(78 days)
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.
The Certas Programmable Valve System is designed for shunting 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 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 provided text describes a 510(k) submission for the CODMAN CERTAS Programmable Valve System and CODMAN CERTAS Therapy Management System, focusing on demonstrating substantial equivalence to a predicate device after extending its shelf life from 1 year to 5 years.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds, but rather implied by "no change" and "maintained" functionality. The performance data demonstrates that these criteria were met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Packaging integrity maintained for 5 years after accelerated aging | "The packaging stability study shows that there was no change in post-sterile seal strength after accelerated aging." |
| Product functionality maintained for 5 years 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." |
| No changes to intended use, materials, or principles of operation | "No changes are being made to the intended use, performance characteristics, materials, and principles of operation of the valve or its accessories." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the stability testing (both packaging and product). It refers to "packaging stability study" and "product stability testing" without providing specific numbers of units tested.
- Sample Size: Not explicitly stated.
- Data Provenance: The studies were conducted by the manufacturer, Medos International Sarl, as part of their regulatory submission. The context suggests these were prospective tests designed specifically to demonstrate the extended shelf life. The country of origin of the data is not specified beyond the company's location (Switzerland/US branch).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable (N/A) to this device submission. This submission concerns a physical medical device (a valve system) and its mechanical/functional performance after aging, not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. The "ground truth" here is the physical measurement of performance parameters (e.g., seal strength, pressure-flow, leak, reflux) against established engineering standards (EN ISO 7197:2009).
4. Adjudication Method for the Test Set
This is N/A for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used for expert reviews in image analysis or clinical assessments where there might be inter-observer variability. For objective physical device testing, the results are measured against defined performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is N/A. This submission is for a physical medical device (hydrocephalus shunt valve) for which MRMC comparative effectiveness studies with or without AI assistance are not relevant. This type of study is typically performed for AI-powered diagnostic tools or image analysis software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is N/A. The device is a physical valve system and a programming system, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this testing is based on:
- Objective physical measurements: Assessing parameters like seal strength, adjustment/indication capability, pressure-flow characteristics, and leak/reflux.
- Engineering Standards: Conformance to recognized international standards like EN ISO 7197:2009 for hydrocephalus shunts. The "ground truth" is that the device must continue to meet these functional and safety specifications after accelerated aging.
8. The Sample Size for the Training Set
This is N/A. This device is not an AI/machine learning product, so there is no "training set" in the context of data-driven model development. The product development likely involved engineering design and testing, but not a data-based training set.
9. How the Ground Truth for the Training Set was Established
This is N/A for the same reasons as point 8.
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FEB 1 6 2012
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510(k) SUMMARY
| Company Name: | Medos International Sarl |
|---|---|
| Company Address: | Chemin-Blanc 38CH 2400 LeLocle, Switzerland |
| Phone: | (508) 828-3421 |
| 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
| ProductCode | 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 (800) 638-2041 or (301) 796-7100 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
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 distalcatheter) |
| 82-8804 | Certas Inline Valve with Siphonguard (includes a PrimingAdapter) |
| 82-8805 | Certas Inline Valve with Siphonguard and Accessories |
| 82-8806 | Certas Inline Valve with Siphonguard and Accessories(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
Page 1 of
§ 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).