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510(k) Data Aggregation

    K Number
    K011576
    Device Name
    MEDCOMP ASH SPLIT
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Date Cleared
    2001-06-21

    (30 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K972207
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medcomp Safety Slide Clamp is intended to provide a secondary extension tube clamp on the Medicomp Ash Split-Cath, Duo-Flow 400XL and Duo-Split Catheters to prevent leakage during connection or disconnection of the bloodlines.

    Device Description

    Medcomp selected a standard "off the shelf" slide clamp designed to pinch or occlude a variety of medical tubing. This slide clamp is widely used throughout the medical device industry to prevent air or fluid communication.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp Safety Slide Clamp:

    Unfortunately, the provided text does not contain a detailed table of acceptance criteria or specific performance data with numerical metrics. It focuses more on the problem the device addresses (faulty original clamps) and the fact that a "simulated use testing" was performed, which is referred to as "Performance Data (Simulated Use Testing V-1026)". There are no explicit performance metrics, target values, or reported device performance against those targets.

    However, based on the information provided, we can infer some aspects:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred from Problem Statement)Reported Device Performance (Inferred from Study Conclusion)
    Clamp must effectively occlude the extension tube.The retrofit of the safety slide clamp proves to be a safe and effective correction for implanted catheters. It successfully prevents blood loss.
    Clamp must prevent blood loss between dialysis treatments.The retrofit of the safety slide clamp proves to be a safe and effective correction for implanted catheters.
    Clamp must not damage the extension tube with repeated application."This failure mode [extension tube damage] did not occur during the 52-week simulated use testing."
    Device must be safe for use.The retrofit of the safety slide clamp proves to be a safe and effective correction.

    2. Sample Size for the Test Set and Data Provenance

    • Sample Size: The document mentions "52-week simulated use testing." While the specific number of devices or tests performed is not explicitly stated as a sample size, the duration (52 weeks) indicates a prolonged test. It also refers to "performance data (Simulated Use Testing V-1026)", which implies a specific test protocol.
    • Data Provenance: The study was conducted by Medcomp ("Medcomp confirmed the complaints and determined the root cause... Medcomp has determined that to prevent possible leakage..."). It is a retrospective analysis in the sense that the need for the device arose from existing complaints. The testing itself (simulated use) would be considered prospective for the new clamp design. The country of origin for the data is not explicitly stated, but Medcomp is a US-based company (Harleysville, PA).

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

    • The document does not mention the use of external experts to establish ground truth for the simulated use testing. The "ground truth" for the effectiveness of the clamp seems to be based on the direct observation during the simulated use testing and the conclusion of Medcomp's internal assessment that the clamp prevented the target failure mode.

    4. Adjudication Method for the Test Set

    • The document does not describe an adjudication method involving multiple reviewers for establishing ground truth within the simulated use testing. The evaluation appears to be a direct assessment of the clamp's function during the simulated use.

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

    • No, an MRMC comparative effectiveness study was not conducted or mentioned. This approval is for a device modification (a clamp), and the "study" described is a simulated use test, not a comparative human reader study. Therefore, there's no discussion of human reader improvement with or without AI assistance.

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

    • This question is not applicable as the device is a physical medical device (a clamp), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

    7. The Type of Ground Truth Used

    • The ground truth for the simulated use testing was direct observation of physical performance and absence of failure modes (e.g., no leakage, no damage to the extension tube). It is performance-based ground truth derived from a physical test.

    8. The Sample Size for the Training Set

    • This question is not applicable as the device is a physical medical device (a clamp), not an AI algorithm. There is no concept of a "training set" in this context.

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

    • This question is not applicable as the device is a physical medical device and does not involve a training set.
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