(156 days)
Our TrimPort Systems are indicated for use whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.
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, the TrimPort Implantable Access System, and its regulatory clearance, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The document is a "Summary of Safety and Effectiveness Information" (a 510(k) submission summary) and the FDA's clearance letter. These documents attest to the device's substantial equivalence to a predicate device and its intended use, but they do not detail performance studies with acceptance criteria in the manner requested.
Specifically, the document discusses:
- Device Description and Intended Usage: Explains what the TrimPort is and how it's used.
- Device Design, Testing, and Potential Adverse Occurrences: Mentions design considerations to minimize risks like catheter disconnection, system leaks, and occlusions. It states, "To ensure this, we mandate that all new designs must be able to pass each of our standard usage and extreme misuse tests." However, it does not provide the acceptance criteria for these tests nor does it report the results of these tests.
- FDA Clearance Letter: Confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device. This is a regulatory finding, not a report of specific performance study results against defined acceptance criteria.
- Indications For Use: States the conditions under which the device is intended to be used.
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval rather than a detailed report of a performance study against acceptance criteria.
§ 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.