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510(k) Data Aggregation

    K Number
    K083690
    Device Name
    FEMVUE(TM) CATHETER SYSTEM
    Manufacturer
    FEMASYS INC.
    Date Cleared
    2009-06-23

    (193 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FEMVUE(TM) CATHETER SYSTEM

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

    The FemVue™ Catheter System is intended for the delivery of contrast media during hysterosalpingography (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.

    Device Description

    The FemVue Catheter System ("FCS") is comprised of two components: a Sheath and a latex free balloon Catheter. The Sheath is used to deliver the Catheter into the uterus.

    AI/ML Overview

    The provided text for the FemVue™ Catheter System (K083690) is a 510(k) summary and FDA clearance letter. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

    The summary focuses on demonstrating substantial equivalence to predicate devices through:

    • Equivalent device type, indication for use, principle of operation, and device description.
    • Similar principles of operation for device placement, device description, and safety features.
    • Substantially equivalent indication for use, placement location, and principle of operation for evaluation of the fallopian tubes.

    The only "testing" mentioned is biocompatibility testing (cytotoxicity, irritation, and sensitization) in compliance with ISO 10993. This type of testing ensures the material safety of the device when in contact with tissues, but it does not evaluate the device's functional performance in terms of diagnostic accuracy or effectiveness for its intended use (e.g., evaluating fallopian tube patency or uterine abnormalities).

    Therefore, based solely on the provided text, I cannot complete the requested tables and sections related to performance acceptance criteria and a study demonstrating that the device meets those criteria. Such information is typically found in the clinical study section of a 510(k) submission, which is not included here.

    The document indicates that the device was cleared based on substantial equivalence to existing devices, implying that its performance is presumed to be similar to its predicates, rather than requiring a de novo performance study with specific acceptance criteria.

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