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510(k) Data Aggregation

    K Number
    K241693
    Device Name
    FemChec Controlled Saline-Air Device (FCD-250)
    Manufacturer
    Femasys Inc.
    Date Cleared
    2024-09-06

    (86 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K110288
    Why did this record match?
    Device Name :

    FemChec Controlled Saline-Air Device (FCD-250)

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

    FemChec® is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).

    Device Description

    FemChec® is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via EO sterilization and is intended for single-use.

    AI/ML Overview

    The provided text is a 510(k) summary for the FemChec Controlled Saline-Air Device (FCD-250), which is a medical device and not an AI or software device. Therefore, the questions related to AI/algorithm performance, training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data for a physical medical device.

    However, I can extract the acceptance criteria and a summary of the studies performed from the provided text for the FemChec device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Tests/CriteriaReported Device Performance
    SterilizationEthylene Oxide Sterilization Validation per ISO 11135-1:2014, AAMI TIR 28:2016, ISO 10993-7:2008Not explicitly stated "met criteria," but implied that testing was performed to support substantial equivalence.
    PackagingVisual inspection, Bubble Leak test per ASTM F2096-11, Seal Strength testing per ASTM F88/F88M-15Not explicitly stated "met criteria," but implied that testing was performed to support substantial equivalence.
    TransportationTransportation Simulation testing per ASTM D4169-14Not explicitly stated "met criteria," but implied that testing was performed to support substantial equivalence.
    BiocompatibilityCytotoxicity per ISO 10993-5:2009, Sensitization ISO 10993-10:2021, Irritation per ISO 10993-10:2021Tested to be non-cytotoxic, non-sensitizing, and non-irritating.
    Bench PerformanceVisual Inspection, Functional/Cycle Testing, Saline-Air Quantification (before and after accelerated aging to 12 months real-time aging per ASTM F1980-16)All predetermined acceptance criteria were met.

    2. Sample Size Used for the Test Set and Data Provenance

    This information is not applicable as the studies conducted are non-clinical bench performance and material compatibility studies for a physical device, not a performance study involving a test set of data points or images.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

    This information is not applicable. Ground truth establishment by experts is relevant for AI/software devices requiring interpretation of data (e.g., medical images), which is not the case for this physical medical device.

    4. Adjudication Method for the Test Set

    This information is not applicable. Adjudication methods are relevant for studies where multiple readers/experts assess cases, which is not applicable to the non-clinical studies for this physical device.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance studies for a physical device.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    This information is not applicable. The device is a physical medical instrument, not an algorithm.

    7. The Type of Ground Truth Used

    This information is not applicable in the context of AI/software performance. For the described bench tests, the "ground truth" would be established by the specifications and standards (e.g., flow rates, material properties, sterility levels) defined in the test protocols themselves, which are based on recognized international and ASTM standards.

    8. The Sample Size for the Training Set

    This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set.

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