(90 days)
A Pole Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by using electrical stimulation 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 or a radiofrequency lesion may be made.
There are four types of needles: SMK Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible Needles.
SMK Cannulae is used in radiofrequency (RF) lesion procedures for the relief of pain. The device allows a injection of local anesthetic to relieve the pain of RF. A SMK-TC electrode is then placed into the cannulae to create the lesion. The length of the cannula is insulated except for a section of the tip. The RF energy is then transferred from the electrode through this uninsulated portion which heats the surrounding tissue to create a lesion.
RF Pole is used for percutaneous facet denervations. The device consists of a shaft of hypodermic tubing which is insulated except for 5mm at the tip. Plastic tubing and an electrical lead are unitized in a single flexible leader portion which connects to the shaft. The lead is insulated and feed through the plastic tube. A Luer hub on the tubing allows injection of local anesthetic. The needle can be connected to a Radionics generator for stimulation and lesioning. The RF pole does not allow for temperature monitoring.
Pole is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.
Flexible Injection Needle is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hypodermic tubing attached to PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needles field.
The provided text is a 510(k) Summary for the Radionics Pole Needles. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement for the purpose of demonstrating device performance.
This document is a regulatory submission for premarket notification, often used to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria. The FDA's letter (K021942) also confirms that the device is substantially equivalent to a predicate, which means it meets the regulatory requirements based on that comparison, not necessarily on a new clinical performance study.
Therefore, I cannot populate the requested table or answer the questions related to the study that proves the device meets acceptance criteria, as that information is not present in the provided text.
§ 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).