(52 days)
The tool is intended for use in assisting to externally stabilize the area of skin over the site of an implanted vascular access device, while a needle, which is implanted into the device, is removed from the device, manually, without direct contact between the user's hands and the intravascular access device site.
The BPOS-IVAD STABILIZER is a non-invasive two-pronged device used to stabilize an area of the skin over an implanted vascular access device while performing a procedure on that immediate area.
The provided text is a 510(k) summary for the BPOS-IVAD Stabilizer, dated November 23, 1998. It explicitly states under section "6. DEVICE TESTING" that "No testing has been done."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study or testing was conducted or reported in this submission. The device received 510(k) clearance based on substantial equivalence to a predicate device, not on performance testing.
§ 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.