(148 days)
The Contiplex C Continuous Peripheral Nerve Block Needle is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or by ultrasound visualization of the device. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle in general and orthopedic surgery.
In set configuration, the B. Braun Contiplex C Continuous Peripheral Nerve Block Set, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The catheter may remain indwelling for up to 72 hours.
The Contiplex C Continuous Peripheral Nerve Block Needle is a needle comprised of an open tip catheter over an insulated needle with a positioning component, a needle hub with integrated injection tubing and cable, and connection tubing.
This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the typical acceptance criteria and study designs associated with AI/ML performance (e.g., sensitivity, specificity, AUC, human reader studies, ground truth establishment with experts) are not applicable here.
This submission focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing to ensure the device's safety and effectiveness for its intended use.
Here's an analysis of the provided text in the context of device acceptance, though it won't align perfectly with the AI/ML specific questions due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
Since this is a traditional medical device (a nerve block needle), the "acceptance criteria" are compliance with established performance standards and the "reported device performance" is that the device met these standards.
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1 for external communicating device with tissue contact ( 24 hours, |
§ 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).