LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K161323
    Device Name
    Solution Set for Epidural Use
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Date Cleared
    2016-11-30

    (203 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K142011,K925058
    Why did this record match?
    Device Name :

    Solution Set for Epidural Use

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

    For the administration of fluids from a container into the patient's epidural space with Baxter infusion pumps.

    Device Description

    The Solution Set for Epidural Use is a single use disposable device intended for the administration of fluids from a container into the epidural space. The set is used for epidural infusions of fluids (typically analgesic or anesthetic) as an intermittent or continuous infusion to reduce chronic or post-operative pain. The set consists of a nonvented spike, 60 drops per mL drip chamber, minidrip adapter, tubing, fixtured slide clamp, on-off roller clamp, and a male epidural lock connector. The connector is compliant to the provisional AAMI/CN6:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.

    AI/ML Overview

    The provided text describes the Baxter Healthcare Corporation's "Solution Set for Epidural Use" (K161323) and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

    The document is a 510(k) premarket notification for a traditional medical device (an epidural IV administration set), not an AI/ML device. Therefore, the questions regarding AI/ML device performance, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies are not applicable to this document.

    The document focuses on:

    • Substantial equivalence to an existing predicate device (Bard Epidural Spike Tubing Set, K925058).
    • Nonclinical bench testing to evaluate functional performance (e.g., Drop Volume Test, Cannula Pull Out Test, Pump Tests).
    • Biocompatibility testing (e.g., Cytotoxicity, Systemic Toxicity).
    • Sterility testing.
    • Shelf-life testing.

    All these tests are reported to have "met the acceptance criteria," but the specific numerical acceptance criteria and the detailed results are not provided in this summary.

    Therefore, I cannot fulfill your request using the provided text because it does not pertain to an AI/ML device and lacks the specific details about acceptance criteria and study results in the format you requested for an AI/ML model.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1