CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD

K053107 · Codman & Shurtleff, Inc. · JXG · Jan 19, 2006 · Neurology

Device Facts

• Record ID: K053107
• Device Name: CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
• Applicant: Codman & Shurtleff, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Codman HAKIM Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CFS for the management of hydrocephalus and other conditions in which CSF flow and absorption are impaired. The SIPHONGUARD device can be used as a component of hydrocephalus shunt systems to shunt CSF from the ventricles of the brain into the peritoneal cavity or right atrium of the heart. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

Device Story

Codman HAKIM Programmable Valve (CHPV) is an implantable variable pressure valve for hydrocephalus management; provides constant intraventricular pressure and CSF drainage. SIPHONGUARD is an optional flow-regulating antisiphon accessory. Valve settings are adjusted non-invasively via an external programming system. Device shunts CSF from brain ventricles to peritoneal cavity or right atrium. Used in clinical settings by neurosurgeons. Benefits include controlled CSF drainage and mitigation of excessive pressure drops when patients are upright.

Clinical Evidence

Bench testing only.

Technological Characteristics

Implantable variable pressure hydrocephalus valve. Includes optional antisiphon flow-regulating device. Features non-invasive external programming for pressure settings. Class II device (21 CFR 882.5550).

Indications for Use

Indicated for patients requiring management of hydrocephalus or conditions with impaired CSF flow/absorption. The device provides constant intraventricular pressure and CSF drainage. The SIPHONGUARD component is indicated to reduce hazards of excessive intraventricular pressure reduction in upright positions.

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, Programmable (K041296)
• Valve System, Micro-Programmable Valve System and SIPHONGUARD (K041296)
• HAKIM Programmer and Transmitter (K020667)
• SIPHONGUARD CSF Control Device (K992173)
• HAKIM Micro Programmable Valve (K980778)
• HAKIM Programmable Valve (K974739)

Submission Summary (Full Text)

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Kas3107

## 510(k) Summary of Safety and Effectiveness

### A. Submitter Information

| A. Submitter Information<br>Submitter's Name:<br>Address:<br>Telephone:<br>Fax:<br>Contact Person:<br>Date of Submission: | Codman & Shurtleff, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767<br>508-880-8097<br>508-828-2777<br>Susan Kagan<br>November 2, 2005 |
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| B. Trade Name/Device Name: | Codman® HAKIM™ Programmable Valve<br>HAKIM™ Micro Programmable Valve<br>SIPHONGUARD™ CSF Control Device |
| Common Name: | Hydrocephalus Shunt System |
| Classification: | Central Nervous System Fluid Shunt and Components |
| Regulation Number: | 21 CFR § 882.5550 |
| C. Predicate Device: | K041296, HAKIM Precision Valve System, Programmable<br>Valve System, Micro-Programmable Valve System and<br>SIPHONGUARD--Epoxy change<br>K020667, HAKIM Programmer and Transmitter<br>K992173, SIPHONGUARD CSF Control Device<br>K980778, HAKIM Micro Programmable Valve<br>K974739, HAKIM Programmable Valve |
| D. Device Description: | The Codman HAKIM Programmable Valve (CHPV) is a<br>variable pressure setting hydrocephalus valve, that<br>provides constant intraventricular pressure and drainage of<br>cerebrospinal fluid for the management of hydrocephalus<br>and other conditions in which CSF flow and absorption are<br>impaired. The valve settings can be changed non-<br>invasively by applying an external programming system.<br><br>An accessory to the Codman HAKIM Programmable Valve<br>is the SIPHONGUARD CSF Control Device. This flow<br>regulating antisiphon device can be used as an integral<br>component of the Codman HAKIM Programmable Valve<br>shunt system. |
| E. Intended use: | The Codman HAKIM Programmable Valve is an<br>implantable device that provides constant intraventricular<br>pressure and drainage of CFS for the management of<br>hydrocephalus and other conditions in which CSF flow and<br>absorption are impaired. |

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The SIPHONGUARD device can be used as a component of hydrocephalus shunt systems to shunt CSF from the ventricles of the brain into the peritoneal cavity or right atrium of the heart. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

- F. Summary of technological characteristics of the proposed to the predicate device.
There have been no changes made to the technological characteristics of the device.

#### G. Performance Data:

Bench testing has been completed and supports the safety and effectiveness of the proposed device for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

Ms. Susan Kagan Senior Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K053107

KUS3107
Trade/Device Name: HAKIM® Programmable Valve with/without SIPHONGUARD™ Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: December 19, 2005 Received: December 21, 2005

Dear Ms. Kagan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocaren a seen fre device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the energeness of 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, de rices that have been 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 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 adviscd 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); 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.

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#### Page 2 - Ms. Kagan

This letter will allow you to begin marketing your device as described in your Section 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), please contact 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/industry/support/index.html.

Sincerely yours,

Karbarz Bruckup

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division D.O. f/t:DXY:rrr: 01/13/06

:

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# Indications for Use

510(k) Number (if known): K053107

Device Name: Codman® HAKIM® Programmable Valve

Indications For Use:

The Codman HAKIM Programmable Valves (CHPV) are implantable devices that provide constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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)

ncurrence of CDRH, Office of Device Evaluation (ODE)

Vaucluz Vaucluz

Division of General, Restorative, and Neurological Devices

**510(k) Number** K053107

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## Indications for Use

510(k) Number (if known): K053107

Device Name: SIPHONGUARD CSF Control Device

Indications For Use:

The SIPHONGUARD device can be used as a component of hydrocephalus shunt systems to shunt CSF from the ventricles of the brain into the peritoneal cavity or right atrium of the heart. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

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)

Oa. Dave Buell

Restorative. and Neurological Devices

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**510(k) Number** K053107