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    K Number
    DEN170064
    Device Name
    Comaneci, Comaneci Petit, Comaneci 17
    Manufacturer
    Rapid-Medical Ltd.
    Date Cleared
    2019-04-24

    (573 days)

    Product Code
    PUU
    Regulation Number
    882.5955
    Type
    Direct
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Comaneci, Comaneci Petit, Comaneci 17

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

    The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm defines the neck width as ≥ 4 mm or a dome-to-neck ratio

    Device Description

    The Comaneci Embolization Assist Device consists of three device models: Comaneci, Comaneci Petit, and Comaneci 17 (see Table 1). The Comaneci Embolization Assist Device is intended for temporary use and is introduced through an endovascular approach to the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width

    AI/ML Overview

    The Comaneci Embolization Assist Device is a Class II device (Product Code: PUU, Regulation Number: 21 CFR 882.5955) intended for temporary use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.

    The acceptance criteria for the Comaneci Embolization Assist Device, as derived from the provided text, are multifaceted, encompassing non-clinical bench testing, animal studies, and a retrospective clinical study.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are not explicitly presented in a single table with numerical targets, but rather are implicitly defined by the successful outcomes of various tests and the conclusions drawn from them. Below is a structured presentation of the implicit acceptance criteria based on the described studies and the reported device performance.

    Acceptance Criterion CategorySpecific Acceptance Criterion (Implicit)Reported Device Performance and Evidence
    BiocompatibilityDevice components in contact with the patient (e.g., blood) must be biocompatible according to ISO 10993-1, covering hemocompatibility (complement activation, thrombogenicity, indirect/direct hemolysis), cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity. (Ref: Section 'BIOCOMPATIBILITY/MATERIALS')Evaluated as an external communicating device of limited contact duration ( (
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