RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT

K980903 · Radionics, Inc. · JXG · Apr 19, 1999 · Neurology

Device Facts

• Record ID: K980903
• Device Name: RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
• Applicant: Radionics, Inc.
• Product Code: JXG · Neurology
• Decision Date: Apr 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ are designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity.

Device Story

Cerebrospinal fluid (CSF) shunt system comprising Equi-Flow valve, ventricular catheter, and peritoneal catheter. Valve incorporates membrane mechanism with integral Siphon Limiting Device to mitigate excessive intraventricular pressure reduction caused by hydrostatic siphoning when patient changes position (e.g., sitting/standing). EZ-Coat hydrophilic surface modification applied to components. Used by neurosurgeons in clinical/surgical settings to manage hydrocephalus. Device shunts CSF from ventricles to drainage site (e.g., peritoneal cavity). Benefits include prevention of overdrainage complications associated with postural changes. No changes to base design, dimensions, or specifications compared to predicate; modification limited to surface coating.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility testing per ISO 10993 to confirm that the EZ-Coat surface modification does not negatively impact device performance or safety compared to the unmodified predicate devices.

Technological Characteristics

Cerebrospinal fluid shunt system. Components: membrane valve with integral Siphon Limiting Device, ventricular catheter, peritoneal catheter. Surface modification: EZ-Coat (hydrophilic). Biocompatibility: ISO 10993 compliant. Mechanical operation: passive fluid shunting with siphon-limiting mechanism. No electronic components or software.

Indications for Use

Indicated for the treatment of hydrocephalus in patients requiring cerebrospinal fluid shunting from brain ventricles to a drainage site (e.g., peritoneal cavity). Specifically indicated for patients at risk of excessive reduction in intraventricular pressure or volume due to siphoning effects caused by hydrostatic pressure in the distal catheter.

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

• Radionics Contour Flex Plus Valve
• Radionics Mini Shunt Valve System
• Radionics Standard Shunt Valve System

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

980903

## General Information

| Classification: | Class II |
|------------------------------------|------------------------------------------------------------|
| Common Name: | Central nervous system fluid shunt component |
| Device Trade Name: | Radionics Equi-Flow™ Valve with EZ-Coat™ |
| | Radionics EZ-Coat™ Ventricular Catheter |
| | Radionics EZ-Coat™ Peritoneal Catheter |
| Intended Uses: | The Equi-Flow™ Valve, Ventricular Catheter, and |
| | Peritoneal Catheter with EZ-Coat™ are designed to shunt |
| | cerebrospinal fluid from the ventricles of the brain to an |
| | appropriate drainage site, such as the peritoneal cavity. |
| Predicate Device: | Radionics Contour Flex Plus Valve and the Radionics |
| | Mini and Standard Shunt Valve Systems |
| Establishment Name and Address: | Radionics, Inc. |
| | 22 Terry Avenue |
| | Burlington, MA 01803 |
| Contact Name and Phone: | Michael Arnold [phone] |
| Establishment registration number: | 1219140 |
| Performance Standard: | None established under Section 514 |

### Substantial Equivalence Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

#### Safety Summary

The labeling for the Radionics Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter contains instructions for the proper use of the device. The labeling includes a description of the product, directions for use, and applicable safety information including contraindications, precautions, and warnings. These instructions ensure safe and effective use of the device when followed by the physician.

#### Description of the Device and Basis for Substantial Equivalence

The Equi-Flow Valve™ with EZ-Coat, the EZ-Coat™ Ventricular Catheter, and the EZ-Coat™ Peritoneal Catheter are designed for use as a cerebrospinal fluid shunts. The Equi-Flow Valve with EZ-Coat is a membrane valve with an integral Siphon Limiting Device. The Siphon Limiting Device limits the reduction of the intraventricular pressure and volume caused by the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter (often caused by the patient sitting or standing). This 510(k) covers the use of a hydrophilic surface modification that has been incorporated into the commercially available Equi-Flow Valve and Catheters. This material was subjected to and passes biocompatibility testing like the unmodified commercially available valves and catheters designed to meet the requirements of the ISO Standard 10993. In addition, performance testing was performed on the valves with the EZ-Coat modification to confirm valve performance. There is no change to the designs. dimensions, or specifications of the valves with the use of the EZ-Coat surface modification.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 1999

Michael A. Arnold, Ph.D. Vice President Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803

K980903 Re:

> Trade Name: Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ Regulatory Class: II Product Code: JXG Dated: January 13, 1999 Received: January 19, 1999

Dear Dr. Arnold:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Michael A. Arnold, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

f

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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980903

## Indications for Use

The Radionics Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ are indicated for the treatment of hydrocephalus. They are devices designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity. The Equi-Flow™ Valve with EZ-Coat™ is indicated for patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the distal catheter of the shunt system.

Prescription Use (Per 21 CFR 801.109)

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Division of General Restorative Devices, K980903
510(k) Number