Search Results

Not Found

The CELSITE® Pediatric Venous Port is a implanted catheter system which allows safe, repeated access to the patient's bloodstream. The chamber and catheter design can be use for the administration of medications and fluids. B. Braun Medical, Inc. intends to introduce into interstate commerce Celsite Pediatric Venous Port.

The provided 510(k) summary for the Celsite® Pediatric Venous Port does not include the type of detailed information requested regarding acceptance criteria and a study proving device performance.

The document focuses on demonstrating substantial equivalence to previously cleared devices (K902401 and K942024) and highlights material safety based on Tripartite Guidance for Plastics. It also mentions that the manufacturing site passed an FDA inspection and generally states that implanted ports "have demonstrated themselves on the whole to be safe and effective devices."

Therefore, I cannot provide the requested information in the structured format because it is not present in the given text.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance: No specific performance metrics or acceptance thresholds are mentioned.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for any study: There is no description of any specific study conducted to establish performance criteria or demonstrate efficacy.
3. Training set sample size or how its ground truth was established: No training data is mentioned as no specific study is described.

Ask a specific question about this device