(530 days)
The SonixGPS Nerve Block Needle Kit is intended for use in regional anesthesia and pain therapy by a trained physician, to target peripheral nerves by visualization at the needle tip using an ultrasound imaging device. The needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "SonixGPS Nerve Block Needle Kit." This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a study report.
The letter primarily confirms that the device has been found substantially equivalent to predicate devices and outlines regulatory compliance requirements. It details the device's name, regulation class, product code, and indications for use.
Therefore, I cannot extract the requested information as it is not present in the provided document.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).