CORDIS VENTRICULAR ANTECHAMBER (VA)

K955832 · Cordis Corp. · JXG · Mar 25, 1996 · Neurology

Device Facts

• Record ID: K955832
• Device Name: CORDIS VENTRICULAR ANTECHAMBER (VA)
• Applicant: Cordis Corp.
• Product Code: JXG · Neurology
• Decision Date: Mar 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis Ventricular Antechamber (VA) is a component of a central nervous system (CNS) fluid shunt. It connects the ventricular catheter to the valve’s integral tubing. In this configuration, it serves to conduct cerebrospinal fluid (CSF) from this catheter to the valve. It may also be used with a ventricular catheter alone. In either configuration, the VA facilitates CSF sampling.

Device Story

Component of CNS fluid shunt system; connects ventricular catheter to valve tubing or used with ventricular catheter alone; facilitates CSF sampling; used in clinical settings by neurosurgeons; provides conduit for CSF flow; enables access for fluid collection; benefits patient by maintaining shunt patency and allowing diagnostic sampling.

Clinical Evidence

Bench testing only; biocompatibility testing performed on materials.

Technological Characteristics

Materials: silicone elastomer (with/without barium sulfate), polysulfone, and barium sulfate-impregnated polypropylene. Form factor: ventricular antechamber component for CNS shunt systems.

Indications for Use

Indicated for patients requiring a central nervous system (CNS) fluid shunt for the management of cerebrospinal fluid (CSF) flow; facilitates CSF sampling.

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 Orbis Sigma Valve (OSV)
• Cordis Polypropylene Burr Hole Reservoirs
• Cordis CSF Reservoir
• Cordis Right Angle Guide
• Cordis Right Angle Catheter
• Cordis Polypropylene Straight, “Y” & “T” Connectors

Submission Summary (Full Text)

{0}

00-00004
K955832

# SECTION - 2

## SUMMARY AND CERTIFICATION

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

1. Trade (proprietary) Name

Cordis Ventricular Antechamber (VA)

2. Common/Classification Name

Ventricular Antechamber/Central nervous system fluid shunt and components

3. Applicant’s Name and Address

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

4. Classification

This device is classified as Class II (21 CFR 882.5550)

5. Predicate Devices

Cordis Orbis Sigma Valve (OSV)
Cordis Polypropylene Burr Hole Reservoirs
Cordis CSF Reservoir
Cordis Right Angle Guide
Cordis Right Angle Catheter
Cordis Polypropylene Straight, “Y” & “T” Connectors

6. Performance Standards

No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.

7. Intended Use and Device Description

The Cordis Ventricular Antechamber (VA) is a component of a central nervous system (CNS) fluid shunt. It connects the ventricular catheter to the valve’s integral tubing. In this configuration, it serves to conduct cerebrospinal fluid (CSF) from this catheter to the valve. It may also be used with a ventricular catheter alone. In either configuration, the VA facilitates CSF sampling. The Cordis Ventricular Antechamber is manufactured from silicone elastomer (with/without barium sulfate), polysulfone and polypropylene impregnated with barium sulfate.

{1}

00-00005

## 8. Biocompatibility

The materials used to manufacture the Cordis Ventricular Antechamber have been subjected to biocompatibility testing and are safe for their intended use.

## 9. Summary of Substantial Equivalence¹:

The indications and contraindications of the Cordis Ventricular Antechamber are the same as those for the predicate Cordis antechambers. The design, materials, manufacturing methods and specifications of the Cordis Ventricular Antechamber are equivalent to those of the predicate devices and do not raise any new issues relating to safety and effectiveness for its intended use.

---

¹Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without premarket approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, “... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits.” 42 Fed. Reg. 42,520 et seq. (1977).