(67 days)
Intended Use: The Navigus II Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The device is ETO sterilized and for one time use.
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The provided text is a 510(k) clearance letter from the FDA for a device called "Navigus II Trajectory Guide." It primarily focuses on the regulatory aspects of the device's clearance and does not contain detailed information about specific acceptance criteria or a study that proves the device meets those criteria.
Therefore, I cannot extract the information required to populate the fields in your request based solely on the provided text. The document confirms that the device is "substantially equivalent" to a legally marketed predicate device, but it does not describe the specific performance testing or the details of a study with acceptance criteria.
§ 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).