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The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours.

The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.

The FX catheters are regional anesthesia catheres intended to provide, via percutaneous administration, continuous and/or internittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. The catheters may remain indwwelling for up to 72 hours. Routes of administration are epidural (peripheral nerve block (PNB)). The catheter is available in both open and closed tip designs. The open-tip polyamide catheter is intended to facilitate continuous delivery of anesthetic fluid via one opening at the tip, while the closed-tip polyamide catheter facilitates the administration of anesthetic through three sideports. Both catheters have ink markings, which are located in 10 mm increments along the catheter. The ink markings provide a visual indication of the depth of catheter insertion. When used according to the conditions listed on the product labeling, the FX Catheters may remain in a patient while in an MR environment.

This document is a 510(k) summary for the Perifix FX Catheter and Contiplex FX Catheter manufactured by B. Braun Medical Inc. It concerns a traditional medical device (anesthesia conduction catheters) and does not involve Artificial Intelligence (AI). Therefore, the questions related to AI device performance, such as acceptance criteria for AI, training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to this submission.

The 510(k) submission (K231242) focuses on demonstrating substantial equivalence to predicate devices (K991879 and K113059). The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

"MRI testing was performed. Testing supports the device being labeled as MRI Conditional. No changes have been made to the device therefore, the device continues to be safe and effective and performs the same as the predicate device."

This indicates that the primary testing performed was related to MRI compatibility, and the unchanged nature of the device from its predicates means that prior safety and efficacy data for the predicates are considered applicable.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details because this 510(k) submission is not for an AI device.

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