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510(k) Data Aggregation

    K Number
    K241626
    Device Name
    SperSort™ Sperm Sorting Chip (IPG02)
    Manufacturer
    iPreg Incorporation
    Date Cleared
    2025-02-20

    (259 days)

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

    iPreg Incorporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SperSort™ Sperm Sorting Chip 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 SperSort™ Sperm Sorting Chip is used to prepare motile sperm for assisted reproductive technology (ART) procedures. The device separates motile sperm from the semen based on the mobility (i.e., swim-up nature) of motile sperm. The SperSort™ Sperm Sorting Chip consists of an upper collection chamber and a lower semen sample chamber. The chambers are separated by porous filter which allow motile sperm to pass from the lower chamber to the upper chamber. Both the semen sample injection port and sperm collection port are located on the upper cover. The semen sample injection port directly connects to the lower chamber, while the sperm collection port is connected to the upper chamber. The SperSort™ Sperm Sorting Chip accommodates a 1.9 mL semen sample. Liquefied semen is added to the lower chamber and cleared sperm washing medium (1.5 mL) is added to the upper chamber. Following incubation for 30 minutes at 37°C, the isolated sperm are gathered from the collection port. The SperSort™ Sperm Sorting Chip is a radiation-sterilized device with a sterility assurance level (SAL) of 10-9. They are individually packaged and for single use only.
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