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510(k) Data Aggregation

    K Number
    K053494
    Device Name
    OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE
    Manufacturer
    FERTI PRO N.V.
    Date Cleared
    2006-03-23

    (98 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K011462,K030116,K030117
    Why did this record match?
    Device Name :

    OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE

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

    Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.

    Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.

    SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

    Device Description

    Oil For Tissue Culture is a colorless liquid paraffin.

    Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%.

    SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the requested information. The document focuses on a 510(k) summary for reproductive media devices (Oil for Tissue Culture, Gradient System, and SpermFreeze) and primarily discusses their equivalence to predicate devices and their intended indications for use.

    The text does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes (for test or training sets), expert qualifications, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria.

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    K Number
    K011462
    Device Name
    OIL FOR TISSUE CULTURE
    Manufacturer
    CONCEPTION TECHNOLOGIES
    Date Cleared
    2001-06-13

    (30 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OIL FOR TISSUE CULTURE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K991380
    Device Name
    OIL FOR TISSUE CULTURE
    Manufacturer
    ADVANCED REPRODUCTIVE TECHNOLOGIES
    Date Cleared
    2000-04-19

    (364 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OIL FOR TISSUE CULTURE

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

    Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter granting 510(k) clearance for "Oil for Tissue Culture" and an "Indications For Use" statement. It does not include any technical or performance study details.

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