Codman Certas Plus Programmable Valve

K152152 · Medos International SARL · JXG · Oct 27, 2015 · Neurology

Device Facts

• Record ID: K152152
• Device Name: Codman Certas Plus Programmable Valve
• Applicant: Medos International SARL
• Product Code: JXG · Neurology
• Decision Date: Oct 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Implantable pressure-regulating valve for hydrocephalus management; utilizes ruby ball-in-cone mechanism with pressure-inducing spring to maintain intraventricular pressure and regulate CSF flow. As differential pressure increases, ball displaces from cone to increase flow. Features 8 performance settings (25-215 mmH2O range, plus 'virtually off' at 400 mmH2O). Settings adjusted post-implantation noninvasively by physician using magnetic Codman Certas Tool Kit. Device provides constant intraventricular pressure and drainage. Used in neurosurgical settings; intended for patients requiring CSF shunting, including ventriculo-atrial (VA) shunting.

Clinical Evidence

No clinical studies were required. Evidence consists of bench testing (reflux testing per ISO 7197:2009 and ASTM F647:1994) and a biocompatibility evaluation per ISO 10993-1 and ISO 10993-4. Results demonstrated that the device conforms to performance expectations for VA shunting.

Technological Characteristics

Implantable pressure-regulating valve; ruby ball-in-cone mechanism; 8 programmable pressure settings; magnetic adjustment via external tool kit. Materials unchanged from predicate. Standards: ISO 7197:2009 (reflux), ASTM F647:1994 (shunt assembly), ISO 10993 (biocompatibility).

Indications for Use

Indicated for the management of hydrocephalus in patients requiring CSF drainage via ventriculo-atrial or other shunting procedures.

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)

Reference Devices

• Codman Certas Plus Programmable Valve (K143111)
• Codman Certas Programmable Valve (K112156)

Submission Summary (Full Text)

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

October 27, 2015

Medos International Sarl Ms. Jocelyn Raposo Project Manager, Regulatory Affairs Chemin-Blanc 38 Le Locle, Switzerland CH-2400

Re: K152152

Trade/Device Name: Codman Certas Plus Programmable Valve Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: July 31, 2015 Received: August 3, 2015

Dear Ms. Jocelyn 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 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 of medical devicerelated 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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -SD/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K152152

Device Name

Codman Certas Plus Programmable Valve

#### Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |

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# CODMAN NEURO

O DePuy Synthes

## 510(k) Summary

| I. Submitter | Codman & Shurtleff, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--|
| | On behalf of:<br>Medos International SARL<br>Chemin-Blanc 38<br>CH 2400 LeLocle, Switzerland | | |
| | Phone: [phone]<br>Fax: [phone] | | |
| | Contact Person: Jocelyn Raposo | | |
| | Date of Submission: July 31, 2015 | | |
| II. Device | Name of Device | Codman Certas Plus Programmable Valve | |
| | Common Name | Hydrocephalus Shunt | |
| | Classification Name | Central Nervous System Fluid Shunt and Components<br>(21 CFR 882.5550) | |
| | Regulatory Class | II | |
| | Product Code | JXG | |
| III. Predicate Device | Codman Hakim Programmable Valve, K974739.<br>The following reference devices were used in this submission:<br>Codman Certas Plus Programmable Valve, K143111<br>Codman Certas Programmable Valve, K112156 | | |
| IV. Device Description | The Codman Certas Plus Programmable Valve is a sterile, single use, implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.<br><br>The Codman Certas Plus Programmable Valve is a pressure-regulating valve utilizing the ruby ball-in-cone principle with a pressure inducing spring design. Intraventricular pressure is maintained by the ball and cone valve seat | | |

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| IV. Device<br>Description<br>(Cont.) | design. As the differential pressure across the shunt increases, the ball further<br>displaces from the cone, through which CSF flows, thereby increasing flow<br>and re-establishing the selected pressure. The ball is manufactured of<br>synthetic ruby, as is the matching cone. Together these components provide a<br>precise fit for regulating the flow of CSF through the valve.<br><br>The valve is available with 8 different performance settings for constant<br>intraventricular pressure and drainage of CSF. Seven (7) of the settings<br>provide for a change in operating pressure, with a range of 25 to 215 mmH2O.<br>The eighth setting provides a minimum opening pressure of '400' mmH20,<br>thus allowing a physician to turn the valve "virtually off" without the need to<br>surgically remove the valve to limit flow. The pressure of the valve is set<br>preoperatively and can be noninvasively changed post-implantation by using<br>the Codman Certas Tool Kit, which employs magnetic force to select one of<br>the 8 settings. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| V. Indications<br>for Use | The Indications for Use statement is identical to the predicate Codman Hakim<br>Programmable Valve.<br><br>The Codman Certas Plus Programmable Valve is an implantable device that<br>provides constant intraventricular pressure and drainage of CSF for the<br>management of hydrocephalus. |
| VI.<br>Comparison to<br>Predicate<br>Device | Codman has modified the intended use of the Codman Certas Plus<br>Programmable Valve to include ventriculo-atrial (VA) shunting. Currently,<br>there is a contraindication for VA shunting in the instruction for use (IFU)<br>that has been removed, thereby allowing Certas Plus Programmable Valves<br>without Bactiseal antimicrobial catheters to be used for VA shunting.<br><br>The Codman Certas Plus Programmable Valve with the proposed intended is<br>substantially equivalent to the predicate Codman Hakim Programmable Valve<br>which has been cleared for VA shunting under K974739 on July 1, 1998. The<br>Codman Hakim Programmable Valve has the same intended use, design<br>principles, and similar operational principles and materials as the Certas Plus<br>Programmable Valve. |

The labeling modifications are specified in Table 1.

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| Table 1. Labeling Modifications Proposed for the Codman Certas Plus Programmable Valve | | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Component | Modification | Rationale |
| Instructions for Use (IFU) | The IFU has been updated to remove the contraindication for draining cerebrospinal fluid to the atrium (also known as ventriculo-atrial (VA) shunting); thereby allowing Certas Plus Programmable Valves without Bactiseal antimicrobial catheters to be used for VA shunting.<br>Precautions regarding ventriculo-atrial (VA) shunting have been added to the IFU. | Removing the contraindication allows physicians the option of using the Certas Plus Programmable Valve without Bactiseal antimicrobial catheters for VA shunting.<br>No changes are being made to the technological characteristics (i.e. design, materials, and function) of the Certas Plus Programmable Valve. |

VII. Codman previously received clearance for the Certas Plus Programmable Performance Valve via K143111; all performance testing included in that submission Data pertains to the Certas Plus Programmable Valve described in this submission as well.

> The following performance data has been provided in support of the substantial equivalence determination.

## Bench Testing

Bench testing was performed to demonstrate that the Codman Certas Plus Programmable Valve can be used for VA shunting. The testing consisted of the following:

- Reflux testing in accordance with ISO 7197:2009 Neurosurgical Implants - Sterile, Single-Use Hydrocephalus Shunts and Components and ASTM F647:1994 (R2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for for Neurosurgical Application
- . Shelf Life testing

The test results met the acceptance criteria; therefore, the Codman Certas Plus Programmable Valve conforms to the expected device performance and proposed intended use. Results of verification testing have demonstrated that the Codman Certas Plus Programmable Valve with the proposed intended use for VA shunting is substantially equivalent to the predicate Codman Hakim Programmable Valve and does not raise new questions of safety and effectiveness.

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## Biocompatibility Testing

The Certas Plus Programmable Valve components and materials have not changed, but the distal catheter (without Bactiseal antimicrobials), provided with the valve, can now be placed into direct contact with blood when used for VA shunting. The same distal catheter is currently cleared for use with the predicate Codman Hakim Programmable Valve (K974739) for VA shunting; the only difference is the sterilization method. As a result, Codman performed a biocompatibility evaluation in accordance with ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, ISO 10993-4 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood, and FDA draft guidance, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, published April 23, 2013. The evaluation concluded that additional biocompatibility testing was not required.

## Animal Studies

No animal studies were required as appropriate verification of the new intended use was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing and the biocompatibility evaluation.

### Clinical Studies

No clinical studies were required as appropriate verification of the new intended use was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing and the biocompatibility evaluation.

VIII. Based upon the intended use, design, materials, function, comparison to Conclusion currently marketed devices, and testing performed by Codman & Shurtleff, Inc., it is concluded that the Codman Certas Plus Programmable Valve with the proposed intended use for VA shunting is substantially equivalent to the predicate Codman Hakim Programmable Valve and therefore, does not raise any new questions of safety and effectiveness.