(113 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 Tool Kit allows the noninvasive reading or adjustment of the valve setting.
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 Valves are pressure-regulating valves 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 does not contain information related to the acceptance criteria and study details for an AI/ML-based device. The document is a 510(k) premarket notification for a medical device (Codman Certas Plus Programmable Valve and Codman Certas Tool Kit), which is a physical implantable device and its accompanying tool kit, not a software or AI/ML algorithm.
Therefore, the specific questions regarding AI/ML performance metrics, sample sizes for AI/ML models, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.
The document discusses various forms of bench testing, MRI testing, and biocompatibility testing for the physical device, and states that no animal or clinical studies were required due to the device's similarity to a predicate device and successful bench testing.
There is no information in the provided text that allows for the completion of the requested table and answers related to AI/ML device criteria.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2015
Medos International Sarl % Michelle Godin Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
Re: K143111
Trade/Device Name: Codman Certas Plus Programmable Valve: Codman Certas Tool Kit Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: October 28, 2014 Received: October 29, 2014
Dear Ms. Godin,
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 (reporting of medical device
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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 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 -S
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) K143111
Device Name
Codman Certas Plus Programmable Valve; Codman Certas Tool Kit
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.
The Codman Certas Tool Kit allows the noninvasive reading or adjustment of the valve setting.
| 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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6. 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: 508-828-3312 508-977-6979 Fax:
Contact Person: Michelle Godin Date of Submission: October 28, 2014
II. Device
| Name of Device | Codman Certas Plus Programmable ValveCodman Certas Tool Kit |
|---|---|
| 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 Codman Certas Programmable Valve System and Codman Certas Therapy Device Management System (K112156)
IV. Device The Codman Certas Plus Programmable Valve is a sterile, single use, Description implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.
The Codman Certas Plus Programmable Valves are pressure-regulating valves 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.
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| IV. DeviceDescription(Cont.) | 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 statements are identical to the predicate device. |
| The Codman Certas Plus Programmable Valve is an implantable device thatprovides constant intraventricular pressure and drainage of CSF for themanagement of hydrocephalus. | |
| The Codman Certas Tool Kit allows the noninvasive reading or adjustment ofthe valve setting. | |
| VI.Comparison toPredicate | Compared to the predicate device, the Codman Certas Plus ProgrammableValve and Codman Certas Tool Kit include the modifications listed in Table |
| Predicate |
|---|
| Device |
l
| Table 1. Modifications Proposed for the Codman Certas Plus Programmable Valve andCodman Certas Tool Kit | ||
|---|---|---|
| Component | Modification | Rationale |
| Codman CertasPlusProgrammableValve | Changes to components contained in theAdjustable Mechanism of the programmablevalveMinor dimensional changes to the profileof the Cam of the Rotating Construct anddimensional changes to the Cam/Ball ArmAssembly Addition of Ruby Bearing (same rubymaterial currently used in the predicatedevice, K112156) to through-hole of theRotating Construct | Minor modifications improve the overallperformance of the programmable valvewithout changing the fundamentalscientific technology or intended use ofthe predicate device. |
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510(k) Summary (Cont)
| Table 1. Modifications Proposed for the Codman Certas Plus Programmable Valve andCodman Certas Tool Kit | ||
|---|---|---|
| Component | Modification | Rationale |
| Codman CertasTool Kit | Locator Tool: Includes 2 Locator Tools: TheLow Profile Locator Tool which allows theclinician to get as close to the valve aspossible in cases of edema and an AdjustableHeight Locator Tool which allows theclinician to rotate the center ring to change theheight of the locator when valve protrusionexists in a patient. In addition, the petals willbe slightly wider for better grip on both tools.Minor enhancements to the tools includemachined black centering lines versus padprinted black lines to improve precision forlocation and the addition of a v-groove tocontain the 360° stop alignment pin forincreased pin retention strength. | Modification of ergonomic and userinterface; no change to fundamentalscientific technology or intended use ofpredicate device. |
| Indicator Tool: Removed the black buttonand improved the pivot-bearing design toreduce toggle time to indicating a valvesetting. Modified background of settingnumber and added a contoured handle. | ||
| Carrying Case: Increased in size toaccommodate 4 tools rather than 3 tools andadded a bump feature for easier removal of theAdjustment Tool. | ||
| Accessory Tool: X-ray Overlay Tool added toverify the valve setting on x-ray. | ||
| Labeling | Updated IFU and product labeling for namechange, clarification, and/or additional steps. | Labeling update to ensure proper use ofdevice, no change to indications for use orintended use. |
The following performance data were provided in support of the substantial VII. Performance equivalence determination. Data
Bench Testing
Bench testing on the proposed device, Codman Certas Plus Programmable Valve and Certas Tool Kit, included the following:
- Structural testing
- . Pressure flow testing in accordance with ISO 7197:2009 Neurosurgical Implants – Sterile, Single-Use Hydrocephalus Shunts and Components and ASTM F647:1994 (R2006) Standard Practice
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for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
- MRI testing ●
- Indication and Adjustment testing ●
- Shelf Life testing including structural testing, pressure flow testing, ● and MRI testing.
Validation testing included:
- Pre-implantation Use in-package indication and programming ●
- Post-implantation Use indication and adjustments post-implantation ● using simulated skin thicknesses
- Valve patency
- . Tool Kit validation
- Identifying the valve setting on x-ray with and without using the X-● Ray Overlay Tool
- Manometer IFU language ●
Test results demonstrated that the acceptance criteria were met, therefore, the Codman Certas Plus Programmable Valve and the Codman Certas Tool Kit conform to expected device performance and intended use. Results of verification and validation testing have demonstrated that the proposed Codman Certas Plus Programmable Valve and the Codman Certas Tool Kit are substantially equivalent to the predicate Codman Certas Programmable Valve and Codman Therapy Management System, and that the modifications do not impact the safety or effectiveness of the proposed device.
Magnetic Resonance (MR) Testing
The safety test requirements of the ASTM MR standards for the proposed Certas Plus Programmable Valve have been met through testing (ASTM F2052-14 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment; ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging; ASTM F2119-07 (R2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants; ASTM F2213-06 (R2011) Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment).
The Codman Certas Plus Programmable Valve is MR-Conditional at 3.0 Tesla per the ASTM standards.
Biocompatibility Testing
The biocompatibility evaluations for the Codman Certas Plus Programmable Valve and the Codman Certas Tool Kit were conducted in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and
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Testing May 1, 1995, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process as recognized by FDA.
Codman Certas Plus Programmable Valve
The Codman Certas Plus Programmable Valve is considered a permanent contact implant device. The only new component in the proposed device is the inclusion of a ruby bearing. Since the same ruby material is already included in the predicate Codman Certas Programmable Valve, additional biocompatibility testing was not required. However, as part of a cleaning validation for this component, cytotoxicity testing was completed with passing results.
Codman Certas Tool Kit
The Codman Certas Tool Kit is considered a surface device with limited contact (≤24 hours) with breached or compromised surfaces. Biocompatibility testing was completed with passing results. The following tests were conducted:
- Cytotoxicity ●
- Sensitization ●
- Irritation
- . USP Limits Testing for USP <661> for Plastics, Physiochemical Testing
Animal Studies
No animal studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Clinical Studies
No clinical studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Based upon the intended use, design, materials, function, comparison to VIII. Conclusion currently marketed devices, and testing performed by Codman & Shurtleff, Inc., it is concluded that the Codman Certas Plus Programmable Valve and Codman Certas Tool Kit was found to have a safety and effectiveness profile that is similar to the predicate device.
§ 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).