(336 days)
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical 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 cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
- Craniotomies/Craniectomies (e.g., Tumor Resection)
- Skull Base Procedures
- Cranial Biopsies
- General Catheter Shunt Placement
The Fiagon Navigation System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. For cranial procedures, the use of this device is restricted to rigid fixation with a patient reference localizer attached directly to the skull clamp. The position of the instrument with integrated sensor and the patient referencing localizer (attached to the skull clamp) 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 device Fiagon Navigation System utilizing similar technology than the proposed device has been previously cleared for a different intended use. This device is listed as a reference device.
The components of the navigation system are
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- Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4.
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- Navigation sensor (Headrest with field generator)
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- Navigation instrument
- Patient reference localizer (with fixation of the localizer on the skull clamp using the adhesive pad)
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 the spatial measuring device electronics as well. This has connections to the field generating device (navigation sensor), the patient reference 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 skull clamp and references the patient's anatomy, while the instrument is tracked in relation to the patient reference localizer and thus to the patient's anatomy.
Here's a breakdown of the acceptance criteria and study information for the "Fiagon Navigation System" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Accuracy) | Reported Device Performance (Bench Accuracy) |
|---|---|
| Position Mean: |
§ 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).