(85 days)
The Codman Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
The Codman Certas Plus Programmable Valve is a sterile, single use, implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.
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 design. As the differential pressure across the shunt increases, the ball further displaces from the cone, through which CSF flows, thereby increasing flow and re-establishing the selected pressure. The ball is manufactured of synthetic ruby, as is the matching cone. Together these components provide a precise fit for regulating the flow of CSF through the valve.
The valve is available with 8 different performance settings for constant intraventricular pressure and drainage of CSF. Seven (7) of the settings provide for a change in operating pressure, with a range of 25 to 215 mmH2O. The eighth setting provides a minimum opening pressure of '400' mmH20, thus allowing a physician to turn the valve "virtually off" without the need to surgically remove the valve to limit flow. The pressure of the valve is set preoperatively and can be noninvasively changed post-implantation by using the Codman Certas Tool Kit, which employs magnetic force to select one of the 8 settings.
The provided text describes a 510(k) premarket notification for the Codman Certas Plus Programmable Valve, where the manufacturer is seeking to expand its indications for use to include ventriculo-atrial (VA) shunting. The key focus of the submission is to demonstrate substantial equivalence to a predicate device for this expanded use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Results |
|---|---|---|
| Bench Testing | Reflux testing per ISO 7197:2009 and ASTM F647:1994 (R2006) for Neurosurgical Implants (Hydrocephalus Shunts) | "The test results met the acceptance criteria" |
| Bench Testing | Shelf Life testing | "The test results met the acceptance criteria" |
| Biocompatibility | Evaluation per ISO 10993-1, ISO 10993-4, and FDA draft guidance (2013) for devices with blood contact (VA shunting). | "The evaluation concluded that additional biocompatibility testing was not required." (This implies that the existing materials were deemed biocompatible for blood contact, or the risk was mitigated by similarity to the predicate and existing data). The same distal catheter, cleared for the predicate for VA shunting, was noted to be the only difference in sterilization method, which suggests prior approval based on similar material composition for blood contact. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Bench Testing: The document does not specify the exact sample sizes used for reflux testing or shelf-life testing.
- Data Provenance: The data comes from internal testing conducted by Codman, the device manufacturer. It is prospective testing, performed specifically to support this 510(k) submission for expanded indications. The country of origin of the data is not explicitly stated, but the submitter is Codman & Shurtleff, Inc., based in Raynham, MA, USA, and Medos International SARL in Le Locle, Switzerland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No external experts were used to establish ground truth for the bench testing. The "ground truth" for these tests is defined by the international standards (ISO and ASTM) and internal company specifications for performance.
4. Adjudication Method for the Test Set
- No adjudication method is described as the testing performed was objective bench testing against pre-defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC comparative effectiveness study was done. This filing is for a physical medical device (a programmable valve) and not an AI/imaging diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- For bench testing, the ground truth is defined by international consensus standards (ISO 7197:2009, ASTM F647:1994 (R2006)) and internal company specifications that ensure the device meets predefined performance characteristics (e.g., reflux limits, shelf life stability).
- For biocompatibility, the ground truth is based on regulatory and scientific standards (ISO 10993-1, ISO 10993-4) and FDA guidance, often relying on established material safety data.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set. The device itself is the product under review.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) |
|---|
| ☑ 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.325 Paramount DriveRaynham, MA 02767 | ||
|---|---|---|---|
| On behalf of:Medos International SARLChemin-Blanc 38CH 2400 LeLocle, Switzerland | |||
| Phone: 508-828-3421Fax: 508-977-6979 | |||
| 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(21 CFR 882.5550) | ||
| Regulatory Class | II | ||
| Product Code | JXG | ||
| III. Predicate Device | Codman Hakim Programmable Valve, K974739.The following reference devices were used in this submission:Codman Certas Plus Programmable Valve, K143111Codman 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.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. DeviceDescription(Cont.) | design. As the differential pressure across the shunt increases, the ball furtherdisplaces from the cone, through which CSF flows, thereby increasing flowand re-establishing the selected pressure. The ball is manufactured ofsynthetic ruby, as is the matching cone. Together these components provide aprecise fit for regulating the flow of CSF through the valve.The valve is available with 8 different performance settings for constantintraventricular pressure and drainage of CSF. Seven (7) of the settingsprovide for a change in operating pressure, with a range of 25 to 215 mmH2O.The eighth setting provides a minimum opening pressure of '400' mmH20,thus allowing a physician to turn the valve "virtually off" without the need tosurgically remove the valve to limit flow. The pressure of the valve is setpreoperatively and can be noninvasively changed post-implantation by usingthe Codman Certas Tool Kit, which employs magnetic force to select one ofthe 8 settings. |
|---|---|
| V. Indicationsfor Use | The Indications for Use statement is identical to the predicate Codman HakimProgrammable Valve.The Codman Certas Plus Programmable Valve is an implantable device thatprovides constant intraventricular pressure and drainage of CSF for themanagement of hydrocephalus. |
| VI.Comparison toPredicateDevice | Codman has modified the intended use of the Codman Certas PlusProgrammable Valve to include ventriculo-atrial (VA) shunting. Currently,there is a contraindication for VA shunting in the instruction for use (IFU)that has been removed, thereby allowing Certas Plus Programmable Valveswithout Bactiseal antimicrobial catheters to be used for VA shunting.The Codman Certas Plus Programmable Valve with the proposed intended issubstantially equivalent to the predicate Codman Hakim Programmable Valvewhich has been cleared for VA shunting under K974739 on July 1, 1998. TheCodman Hakim Programmable Valve has the same intended use, designprinciples, and similar operational principles and materials as the Certas PlusProgrammable 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.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.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.
§ 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).