(96 days)
The theraPORT Low-Profile Vascular Access System is a totally implantable venous access system intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling. Because of its low-profile design, it is indicated for either traditional chest placement or placement in the upper arm, and is appropriate for use in pediatric patients and small adults.
The theraPORT® Low-Profile Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.
The provided text describes the theraPORT® Low-Profile Vascular Access System, a medical device, and its regulatory submission. It does not contain information about acceptance criteria for an AI/CAD/software device, nor does it detail a study proving such a device meets acceptance criteria. The document is a 510(k) summary for a physical implanted medical device.
Therefore, I cannot provide the requested information. The document explicitly states: "Clinical studies were not conducted as they were determined to be not necessary due to the similarity in design, performance, materials, function and intended use of the theraPORT® Low-Profile Vascular Access System to other commercially available systems."
The "Performance Testing" section describes mechanical tests of the physical device rather than a study of an AI/CAD/software system. These tests are:
- Catheter-to-port connection strength tests
- Septum puncture durability tests
- Port leakage integrity tests
- Port/catheter clearance tests
These are not relevant to the performance metrics typically associated with AI/CAD systems (e.g., sensitivity, specificity, AUC).
§ 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.