(27 days)
CODMAN HAKIM™ Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
CODMAN HAKIM™ Shunt Systems are available with or without CODMAN BACTISEAL™ catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.
CODMAN HAKIM™ Shunt Systems are also available with or without SIPHONGUARD™. 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.
The CODMAN HAKIM™ Shunt Systems are variable composite devices, incorporating different configurations of the above-listed predicate devices per the physician's preferences. When placing an order, the physician may choose from the following features: valve type, pressure setting, housing style, reservoir style and base, anti-siphon device, catheter interface, catheter radiolucency, catheter tip style, and catheter anti-microbial treatment.
The provided document is a 510(k) summary for the CODMAN HAKIM™ Shunt Systems. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt.
This type of submission primarily focuses on demonstrating equivalence to already approved devices and does not typically include detailed performance study data in the public summary. Therefore, I cannot extract the requested information from the provided text.
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020667
MAR 2 8 2002
510(k) Summary
Submitter:
Contact Person:
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767
Elizabeth Dolan Phone Number: (508) 828-3262 Fax Number: (508) 828-3212
Date Prepared:
February 28, 2002
Classification Name:
Proprietary Name:
Predicate Devices:
Intended Üse:
Materials:
Central Nervous System Fluid Shunt and Components
CODMAN HAKIM™ Shunt Systems
CODMAN HAKIM™ Precision Valve Shunt System (K944222), CODMAN HAKIM™ Micro Precision Valve Shunt System (K973774), CODMAN HAKIMTM Programmable Valve Shunt System (K974739), CODMAN HAKIM™ Micro Programmable Valve Shunt System (K980778), SIPHONGUARD™ CSF Control Device (K992173), and CODMAN BACTISEALTM catheter (K003322)
CODMAN HAKIM™ Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
CODMAN HAKIM™ Shunt Systems are available with or without CODMAN BACTISEAL™ catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.
CODMAN HAKIM™ Shunt Systems are also available with or without SIPHONGUARD™. 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.
Identical to those of the relevant predicate devices.
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Device Description:
The CODMAN HAKIM™ Shunt Systems are variable composite devices, incorporating different configurations of the above-listed predicate devices per the physician's preferences. When placing an order, the physician may choose from the following features: valve type, pressure setting, housing style, reservoir style and base, anti-siphon device, catheter interface, catheter radiolucency, catheter tip style, and catheter anti-microbial treatment.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2002
Ms. Elizabeth Dolan Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-00350
Re: K020667
Trade/Device Name: CODMAN HAKIM™Shunt Systems Regulation Number: 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: II Product Code: JXG Dated: February 28, 2002 Received: March 1, 2002
Dear Ms. Dolan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device American of to connicited phor to May 20, 1978, as can as a cordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costietic Act (71ct) that to nov requestly of the general controls provisions of the Act. The r ou may, therefore, mances of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elassined (over as controls. Existing major regulations affecting your device can may be subject to back accurations, 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 r toase of action and betermination that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any I caefal statutes and registments, including, but not limited to: registration and listing (21 Comply with an the Net 810 care 801); good manufacturing practice requirements as set Of R Fatt 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Elizabeth Dolan
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Muriam C. Provost
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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Indications for Use Statement
510(k) Number (if known): K020667
Device Name CODMAN HAKIM™ Shunt Systems
Indications for Use
CODMAN HAKIM™ Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
CODMAN HAKIM™ Shunt Systems are available with or without CODMAN BACTISEAL™ Catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.
CODMAN HAKIM™ Shunt Systems are also available with or without SIPHONGUARD™. The SIPHONGUARD™ device is designed to reduce the potential hazards of excessive lowering of intraventicular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020067
§ 882.5550 Central nervous system fluid shunt and components.
(a)
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.(b)
Classification. Class II (performance standards).