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K Number
K051830
Device Name
NEURODRIVE SYSTEM
Manufacturer
ALPHA OMEGA LTD.
Date Cleared
2005-09-16

(72 days)

Product Code
GZL
Regulation Number
882.1330
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Alpha Omega NeuroDrive system is intended to be used to Assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.

Device Description

NeuroDrive system

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the Alpha Omega NeuroDrive system. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of FDA letter confirms substantial equivalence to a predicate device, which allows the company to market it. It does not typically include detailed study results, sample sizes, or ground truth methodologies that would be found in a clinical trial report or a scientific publication.

Therefore, I cannot provide the requested information from this document.

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).