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510(k) Data Aggregation

    K Number
    K220772
    Device Name
    HydroMID 4F Single Lumen Midline Catheter
    Manufacturer
    Access Vascular, Inc.
    Date Cleared
    2022-12-07

    (266 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K161866,K203069
    Why did this record match?
    Reference Devices :

    K161866

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

    The HydroMID is indicated for short term access (

    Device Description

    The HydroMID catheter is a 4 French, single lumegemidfifie catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp.

    HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

    AI/ML Overview

    The provided text describes the 510(k) summary for the HydroMID 4F Single Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device (HydroMID 4F Single Lumen Catheter, K203069) rather than presenting a performance study with specific acceptance criteria and reported device performance in the format requested.

    Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Sample size used for the test set and data provenance," "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established," the document does not provide the requested quantitative information typically found in clinical or AI algorithm performance studies.

    Instead, the document primarily addresses the following:

    1. Acceptance Criteria and Device Performance (Qualitative Description):

    The device is deemed to meet its intended purpose and be substantially equivalent to the predicate device based on various bench tests and biocompatibility testing. The "acceptance criteria" are implied to be adherence to various consensus standards and FDA guidance.

    TestConsensus Standard/FDA Guidance/DescriptionReported Device Performance
    Bench testing (Catheter length, marking spacing, surface continuity, in-life durability)"Confirm that the device meets intended product specifications"The device passed these tests, confirming it meets intended product specifications.
    Biocompatibility testingFDA Final Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 2020)The device passed biocompatibility testing according to the specified FDA guidance and ISO 10993 standards (1, 4, 5, 10, 12).

    The document states, "All necessary performance testing has been conducted on the HydroMID to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices."

    Regarding the other requested information:

    • Sample size used for the test set and the data provenance: Not specified. The document mentions "test units representative of finished devices" for bench testing.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This type of information is typically for AI/diagnostic device studies.
    • Adjudication method: Not applicable or not specified.
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI diagnostic device.
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical catheter, not an algorithm.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical characteristics, the ground truth would be engineering specifications and measurements. For biocompatibility, it's the results of standardized biological assays.
    • The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.
    • How the ground truth for the training set was established: Not applicable.

    Summary of what the document focuses on instead:

    The document focuses on demonstrating substantial equivalence to a predicate device (HydroMID 4F Single Lumen Catheter, K203069) by highlighting:

    • Identical intended use, principle of operation, and similar technological characteristics.
    • Minor differences (e.g., removal of certain warnings for midline therapies, addition of Copper Phthalocyanine Blue 15:1 material for catheter markings, addition of catheter markings) are addressed and supported by bench testing and biocompatibility data.
    • Adherence to various international and FDA consensus standards for medical devices (ISO 10555, ISO 11135, AAMI TIR28, ISO 15223, ISO 10993).
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