K Number
K091346
Device Name
CODMAN HAKIM MICRO II VALVE
Date Cleared
2009-06-02

(26 days)

Product Code
Regulation Number
882.5550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
Device Description
The Codman Hakim Shunt System incorporates all the possible shunt system features commercially available in the Codman Hakim line of products. The proposed device is adding a dimensional modification to the predicate valves listed above that are part of the Codman Hakim Shunt System.
More Information

Not Found

No
The summary describes a mechanical shunt system with dimensional modifications and mentions no AI/ML components or capabilities.

Yes
This device is designed to provide constant intraventricular pressure and drain cerebrospinal fluid, which directly treats the condition of hydrocephalus, fulfilling the definition of a therapeutic device.

No
Explanation: The device is an implantable shunt system designed to manage hydrocephalus by draining cerebrospinal fluid and regulating intraventricular pressure. It is a therapeutic device, not a diagnostic one.

No

The device description explicitly states it is an "implantable device" and discusses "dimensional modification to the predicate valves," indicating it is a physical hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is an implantable device for the management of hydrocephalus by draining cerebrospinal fluid. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
  • Device Description: The description reinforces that it's a shunt system, an implanted medical device.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical (pressure regulation and drainage).

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

N/A

Intended Use / 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 intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

Product codes

JXG

Device Description

The Codman Hakim Shunt System incorporates all the possible shunt system features commercially available in the Codman Hakim line of products. The proposed device is adding a dimensional modification to the predicate valves listed above that are part of the Codman Hakim Shunt System.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K020667, K980778, K974739, K973774, K944222

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

K691346

SECTION 4 510(k) Summary

A. Submitter Information

Submitter's name: Address:

Telephone: Fax: Contact Person: Date of Submission:

Codman & Shurtleff, Inc. 325 Paramount Drive Raynham. MA 02767 508-880-8349 508-828-2777 Sharon McDermott May 6, 2009

B. Trade/Devicc Name: Common Name: Classification Name: Regulation Number:

C. Predicate Device:

· D. Device Description:

E. Intended Use:

Codman Hakim Micro II Valve Shunt Central Nervous System Fluid Shunt and Components 882.550

Codman Hakim Shunt Systems (K020667) Hakim Micro Programmable Valve System (K980778) Codman Hakim Programmable Valve (K974739) Codman Hakim Micro Precision Valve (K973774) Codman Hakim Precision Valve (K944222)

The Codman Hakim Shunt System incorporates all the possible shunt system features commercially available in the Codman Hakim line of products. The proposed device is adding a dimensional modification to the predicate valves listed above that are part of the Codman Hakim Shunt System.

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.

JUN - 2 2009

11

1

  • F. Summary of technological characteristics of the proposed to the predicate device. The technological characteristics of the proposed device are substantially equivalent as the predicate device. .

G. Performance Data

:

Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device.

2

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Codman & Shurtleff, Inc. c/o Sharon McDermott Regulatory Affairs Specialist II 325 Paramount Dr. Raynham, MA 02767

JUN - 2 2009

Re: K091346

Trade/Device Name: CODMAN® HAKIM® MICRO II Programmable and Precision Valves

Regulation Number: 21 CFR 882.5550

Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: II Product Code: JXG Dated: May 6, 2009 Received: May 7, 2009

Dear Ms. McDermott

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not 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 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 advised 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Malvina B. Eglehnus, m.s.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 3 Indications For Use

510(k) Number (if known): K091346

K091346

Device Name: Codman® Hakim® Micro II Progammable Valve Codman® Hakim® Micro II Precision Valve

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 intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

.
Division Sign-Off

Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K091346