(85 days)
No
The description details a mechanical valve with programmable pressure settings adjusted by a magnetic tool. There is no mention of AI or ML in the device's function or operation.
Yes
This device is a therapeutic device because its intended use is to manage hydrocephalus by providing constant intraventricular pressure and drainage of CSF, which directly treats the condition.
No
Explanation: The device is an implantable valve used for the treatment of hydrocephalus by managing constant intraventricular pressure and drainage of CSF. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is an "implantable device" and describes physical components like a "ruby ball-in-cone principle" and a "pressure inducing spring design," indicating it is a hardware device, not software-only.
Based on the provided information, the Codman Certas Plus Programmable Valve is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the management of hydrocephalus by providing constant intraventricular pressure and drainage of CSF. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as an implantable device designed for shunting cerebrospinal fluid. This is a mechanical device that directly interacts with the patient's body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Codman Certas Plus does not perform any such analysis of bodily fluids or tissues.
Therefore, the Codman Certas Plus Programmable Valve is a Class III implantable medical device used for the treatment of a medical condition, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraventricular (for the management of hydrocephalus, and ventriculo-atrial shunting)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Clinical Studies: No clinical studies were required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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.
1
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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3
CODMAN NEURO
O DePuy Synthes
510(k) Summary
| I. Submitter | Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767 | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--|
| | On behalf of:
Medos International SARL
Chemin-Blanc 38
CH 2400 LeLocle, Switzerland | | |
| | Phone: 508-828-3421
Fax: 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, K143111
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.
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 | | |
4
| IV. Device
Description
(Cont.) | 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. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| V. Indications
for Use | The Indications for Use statement is identical to the predicate Codman Hakim
Programmable Valve.
The Codman Certas Plus Programmable Valve is an implantable device that
provides constant intraventricular pressure and drainage of CSF for the
management of hydrocephalus. |
| VI.
Comparison to
Predicate
Device | Codman has modified the intended use of the Codman Certas Plus
Programmable 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 Valves
without Bactiseal antimicrobial catheters to be used for VA shunting.
The Codman Certas Plus Programmable Valve with the proposed intended is
substantially equivalent to the predicate Codman Hakim Programmable Valve
which has been cleared for VA shunting under K974739 on July 1, 1998. The
Codman Hakim Programmable Valve has the same intended use, design
principles, and similar operational principles and materials as the Certas Plus
Programmable Valve. |
The labeling modifications are specified in Table 1.
5
| 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.
6
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.