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510(k) Data Aggregation

    K Number
    K112644
    Device Name
    SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
    Manufacturer
    Date Cleared
    2012-12-19

    (464 days)

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

    LOTUS BIO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Seaforia™ Sperm Separation Assistance System Disposable Kit is intended for preparing motile sperm using the swim-up (SU) separation method and holding sperm for use in assisted reproductive procedures such as intrauterine insemination (IUI), intracervical insemination (ICI) and in-vitro fertilization (IVF). The Seaforia™ Sperm Separation Assistance System Disposable Kit is indicated for incubation periods not exceeding one (1) hour. The Seaforia ™ Sperm Separation Assistance System Heating Device is indicated for use only with the Seaforia ™ Sperm Separation Assistance System Disposable Kit to maintain the temperature (37°C ±0.5) of sperm during the swim-up (SU) separation procedure.
    Device Description
    The SeaforiaTM Sperm Separation Assistance System separates motile/progressively motile sperm cells from debris and non-motile sperm cells from the original semen sample for further use in assisted reproductive procedures, including intrauterine insemination (IUI), intra-cervical insemination (ICI) and in-vitro fertilization (IVF). The system provides conditions such as temperature 37°C ±0.5 and effective surface area for the separation of motile human sperm cells. Note: The separation media is not included with the Seaforia" Sperm Separation Assistance System. LOTUS BIO® requires that the media used with the Seaforia'™ Sperm Separation Assistance System be a media cleared for use in the United States that is indicated for sperm handling, washing, or swim-up procedures with a formulation compatible with use outside of a CO2 environment. The system is composed of the following units: - . Seaforia™ Sperm Separation Assistance System Disposable Kit - includes designated containers (separators) for the separation media available in various volumes and labware accessories such as syringes, polypropylene tips, pipette and vials. Five versions of the kit will be available to accommodate sperm samples ranging from 0.5-6 ml (Versions 0.5-2 ml. 2.5-3.0 ml. 3.5-4.0 ml, 4.5-5.0 ml, and 5.5-6.0 ml). - Seaforia™ Sperm Separation Assistance System Heating Device capable . of maintaining the sperm sample at the required temperature (37℃ ±0.5). The sperm separation procedure takes place within the separator and is based on the original swim-up technique. Media is layered over the liquefied semen sample and during a subsequent incubation period of 30 minutes in the Seaforia™ Sperm Separation Assistance System Heating Device, the motile sperm cells migrate from the semen layer into the media.
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