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510(k) Data Aggregation

    K Number
    K021438
    Device Name
    INSEMINATION CATHETER, MODEL 320301
    Manufacturer
    LABOTECT LABOR-TECHNIK GOTTINGEN
    Date Cleared
    2002-07-16

    (71 days)

    Product Code
    MFD
    Regulation Number
    884.5250
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    k910577,k980061,k972823,k982628,k914150
    Why did this record match?
    Device Name :

    INSEMINATION CATHETER, MODEL 320301

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

    The Insemination Catheters are used for transferring sperms into the uterine cavity.
    The catheter is used for intrauterine insemination.

    Device Description

    The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Labotect Insemination Catheter 320301.

    It's important to note that this document describes a traditional medical device (catheter) and not an AI/ML-driven device. Therefore, many of the questions related to AI performance, ground truth, training sets, and expert consensus for AI will not be directly applicable. The details provided are for a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, which focuses on design, material, and manufacturing standards, not algorithmic performance.

    Acceptance Criteria and Device Performance

    Since this is not an AI/ML device, the "acceptance criteria" are related to manufacturing standards, biocompatibility, and functional aspects for an insemination catheter. The device performance is tied to meeting these specific criteria for safety and effectiveness.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    BiocompatibilityTested according to ISO 10993 (cytotoxicity, sensitization, irritation/intracutaneous reactivity)"Biocompatibility is assured according to ISO 10993." (implicitly passed all tests as per Blue Book memorandum #G95-1)
    Sterilization ValidationGamma sterilization validated according to ANSI/AAMI/ISO 11137 and EN 556, SAL 10⁻⁶Fully validated.
    Mouse Embryo Assay (MEA)Two-Cell-MEA, blastocyst hatching >80%"Mouse Embryo Assay batch tested: Two-Cell-MEA, blastocyst hatching >80%" (Indicates routine batch testing to meet this spec.)
    Endotoxin (Bacterial)Bacterial Endotoxin Assay, Endotoxin Value 80% blastocyst hatching), and Endotoxin levels (
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