(52 days)
The FlexPointer 1.5 is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.
It is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.
The Fiagon Navigation - FlexPointer 1.5 is a reusable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated devices that is
- a. Navigated pointing devices (maleable, sensor within the tip)
Each device incorporates a sensor device, which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)
The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)
This document describes the Fiagon FlexPointer 1.5mm, an electromagnetically navigated pointing device intended for aiding in precisely locating anatomical structures during ENT surgeries. The primary purpose of the submission is to gain clearance for a geometrically modified instrument for the existing Fiagon Navigation system (K133573).
Here's a breakdown of the requested information based on the provided text:
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance 95% confidence level of bench accuracy
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).