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510(k) Data Aggregation

    K Number
    K172209
    Device Name
    AURA ICP MONITORING SYSTEM
    Manufacturer
    Branchpoint Technologies, INC.
    Date Cleared
    2018-05-18

    (298 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K042728
    Why did this record match?
    Reference Devices :

    K042728

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

    The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

    Device Description

    The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages:
    Package 1) AURA™ Sensor Tray (Model SP101-A)

    • AURA™ Sensor (Model 10025G)
    • Disposable Scalp Retractor (Model OS0001B)
    • Disposable Drill Bit with Collar (Model 10008C)
    • Disposable Torque Wrench (Model OS0004C)
    • Disposable Antenna Holster (Model 10007A)
      Package 2) AURA™ Monitor Pack (Model TK101-A)
    • AURA™ Monitor (Model T0011B)
    • AURA™ Antenna (Model T0010A)
    • 2x Lithium-Ion 11v Rechargeable Batteries (Model T0032A)
    • Two-bay battery charger (Model T0014A)
      Package 3) AURA™ Data Receiver Pack (Model DG101-A)
    • AURA™ Data Receiver (Model D0004B)
    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the AURA™ ICP Monitoring System, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The FDA 510(k) summary provides a list of non-clinical bench tests performed to support substantial equivalence and demonstrate device performance. For the direct ICP measurement, the relevant standard is ANSI/AAMI NS28:1988(r)2010. While specific numerical acceptance criteria and precise reported device performance values for ICP measurement itself are not detailed in the provided text beyond meeting the standard, the document states:

    Acceptance Criterion (Test Name)Reported Device Performance
    ICP Monitor performance testing (ANSI/AAMI NS28:1988(r)2010)Meets pre-defined acceptance criteria (implied compliance with standard)
    Pressure measurement resolution testingMeets pre-defined acceptance criteria (implied satisfactory resolution)
    Barometric pressure compensation testingMeets pre-defined acceptance criteria (implied satisfactory compensation)
    System response time testingMeets pre-defined acceptance criteria (implied satisfactory response time)

    For Biocompatibility, specific results are provided:

    Test (ISO 10993 Series)Acceptance Criterion (implicitly, "non-cytotoxic," "non-sensitizer," etc.)Reported Device Performance
    MEM Elution (ISO 10993-5)Non-cytotoxicNon-cytotoxic: score of 0.
    Sensitization Maximization Extract (ISO 10993-10)Non-sensitizerNon-sensitizer: No irritation was found on any of the negative control or test animals.
    Intracutaneous Reactivity (ISO 10993-10)Non-IrritantNon-Irritant: The test device score for both extracts was 0.
    Acute Systemic Injection (ISO 10993-11)No systemic toxicityNo systemic toxicity: No test or control animals exhibited signs of toxicity.
    Subacute and Subchronic Toxicity (IV) (ISO 10993-11)No systemic toxicityNo systemic toxicity: No systemic toxic effects were observed.
    Subacute and Subchronic Toxicity (IP) (ISO 10993-11)No systemic toxicityNo systemic toxicity: No systemic toxic effects were observed.
    Genotoxicity - Ames (ISO 10993-3)Non-mutagenicNon-mutagenic: The test article did not cause an increase in revertant colonies for any strain greater than two-fold over negative control values.
    Genotoxicity - Mutagenicity (ISO 10993-3)Non-clastogenic & non-genotoxicNon-clastogenic & non-genotoxic: No statistical significant differences (p ≥ 0.05) were noted between the test and control extracts.
    Genotoxicity - Mouse Lymphoma (ISO 10993-3)Non-mutagenic & non-clastogenicNon-mutagenic & non-clastogenic: RTG was > 10%.
    Subcutaneous Implantation (ISO 10993-6)Acceptable tissue reactionMacroscopic reaction not significant compared to control; microscopically, slight irritant.
    Brain Tissue Implantation (ISO 10993-6)Acceptable tissue reactionNeurobehavioral, gross pathological, clinical reactions not significant; histologically, minimal or no reaction.
    Mediated Material Pyrogenicity (ISO 10993-11)Non pyrogenicNon pyrogenic: Temperature increase was
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