(271 days)
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.
The Navient 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, such as the skull, can be identified relative to a CT, MR based model of the anatomy.
Indications:
Example procedures include but are not limited to:
- Cranial Procedures:
- Tumor resections
- · Cranial biopsies
- · Craniotomies
- · Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
Navient is an image quided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via (infrared) tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory sets intended for specific clinical applications.
Navient's quidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.
Depending on the desired clinical application, the Navient system also includes the following instrument/accessory kits. These reusable instruments are intended to be sterilized/disinfected prior to use.
- Cranial Accessory Kit (955-NC-AKC) o
- Biopsy Accessory Kit (955-NC-AKB) O
Disposable tracker instruments are also available based on user preference.
The provided document is a 510(k) summary for the ClaroNav Navient Image Guided Navigation System, Cranial. This document describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance:
The primary acceptance criteria for the Navient system is its accuracy, specifically in terms of positional and angular error. The document states: "Navient has been validated to a mean positional error of ≤ 2.0 mm and a mean anqular error of ≤ 2.0deq."
Here's a table summarizing the acceptance criteria and reported device performance:
| Acceptance Criterion | Requirement | Reported Device Performance (Mean) | Standard Deviation | 99% Confidence Interval |
|---|---|---|---|---|
| Positional Error (mm) | ≤ 2.0 mm (mean) | 1.36 mm | 0.66 mm | 2.89 mm |
| Angular Error (degree) | ≤ 2.0 deg (mean) | 1.01 deg | 0.40 deg | 1.95 deg |
| Accuracy when exchanging cranial reference frame |
§ 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).