(470 days)
Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
"Phoenix" Epidural and Spinal Needles.
The provided text is a 510(k) clearance letter for "Dr. Japan's Phoenix Brand Spinal and Epidural Needles" and related documentation, dated June 2, 2000. It concerns the substantial equivalence of this device to legally marketed predicate devices.
This type of document (a 510(k) clearance letter from the FDA) does not contain information about acceptance criteria, detailed study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies. It confirms that the device has been found substantially equivalent to a predicate device based on the information provided in the 510(k) submission, allowing it to be marketed.
Therefore, I cannot extract the requested details from the provided text. The document is strictly about the regulatory clearance, not the technical performance details of a new device's study.
§ 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).