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R2P NaviCross is indicated to guide and support a guidewire during access of the peripheral vasculature through an access site, including but not limited to the radial artery, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.

R2P NaviCross is a low-profile, 4.5Fr, 200cm length catheter. It is intended to guide and support a 0.035" or smaller guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents. The catheter is ethylene oxide sterilized for single use only. The catheter features a three-layer construction, consisting of a stainless steel double braid mesh sandwiched between an outer and inner layer of polyester elastomer. The mesh is embedded within the catheter wall the entire length of the catheter with the exception of the distal tip. The distal tip is comprised of a polyester elastomer and is offered in both a straight and an angled tip shape. The catheter features three embedded radiopaque markers, one platinum alloy marker located 2mm from the distal tip, and two gold alloy markers. The first gold alloy marker is located 40mm from the distal edge of the platinum alloy marker, and the second gold marker is located 60mm from the distal edge of the first gold marker. There are also two proximal depth markers (pigment), located at 120cm and 150cm, which are there to help with procedural efficiency and minimize the use of fluoroscopy. The distal 40cm portion of the device has a hydrophilic coating. The catheter body is attached to a polyamide hub and a strain relief that contains a polyether block amide (PEBA with colorant and HLS). The device is offered in an effective length of 200cm.

The document provided does not describe an AI/ML powered medical device. Instead, it is a 510(k) premarket notification for a physical medical device called R2P NaviCross, a support catheter. Therefore, the requested information about acceptance criteria, study details, and impact of AI assistance is not applicable in this context.

The document focuses on demonstrating the substantial equivalence of the R2P NaviCross to a legally marketed predicate device (K110540, NaviCross ™, Terumo Support Catheter) and other reference devices based on non-clinical performance, biocompatibility, and sterilization testing. No clinical tests were performed for this 510(k) submission.

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