(25 days)
The OWL Radiofrequency System, Model URF-2AP, intended use is for:
- lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
- radiofrequency heat lesion procedures for the relief of pain.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a letter from the FDA regarding a 510(k) premarket notification for a device called the "OWL Radiofrequency System, Model URF-2AP." The letter confirms the device's substantial equivalence to previously marketed devices and lists its indications for use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2002
Diros Technology, Inc. Leslie W. Organ, M.D. Vice-President, Research and Development 1837 Kempton Road Charleston, South Carolina 29412
Re: K021869
Trade Name: OWL Radiofrequency System,Model URF-2AP Regulation Number: 882.4400; 882.4725; 882.1330 Regulation Name: Radiofrequency lesion generator; Radiofrequency lesion probe; Depth electrode Regulatory Class: II Product Code: GXD; GXI; GZL Dated: June 4, 2002 Received: June 6, 2002
Dear Dr. Organ:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (Aci) 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 - Dr. Leslie W. Organ .
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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 vours.
lye Stype K Rhodes
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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アイテム、東京、東京都の
Attachment 2
Indications for Use Statement
510(k) Number (if known)
.
Device Name
OWL Radiofrequency System, Model URF-2AP
Indications for
Use
The OWL Radiofrequency System, Model URF-2AP, intended use is for:
-
- lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
-
- radiofrequency heat lesion procedures for the relief of pain.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| -- | ---------------------------- |
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K021869 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
§ 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).