(576 days)
The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves (when used with a nerve stimulator) and administration of anesthesia drugs.
Polymedic UPA, UPC, Polyplex N, and Polyplex C Nerve Stimulation Needles
I apologize, but the provided text does not contain information about the acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for nerve stimulation needles, confirming "substantial equivalence" to previously marketed devices. It does not include a scientific study report or data on performance metrics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).