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510(k) Data Aggregation

    K Number
    K123338
    Device Name
    BARRICADE EMBOLIZATION COIL SYSTEM
    Manufacturer
    BLOCKADE MEDICAL
    Date Cleared
    2013-03-28

    (148 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K093142,K120908,K093358
    Why did this record match?
    Reference Devices :

    K10335,K093142,K120908,K093358

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

    The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

    Device Description

    The Barricade Embolization Coil System (BCS) is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher with an introducer sheath to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.

    AI/ML Overview

    The provided text describes the 510(k) summary for the Barricade Embolization Coil System, a neurovascular embolization device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies is not available in this document.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not present a formal table of acceptance criteria with specific quantitative targets for device performance in the way an AI/software device would. Instead, it lists various verification and validation tests and their results, primarily focusing on proving safety and substantial equivalence to predicate devices. The "acceptance criteria" are implied by the successful completion of these tests and their favorable outcomes, indicating non-toxicity, appropriate mechanical properties, and similar performance to predicate devices.

    Test CategoryImplied Acceptance Criterion (from results)Reported Device Performance (from results)
    Biocompatibility (Implant)Non-cytotoxic, non-sensitizing, non-irritant, non-hemolytic, non-toxic, non-pyrogenic, non-mutagenic, non-reactive.97% cell viability (Non-cytotoxic), No reaction (Non-sensitizing), No significant greater biological reaction than controls (Non-irritant),
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