(161 days)
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation System 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 System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The position of the instrument with integrated sensor and the patient equipped with localizers are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.
The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching,
Thereafter the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.
The components of the navigation system are
- Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4.
- Navigation sensor (Headrest with field generator)
- Navigation instrument,
- Patient reference localizer (with fixation material) :
The navigation unit, is connected to a medical monitor. The unit runs the navigation software. Preoperative radiological images of the patient (DICOM CT, CBCT, MR) is imported to the system by means of CD-ROM, USB storage media or LAN network and displayed in appropriate way (defined by the software)
The navigation unit compromises as well the spatial measuring device electronics. This has connections to the field generating device (navigation sensor), the patient localizer and the navigation instrument.
Patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices.
The patient reference localizer is fixed to the patients anatomy and references it, while the instrument is tracked in relation to the patient localizer and thus to the patient's anatomy.
Here's a summary of the acceptance criteria and study details for the Fiagon Navigation System, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Predicate Bench/Clinical Accuracy) | Reported Device Performance (Fiagon Navigation System) |
|---|---|
| Bench Accuracy: 0.8 mm to 1.0 mm | Bench Accuracy: 0.9 mm (SD 0.34 mm) |
| Field Distortion Detection: 1.0 mm | Field Distortion Detection: |
§ 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).