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510(k) Data Aggregation

    K Number
    K030963
    Device Name
    TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Date Cleared
    2003-06-20

    (85 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K014041
    Predicate For
    K063254,K123560
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TRUFILL DCS ORBIT™ Detachable Coil is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: very high risk for management by traditional operative techniques, or, 1. inoperable, 2. and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

    Device Description

    The TRUFILL DCS ORBIT™ Detachable Coil System is comprised of the TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe.

    • The TRUFILL DCS ORBIT™ Detachable Coil consists of a delivery system . (delivery tube and coil introducer) and an embolic coil. The delivery tube segment comprises the body of the device and has the combined functionality of a guidewire and a mini infusion catheter. The coil introducer is a tube designed to protect the detachable embolic coil in the packaging dispenser and provide support for introducing the embolic coil into the infusion catheter. The embolic coil is the implantable segment of the device.
    • The TRUFILL® DCS Syringe is used to generate a controlled pressure for . preparation and detachment of the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe consists of a 25-cc barrel with a pressure gauge, a threaded plunger assembly with a locking wing mechanism, and a flexible high-pressure extension tube. The gauge faceplate is calibrated for three settings for use with the TRUFILL® family of Detachable Coils.
    AI/ML Overview

    The provided text is a 510(k) summary for the TRUFILL DCS ORBIT™ Detachable Coil System. It details the device's intended use, comparison to a predicate device, and summaries of non-clinical performance data.

    However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in a format applicable to AI/ML device evaluations. The document describes a traditional medical device submission for substantial equivalence based on in-vitro and animal testing and comparison to a predicate device, not an AI/ML algorithm.

    Therefore, I cannot populate the requested table and information points. The information about sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this type of submission.

    The document discusses "Performance Standards" but states "There are no performance standards applicable under Section 514 of the Food, Drug and Cosmetic Act for Artificial Embolization Devices." This further indicates that the requested type of acceptance criteria and performance study (as would be typical for AI/ML) is not a component of this submission.

    In summary, this document is not a study proving an AI/ML device meets acceptance criteria, but rather a 510(k) summary for a physical medical device.

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