(83 days)
The NBD Disposable RF Needle are indicated for use in radio frequency heat lesion procedures for relief of pain.
Not Found
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.
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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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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.
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
§ 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).