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    K Number
    K060119
    Device Name
    MCKINLEY SATURATION CATHETER
    Manufacturer
    MCKINLEY MEDICAL LLC
    Date Cleared
    2006-04-12

    (85 days)

    Product Code
    FRN,BSO
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K031600,K003966,K994374
    Why did this record match?
    Device Name :

    MCKINLEY SATURATION CATHETER

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

    The McKinley Saturation Catheter™ is intended for continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous.

    Device Description

    The McKinley Saturation Catheter™ is a single patient use disposable infusion catheter, intended for connection to an infusion device, used to deliver pain medication to a patient for pain management. The McKinley Saturation Catheter™ is a flexible, tubular infusion catheter with multiple holes located throughout the fenestrated segment along the distal end of the catheter. The catheter will be available in different sizes (varying length of fenestrated segment, number of holes, diameter of catheter body), as appropriate for use in a variety of catheter placements. The McKinley Saturation Catheter™ connects to an infusion device via a proximal luerlock connector.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the McKinley Saturation Catheter, organized according to your requested format.

    It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical study. Therefore, many of your requested fields will reflect this rather than a typical performance study.

    Acceptance Criteria and Study for the McKinley Saturation Catheter™

    This 510(k) submission for the McKinley Saturation Catheter™ primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing performance against new, quantitative acceptance criteria through a dedicated clinical study. The "acceptance criteria" here are implicitly about meeting the safety, effectiveness, intended use, function, materials, and performance standards of the chosen predicate devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implicit from Substantial Equivalence)Reported Device Performance
    Intended Use: Continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space, via intraoperative, subcutaneous, or percutaneous routes.The McKinley Saturation Catheter™ is intended for identical use as the predicate devices: "continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous." This indicates it meets the functional requirements for its intended application.
    Function: Deliver pain medication.The device is described as "a single patient use disposable infusion catheter, intended for connection to an infusion device, used to deliver pain medication to a patient for pain management." Its design with multiple holes (fenestrations) specifically supports this function, similar to predicate devices.
    Materials: Material composition is safe and effective for infusion of pain medication."The materials contained in the McKinley Saturation Catheter™ are substantially equivalent to those contained in the legally-marketed predicate devices." This implies that the materials are accepted as safe and effective based on prior market approval of the predicates.
    Design/Performance Characteristics: Flexible, tubular infusion catheter with multiple holes, available in different sizes, luerlock connector. No new safety or efficacy concerns.The device is described as "a flexible, tubular infusion catheter with multiple holes located throughout the fenestrated segment along the distal end of the catheter. The catheter will be available in different sizes... connects to an infusion device via a proximal luerlock connector." The conclusion states, "The McKinley Saturation Catheter™ does not raise any new safety and efficacy concerns when compared to the predicate devices."

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

    • Sample Size: Not applicable. This submission does not report on a specific "test set" of patients or data from a clinical performance study. The evaluation is based on a comparison to predicate device characteristics and existing regulatory approvals.
    • Data Provenance: Not applicable for a performance study. The data provenance relevant to the 510(k) is the regulatory history and technical specifications of the predicate devices: Micor Wundcath Conduction Catheter (K031600 & K003966) and I-Flow Soaker Catheter (K994374).

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    • Number of Experts: Not applicable. There was no independent expert panel used to establish ground truth for a clinical test set for this 510(k) submission.
    • Qualifications: Not applicable.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed or reported in this submission.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • MRMC Study: No. An MRMC comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging devices where human interpretation is a key component, not for an infusion catheter.
    • Effect Size of Human Readers Improvement: Not applicable.

    6. Standalone (Algorithm Only) Performance

    • Standalone Performance: Not applicable. The McKinley Saturation Catheter™ is a medical device (catheter), not an algorithm or AI system. Therefore, standalone performance in that context is irrelevant.

    7. Type of Ground Truth Used

    • Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety, effectiveness, and regulatory compliance of the predicate devices. The substantial equivalence argument relies on the well-understood performance of the Micor Wundcath Conduction Catheter and the I-Flow Soaker Catheter, which have already gone through their own approval processes and have a history of safe and effective use.

    8. Sample Size for the Training Set

    • Sample Size: Not applicable. There was no "training set" in the context of an algorithm or machine learning model. The development of the catheter would be based on engineering design principles, material science, and manufacturing processes, guided by the characteristics of the predicate devices.

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

    • Ground Truth Establishment: Not applicable. As there was no training set, there was no ground truth for it to be established. The design and development of the McKinley Saturation Catheter™ were guided by the known characteristics and approved uses of the predicate devices.
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