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510(k) Data Aggregation

    K Number
    K030442
    Device Name
    CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2003-07-21

    (160 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K022561
    Predicate For
    K063446
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter, and HemoSplit™ Long-Term Hemodialysis Catheter.

    Device Description

    The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

    AI/ML Overview

    Here's an analysis of the provided text regarding the HemoSplit Repair Kit, focusing on the acceptance criteria and study information:

    HemoSplit Repair Kit: Acceptance Criteria and Study Information

    Note: The provided documentation (K030442) is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) or a more extensive clinical trial report would. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement, and advanced study methodologies like MRMC or standalone performance, is not present in this document. The "study" here is largely based on demonstrating equivalence rather than new performance.

    1. Table of Acceptance Criteria and Reported Device Performance

    Given the nature of this 510(k) submission, the "acceptance criteria" are interpreted as the requirements for demonstrating substantial equivalence, and the "reported device performance" is framed in terms of meeting those equivalence criteria.

    Acceptance Criterion (for Substantial Equivalence)Reported Device Performance (as per 510(k))
    Same Indication StatementNo. The new device's indication statement changed to remove a generic trade name and add the HemoSplit™ catheter to the list of repairable catheters.
    Differences Alter Intended Therapeutic Effect?No. Stated as "No, the intended use is the same. There is only the addition of a catheter trade name to the list of repairable catheters."
    Same Intended Use?Yes. Stated as "Yes, the intended use is identical."
    Same Technological Characteristics (design, materials, etc.)?Yes. Stated as "Yes, the technological characteristics are exactly the same."
    Descriptive Characteristics Precise Enough to Ensure Equivalence?Yes.

    Conclusion from the 510(k): Based on these criteria, the Catheter Repair Kit with Replacement Connector (HemoSplit Repair Kit) was deemed substantially equivalent to the predicate device (Catheter Repair Kit with Replacement Connector, K022561).

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

    • Sample Size for Test Set: Not applicable / Not mentioned. This 510(k) submission does not describe a separate "test set" in the context of performance evaluation with specific data points. The focus is on comparing the design and stated intended use to a predicate device.
    • Data Provenance: Not applicable / Not mentioned. No specific data is presented that would have a country of origin or be classified as retrospective/prospective.

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

    • Number of Experts: Not applicable / Not mentioned. As there is no specific "test set" described for performance evaluation, there's no mention of experts establishing ground truth for such a set.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable / Not mentioned. Without a test set and expert review, an adjudication method is not relevant to this submission.

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

    • MRMC Study: No. This type of study is not described or referenced in the 510(k) summary. The device is a physical repair kit, not an AI or imaging diagnostic tool where MRMC studies are common.
    • Effect Size of Human Readers Improve with AI vs. Without AI: Not applicable. (See above.)

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    • Standalone Study: Not applicable. This device is a physical product (a repair kit), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of AI/software does not apply.

    7. Type of Ground Truth Used

    • Type of Ground Truth: The "ground truth" in this 510(k) submission is the established performance and safety profile of the predicate device (Catheter Repair Kit with Replacement Connector, K022561). The new device demonstrates "substantial equivalence" to this known entity.

    8. Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable / Not mentioned. This submission does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.

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

    • How Ground Truth for Training Set Was Established: Not applicable / Not mentioned. (See above.)
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