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The Cordis Ventricular Catheter (with radiopaque dots) is a component of an implanted cerebrospinal fluid shunt system. It serves to transmit cerebrospinal fluid (CSF) to the valve mechanism from the cerebral ventricles or from extraventricular structures. It is a component sold alone for use in implanted hydrocephalus shunt systems or in kits containing all components for hydrocephalus shunt system implantation. Indications and contraindications are the same as the Cordis Ventricular Catheters which have been sold by Cordis for over 20 years.

The Cordis Ventricular Catheter (with radiopaque dots) is manufactured from silicone elastomer made radiopaque with barium sulfate. The radiopaque dots are formed by mixing tantalum powder in Liquid Silicone Rubber (LSR) and applying the mixture, fully coated with silicone elastomer, to the wall of a catheter to provide a means of determining the location and depth of the catheter on X-rav.

This document is a summary of safety and effectiveness for a medical device (Cordis Straight or Finned Ventricular Catheter with radiopaque dots) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market. Manufacturers use this approach to gain market clearance for new devices that are similar to existing ones, rather than conducting extensive new clinical studies with established acceptance criteria.

The document discusses:

• Intended Use and Device Description: Explains the purpose of the device and its components, particularly highlighting the addition of radiopaque dots.
• Biocompatibility: Mentions the materials used and their contact with body tissues.
• Summary of Substantial Equivalence: This is the core of the document, where it argues that the new device is substantially equivalent to predicate devices based on:
  • Identical indications and contraindications.
  • Identical dimensions (design).
  • Similar materials (with the addition of tantalum dots, which have been used in other predicate devices).
  • Similar manufacturing processes.
  • Identical specifications (e.g., radiopacity, pull strength).
• Conclusion: Reaffirms substantial equivalence, stating the addition of radiopaque dots raises no new issues of safety or effectiveness.

Therefore, I cannot provide the requested table or details about a study proving acceptance criteria because this information is not present in the provided text. The document's purpose is to argue for substantial equivalence based on existing devices, not to present a de novo study with specific acceptance criteria and performance data.

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