(111 days)
The Diros OWL RF Insulated Cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Diros Technology Inc. regarding their Owl RF Insulated Cannulae. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include data regarding device performance metrics, sample sizes, expert qualifications, or ground truth establishment.
The letter primarily confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information for further inquiries. The "Indications for Use" section describes the intended use of the device but does not present any performance data or study details.
Therefore, I cannot provide the requested information based on the given input.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a single, abstract shape.
June 27, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Diros Technology Inc. Mr. Ron Baker Chief Operating Officer 120 Gibson Drive Markham, Ontario, L3R 2Z3 CA
Re: K170708
Trade/Device Name: Owl RF Insulated Cannulae Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: May 30, 2017 Received: June 1, 2017
Dear Mr. Baker:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device
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related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170708
Device Name OWL RF INSULATED CANNULA
Indications for Use (Describe)
The Diros OWL RF Insulated Cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 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).