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510(k) Data Aggregation

    K Number
    K242480
    Device Name
    FLASH EVD System (10-0002)
    Manufacturer
    7D Surgical ULC
    Date Cleared
    2024-12-27

    (128 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K192945
    Why did this record match?
    Applicant Name (Manufacturer) :

    7D Surgical ULC

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

    FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.

    Device Description

    FLASH EVD System is a stereotactic image guided surgical navigation system during cranial procedures. The FLASH EVD software assists in guiding surgeons during external ventricular drainage (EVD) catheter placement procedure, also known as a ventriculostomy, is prescribed to relieve elevated intracranial pressure when there is a disruption in the normal flow of cerebrospinal fluid (CSF) within the brain.

    AI/ML Overview

    The provided text describes the 7D Surgical FLASH EVD System and its 510(k) submission for clearance. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria metrics and a multi-reader, multi-case (MRMC) comparative effectiveness study.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device (7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, K192945) through non-clinical testing.

    Here's a breakdown of what can be extracted and what information is missing based on your prompts:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document specifies "System Accuracy Requirement" for the predicate device, which the FLASH EVD System also adopts as "Same as K192945." These are the closest things to acceptance criteria mentioned.

    Acceptance CriteriaReported Device Performance
    Linear Placement Error:
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