(223 days)
The ArrowEVOLUTION™ Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term 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 ArrowEVOLUTION™ Pressure Injectable PICC may not exceed 300 psi.
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 were 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 ArrowEVOLUTIONTM Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 5 5 em. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 rnL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties. The catheters will be packaged sterile in both nursing and radiology configurations. Both configurations will include components to facilitate insertion.
This is a 510(k) premarket notification for a medical device (PICC). It does not appear to describe a study proving the device meets acceptance criteria in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on non-clinical testing (in vitro and in vivo animal studies) for antithrombogenic effectiveness, and antimicrobial properties.
Therefore, I cannot provide the specific information requested in points 1 through 9 because the provided text does not contain details of a clinical study with acceptance criteria and reported device performance in terms of metrics like sensitivity, specificity, or reader improvement with AI.
The document states:
- Nonclinical Testing: "In vitro and in vivo testing was performed to assess the antithrombogenic effectiveness of the proposed device. Testing included in vitro thrombogenicity (platelet adhesion) and patency and in vivo animal studies comparing the proposed device and the predicate Zeus device. The ArrowEVOLUTION™ catheter performed as well as or better than the Zeus predicate device in both in vitro testing making the proposed device substantially equivalent to the Zeus predicate in terms of technological performance."
- No Correlation to Clinical Outcome: "Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained."
This indicates that the evaluation was primarily based on laboratory and animal studies, not a human clinical trial that would typically define acceptance criteria based on performance metrics against a ground truth established by experts.
Summary of available information relevant to your request, but not meeting all points:
- Study described: Non-clinical (in vitro and in vivo animal studies) comparing the proposed device to a predicate device (Zeus™ CT PICC, K083763).
- Purpose of study: To assess antithrombogenic effectiveness and support substantial equivalence.
- Outcome: The proposed device performed "as well as or better than" the predicate device in in vitro testing.
- Ground Truth: In this context, the "ground truth" would be the direct measurement of thrombogenicity (platelet adhesion) or patency in the laboratory/animal models, rather than a clinical outcome or expert consensus on images.
- No human-in-the-loop or standalone AI: This is a physical medical device, not an AI/software device.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”