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K Number
K032196
Device Name
NBD DISPOSABLE RF CANNULAE
Manufacturer
NEW BUSINESS DEVELOPMENT, LLC
Date Cleared
2003-10-09

(83 days)

Product Code
GXI,GXD
Regulation Number
882.4725
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NBD Disposable RF Needle are indicated for use in radio frequency heat lesion procedures for relief of pain.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "NBD Disposable RF Needle." It confirms substantial equivalence to a predicate device and allows the marketing of the device. However, it does not contain any information about acceptance criteria, device performance, study details, ground truth establishment, or sample sizes related to AI or algorithm performance studies.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on the technical performance data of the device itself in the context of a study.

§ 882.4725 Radiofrequency lesion probe.

(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).