(85 days)
The AMT NanoCath™ epidural catheter is intended for administration of local anesthetics into the epidural space to provide continuous epidural caudal anesthesia for up to 72 hours
The AMT NanoCath is comprised of a tightly coiled stainless steel, covered over most of its length with polvethylene terphthalate. The tip of the catheter is welded into a smooth cover to which is welded a safety ribbon of stainless steel. A stylet of stainless with a plastic handle made of delrin or polycarbonate fits inside the catheter. The catheter is available in 19 - 21 gauge, in lengths of 30 to 90 cm. The wire coil has an outer diameter from 0.8 to 1.0 mm. The NanoCath was compared with substantially equivalent devices in fatigue tests and shown equivalent.
The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/algorithm-based medical device. Instead, it is a 510(k) summary for the AMT NanoCath™ epidural catheter, focusing on its substantial equivalence to predicate devices based on material characteristics, intended use, and bench testing.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study design, expert involvement, or AI performance. The document describes a traditional medical device submission, not an AI/ML medical device submission.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).