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Intended Use: The Navigus II Trajectory Guide with Verification Reticules 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) premarket notification letter from the FDA to Image-Guided Neurologics, Inc. for their Navigus II Trajectory Guide with Verification Reticules. This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested details based on the input text. The document primarily focuses on:

• Device Name: Navigus II Trajectory Guide with Verification Reticules
• Regulation Number: 882.4560
• Regulation Name: Stereotaxic instrument
• Regulatory Class: Class II
• Product Code: HAW
• Intended Use: 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.
• Sterilization: ETO sterilized and for one-time use.
• FDA Determination: Substantially equivalent to legally marketed predicate devices.

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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.

Not Found

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.

Ask a specific question about this device