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.

AI/ML Overview

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.

Summary

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OCT 25 1996

Appendix III

K960159

Summary of Safety and Effectiveness

Pursuant to Section 513(I) of the Federal Food, Drug, and Cosmetic Act

General Information ﻟﺴﺎ

Classification Name:

Central nervous system fluid shunt system component

Common/Usual Name:

Ventricular Catheter

Proprietary Name:

Cordis Straight or Finned Ventricular Catheter (with radiopaque dots)

Applicants Name and Address:

Cordis Corporation P. O. Box 025700 Miami, FL 33102-5700

Name of predicate device(s): II.

Cordis Straight Ventricular Catheter (Cat. No. 951-102) Cordis Finned Ventricular Catheter (Cat. No. 951-101)

Heyer-Schulte In-Line Valve System

Heyer-Schulte Portnoy Ventricular Catheter

III. Classification:

Central nervous system fluid shunts and components were reviewed by the Neurological Devices Classification Panel and placed in Class II (21 CFR 882.5550).

IV. Performance Standards:

No applicable performance standards have been established by FDA under section

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514 of the Food, Drug and Cosmetic Act.

V. Intended Use and Device Description:

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. Catheters are manufactured from the same materials currently used in other Cordis catheters with the exception of the addition of tantalum in the dot. 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.

VI. Biocompatibility:

Implanted materials in contact with body tissues or body fluids are silicone elastomer with barium sulfate, and Liquid Silicone Rubber.

VII. Summary of Substantial Equivalence:

Indications: The indications and contraindications of the Cordis Ventricular Catheter (with radiopaque dots) are the same as those for the Cordis Straight or Finned Ventricular Catheters.

Design: The dimensions of the Cordis ventricular catheters (with radiopaque dots) are the same as those for predicate Cordis ventricular catheters.

Materials: The materials used in the manufacturing of the Cordis ventricular catheters (with radiopaque dots) are the same as those for the predicate Cordis ventricular catheters except for the addition of tantalum markers. Tantalum dots have been used in conjunction with the predicate Heyer-Schulte devices.

Manufacturing: The manufacturing process used in the production of Cordis ventricular catheters (with radiopaque dots) is similar to those used for predicate Cordis ventricular catheters. No new safety or effectiveness issues are raised.

Specifications: The specifications (radiopacity, pull strength, etc.) for the Cordis ventricular catheters (with radiopaque dots) are the same as for the predicate Cordis ventricular catheters.

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Conclusions: The indications, design and specifications of the Cordis ventricular catheters (with radiopaque dots) are the same as the predicate Cordis ventricular catheters. The addition of radiopaque dots raise no new issues of safety or effectiveness.

Cordis thus considers the Cordis Straight or Finned Ventricular Catheters (with radiopaque dots) to be substantially equivalent to the predicate Cordis and Heyer-Schuite ventricular catheters with radiopaque markings.

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).