(189 days)
The Celsite™ Port with Preconnected Catheter is an implanted port with a catheter system attached which allows safe , repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.
The Celsite™ Port with Preconnected Catheter is an implanted port with a catheter system attached which allows safe , repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.
This 510(k) summary does not contain the information required to populate the requested table and sections regarding acceptance criteria and device performance studies. The document describes a medical device (Celsite™ Port with Preconnected Catheter) and focuses on demonstrating substantial equivalence to a previously cleared device (CELSITE™ Venous Access System, K952548).
Here's why the information is not present:
- Acceptance Criteria and Device Performance: The document does not define specific performance metrics (e.g., accuracy, sensitivity, specificity, throughput) with corresponding acceptance thresholds. Instead, it argues for substantial equivalence based on identical intended use, function, and materials, and a general statement that implanted ports "have demonstrated themselves on the whole to be safe and effective devices."
- Study Details: There are no details of a formal study (clinical trial, standalone performance study, MRMC study) designed to measure the device's performance against predefined acceptance criteria. The "evidence" presented for safety and effectiveness is largely based on the established safety record of similar devices and the manufacturing site's inspection history.
Therefore, I cannot provide a table or address the specific questions from sections 1-9 based on 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.