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510(k) Data Aggregation

    K Number
    K051137
    Device Name
    TECHDEVICE OCCLUSION BALLOON CATHETER
    Manufacturer
    TECHDEVICE CORPORATION
    Date Cleared
    2006-02-24

    (296 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K021721
    Why did this record match?
    Device Name :

    TECHDEVICE OCCLUSION BALLOON CATHETER

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

    The TechDevice Percutaneous Occlusion Balloon Catheter is for temporary vessel occlusion, where the stoppage of blood flow is desirable. This device is not indicated for neuro, or cardiac use.

    Device Description

    The occlusion balloon catheter consists of a latex balloon (outside diameter 11mm, 15mm, 18mm or 27mm) mounted on the distal end of a 5 French catheter shaft ( 45cm -- 100cm in length). The dual-lumen catheter shaft terminates in a proximal molded bifurcation attached to luer connectors. The hub labeled "Distal" connects to the distal lumen which passes completely through the catheter and can be used for catheter placement over a guidewire, or fluid infusion into the vessel. The second hub, labeled "Balloon", terminates under the balloon via an opening skived into the extrusion. This is used for balloon inflation.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device, the "TechDevice Percutaneous Occlusion Balloon Catheter." This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than performance against specific acceptance criteria for a diagnostic or AI-driven decision-making system.

    Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory submission. The submission details physical and performance design characteristics and bench testing, but not clinical study data for AI or diagnostic performance.

    Here's an attempt to address the request based on the provided text, highlighting where information is not available:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from text)Reported Device Performance (from text)
    Not explicitly stated as "acceptance criteria" for a study.Tensile Strength (balloon-to-shaft and hub/lube-to-shaft): No specific values reported, but comparative testing was performed and deemed equivalent.
    Balloon Burst Testing: No specific values reported, but comparative testing was performed and deemed equivalent.
    Balloon Multiple Inflation Testing: No specific values reported, but comparative testing was performed and deemed equivalent.
    Substantial equivalence to predicate device (K021721).The device has been shown to be safe and effective for its intended use based on comparison to predicate and results of comparative bench testing.

    2. Sample size used for the test set and data provenance

    • Sample Size for Test Set: Not applicable. The submission refers to "comparative bench testing" rather than a clinical trial with a test set of patient data. The sample sizes for the bench tests (e.g., number of catheters tested for burst strength) are not provided.
    • Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this was bench testing, not patient data.

    3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

    • Not applicable. Ground truth is not established by experts for bench testing of device physical properties. The "ground truth" here would be the physical properties of the predicate device.

    4. Adjudication method for the test set

    • Not applicable. There is no adjudication method described for bench testing results against a "ground truth" in the context of expert consensus.

    5. 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

    • No. This is not an AI/diagnostic device. An MRMC study was not performed.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    • No. This is not an AI/diagnostic device. A standalone algorithm performance was not done.

    7. The type of ground truth used

    • For the bench testing, the "ground truth" would be the established performance characteristics of the predicate device (Equalizer Balloon Catheter K021721). The TechDevice catheter's performance was compared to these.

    8. The sample size for the training set

    • Not applicable. There is no "training set" as this is not an AI or diagnostic device based on machine learning.

    9. How the ground truth for the training set was established

    • Not applicable. There is no "training set" and therefore no ground truth established for it.
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