OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM

K092395 · Integra Lifesciences Corp. · JXG · Nov 19, 2009 · Neurology

Device Facts

• Record ID: K092395
• Device Name: OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
• Applicant: Integra Lifesciences Corp.
• Product Code: JXG · Neurology
• Decision Date: Nov 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSV II® Lumbar Valve System is an implantable system used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity. The OSV II Low Flow Lumbar Valve System is an implantable system used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

Device Story

Implantable variable resistance valve system for controlled cerebrospinal fluid (CSF) drainage from lumbar subarachnoid space to peritoneal cavity. Device utilizes silicone elastomer diaphragm, synthetic ruby seat, and notched pin to regulate flow based on differential pressure (DP). Operates in three stages: low DP (5-18 ml/hr), flow regulation (120-300 mm H2O DP), and pressure relief mode for rapid flow during abrupt intraventricular pressure elevation. System includes 14G tuohy needle, F5 lumbar catheter, guidewire, and connectors. Used by neurosurgeons in clinical settings to manage hydrocephalus by maintaining constant drainage rates (approx. 20ml/hr for OSV II; 10ml/hr for Low Flow). Output is physical CSF diversion; helps normalize intracranial pressure and treat hydrocephalus symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design, materials, and principle of operation to predicate devices.

Technological Characteristics

Variable resistance valve; materials: silicone elastomer (with/without barium sulfate), polysulfone, synthetic ruby, silicone adhesive, tantalum, polypropylene, epoxy. Accessories: stainless steel, PTFE-coated guidewire, polycarbonate. Mechanical sensing via diaphragm/pin/seat mechanism. Non-powered, implantable.

Indications for Use

Indicated for patients with communicating hydrocephalus requiring CSF shunting from the lumbar subarachnoid region to the 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

• OSV II (K971799)
• Integra NPH Low Flow Valve System (K081773)
• Integra NPH Low Flow Valve System (K042192)
• Integra H-V Lumbar Valve System (K944595)

Submission Summary (Full Text)

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

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitter's Name and Address:

NOV 1 9 2009

... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Telephone: [phone] Facsimile: [phone]

### Contact Person and Telephone Number:

Donna Millisky Regulatory Associate II Integra LifeSciences Corporation Integra NeuroSciences Division Telephone: [phone] Facsimile: [phone] E-mail: donna.millisky(@Integra-LS.com

Date Summary was Prepared: July 31, 2009

Name of the Device:

Trade Names:

Common Name: Classification Name: Product Code: Classification Panel:

OSV II® Lumbar Valve System OSV II® Low Flow Lumbar Valve System Central Nervous System Fluid Shunt and Components Hydrocephalus Valve JXG Neurology

### Device Description:

The OSV II® Lumbar Valve System (OSV II Valve) and the OSV II® Low Flow Lumbar Valve System (OSV II Low Flow Valve) are implantable devices for controlled cerebrospinal fluid drainage (CSF) from the lumbar subarachnoid region to the peritoneal cavity. 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. They maintain a drainage rate around 20ml/hr for OSV II Valves and around 10ml/hr for OSV II Low Flow Valves.

The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are provided with accessories including a 14G tuohy needle, a F5 lumbar catheter, a guidewire, a luer lock connector and a F8-F5 stepdown connector, which are required for using the valves in a lumbar approach. The designs of the accessories are identical to the accessories currently provided with the Integra H-V Lumbar Valve System.

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

# Indications for Use:

Both the OSV II Lumbar Valve System and the OSV II Low Flow Lumbar Valve System are indicated as implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

# Principle of Operation:

The Principle of Operation of both the OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are as follows:

The variable flow restrictor consists of a silicone elastomer diaphragm, synthetic ruby seat, and notched pin. The diaphragm reacts to differential pressure (DP) variations. The seat is inserted into the center of the diaphragm. As differential pressure varies, the clearance between the seat and the pin increases depending on seat movement along the pin. Changes in the seat and pin clearance vary flow rates.

Note - Differential pressure/flow characteristics for each valve are verified to be within specification at time of manufacture.

The three stages of operation of the OSV II® Lumbar Valve System and the OSV II Low Flow Lumbar Valve System are defined below:

# Stage I - Low Differential Pressure

This stage begins when the flow rate through the valve reaches 5ml/hr (DP will be between 30 and 80 mm H20). The valve remains in Stage I with CSF flow rates up to 18 ml/hr (up to 8 ml/hr for the OSV II Low Flow) (DP will be between 40 and 120 mm and 120 mm H20).

#### Stage II - Flow Regulation

When the DP increases, the valve operates as a variable resistance flow regulator. At DP ranges between 120 and 300 mm H20, the valve restricts flow between 18 and 30 ml/hr (between 8 and 17 ml/hr for the OSV II Low Flow).

#### Stage III - Pressure Relief Mode

Should the intraventricular pressure (IVP) elevate abruptly, the shunt operates in a rapid flow rate mode to facilitate IVP normalization. The valve then reverts to Stage II or I, depending upon conditions.

# Materials:

The materials of composition for both the OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are identical: silicone elastomer with or without barium sulfate, polysulfone, synthetic ruby, silicone adhesive, tantalum, polypropylene and epoxy.

The accessories include a lumbar catheter and suture clamp made of silicone elastomer with

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

# Integra LifeSciences Corporation-Traditional 510(k) Bundled OSV II and OSV II Low Flow Valve Systems - Lumbo-Periotoneal

barium sulfate. The guidewire used to introduce the catheter is made of stainless steel, coated with polytetrafluoroethylene (PTFE), the stepdown connector is made of polypropylene with barium sulfate and the luer connector (to flush catheter) is made of polycarbonate. The 14G tuohy needle is made of stainless steel, with polycarbonate wings. The materials used in the accessories are identical to those materials used in the H-V Lumbar Valve accessories. except the F8-F5 stepdown connector is made of stainless steel in the H-V Lumbar Valve and is made of polypropylene with barium sulfate for the proposed OSV II and OSV II Low Flow valves. The current OSV II and Integra NPH Low Flow Valve systems already provide straight connectors made of the same polypropylene with barium sulfate and a lumbar catheter made with silicone elastomer.

# Substantial Equivalence:

The proposed OSV II and OSV II Low Flow Valves are substantially equivalent in function to the currently approved OSV II and Integra NPH Low Flow Valve Systems cleared to market by FDA under K971799, K081773, and K042192. This bundled 510(k) supports the use of both valve systems using a lumbo-peritoneal approach. The accessories provided allow for a lumbar approach and are substantially equivalent to the accessories provided with the Integra H-V Lumbar Valve System, which was cleared by FDA under K944595 for the same intended use. These accessories include a 14G tuohy needle, F5 lumbar catheter, guidewire, stepdown connector, and suture clamp.

The OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are designed the same as the valves currently used with the OSV II and Integra NPH Low Flow Valve Systems provided for the ventricular approach. Since the valves are the same, the product and performance specifications are the same as the predicate valves.

The Principle of Operation, intended use, design, materials of composition and manufacturing processes for both the OSV II Lumbar Valve System and OSV II Low Flow Lumbar Valve System are the same as for the current OSV II and Integra NPH Low Flow hydrocephalus valves. The labeling has been revised to include the indications for treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity. Based upon the stated information and supported by the clinical evidence included in this 510(k), Integra concludes that both systems are equivalent to the predicates defined in this submission.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Integra LifeSciences Corporation c/o Ms. Donna Millisky Regulatory Associate II 311 Enterprise Drive Plainsboro, NJ 08536

# NOV 1 9 2009

Re: K092395

Trade/Device Name: OSV II® Lumbar Valve System, OSV II® Low Flow Lumbar Valve System Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: II Product Code: JXG Dated: October 23, 2009 Received: October 26, 2009

Dear Ms. Millisky:

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 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 Federal 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number:

K092395

Device Name: OSV II Lumbar Valve System

Indications for Use:

The OSV II® Lumbar Valve System is an implantable system used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

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

Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092395

{6}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

K092395 510(k) Number: Device Name: OSV It Low Flow Lumbar Valve System Indications for Use: The OSV II Low Flow Lumbar Valve System is an implantable system used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter-Use_ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joe HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092395

Page 1 of 1