(65 days)
The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc™ safety infusion set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
The subject Titanium PowerPort™ isp device with 6 Fr ChronoFlex® polyurethane catheter is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a titanium port and ChronoFlex® polyurethane catheter that is attached to the port with a cathlock compression fitting. The subject device is distinguishable as a member of BAS's power injectable port series by the triangular body shape, unique purple coloring, and three palpation bumps on the septum. PowerPort™ implanted ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort™ ports must be accessed with a Bard PowerLoc™ safety infusion set to create a power injectable system.
The provided text from K072549 predominantly describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria for device performance, the study design, or specific performance metrics typically found in validation studies for AI/algorithm-based medical devices.
Therefore, I cannot populate the requested table with acceptance criteria and reported device performance, nor can I answer questions about sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.
The document states:
- "No performance standards have been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act."
- "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. However, design verification testing was performed according to protocols based on the recommendations/requirements of applicable FDA guidance and FDA recognized international standards. Verification testing, determined to be applicable to the safety and efficacy of the device, was shown to meet predetermined acceptance criteria listed therein."
This indicates that internal acceptance criteria were used for design verification testing, but the document does not specify these criteria or the results against them. The device is a physical implanted port and catheter, not an AI/algorithm.
Conclusion: The provided text does not contain the necessary information to answer your questions regarding acceptance criteria and performance studies for an AI/algorithm-based device. The document is a 510(k) summary for a physical medical device (an implanted port and catheter) and focuses on its substantial equivalence to existing predicate devices, rather than the validation of an AI algorithm.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.