(25 days)
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Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, or related concepts. The device description and intended use are focused on radiofrequency lesioning for neurosurgical procedures and pain relief.
Yes
The device is intended for "lesioning nerve tissue for functional neurosurgical procedures" and "radiofrequency heat lesion procedures for the relief of pain," which are therapeutic applications.
No
The device is described as lesioning nerve tissue for functional neurosurgical procedures or for pain relief, which indicates it is a therapeutic device rather than a diagnostic one. It performs an active intervention (lesioning) rather than detecting, identifying, or monitoring a disease or condition.
No
The device description is not found, but the intended use clearly describes a "Radiofrequency System" which implies hardware components for generating and delivering radiofrequency energy for lesioning nerve tissue. This is not a software-only function.
Based on the provided information, the OWL Radiofrequency System, Model URF-2AP, is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- OWL Radiofrequency System's Intended Use: The intended use of the OWL system is to directly lesion nerve tissue within the body for surgical procedures or pain relief. This is an in vivo procedure, not an in vitro diagnostic test.
The device is a therapeutic device used for surgical intervention, not a diagnostic device used for testing biological samples.
N/A
Intended Use / 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.
Product codes
GXD; GXI; GZL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HC" is arranged vertically.
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.
1
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
2
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) |