NBD DISPOSABLE RF CANNULAE

K032196 · New Business Development, LLC · GXI · Oct 9, 2003 · Neurology

Device Facts

• Record ID: K032196
• Device Name: NBD DISPOSABLE RF CANNULAE
• Applicant: New Business Development, LLC
• Product Code: GXI · Neurology
• Decision Date: Oct 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NBD Disposable RF Needle is a sterile, single-use device designed for radiofrequency (RF) heat lesion procedures. It functions as an electrode to deliver RF energy to targeted tissue to create lesions for pain management. Used by clinicians in clinical settings, the needle facilitates precise energy delivery. By creating controlled thermal lesions, the device interrupts pain signaling pathways, providing therapeutic relief to patients suffering from chronic pain. The disposable nature of the needle eliminates the need for reprocessing, reducing cross-contamination risks.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Disposable radiofrequency lesion probe; stainless steel construction; designed for RF energy delivery; single-use; sterile.

Indications for Use

Indicated for patients undergoing radiofrequency heat lesion procedures for pain relief.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Timothy B. Lusby President and CEO New Business Development, LLC 605 Industrial Court Woodstock, Georgia 30189

Re: K032196

Trade/Device Name: NBD Disposable RF Needle Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: July 16, 2003 Received: July 22, 2003

Dear Mr. Lusby:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Timothy B. Lusby

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1.

K032196

510(K) Number:

Device Name:

NBD Disposable RF Needle

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

neral. Restorative and Neurological Devic

510(k) Number K032196