HAKIM PROGRAMMABLE VALVE SYSTEM

K974739 · Johnson & Johnson Professionals, Inc. · JXG · Jul 1, 1998 · Neurology

Device Facts

• Record ID: K974739
• Device Name: HAKIM PROGRAMMABLE VALVE SYSTEM
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jul 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HP Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.

Device Story

Implantable hydrocephalus shunt; manages CSF drainage and intraventricular pressure. Features ruby-ball-in-cone valve seat; flat spring attached to fixed fulcrum; eighteen-position spiral staircase cam on titanium pivot. Surgeon adjusts operating pressure non-invasively via external programmer transmitting coded magnetic signals to rotate cam. Provides 18 pressure settings (30-200mm H2O). Used in neurosurgical clinical settings. Benefits patient by allowing pressure adjustment without repeat surgery.

Clinical Evidence

Controlled, randomized clinical trial with 377 patients followed for two years. Results demonstrated the HP Valve System performs as well as and is as safe and effective as currently marketed hydrocephalus shunt systems.

Technological Characteristics

Implantable shunt; ruby-ball-in-cone valve mechanism; stainless steel flat spring; titanium pivot. Complies with ASTM F647-94 for implantable shunt assemblies. Biocompatible materials per ISO 10993. Magnetic programming interface.

Indications for Use

Indicated for the management of hydrocephalus in patients requiring cerebrospinal fluid drainage and constant intraventricular pressure regulation.

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

• HAKIM Precision Valve System (K944222)

Submission Summary (Full Text)

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## EXHIBIT I

### 510K Summary HP Valve System December 18, 1997

#### Submitter 1.

1 1998

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767 Diane Minear, Senior Regulatory Consultant, [phone]

#### Device Name 2.

| Proprietary Name: | HP Valve System |
|----------------------|---------------------------------------------------|
| Common Name: | Hydrocephalus Shunt |
| Classification Name: | Central Nervous System Fluid Shunt and Components |
| Regulatory Class: | Class II by 21 CFR §882.5550 |

#### 3. Intended Use

The HP Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.

#### 4. Device Description

The HP Valve System is a hydrocephalus shunt designed to allow the surgeon to change the valve operating pressure without surgical intervention. Intraventricular pressure is maintained at a constant level by the device's rubyball-in-cone valve seat design. The center of a flat spring is attached to a fixed fulcrum, with one end resting on the ruby ball and the other end resting on an eighteen position spiral staircase shaped cam that rotates on a titanium pivot. When the cam rotates the tension on the spring changes as the distal end of the spring moves up or down the cam. The operating pressure of the valve is thereby adjusted. During programming, the programmer transmits a coded magnetic signal to the device, causing the cam to rotate. The device has 18 pressure settings, ranging from 30mm to 200mm H20, in 10mm increments.

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### Predicate Device Comparison 5.

The HP Valve System is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the HAKIM Precision Valve System (K944222). Both devices utilize the same ball-in-cone valve mechanism to maintain intraventricular pressure. The valve design maintains intraventricular pressure at a constant selected level. Depending on the CSF flow rate and/or viscosity, the ball moves up or down within the cone under the control of the calibrated flat stainless steel spring. The cross section of the valve through which CSF flows automatically increases or decreases, therefore maintaining the selected pressure.

While the pressure regulating mechanism is identical in both devices, the variable pressure setting feature is only available with the HP Valve System, while the HAKIM Precision Valve System is available in five fixed pressure ranges.

#### Device Testing Summary હે.

| Testing Performed | Comments |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility<br>Testing | Biocompatibility tests were performed per the Tripartite<br>Biocompatibility Guidance for Medical Devices and ISO 10993<br>Biological Testing of Medical and Dental Materials and<br>Devices. Testing results demonstrated that the device<br>materials are biocompatible. |
| Performance Testing | Performance testing was conducted per and complies with the<br>applicable sections of ASTM F647-94 - Standard Practice for<br>Evaluating and Specifying Impantable Shunt Assemblies for<br>Neurosurgical Applications. Performance testing included the<br>following areas; Reprogramming, Fatigue, Corrosion, MRI, Wet Pressure and Programmer Evaluation. Testing results<br>demonstrated the suitability of the device for its intended use. |
| Clinical Evaluation | A controlled, randomized, clinical trial was conducted to<br>support a claim of substantial equivalence. 377 patients were<br>enrolled and followed for two years. Results indicated that the<br>HP Valve System performs as well as and is as safe and<br>effective as currently marketed hydrocephalus shunt systems. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1998

Ms. Diane Minear ·Senior Regulatory Consultant Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K974739 Trade Name: Hakim Programmable Valve System Regulatory Class: II Product Code: JXG Dated: June 24, 1998 Received: June 25, 1998

Dear Ms. Minear:

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 (OS) 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 - Ms. Minear

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,

Celia M. Witten, Ph.D., M.D.

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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# HAKIM PROGRAMMABLE VALVE SYSTEM Indications For Use

1<974739

The HP Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ge 510(k) Numb

Prescription Use
(Per 21 CFR §801.109)

OR

Over-the-Counter Use_

(Optional Format 1-2-96)