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K Number
K052878
Device Name
NT-1000
Manufacturer
NEUROTHERM, INC.
Date Cleared
2006-01-23

(103 days)

Product Code
GXD
Regulation Number
882.4400
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NT 1000 is intended for use to create lesions in neural tissue. The NT 1000 is to be used with separately approved lesion/temperature probes such as NeuroTherm radiofrequency probes, Smith & Nephew Spinecath™ and Acutherm™ catheters, and Radionics DiskTrode™ radiofrequency probes.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The document is a clearance letter from the FDA for a 510(k) premarket notification, indicating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information and indications for use, but it does not detail any performance studies, acceptance criteria, or specific performance metrics.

§ 882.4400 Radiofrequency lesion generator.

(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).