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510(k) Data Aggregation

    K Number
    K013401
    Device Name
    K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
    Manufacturer
    K-SYSTEMS, KIVEX BIOTEC LTD.
    Date Cleared
    2001-12-14

    (60 days)

    Product Code
    MQG
    Regulation Number
    884.6120
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The K-Systems Culture bag system is intended for use during Assisted Reproduction Technology (ART).

    The K-SYSTEMS Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO2 and pH microenviroment.

    The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO2 and which are flexible and transparent making it possible to evaluate the cells within the culture bag.

    When the K-Systems Culture Bags have been filled with the appropriate gas mixture the K-Systems Culture Bags are placed in a conventional incubator for maintaining the temperature.

    The K-Systems culture bag sytem is a closed system that reduces the risk of cross contamination within the incubator.

    Device Description

    The K-Systems Culture Bag System is a device for storing culture dishes (with embryos and gametes) and to provide a stable CO2 and pH microenvironment. The K-Systems Culture Bag Sealer is a bench top device which inflates the K-Systems Culture Bags with correct gas mixture and which seals the K-Systems Culture Bags. The K-Systems Culture Bags are specially designed Culture Bags which have low penetration value for Oxygen and CO2 and which are flexible and transparent making it possible to evaluate the cells within the culture bag.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the K-Systems Culture Bag Sealer and Culture Bags. It outlines the intended use of the device and confirms its substantial equivalence to a legally marketed predicate device.

    This document DOES NOT contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for device performance.

    The letter is a regulatory approval, not a scientific study report. Therefore, I cannot provide the requested information from the provided text.

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