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510(k) Data Aggregation

    K Number
    K241348
    Device Name
    SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
    Manufacturer
    MotilityCount ApS
    Date Cleared
    2025-01-31

    (263 days)

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

    SwimCount**®** Harvester (1 mL); SwimCount® Harvester (3 mL)

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

    The SwimCount® Harvester is intended for preparing motile sperm cells 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 SwimCount® Harvester (1 mL and 3 mL) is a sperm separation device used to prepare sperm samples for Assisted Reproductive Technology (ART) procedures. The SwimCount® Harvester separates the sperm sample by allowing motile sperm cells to pass the SwimCount® Harvester's membrane system. The SwimCount® Harvester has a design/technology that utilizes the motility of the sperm cells (i.e. swim-up nature) to separate the motile sperm cells from the rest of the sperm population.

    The SwimCount® Harvester has two processing volumes, 1 mL and 3 mL. The device consists of 3 compartments: 1) Sample compartment (1 mL or 3 mL), 2) Medium/Harvest compartment (0.8 mL for both device versions), and 3) Microporous polycarbonate (PC) filter membrane (10 um pore size).

    Each device version has a Semen Inlet port that communicates with the lower sample compartment. The sample compartment is separated from the upper collection compartment by the microporous filter membrane. Semen is added to the lower compartment through the sample inlet port and cleared sperm separation medium (not provided) is added to the upper collection compartment through the Medium Inlet port. After incubation, the separated motile sperm cells are collected from the upper collection compartment through the Harvest Outlet port and used for subsequent assisted reproduction fertilization procedures.

    The SwimCount® Harvester is supplied to the user as sterile (radiation), with a sterility assurance level of (SAL) of 10 6. The devices are individually packed and for single use only.

    AI/ML Overview

    The provided text describes the 510(k) summary for the SwimCount® Harvester, a device for preparing motile sperm cells. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided information:

    1. Table of acceptance criteria and the reported device performance

    Acceptance Criteria (from predicate comparison or performance testing)Reported Device Performance
    Endotoxin:
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