HAKIM MICRO PROGRAMMABLE VALVE SYSTEM

K980778 · Johnson & Johnson Professionals, Inc. · JXG · Jul 17, 1998 · Neurology

Device Facts

• Record ID: K980778
• Device Name: HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HAKIM Micro Programmable (HMP) 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 opening pressure non-invasively via external programmer transmitting coded magnetic signal to rotate cam. Pressure settings range 30-200mm H2O in 10mm increments. Used in clinical settings by neurosurgeons. Benefits patient by allowing pressure adjustment without repeat surgery.

Clinical Evidence

Bench testing only. Performance testing conducted to confirm device functionality for intended use as a hydrocephalus shunt; results demonstrate equivalence to currently marketed products.

Technological Characteristics

Implantable shunt; ruby ball-in-cone valve seat; stainless steel flat spring; titanium pivot; 18-position spiral staircase cam. Pressure range: 30-200mm H2O. Magnetic programming interface. Class II device.

Indications for Use

Indicated for patients requiring management of hydrocephalus via constant intraventricular pressure and CSF drainage.

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

• CODMAN HAKIM Micro Precision Valve System (K973774)

Submission Summary (Full Text)

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## EXHIBIT E

### 510K Summary HAKIM Micro Programmable Valve System

February 26, 1998

#### Submitter 1.

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

#### 2. Device Name

| Proprietary Name: | HAKIM Micro Programmable Valve System |
|----------------------|------------------------------------------------------|
| Common Name: | Hydrocephalus Shunt |
| Classification Name: | Central Nervous System Fluid Shunt and<br>Components |
| Regulatory Class: | Class II by 21 CFR §882.5550 |

#### 3. Intended Use

The HAKIM Micro Programmable (HMP) 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 HMP Valve System is a hydrocephalus shunt designed to allow the surgeon to change the valve opening pressure without surgical intervention. Intraventricular pressure is maintained at a constant level by the device's ruby ball-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 opening 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 HMP Valve System is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the CODMAN HAKIM Micro Precision Valve System (K973774). Both devices utilize the same ball-in-cone Frecision valve oyotom (traventricular pressure. 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 HMP Valve System, while the HAKIM Micro Precision Valve System is available in five fixed pressure ranges.

#### Device Testing Summary 6.

Performance testing was conducted to confirm device functionality for its intended use as a hydrocephalus shunt. Results of all testing demonstrate that the HAKIM Micro Programmable Valve System is equivalent to currently marketed products in its performance as a hydrocephalus shunt.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA," which is arranged in a circular pattern around the left side of the logo.

JUL 1 7 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K980778 Trade Name: Hakim Micro Programmable Valve System Regulatory Class: II Product Code: JXG Dated: June 15, 1998 Received: June 16, 1998

Dear Ms. Minear:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desirent 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) or class
regulations affecting your device as no found in the final controls. Existing major regulations affecting your device can be for attend 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 (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) and that,
such assumptions Failure to comply with the CMD such assumptions. Failure to comply with the GMP regulation may result in 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Flectronic nave under sections 531 through 542 of the Act for
regulations. regulations.

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Page 2 - Ms. Diane 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,

C. Witt, Ph.D., M.P.

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 Micro Programmable Valve System INDICATIONS FOR USE

The HAKIM Micro Programmable Valve System is an implantable device that provides The HARM Micro Programmatic Introller of cerebrospinal fluid (CSF) for the management of hydrocephalus

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K980778

Prescription Use
(Per 21 CFR §801.109)

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Over-the-Counter Use

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