(202 days)
The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug. These needles are to be used with battery powered periphera1 nerve locators only. These needles are specifically not intended for nerve stimulation for purposes other than nerve location. These needles are specifically not intended for neurolytic ablation.
The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug.
This document is a 510(k) premarket notification letter from the FDA regarding the AVID-NIT Nerve Stimulation Needles. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements that the manufacturer must comply with, but it does not detail any performance studies, test sets, ground truth, or expert involvement as requested in your prompt.
Therefore, I cannot provide the information requested in your prompt based on the provided document.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).