(132 days)
THE POWER INJECTABLE IMPLANTABLE INFUSION PORT IS INDICATED FOR PATIENT THERAPIES REQUIRING REPEATED ACCESS TO THE VASCULAR SYSTEM. THE PORT SYSTEM CAN BE USED FOR INFUSION OF MEDICATIONS, I.V. FLUIDS, PARENTERAL NUTRITION SOLUTIONS, BLOOD PRODUCTS AND FOR THE WITHDRAWAL OF BLOOD SAMPLES.
WHEN USED WITH A POWER INJECTABLE NEEDLE, THE POWER INJECTABLE INFUSION PORT IS INDICATED FOR POWER INJECTION OF CONTRAST MEDIA. FOR POWER INJECTION OF CONTRAST MEDIA, THE MAXIMUM RECOMMENDED INFUSION RATE IS 5 ML/S WITH A 19 OR 20 GAUGE NON-CORDIG POWER INJECTABLE NEEDLE.
The Power Injectable, Infusion Port is a subcutaneously implantable single fluid reservoir port offered with a choice of a silicone (9.6F) or polyurethane (8F) catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catheter lock provides securement of the catheter to the port stem. The port is accessed by inserting a non-coring needle through the skin into the self-sealing septum.
The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port. The assembly is over molded with an optically clear silicone to prevent tissue in growth to the sufure holes that are easily accessed through the silicone. The rigid top half of the port centers the silicone septum and aids in locating the implanted device under the skin.
Power injection of contrast media, can be safely administered with a 19 or 20 gauge power iniectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/s.
The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.
The body of the port is manufactured with a polysulfone housing as the predicate device cleared under K864349. The addition of power injection capability is comparable to the currently marketed PowerPort cleared under K060812.
The provided document is a 510(k) summary for a medical device (Power Injectable, Implantable, Infusion Port) and does not describe software or AI. Therefore, it does not contain the information requested in the prompt, which is typically relevant for AI/ML-based medical devices.
Specifically, the document does not contain any of the following details:
- A table of acceptance criteria and the reported device performance, as the device is a physical infusion port, not an AI system with performance metrics like accuracy, sensitivity, or specificity.
- Sample sizes used for a test set or data provenance for an AI model.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Stand-alone algorithm performance (as there is no algorithm).
- Type of ground truth used relevant to AI (e.g., pathology, outcomes data for AI classification tasks).
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document focuses on:
- Device Description: A subcutaneously implantable single fluid reservoir port for vascular access.
- Intended Use: For repeated access to the vascular system for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, withdrawal of blood samples, and power injection of contrast media.
- Comparison to Predicate Devices: Substantial equivalence to existing devices (Mediport II and PowerPort).
- Safety and Effectiveness / Performance Data: States that "In vitro testing was performed... to assure reliable design and performance" and "Biocompatibility testing on the Power Injectable. Infusion Port demonstrates that the materials used meet the requirements of ISO 10993." It explicitly states that "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices."
The "acceptance criteria" for this device appear to be primarily based on in-vitro testing and comparison to predicate devices to demonstrate substantial equivalence, rather than specific performance metrics against a clinical ground truth as would be seen with an AI diagnostic tool. The document indicates that the device met these criteria through in-vitro testing and material biocompatibility, aligning with relevant FDA guidance (Guidance on 510(k) Submissions for Implanted Infusion Ports dated October 1990) and ISO standards (ISO 10993).
§ 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.