CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)

K960159 · Cordis Corp. · JXG · Oct 25, 1996 · Neurology

Device Facts

• Record ID: K960159
• Device Name: CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
• Applicant: Cordis Corp.
• Product Code: JXG · Neurology
• Decision Date: Oct 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Ventricular catheter component for implanted cerebrospinal fluid (CSF) shunt systems; transmits CSF from cerebral ventricles or extraventricular structures to valve mechanism. Device features radiopaque tantalum dots to assist clinicians in determining catheter location and depth via X-ray. Used in neurosurgical procedures for hydrocephalus management. Operates as a passive conduit; no active sensing or processing. Benefits patient by facilitating CSF drainage and allowing radiographic verification of placement.

Clinical Evidence

No clinical data; bench testing only. Substantial equivalence based on design, material, and specification comparison to predicate devices.

Technological Characteristics

Silicone elastomer with barium sulfate; tantalum powder in Liquid Silicone Rubber (LSR) for radiopaque dots. Passive fluid conduit. Dimensions and pull strength specifications identical to predicate Cordis catheters.

Indications for Use

Indicated for patients requiring implanted cerebrospinal fluid shunt systems for the treatment of hydrocephalus.

Regulatory Classification

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.

Predicate Devices

• 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

Submission Summary (Full Text)

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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

## I. General Information

**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

## II. Name of predicate device(s):

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-ray.

## 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-Schulte ventricular catheters with radiopaque markings.