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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.

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