(14 days)
The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.
The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.
The provided document is a 510(k) premarket notification summary and FDA clearance letter for a medical device (Vaxcel™ with PASV® implantable port system). It describes the device's intended use and claims substantial equivalence to predicate devices.
However, this document does not contain information about acceptance criteria for device performance, nor does it detail any specific study proving the device meets such criteria.
The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing features, materials, general performance, and intended use against the predicate, rather than establishing new performance benchmarks through clinical trials or detailed performance studies with acceptance criteria.
The sections you requested for information about acceptance criteria and a study design are therefore not applicable or available in this document. The document explicitly states:
- "Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act" for this device type. This means there are no predefined regulatory performance criteria the device must meet for this specific submission.
- The "Summary of Substantial Equivalence" indicates that the device has been tested and compared to the predicate device, and that "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This comparison forms the basis for clearance, not a study demonstrating achievement of specific performance acceptance criteria.
Therefore, I cannot provide the requested information from this document. If such studies were performed, they would be part of a more detailed 510(k) submission that is generally not made public in its entirety, or they might be internal company testing used to support the substantial equivalence claim.
§ 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.