CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM

K113526 · Medos International SARL · JXG · Feb 16, 2012 · Neurology

Device Facts

• Record ID: K113526
• Device Name: CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
• Applicant: Medos International SARL
• Product Code: JXG · Neurology
• Decision Date: Feb 16, 2012
• Decision: SESE
• Submission Type: Special
• 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 implantable valve (with optional Siphonguard) and external Therapy Management System. Physician uses Therapy Management System to non-invasively read or adjust valve opening pressure settings (eight available settings) pre- or post-implantation. Device facilitates clinical management of CSF flow; helps maintain desired intracranial pressure. No changes to principle of operation or clinical use compared to predicate; primary modification is extended shelf life.

Clinical Evidence

Bench testing only. Packaging stability study confirmed post-sterile seal strength after accelerated aging. Product stability testing evaluated adjustment capability, pressure-flow, leak, and reflux performance per EN ISO 7197:2009 after 5 years of accelerated aging.

Technological Characteristics

Implantable programmable valve; eight pressure settings; optional Siphonguard; non-invasive adjustment mechanism. Tested per EN ISO 7197:2009. Shelf life: 5 years (excluding units with Bactiseal catheters).

Indications for Use

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

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

• Certas Programmable Valve System (K112156)

Submission Summary (Full Text)

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K113526

FEB 1 6 2012

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# 510(k) SUMMARY

| Company Name: | Medos International Sarl |
|---------------------|------------------------------------------------------|
| Company Address: | Chemin-Blanc 38<br>CH 2400 LeLocle, Switzerland |
| Phone: | [phone] |
| Contact Person: | Jocelyn Raposo, Senior Regulatory Affairs Specialist |
| Date: | February 15, 2012 |
| Name of the Device: | |

Propriety / Trade Name: Codman Certas Programmable Valve System Codman Certas Therapy Management System

| Product<br>Code | Description |
|-----------------|---------------------------------------------------------------------------------|
| 82-8800 | Certas Inline Valve (includes a Priming Adapter) |
| 82-8801 | Certas Inline Valve with Accessories |
| 82-8802 | Certas Inline Valve with Accessories (unitized distal catheter) |
| 82-8804 | Certas Inline Valve with Siphonguard (includes a Priming Adapter) |
| 82-8805 | Certas Inline Valve with Siphonguard and Accessories |
| 82-8806 | Certas Inline Valve with Siphonguard and Accessories (unitized distal catheter) |

Hydrocephalus Shunt System Common Name:

Classification:

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Class II (JXG) Central Nervous System Fluid Shunt and Components

### Legally Marketed Predicate Devices:

K112156 – Certas Programmable Valve System

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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 adiust the opening pressure setting before and after implant.

> The Certas Programmable Valve is available with and without the legally marketed SIPHONGUARD CSF Control Device and the Codman BACTISEAL Catheters as well as accessories needed to facilitate placement and use of the 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.

#### Technological Comparison:

The Certas Programmable Valve System with a 5 year shelf life is substantially equivalent to the predicate Certas Programmable Valve System with a 1 year shelf life. No changes are being made to the intended use, performance characteristics, materials, and principles of operation of the valve or its accessories. The 5-year shelf life applies to the Certas Programmable Valve Systems that are not packaged with a Bactiseal catheter. The shelf life of the Therapy Management System is not changing.

Codman has performed both packaging and product stability Performance Data: testing to demonstrate that the packaging integrity and product functionality is maintained for 5 years. The packaging stability study shows that there was no change in post-sterile seal strength after accelerated aging. The product stability testing evaluated Adjustment and Indication capability, Pressure-Flow, as well as Leak and Reflux testing per EN ISO 7197:2009 after 5 years of accelerated aging. The test results demonstrate that the Certas Valve is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Medos International SARL c/o Codman & Shurtleff, Inc. Ms. Jocelyn Raposo Senior Regulatory Affairs Specialist 3325 Paramount Drive Raynham, MA 02767

FEB 1 6 2012

Re: K113526

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: January 17, 2012 Received: January 18, 2012

Dear Ms. 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.

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Page 2 - Ms. Jocelyn Raposo

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.

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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Euch. A. m. h.

Malvina B. Eydelman, M.D. 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): K113526

K113526

Device Name:

CODMAN CERTAS Programmable Valve System CODMAN CERTAS Therapy Management System

| Product Code | Description |
|--------------|------------------------------------------------------------------------------------|
| 82-8800 | Certas Inline Valve (includes a Priming Adapter) |
| 82-8801 | Certas Inline Valve with Accessories |
| 82-8802 | Certas Inline Valve with Accessories (unitized distal<br>catheter) |
| 82-8804 | Certas Inline Valve with Siphonguard (includes a Priming<br>Adapter) |
| 82-8805 | Certas Inline Valve with Siphonguard and Accessories |
| 82-8806 | Certas Inline Valve with Siphonguard and Accessories<br>(unitized distal catheter) |

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 (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 Deyice Evaluation (ODE)

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

510(k) Number_K 10(k) 10)5

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