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510(k) Data Aggregation

    K Number
    K060915
    Device Name
    KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2007-04-17

    (378 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS

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

    The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the Kirwan 45.XXX and 65.XXX Series Appliers.

    Device Description

    The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurvsms. They are also intended to be applied exclusively with the 45.XXX and 65.XXX Series Appliers.

    AI/ML Overview

    The provided 510(k) summary for the Kirwan Series of Aneurysm Clips and Appliers does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving those criteria. This type of regulatory submission typically focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting novel clinical study data or detailed performance metrics against specific acceptance criteria.

    However, based on the available information, I can fill in what is present:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    No new technological risks or characteristics compared to legally marketed predicate devices."Technological safety and effectiveness is established by the fact that these clips do not contain any new technological risks or characteristics when compared to the legally marketed devices offered here as predicates."
    Compliance with specific standards and guidelines."Kirwan aneurysm clips and appliers have been found to comply with the requirements of the applicable sections within the following standards and quidelines:" - ISO 9713 - ISO 5832-2 - ISO 5832-3 - ISO 5832-7 - F 67 - 95 - F 1058 - 97 - F 136 - 98
    Hazard conditions for clips and appliers."Safety and hazard analysis has determined that the hazard conditions for the 45.XXX and 65.XXX Aneurysm Clips and Appliers range in the low-to-moderate level and for this reason are acceptable."
    Substantial equivalence to predicate devices in intended use, technological safety, effectiveness, and performance."Therefore, the 45.XXX and 65.XXX Aneurysm Clips and Appliers are substantially equivalent in intended use, technological safety and effectiveness and performance to the following predicates; - 65.XXX /T Series, REBSTOCK Implant Steel Aneurysm Clips & Titanium Aneurysm Clips. - 55XXX Series, PERNECZKY ANEURYSM CLIP. - FT XXX T Series / FE XXX K Series, AESCULAP YASARGIL ANEURYSM CLIP, (TITANIUM or PHYNOX)."

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

    • Not provided. The document describes a technical assessment based on comparison to predicate devices and compliance with standards, not a clinical study with a test set of data.

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

    • Not applicable. No test set or ground truth establishment by experts is described in this regulatory summary.

    4. Adjudication method for the test set:

    • Not applicable. No test set or adjudication method is described.

    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:

    • Not applicable. This device is a surgical implant/tool (aneurysm clips and appliers), not an AI-assisted diagnostic or decision support system. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.

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

    • Not applicable. This device is a physical surgical product, not an algorithm.

    7. The type of ground truth used:

    • Not applicable. The "ground truth" in this context is adherence to manufacturing standards, material specifications, and a hazard analysis, rather than clinical outcomes or expert consensus on diagnostic data. The primary "truth" being established is substantial equivalence to legally marketed predicate devices.

    8. The sample size for the training set:

    • Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

    • Not applicable. There is no training set mentioned.
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