(175 days)
The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
The Polyplex Stimulating Catheter System is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia.
The Polyplex Stimulating Catheter System is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.
The provided text is a 510(k) summary for the Polyplex Stimulating Catheter System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed studies with specific acceptance criteria, performance metrics, and clinical trial designs typically seen for novel devices or PMAs.
Therefore, the document does not contain the information requested regarding acceptance criteria related to a specific study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth definitions, or training set sizes in the context of device performance claims.
The 510(k) summary details the device description, intended use, predicate devices, and the claim of substantial equivalence based on manufacturing materials, operating principles, and physical/operational/biological specifications. The FDA's letter confirms their review and finding of substantial equivalence, allowing the device to be marketed under general controls.
To reiterate, since this is a 510(k) summary, it relies on demonstrating equivalence to existing devices rather than presenting a de novo study with the kind of performance data you've requested.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).