CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM

K112156 · Medos International SARL · JXG · Oct 17, 2011 · Neurology

Device Facts

• Record ID: K112156
• Device Name: CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
• Applicant: Medos International SARL
• Product Code: JXG · Neurology
• Decision Date: Oct 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CODMAN Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The CODMAN Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.

Device Story

Implantable programmable valve system for hydrocephalus management; provides constant intraventricular pressure and CSF drainage. System includes valve and non-invasive Therapy Management System for reading/adjusting valve settings. Valve offers eight selectable opening pressure settings. Used by clinicians to manage CSF flow; non-invasive adjustment allows post-implant pressure modification without surgery. Benefits include precise pressure control and reduced need for revision surgeries. May be used with SIPHONGUARD CSF control device to mitigate excessive pressure drops in upright positions and BACTISEAL catheters.

Clinical Evidence

Bench testing only. Testing conducted per ISO 7197 included leak, pressure-flow, overpressure, bursting pressure, dynamic break strength, long-term stability, and puncture testing. MRI compatibility verified per ASTM F2052, F2213, F2119, F2182, and F2503 (MR Conditional at 3 Tesla). Biocompatibility met ISO 10993-1 and FDA G95-1. Sterilization validated per ISO 17665 and ISO 11737.

Technological Characteristics

Implantable programmable valve with eight pressure settings. Materials meet ISO 10993-1. MR Conditional (3 Tesla) per ASTM F2503. Sterilization per ISO 17665 and ISO 11737 (SAL 10^-6).

Indications for Use

Indicated for patients requiring management of hydrocephalus via cerebrospinal fluid (CSF) drainage and maintenance of constant intraventricular pressure.

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

• Codman Hakim Programmable Valve (K974739)
• Codman Hakim Shunt System (K091346)
• Codman SIPHONGUARD CSF Control Device (K992173)
• Codman Bactiseal Catheters (K003322)
• Medtronic PS Medical Strata Type Valve (K060681)
• Medtronic PS Strata Valves and Handtools (K040943)
• Sophysa Polaris (K090342)

Submission Summary (Full Text)

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K112156

OCT 1 7 2011

## 510(k) Summary

Medos International Sarl Company Name: Chemin-Blanc 38 Company Address: CH 2400 LeLocle, Switzerland Jocelyn Raposo Contact Person: Senior Regulatory Affairs Specialist [phone] Phone: [e-mail] Email: July 26, 2011 Date: Name of the Device: Codman Certas Programmable Valve System Propriety / Trade Name: Codman Certas Therapy Management System Hydrocephalus Shunt System Common Name: Class II (JXG) Classification: Central Nervous System Fluid Shunt and Components Legally Marketed Predicate Devices: Codman Hakim Programmable Valve K974739 -Codman Hakim Shunt System K091346 -Codman SIPHONGUAFID CSF Control Device K992173 -Codman Bactiseal Catheters K003322 -Medtronic PS Medical® Strata® Type® Valve K060681 -Medtronic PS Strata® Valves and Handtools K040943 -Sophysa Polaris K090342 -The Certas Programmable Valve System is designed for shunting Device Description: cerebrospinal fluid (CSF) for the treatment of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular pressure and drainage of CSF. The Therapy Management System allows the user to non-invasively adjust the opening pressure setting before and after implant.

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K112156

The Certas Programmable Valve will be available with and without the legally marketed SIPHONGUARD CSF Control Device and the Codman BACTISEAL Catheters.

The Certas Programmable Valve includes the same legally marketed accessories that are available with the Hakim Programmable Valve.

The Certas Programmable Valve is an implantable device that Intended Use: provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

> The Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.

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 BACTISEAL catheters 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.

## Technological Comparison:

The Certas Programmable Valve is substantially equivalent to the predicate Hakim Programmable Valve, and the Medtronic Strata and Polaris Sophysa Valves and Adjustment Tool Kits. Substantial equivalence is based on intended use, performance characteristics, materials, and principles of operation.

Preclinical testing was performed to demonstrate that the Certas Performance Data: Programmable Valve and Therapy Management System performs as intended and is safe and effective. Testing was conducted in accordance with ISO 7197 and included Leak, Pressure-Flow, Overpressure, Bursting Pressure, Dynamic Break Strength, Long-Term Stability and Puncture testing. Magnetic Resonance Imaging (MRI) testing was performed according to ASTM F2052, F2213, F2119, and F2182 for Translational Attraction, Torque, Artifact, and Heating, respectively. The MRI testing demonstrated that the

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K112156

Certas valve is MR Conditional in a 3 Tesla MRI system according to ASTM F2503. Biocompatibility was assessed and all of the materials meet the requirements of ISO 10993-1 and FDA Blue Book Memorandum G95-1. Sterilization testing was performed according to ISO 17665 Part 1 and 2 and ISO 11737 demonstrating that a sterility assurance level of 10° was achieved. The test data establish that the Certas Valve and the Certas Therapy Management System are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN" around the left side. To the right of the seal is a stylized symbol that resembles an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OGT 1 7 2011

Codman & Shurtleff, Inc. c/o Jocelyn Raposo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham MA 02767-0350

Re: K112156

Trade/Device Name: Codman Certas Programmable Valve System, Codman Certas Therapy Management System

Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: July 26, 2011 Received: July 27, 2011

Dear Mr. Raposo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalYroblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

E. K. Etem
Malvina B. Eydelman, M.D.

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

Enclosure

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## Indications for Use

510(k) Number (if known):

K112156

Device Name:

CODMAN Certas Programmable Valve CODMAN Certas Therapy Management System

Indications For Use:

The CODMAN Certas Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

The CODMAN Certas Therapy Management System allows the noninvasive reading or adjustment of the valve setting.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K112156