(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.
§ 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).