(236 days)
The Top Neuropole Needles 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.
Top Neuropole Needles are injection needles which are used for temperature controlled radiofrequency lesioning. A nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. After injection of anesthetics the nerve may then be blocked by radiofrequency lesion. Top Neuropole Needles are supplied sterile and are labeled for Single Use Only.
This submission is for a Traditional 510(k) for the Top Neuropole Needles. This device is an injection needle for nerve blocks and radiofrequency lesioning. This submission relies on substantial equivalence to predicate devices, and therefore does not contain acceptance criteria or a study to prove the device meets acceptance criteria. A summary of the device information available in the provided text is included below.
Device Description:
Top Neuropole Needles are injection needles used for temperature-controlled radiofrequency lesioning. They can localize a nerve using electrical stimulation through the needle or by injecting contrast medium and using radiography. After anesthetic injection, the nerve can be blocked by a radiofrequency lesion. The needles are supplied sterile and are for single use only.
Intended Use:
The Top Neuropole Needles are injection needles for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. They localize a nerve by electrostimulation through the needle or by injecting contrast medium with radiography. The nerve can then be blocked by local anesthetic or a radiofrequency lesion.
Technological Characteristics:
The Top Neuropole Needles have the same device characteristics, materials, dimensions, and intended use as their predicate devices. They have been tested to comply with applicable industry standards and US regulations.
Conclusion:
The intended use and performance characteristics of the Top Neuropole Needles are the same as the predicate devices, raising no new questions of safety and effectiveness. The device is substantially equivalent to the predicate devices.
§ 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).