CODMAN VPV SYSTEM, MODEL 82-3192

K050739 · Codman & Shurtleff, Inc. · JXG · Jul 18, 2005 · Neurology

Device Facts

• Record ID: K050739
• Device Name: CODMAN VPV SYSTEM, MODEL 82-3192
• Applicant: Codman & Shurtleff, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jul 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Codman VPV System is designed for use only with the Codman HAKIM™ Programmable Valve in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to adjust the Codman Programmable Valve to the selected setting and provide valve adjustment confirmation. However, radiographic imaging will still be required to confirm the selected setting.

Device Story

The Codman VPV System is a handheld programmer used by clinicians to non-invasively adjust the pressure settings of the Codman HAKIM Programmable Valve in patients with hydrocephalus. The device transmits signals to the implanted valve to modify its performance characteristics. It provides confirmation of the valve adjustment; however, clinicians must perform subsequent radiographic imaging to verify the final setting. The system is intended for use in a clinical setting to manage CSF flow and improve patient outcomes by allowing for adjustable pressure regulation without surgical intervention.

Clinical Evidence

Bench testing only. Performance testing (physical and mechanical) and in vitro testing were conducted to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Handheld hydrocephalus valve programmer. Operates via electromagnetic transmission to adjust implanted valve settings. Designed for use with Codman HAKIM Programmable Valves. Class II device under 21 CFR 882.5550.

Indications for Use

Indicated for patients with hydrocephalus requiring cerebrospinal fluid (CSF) shunting from brain ventricles. Used for adjusting Codman HAKIM Programmable Valves.

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 PROGRAMMER & TRANSMITTER

Submission Summary (Full Text)

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## 510(k) Summary; K050739

### CODMAN® VPV™ System

#### Submitter/Date

Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350 Date: July 7, 2005

#### Contact Person

Karen F. Jurczak Director, Regulatory Affairs Telephone Number: [phone] Fax Number: [phone]

#### Name of Device

| Propriety Name: | CODMAN® VPV™ SYSTEM |
|--------------------|--------------------------------|
| Common Name: | Hydrocephalus Valve Programmer |
| Predicate Devices: | HAKIM PROGRAMMER & TRANSMITTER |

#### Device Classification

Class II for Central Nervous System Fluid Shunt and Components devices 21 CFR 882.5550 (84 JXG) – Classification Panel: Neurological

#### Indications for Use

The Codman VPV System is designed for use only with the Codman HAKIM™ Programmable Valve in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to adjust the Codman Programmable Valve to the selected setting and provide valve adjustment confirmation. However, radiographic imaging will still be required to confirm the selected setting.

#### Device Testing _______________________________________________________________________________________________________________________________________________________________

Substantial equivalence for this device was based upon performance testing (physical and mechanical testing) and in vitro testing. All test results demonstrated the substantial equivalence of the product to commercially distributed predicate device for the same intended use.

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## Statement of Substantial Equivalence__________________________________________________________________________________________________________________________________________

The Codman® VPV™ System is substantially equivalent to the HAKIM PROGRAMMER & TRANSMITTER based on the subject device's similarity to the predicate device including intended use, physical characteristics, and labeling.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2005

Ms. Karen F. Jurczak Director, Regulatory Affairs Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K050739

Trade/Device Name: Codman® VPVTM System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: July 7, 2005 Received: July 8, 2005

Dear Ms. Jurczak:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 encreations) in the enactment date of the Medical Device Amendments, or to conimered prior to may 20, 2017 11:31 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). and Cosmetic (1 tor) that the device, subject to the general controls provisions of the Act. The r ou mayy are second of the Act include requirements for annual registration, listing of general voltable profice, 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 enastined (tional controls. Existing major regulations affecting your device can thay or sate to deem to 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 lease be actived that i Dr over device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith 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 CI It Fart 6077, labeling (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. Karen F. Jurczak

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 premaired 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 If you don't specific at the list 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 other Ectorers, 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,

Signature

Miriam C. Provost, Ph.D. Acting 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

510(k) Number (if known): K050739

Device Name:___ CODMAN® VPV™ System

Indications For Use:

"The system is designed for use only with CODMAN HAKIM Programmable Valves in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to adjust the CODMAN HAKIM Programmable Valve to the selected setting and provide valve adjustment confirmation. However, radiographic imaging will still be required to confirm the selected setting."

Prescription Use X (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)

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

510(k) Number K050739

VPV K050739 Response to FDA

CONFIDENTIAL

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