(262 days)
The Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood.
The implantable segments of the TrimPort System and comparable devices are the portal, the radiopaque catheter, and a locking catheter connector.
The provided text describes a medical device called TrimPort (K954258), an implanted vascular access system. However, it does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific acceptance criteria in the manner requested by the prompt (e.g., sample size, expert qualifications, adjudication methods).
The text focuses on:
- Device Description and Intended Usage: Explains what the TrimPort is and how it's used.
- Device Design, Testing, and Potential Adverse Occurrences: Discusses design considerations and instructions to mitigate potential issues like catheter disconnection, system leaks, and system occlusions. It mentions internal testing ("standard usage and extreme misuse tests") but provides no specific data or methodology.
Therefore, I cannot generate the requested table and study details. The information required (acceptance criteria, specific performance metrics, sample sizes for testing/training, ground truth establishment, expert details, study design like MRMC or standalone performance) 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.