(67 days)
The Avid-NIT Lutz Needle is used for the percutaneous puncture of the back, over the spine and into the epidural space for the administration of anesthetic agents. This needle is not intended for use with an epidural catheter.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for an epidural needle. This type of document does not contain information about acceptance criteria or a study proving device performance related to AI/algorithm performance.
The letter only states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory matters such as good manufacturing practices, labeling, and other general controls.
Therefore, I cannot provide the requested information as it is not present in the given text.
§ 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).