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The indicated use for the Cruz Catheter is for patients requiring a catheter for long term peritoneal dialysis.

Cruz™ Catheter

The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for the Cruz® Peritoneal Dialysis Catheter (K964514). These documents do not contain any information regarding acceptance criteria or a study proving device performance against such criteria. They primarily state that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them based on these documents.

Here's why and what kind of information would be needed:

• Acceptance Criteria: Acceptance criteria for medical devices typically involve performance metrics such as safety, effectiveness, biocompatibility, durability, and specific technical specifications (e.g., tensile strength, flow rate). These would be defined by the manufacturer and assessed by testing.
• Study Data: A study proving device performance would involve details about:
  • Clinical trials or bench testing: Protocols, results, statistical analysis.
  • Sample sizes: How many devices were tested or how many patients were enrolled.
  • Ground truth: How outcomes were determined (e.g., clinical diagnosis, pathology).
  • Expert involvement: If human readers/experts were involved in assessing performance.
  • Comparative studies: If the device was compared to a predicate or alternative treatment.

The documents refer to "general controls provisions of the Act" and "Current Good Manufacturing Practice requirements," which are regulatory frameworks for manufacturing quality and safety, but do not detail specific performance criteria or studies.

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