(26 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 PowerPort™ implanted port with Groshong™ catheter is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a titanium port and silicone Groshong® tipped and valved catheter that is attached to the port with a cathlock compression fitting. The subject port 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 describes a 510(k) premarket notification for a medical device, the PowerPort™ Implanted Port with Groshong™ Catheter. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria for software or AI performance.
The document states:
- "No performance standards have been established by FDA under section 51- of the Federal Food, Drug and Cosmetic Act."
- "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."
- "Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with an internal protocol based on ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices (General). The analysis did not identify any new types of safety or efficacy questions for the subject PowerPort™ implanted port with Groshong™ catheter."
This indicates that internal design verification testing was done to meet predetermined acceptance criteria, and a risk management analysis was performed. However, the document does not describe the specific acceptance criteria, the results of the tests, or any study design details related to AI or algorithm performance. It refers generally to design verification testing and risk management rather than a specific clinical or technical performance study with quantitative results against specified acceptance criteria.
Therefore, I cannot provide the requested table and study details as the information is not present in the provided text.
§ 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.