MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI

K041296 · Codman & Shurtleff, Inc. · JXG · Jun 10, 2004 · Neurology

Device Facts

• Record ID: K041296
• Device Name: MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
• Applicant: Codman & Shurtleff, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nonprogrammable Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The HAKIM™ (and HAKIM™ Micro) Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The SiphonGuard™ device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.

Device Story

Implantable CSF shunt systems; manage hydrocephalus via constant intraventricular pressure regulation and drainage. SiphonGuard™ component reduces risk of excessive pressure drop when patient is upright. Devices surgically implanted; function passively to shunt CSF from lateral ventricles to peritoneal cavity or right atrium. Modification involves substitution of epoxy material (Stycast 1267 replaced by Loctite M-31CL). No change to device function, operation, or clinical application.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data provided.

Technological Characteristics

Implantable CSF shunt valves. Materials: Epoxy (Loctite M-31CL). Passive mechanical pressure regulation. No energy source, software, or connectivity.

Indications for Use

Indicated for patients with hydrocephalus requiring CSF drainage from lateral ventricles to peritoneal cavity or right atrium. SiphonGuard™ indicated to reduce hazards of excessive intraventricular pressure lowering in erect position.

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 (K041296)
• HAKIM™ Programmable Valve System (K041296)
• HAKIM™ Micro Programmable Valve System (K041296)
• SiphonGuard™ CSF Control Device (K041296)

Submission Summary (Full Text)

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Codman & Shurtleff, Inc. Special 510(k): Device Mouilication Special 310(K). Device Moutheaton
CODMAN® HAKIM™ Precision, Programmable, Micro Programmable Valve Systems; and the SiphonGuard™ CSF Control Device

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# K041296

#### (JUN 1 0 2004

#### 510(k) Summary

- Codman and Shurtleff, Inc. Submitter: 325 Paramount Drive Raynham, MA 02780 Kathryn Wunder Contact Person: Phone Number: [phone] Fax Number: [phone] May 13, 2004 Date Prepared: Classification Name: Central Nervous System Fluid Shunt and Components Item 1: HAKIM™ Precision Valve System Proprietary Name: Item 2: HAKIM™ Programmable Valve System Item 3: HAKIM™ Micro Programmable Valve System Item 4: SiphonGuardTM CSF Control Device Item 1: HAKIM™ Precision Valve System Predicate Device: Item 2: HAKIM™ Programmable Valve System Item 3: HAKIM™ Micro Programmable Valve System Item 4: SiphonGuard™ CSF Control Device HAKIM™ Precision Valve System: Intended Use: The Nonprogrammable Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. HAKIM™ (and HAKIM™ Micro) Programmable Valve Shunt System: The HAKIM™ Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. SiphonGuard™ CSF Control Device: The SiphonGuard™ device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.

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| | The SiphonGuard™ device is designed to reduce the potential<br>hazards of excessive lowering of intraventricular pressure (with<br>respect to atmospheric pressure) when a patient is in an erect<br>position. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials: | All materials remain the same for the indicated devices, with the<br>exception of an alternate epoxy. The current epoxy is Stycast<br>1267. The proposed alternative is Loctite M-31CL. |
| Device<br>Description: | The devices that are the subject of this Special 510(k): Device<br>Modification are identical to their respective predicate<br>predecessors, with the exception of one material component. The<br>proposed alternative epoxy is the single difference in the devices. |
| Performance<br>Data: | This submission relied upon appropriate bench and<br>biocompatibility testing necessary to support the device for its<br>intended use. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person with outstretched arms. The seal is black and white and appears to be a logo or emblem.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# 'JUN 1 0 2004

Ms. Kathryn Wunder Regulatory Affairs Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K041296

K041296
Trade/Device Name: HAKIM™ Precision Valve Shunt System
Trade/Device Name: HAKIM™ 20075550 Regulation Number: 21 CFR 882.5550 Regulation Number. 21 CFR 862.9596
Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: May 13, 2004 Received: May 14, 2004

Dear Ms. Wunder:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section >10(t) prematic is substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally marked the of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior to May 28, 1970, the enaculier and other of the Federal Food, Drug, devices that have been reclassified in accordance was are askets on oval application (PMA).
and Cosmetic Act (Act) that do not requires and control controlsions of the Act. and Cosmetic Act (Act) that do not require approvations provisions of the Act. The
You may, therefore, market the device, subject to the general constructions of the Act. You may, therefore, market the device, subject to the gentlal registration, listing of
general controls provisions of the Act include requirements for annual registranding an general controls provisions of the Act mender requirements of the manufacturing and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more controls it (spealations affecting your device can
may be subject to such additional controls. Existing major regulations affec may be subject to such additional controis. Existing major toganto and on addion, FDA may
be found in the Code of Federal-Regulations, Title 21, Parts 800 to 898 - 11 additi be found in the Code of rederaritegalations, Friday, Friday, In the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I-DA's issuance of a subscribe only of the requirements of the Act
that FDA has made a determination that your device also also annones. You must that FDA has made a determilation his your arres on other Fecderal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations administered on registration and listing (21
comply with all the Act's requirements, including, but times assets requirements asst comply with all the Act s requirements, including, out manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the e CFR Part 807); labeling (21 CFR Patt 801); good mananation: and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 2001); 1000-1050 forth in the quality systems (QS) regulanon (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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Page 2 - Ms. Kathryn Wunder

This letter will allow you to begin marketing your device as described in your Section 510(k)
10 Alegal This letter will allow you to begin marketing your active of your device of your device of your device to a legally
premarket notification. The FDA Innding of substantial eq premarket notification. The FDA inding of substantial equive and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please
r the regulation and 1104 - 1001 - 1650 - Also, please note the regulation e If you desire specific advice for your device on our accessing regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the Office of contact the Office of Compliance at (301) 554-407. The Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). Your may oftai "Misbranding by reference to premarkst nonitication " (2) User from the Division of Small
other general information on your responsibilities under (800) 638-204 other general information on your responsibilities and its toll-free number [phone] or
Manufacturers, International and Consumer Assistance as and orders and human Manufacturers, International and Consumer 71355stance as no 1
[phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Merle A. Milliken

L. Merle Milliken, Ph.D., M.D.

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

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510(k) Number (if known):

Device Name:

Indications For Use:

K041296

SiphonGuard™ CSF Control Device

The SiphonGuard™ device can be used as a The Siphon Oudrocephalus shunt systems designed component of myaross lateral ventricles of the brain to shunt OOF front of the right atrium of the heart.

The SiphonGuard™ device is designed to reduce the me olphonomanas of excessive lowering of potential nazarde of exect to atmospheric intraventhoulan 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)

> Office of Device Evaluation (ODE) Concurrence of CDRH

Mark A M

Page 1 of 1

(Division Sign-On)
Division of General, Restorative,
and Neurological Devices

Re

510(k) Number K041296

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K041296

510(k) Number (if known):

Device Name:

Indications For Use:

HAKIM™ Precision Valve Shunt System

The HAKIM™ Precision Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

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)

> Qffice of Device Evaluation (ODE) Concurrence of CDRH,

Mark A. Millheiser

Page 1 of 1

Sign-Off) (Division (Division of General, Restorative, Division of Generalive, Division of General Division
and Neurological Devices

510(k) Number

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K041296

510(k) Number (if known):

Device Name:

Indications For Use:

HAKIM™ Micro Programmable Valve Shunt System

The HAKIM™ Micro Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

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)

> Qffice of Device Evaluation (ODE) Concurrence of CDRH,

Page 1 of 1

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

K04/296

510(k) Number

{7}------------------------------------------------

510(k) Number (if known):

Device Name:

Indications For Use:

K041296

HAKIM™ Programmable Valve Shunt System

The HAKIM™ Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

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)

> Office of Device Evaluation (ODE) Concurrence of CDRH,

Mark A. Wilkerson

Page 1 of 1 __

Sign-Off) (Division (Division Sign Oct)
Division of General, Restorative, Division of General Division of Schoological Devices

K041296

510(k) Number