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510(k) Data Aggregation

    K Number
    K232980
    Device Name
    SpermAlign Sperm Separation Device
    Manufacturer
    CytoSwim Ltd
    Date Cleared
    2024-03-14

    (175 days)

    Product Code
    MQK
    Regulation Number
    884.6160
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K173075
    Why did this record match?
    Device Name :

    SpermAlign Sperm Separation Device

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SpermAlign Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) procedures.

    Device Description

    SpermAlign is a sperm separation device used to prepare motile sperm for assisted reproductive technology (ART) procedures. Separation is achieved through a fluid filled microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilizes a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and sperm washing media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in intracytoplasmic sperm injection (ICSI) or in vitro fertilization (IVF) procedures.

    SpermAlign is sterilized using X-Ray irradiation and has a sterility assurance level (SAL) of 10-6. The devices are individually packaged and for single use only.

    AI/ML Overview

    The provided document is a 510(k) summary for the SpermAlign Sperm Separation Device, indicating substantial equivalence to a predicate device. While it details several non-clinical performance tests, it does NOT contain the specific information requested about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML medical device, particularly regarding test sets, expert adjudication, MRMC studies, or standalone algorithm performance. The device described appears to be a physical labware device, not an AI/ML software device.

    Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML performance, sample sizes for AI/ML test/training data, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document.

    However, I can extract information regarding the non-clinical performance studies conducted for this physical device:

    A table of acceptance criteria and the reported device performance (for physical device tests):

    TestAcceptance CriterionReported Performance
    Sterilization ValidationSterility Assurance Level (SAL) of 10⁻⁶Met SAL of 10⁻⁶
    Endotoxin Testing
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