MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM

K040201 · Integra Neurosciences Implants S.A. · JXG · Feb 26, 2004 · Neurology

Device Facts

• Record ID: K040201
• Device Name: MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
• Applicant: Integra Neurosciences Implants S.A.
• Product Code: JXG · Neurology
• Decision Date: Feb 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Burr Hole Valve and Shunt System is indicated for use in the treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity.

Device Story

Burr Hole Valve and Shunt System; component of hydrocephalus shunt system. Device incorporates membrane valve, integral connectors, and domed reservoir; fits into formal burr hole (12mm or 16mm). Operates via flat silicone membrane seated on conical polypropylene base; provides resistance to CSF flow; prevents retrograde flow. Available in low, medium, and high pressure/flow ranges. Used by neurosurgeons in clinical settings to manage CSF drainage from ventricles to atrium or peritoneal cavity. Provides precise flow regulation; maintains structural integrity. Benefits patient by managing intracranial pressure associated with hydrocephalus.

Clinical Evidence

Bench testing only. Testing included pressure/flow, leakage, catheter elongation and bending, markings visual inspection, pull testing, and radiopacity.

Technological Characteristics

Materials: silicone membrane, polypropylene base. Design: membrane valve with integral connectors and domed reservoir. Sizes: 12mm or 16mm. Pressure/flow ranges: low, medium, high. Sterile and non-pyrogenic. Mechanical flow regulation via membrane resistance.

Indications for Use

Indicated for patients with hydrocephalus requiring cerebrospinal fluid shunting from brain ventricles to drainage sites like the heart atrium or peritoneal cavity.

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

• Burr Hole Valve and Shunt System (K970578)

Submission Summary (Full Text)

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Contidential

04020/

# Burr Hole Valve and Shunt System 510(k) SUMMARY

# Submitter's name and address:

Integra NeuroSciences Implants SA 2905 Route des Dolines 06921 Sophia Antipolis Cedex, France

## Contact person and telephone number:

Valérie Gabert Regulatory Affairs Specialist [phone] Telephone: Facsimile: [phone]

## Date summary was prepared:

January 20, 2004

## Name of the device:

| Proprietary Name: | Burr Hole Valve and Shunt System |
|----------------------|-------------------------------------------------|
| Common Name: | Hydrocephalus Shunt Systems and Components |
| Classification Name: | Central Nervous System Shunt and Components JXG |

## Substantial Equivalence:

The Burr Hole Valve and Shunt System is substantially equivalent in function and intended use to the currently marketed unmodified Burr Hole and Shunt System and the unmodified Burr Hole™ Valve and Shunt System which has been cleared to market under Premarket Notification 510(k) K970578.

#### Intended use:

The Burr Hole Valve and Shunt System is indicated for use in the treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity.

# Device Description:

The Integra NeuroSciences Burr Hole Valve incorporates a membrane valve with integral connectors and domed reservoir to fit into a formal burr hole. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Burr Hole design includes a flat silicone membrane, which provides resistance to CSF flow. The silicone membrane scats on a conical polypropylene base. This base is int4egral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF.

The Burr Hole valve is available in two sizes designed to fit a 12mm or 16mm formal burr Both sizes are available in three (3) pressure/Now characteristics ranges: low, hole. medium, and high.

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# Safety

The Burr Hole Valve and Shunt Systems are provided sterile and non-pyrogenic. The Burr The Dat Hole Valve and Shants bave been tested for pressure/flow, leakage, catheter elongation and bending, markings visual inspection, pull testing and radiopacity.

# Conclusion

The modified Burr Hole Valve and Shunt System is substantially equivalent to the unmodified Burr Hole Valve and Shunt System. The modifications do not affect the intended u se, the fundamental s cientific technology of the device, and do not raise new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 2004

Integra NeuroSciences Implants SA c/o Ms. Judith E. O'Grady Senior Vice President Regulatory, Quality and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K040201

Trade/Device Name: Burr Hole Valve and Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: January 27, 2004 Received: January 29, 2004

Dear Ms. O'Grady::

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other l'ederal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Pagc 2 - Ms. Judith E. O'Grady

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millican

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

Enclosure

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# Indications for Use

k040201 510(k) Number (if known):

Device Name: Burr Hole Valve and Shunt System

# Indications For Use:

The Integra NeuroSciences Burr Hole Valve and Shunt System is used in treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------------------------------------|--------------------------------------------------------|
| (Division Sign-Off)<br>Division of General, Restorative,<br>and Neurological Devices | |
| 510(k) Number- | K040201 |

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