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510(k) Data Aggregation

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

    (464 days)

    Product Code
    MQK,MQG
    Regulation Number
    884.6160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K112413,K002971
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    Acceptance Criteria and Study for the Seaforia™ Sperm Separation Assistance System

    This response outlines the acceptance criteria and the study conducted to demonstrate the performance of the Seaforia™ Sperm Separation Assistance System, based on the provided 510(k) summary.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document describes performance testing for both the disposable kit and the heating device components of the Seaforia™ Sperm Separation Assistance System.

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Disposable Kit
    HSSA (Human Sperm Survival Assay)≥ 70% motility following 1 hour of exposureHSSA ≥ 70% motility following 1 hour
    Endotoxin (LAL)
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