Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K250160
    Device Name
    ANKYRAS
    Manufacturer
    Mentice Spain S.L.
    Date Cleared
    2025-05-06

    (105 days)

    Product Code
    PZO
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mentice Spain S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices. General functionalities are provided such as: - Segmentation of neurovascular structures* - Semi-automatic centerline generation from segmented blood vessels* - Visualization of X-ray based images* - Placing and sizing tools for braided endovascular devices - Save user data - Download** and share simulation*** Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider´s judgment and analysis of the patient´s condition. ANKYRAS is available in different platforms: Standalone, WebGL and Mobile App. *Available for Standalone and WebGL platforms **Available for WebGL platform ***Available for WebGL and Mobile App platforms
    Device Description
    ANKYRAS is a medical device software application that allows the simulation of neurointerventional endovascular braided devices, such as flow diverters (FDs), and is intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions for preoperational planning and sizing for neurovascular interventions and surgery. The software includes a database with braided endovascular FD devices: P100018/S015 - Pipeline Flex Embolization Device and P100018/S026 - Pipeline Flex Embolization Device with Shield Technology, Medtronic, Inc.; P170024/S003 - Surpass Evolve Flow Diverter System, Stryker Neurovascular; P180027 - Flow Re-Direction Endoluminal Device (FRED®) System and P180027/S002 - Flow Re-Direction Endoluminal Device (FRED®) X System, MicroVention, Inc. This database can be customized (among FDA cleared braided endovascular devices previously mentioned) according to the user's institution or needs. ANKYRAS is intended to be used with 3D Rotational Angiography (3DRA) images or with VTK surface models from the target artery. From the 3DRA images, the user can extract the target artery vessel model using ANKYRAS segmentation functionality for further anatomical analysis and computational modeling (simulation) of the listed above FDs: - First, using the vessel model and proximal and distal points selected by the user, ANKYRAS calculates the vessel centerline and displays cross-sectional dimensional information in an interactive chart. - Second, using the vessel model, centerline, and morphology measurements, ANKYRAS simulates the FD devices selected by the user. The user can compare the results between different simulated FD devices and/or different FD positions including simulated device length, expansion along the centerline, and local porosity. The information provided by the software is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition. ANKYRAS software is intended to be user with a user license and can be installed on a computer with Windows operating systems or installed on an iOS/Android mobile device.
    Ask a Question
    K Number
    K230006
    Device Name
    Ankyras
    Manufacturer
    Mentice Spain S.L.
    Date Cleared
    2023-12-28

    (359 days)

    Product Code
    PZO
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mentice Spain S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Semi-automatic centerline generation from segmented blood vessels - Visualization of X-ray based images - Placing and sizing tools for braided endovascular devices - Save user data Information provided by the software is not intended in any way to eliminate, replace or substitute for in part, the healthcare provider's judgment and analysis of the patient's condition.
    Device Description
    ANKYRAS is a software as a medical device that allows the simulation of neurointerventional braided endovascular devices, such as flow diverters (FDs), and is intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions for preoperational planning and sizing for neurovascular interventions and surgery. The software includes a database with FDA-approved FDs: P100018/S015 - Pipeline Flex Embolization Device, Medtronic, Inc.; P170024/S003 - Surpass Evolve Flow Diverter System, Stryker Neurovascular; P180027 - Flow Re-Direction Endoluminal Device (FRED®) System, MicroVention, Inc. ANKYRAS is intended to be used with 3D Rotational Angiography (3DRA) images. From the 3DRA images the user can extract the target artery vessel model using ANKYRAS segmentation functionality for further analysis and computational modeling (simulation) of the listed above FDs: - . First, using the vessel model and proximal and distal points selected by the user, ANKYRAS calculates the vessel centerline and displays cross-sectional dimensional information in an interactive chart. - . Second, using the vessel model, centerline, and dimensions, ANKYRAS simulates the FD devices selected by the user can compare the results between different simulated FD devices and/or different positions including simulated device length, expansion along the centerline, and local porosity. The information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition. ANKYRAS software is intended to be installed on a computer with Windows operating systems.
    Ask a Question

    Page 1 of 1