

    (160 days)

    Product Code
    MQK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DxNow, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZyMot ICSI Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) procedures. The ZyMot Multi Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
    Device Description
    The ZyMōt ICSI Sperm Separation Device and ZyMōt Multi Sperm Separation Device (850μl, 3ml) are used to prepare motile sperm for assisted reproductive technology (ART) procedures. They separate motile sperm from the semen based on the mobility (i.e., swimup nature) of motile sperm. The ZyMōt ICSI Sperm Separation Device has five micro-channels, each accommodating 2ul of semen and processes up to five separations from one semen sample. Each channel has an inlet port for applying the semen sample and an outlet port for collecting the motile sperm. The ports are connected by a fluid-filled micro-channel in which separation occurs. The ZyMōt Multi Sperm Separation Device has two processing volumes, 850µl and 3ml. Each version has an inlet port that communicates with the lower sample chamber. The sample chamber is separated from the upper collection chamber by a microporous filter. Untreated semen is added through the inlet port. After incubation, the separated motile sperm are collected from the upper chamber through the outlet port. The subject devices are radiation-sterilized devices with a sterility assurance level (SAL) of 10-6. They are individually packaged and for single-use only.
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