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The Arrow® Pressure Injectable Midline Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term (< 30 days) peripheral access to the venous therapy, blood sampling. infusion, and pressure injection of contrast media. The maximum pressure injector equipment used with the Arrow Antimicrobial and Antithrombogenic Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis.

The Arrow Pressure Injectable Midline Catheter with Chlorag ard Antimicrobial and Antithrombogenic Technology is a single use catheter designed to provide short-term peripheral access to the venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue FlexTip (flexible distal tip). The catheter is available in 4.5 Fr. Single lumen and 5.5 Fr. Double lumen configurations with a usable catheter length of 15 cm. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The external catheter body and the entire internal fluid path of the device are treated with a Chlorhexidine-based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.

The catheters will be packaged sterile in kits that will include components to facilitate insertion. The Chlorag+ard technology that is incorporated in the modified device's physical design is the same as the reference device.

The provided text is a 510(k) summary for the "Arrow Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. It does not describe a study to prove a device meets acceptance criteria for an AI/algorithm-based medical device.

Instead, this document details the substantial equivalence of a physical medical device (a catheter) to existing predicate devices based on design characteristics, materials, and non-clinical performance testing. The "Chlorag+ard Technology" mentioned refers to a coating on the catheter that has antimicrobial and antithrombogenic properties, which were evaluated using in vitro and in vivo test methods. This is not an AI or algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input document is for a physical medical device, not an AI/algorithm-based one.

If you can provide a different document that describes an AI/algorithm-based medical device, I would be happy to then attempt to answer the questions you've posed.

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