Acclarent ENT Navigation System

Product Overview

Acclarent ENT Navigation System
Carto ENT - 1

Device Description

A mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].

Environmental Conditions

  • Special Storage Condition, Specify
    • Fragile
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 15.00
  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • -10.00

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: PGW

    Device Name: Ear, Nose, And Throat Stereotaxic Instrument

    Device Class: 2

    Physical State: Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer.

    Definition: Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

    Submission Type ID: 1

    Review Panel: EN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Ear, nose and throat

    Regulation Number: 882.4560

    Third Party Flag: N

    Medical Specialty: NE

    Device Identifiers

    Device Id: 10846835017182

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

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