LOW FLOW OSV II HYDROCEPHALUS VALVE

K042192 · Integra Neurosciences Implants S.A. · JXG · Sep 2, 2004 · Neurology

Device Facts

• Record ID: K042192
• Device Name: LOW FLOW OSV II HYDROCEPHALUS VALVE
• Applicant: Integra Neurosciences Implants S.A.
• Product Code: JXG · Neurology
• Decision Date: Sep 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Low Flow OSV II Hydrocephalus Valve is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

Device Story

Implantable variable resistance valve for hydrocephalus treatment; shunts cerebrospinal fluid (CSF) from ventricles to peritoneal cavity or heart's right atrium. Device maintains constant drainage rate within physiological intracranial pressure range. Designed for patients requiring lower drainage rates than standard models. Used by neurosurgeons in clinical settings. Benefits patients by providing controlled CSF drainage to manage intracranial pressure.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including shelf-life simulation and environmental condition testing, and a review of clinical experiences and published scientific literature.

Technological Characteristics

Variable resistance valve; implantable; sterile and non-pyrogenic. Principle of operation relies on mechanical flow regulation to maintain constant drainage rates across physiological intracranial pressure ranges. No software or electronic components.

Indications for Use

Indicated for patients with hydrocephalus requiring CSF shunting from ventricles to peritoneal cavity or other drainage sites (e.g., heart's right atrium).

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

• Precision flow OSV II Hydrocephalus Valve (K971799)

Submission Summary (Full Text)

{0}------------------------------------------------

K042/92 1/2

# Low Flow OSVII Hydrocephalus Valve

## 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:

Anne Bigeard Regulatory Affairs Specialist [phone] Telephone: [phone] Facsimile:

#### Date summary was prepared:

August 11, 2004

#### Name of the device:

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

#### Substantial Equivalence:

The modified OSV II (Low flow OSV II) Hydrocephalus Valve is substantially equivalent in function and intended use to the unmodified OSVII (Precision flow OSV II) Hydrocephalus Valve which has been cleared to market under Premarket Notification 510(k) K971799.

SFP - 2 2004

#### Intended use:

The Low Flow OSV II Hydrocephalus Valve is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

### Device Description:

The Precision Flow OSV II and the modified Low Flow OSV II hydrocephalus valve systems are implantable devices for controlled cerebrospinal fluid drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, they are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.

#### Safety

The Low Flow OSV II Hydrocephalus Valve and the Precision Flow OSV II Hydrocephalus Valve are provided sterile and non-pyrogenic. Performance testing has been performed on The Low Flow OSV II Hydrocephalus Valve reflecting shelf life simulation and environmental conditions. A review of clinical experiences and of published scientific

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the text "Kc42192 2/2" written in black ink on a white background. The text appears to be handwritten. There is a blacked out section above the text.

literature supports the rationale for this additional flow regulation rate which is designed to address the needs of patients who require a lower drainage rate.

#### Conclusion

The Low Flow OSV II Hydrocephalus Vavle is substantially equivalent to the Precision Flow OSV II Hydrocephalus Valve. 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. The design, materials of composition and principle of operation of the Low Flow OSV II Hydrocephalus Valve and the Precision Flow OSV II Hydrocephalus Valve remain the same.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 department's name around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 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: K042192

Trade/Device Name: Low Flow OSV II Hydrocephalus Valve Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: August 11, 2004 Received: August 12, 2004

Dear Ms. O'Grady:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 r ou may, mercere, maxims of the Act include requirements for annual registration, listing of general voltable proving 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 rr your de rise 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 r loase oc acrised that I Drivision that your device complies with other requirements of the Act that I DA has Intact and regulations administered by other Federal agencies. You must of any I cacal stututed and tegenanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K ratt 607); adoling (21 cegulation (21 CFR Part 820); and if applicable, the electronic forth in are qualty by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Judith E. O'Grady

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premated predicated 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 If you don't 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 other Ecolorers, 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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K042192

Low Flow OSV II Device Name:

Indications For Use:

The Low Flow OSV II is an implantable system used in the treatment of patients with The Low Tow OOV 11-10-an inplantalist -55000.
hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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

510(k) Number k042192

Page 1 of 1