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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
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K173075
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    Applicant Name (Manufacturer) :

    iPreg Incorporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The FDA 510(k) summary for the SperSort™ Sperm Sorting Chip (IPG02) provides information on its acceptance criteria and non-clinical performance testing.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are not explicitly stated in a single table, but can be inferred from the performance testing section and comparison with the predicate device.

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance (SperSort™ Sperm Sorting Chip)
    Sterility Assurance Level (SAL)10⁻⁶ (as per predicate device and FDA guidance)10⁻⁶
    Package IntegrityMaintain sterile barrier after simulated transport and agingPassed (Can withstand shipping, sterile barrier maintained)
    Shelf-Life Performance (HSSA)≥ 80% of the control motility at 24 hours after exposure for 30 minutesMaintained performance after two years accelerated aging and passed HSSA (≥ 80% control motility)
    Endotoxin≤ 20 EU/device (device specific)
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