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K Number
K040834
Device Name
NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
Manufacturer
IMAGE-GUIDED NEUROLOGICS, INC.
Date Cleared
2004-06-03

(64 days)

Product Code
HAW,IIA
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 Passive Probe (BL) is intended to be used for trajectory navigation in conjunction with the Navigus family of Image-Guided Systems. The device is provided sterile and for single use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for a medical device (Navigus Passive Probe (BL)) and primarily focuses on regulatory approval based on substantial equivalence to predicate devices. It confirms the device can be legally marketed but does not include the detailed study information required to answer your request.

§ 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).