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The ArrowADVANTAGE TM Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the ArrowADVANTAGE TM Pressure Injectable PICC may not exceed 300 psi.

The ArrowADVANTAGE TM Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter is available in 4 Fr. single lumen and 5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate for the distal lumen is 5 mL/sec. The catheters will be packaged sterile in both nursing and radiology configurations. Both configurations will include components to facilitate insertion.

The provided text does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document describes the ArrowADVANTAGE™ Pressure Injectable Peripherally Inserted Central Catheter (PICC) and its substantial equivalence to predicate devices, as part of a 510(k) premarket notification.

Here's what the document does state:

• Nonclinical Testing: "Bench testing was performed to demonstrate the ability of the proposed ArrowADVANTAGE TM Pressure Injectable PICC to effectively monitor for Central Venous Pressure."
• Conclusion: "Comparative analysis of technological characteristics between proposed and predicate devices and results of verification testing performed demonstrate that the subject device is substantially equivalent to the legally marketed predicate PICC devices. Any differences between the proposed and predicate devices do not raise new issues of safety and effectiveness."

This indicates that while bench testing was performed, the document focuses on demonstrating substantial equivalence to existing devices rather than defining and proving adherence to specific acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) of a new or significantly modified device. Substantial equivalence generally means the device performs as safely and effectively as a legally marketed predicate device.

Therefore, I cannot provide the requested table or details about a study proving specific acceptance criteria because that information is not present in the provided text.

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