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K Number
K023949
Device Name
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
Manufacturer
IMAGE-GUIDED NEUROLOGICS, INC.
Date Cleared
2003-02-25

(90 days)

Product Code
HAW
Regulation Number
882.4560
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

To answer your request, a document detailing the device's technical specifications, validation studies, and performance data would be required.

§ 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).