EQUI-FLOW VALVE AND SHUNT SYSTEM

K042558 · Integra Neurosciences Implants S.A. · JXG · Oct 6, 2004 · Neurology

Device Facts

• Record ID: K042558
• Device Name: EQUI-FLOW VALVE AND SHUNT SYSTEM
• Applicant: Integra Neurosciences Implants S.A.
• Product Code: JXG · Neurology
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Equi-Flow™ Valve and Shunt System is indicated for use in the treatment of patients with hydrocephalus. The valve is a component of a system designed to shunt cereirospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the otriophia the heart or the peritoneal cavity. The Equi-Flow™ Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by a siphoning effect of hydron to pressure in the Distal Catheter.

Device Story

Hydrocephalus shunt system; manages CSF flow from brain ventricles to drainage sites (atrium/peritoneal cavity). Device incorporates multi-function membrane valve with integrated Siphon Limiting Device (SLD), central reservoir for pumping/injection, and proximal/distal occluders. SLD closes upon exposure to negative hydrostatic pressure to prevent over-drainage (siphoning) when patient sits/stands. Flat silicone membrane on conical polypropylene base regulates flow and prevents retrograde flow. Available in two sizes (Regular/Small) and five pressure/flow ranges. Used by neurosurgeons in clinical settings. Provides precise flow regulation and manual pumping capability; benefits patients by maintaining appropriate intracranial pressure and preventing complications associated with over-drainage.

Clinical Evidence

No clinical data. Bench testing only, including pressure/flow performance, leakage, antireflux function, and mechanical integrity (catheter elongation and bending).

Technological Characteristics

Multi-function membrane valve; materials include silicone (flat membrane) and polypropylene (conical base). Features integrated Siphon Limiting Device, central reservoir, and occluders. Available in two sizes and five pressure/flow ranges. Sterile, non-pyrogenic. Mechanical flow regulation via membrane-base interface.

Indications for Use

Indicated for patients with hydrocephalus requiring cerebrospinal fluid (CSF) shunting from brain ventricles to drainage sites (atrium or peritoneal cavity). Indicated for patients at risk of excessive intraventricular pressure/volume reduction due to siphon effects 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

• Equi-Flow™ Valve and Shunt System (K964386)
• Contour-Flex Valve and Shunt System (K971511)
• Equi-Flow™ Valve and Shunt System (K033698)

Submission Summary (Full Text)

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# Equi-Flow™ 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 Telephone: [phone] Facsimile: [phone]

## Date summary was prepared:

September 17, 2004

#### Name of the device:

| Proprietary Name: | Equi-Flow™ Valve and Shunt System |
|----------------------|-------------------------------------------------|
| Common Name: | Hydrocephalus Shunt Systems and Components |
| Classification Name: | Central Nervous System Shunt and Components JXG |

#### Substantial Equivalence:

The Equi-Flow™ Valve and Shunt System is substantially equivalent in function and intended use to the currently marketed Equi-Flow™ Valve and Shunt System and Contour-Flex Valve and Shunt System 510K K033698 which have been cleared to market under Premarket Notifications 510(k)s K964386 and K971511.

## Intended use:

The Equi-Flow™ Valve and Shunt System is indicated for use in the treatment of patients with hydrocephalus. The valve is a component of a system designed to shunt cereirospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the otriophia the heart or the peritoneal cavity.

The Equi-Flow™ Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by a siphoning effect of hydron to pressure in the Distal Catheter.

## Device Description:

The Integra NeuroSciences Equi-Flow™ Valve is a multi-function membrane valve incorporating a normally open Siphon Limiting Device, occluders, and integrant valving connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile.

The Siphon Limiting Device limits the siphon effect in the shunt system by closing when exposed to a negative Hydrostatic pressure (often caused by the patient sitting or standing).

The Equi-Flow Valve incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Equi-Flow Valve design includes a

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flat silicone membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base which is integral to the Siphon Limiting Device. This base is integral 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 Equi-Flow valve is available in two sizes: Regular and Small. Both sizes are available in five pressure/flow characteristics ranges: Low/Low, Low, Low/Medium, Medium and High.

## Safety

The Equi-Flow™ Valve and Shunt Systems are provided sterile and non-pyrogenic. The Equi-Flow™ Valve and Shunt Systems have been tested for pressure/flow, leakage, antireflux, catheter elongation and bending, and markings visual inspection.

## Conclusion

The modified Equi-Flow™ Valve and Shunt System is substantially equivalent to the unmodified Equi-Flow Valve and Shunt System and Contour-Flex Valve and Shunt System. The modifications do not affect the intended use, the fundamental scientific 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2004

Integra NeuroSciences Implants, S.A. c/o Ms. Judith E. O'Grady Sr. Vice President, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K042558

K042338
Trade/Device Name: Equi-Flow™ Valve and Shunt Systems Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: September 20, 2004 Received: September 21, 2004

Dear Ms. O'Grady:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainter nearbeted in interests of the indications felerenced above and nave acterifically marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manated povice Americal Device American works. Or to commerce prior to May 20, 1970, the enaounce with the provisions of the Federal Food. Drug. devices that have been receassined in doese approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine controls provisions of the Act. The You may, therefore, market the device, basjon courements for annual registration, listing of general Controls provisions of the 110 1100 libeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (sociation major regulations affecting your device can may be subject to such additional controller Listen general on 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dr o lesaanse over device complies with other requirements of the Act that FDA has made a dolorizations administered by other Federal agencies. You must of any redital statutes and regalanents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisy of even provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Judith E. O'Grady

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter witification. The FDA finding of substantial equivalence of your device to a legally premated 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 11 you a 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,

Miriam C. Provost

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

510(k) Number (if known):

KAASSE8

Device Name:

# Equi-Flow™ Valve and Shunt Systems

# Indications For Use:

The Equi-Flow™ Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device is 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.

The Equi-Flow™ Valve is indicated in 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.

ਮ Prescription Use (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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K042558