(148 days)
The PowerPICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.
The PowerPICC Catheters are open-ended radiopaque polyurethane catheters. Catheter size is 5 Fr SL with 50 cm usable length. The catheter has a reverse taper design. Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point. Catheters are provided sterile in basic radiology PICC configurations. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate the PowerPICC from other PICC catheters. The catheter extension leg, junction and clamp ID tag were printed with markings to identify the catheter as Power PICC and to include information to facilitate proper use of the device.
The provided text is a 510(k) premarket notification for a medical device (PowerPICC™ Catheters) and does not describe an AI/ML powered device or a study involving such a device. Therefore, I cannot extract the requested information about acceptance criteria and studies related to AI/ML technology from this document.
The document discusses the substantial equivalence of the PowerPICC™ Catheter to a predicate device, focusing on its intended use, technological characteristics, and conformance to existing medical device regulations and standards. It mentions "verification testing" for performance but does not provide details on specific acceptance criteria, study methodologies, or AI/ML performance metrics.
For me to provide the requested information, the input text would need to describe a medical device that utilizes AI/ML, along with a study detailing its performance and acceptance criteria.
§ 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.”