(17 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a valve system for hydrocephalus, with no mention of AI or ML. The 510(k) is for a material change to an accessory.
Yes
The device is an implantable system designed to manage hydrocephalus by regulating intraventricular pressure and draining CSF, which directly addresses a medical condition and restores a physiological function.
No
The device is described as an "implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus." Its function is to relieve intracranial pressure by diverting CSF, not to diagnose a condition.
No
The device description clearly states that the HAKIM® Precision and Programmable Valve Systems are "implantable devices" and describes physical components like valves and introducers. The 510(k) is specifically for a material change to the valve introducers, which are hardware accessories.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage hydrocephalus by draining cerebral spinal fluid (CSF) and maintaining intraventricular pressure. This is a therapeutic intervention performed directly on the patient.
- Device Description: The device is an implantable valve system that physically diverts CSF. It is not used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on in vitro analysis.
The device is clearly described as an implantable medical device used for treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The HAKIM® Precision and Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainage of CFS for the management of hydrocephalus. The material formulation change of the valve introducers does not affect the indications for use or the intended use of the HAKIM® Precision and Programmable Valve System.
The HAKIM® Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The HAKIM® Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Codman HAKIM® Precision and Programmable Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
Hydrocephalus is a condition caused by the excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as the HAKIM® valve, to another body cavity where it is absorbed and subsequently excreted.
Both the HAKIM® Precision and Programmable valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The HAKIM® Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges: The HAKIM® Programmable valves not having fixed pressures, permit non-invasive adjustment of the valve opening pressure, in order for the surgeon to increase or decrease the valve's opening pressure, and can be adjusted to 18 different opening pressure settings.
The purpose of this Special 510(k) premarket notification is to request a material formulation change to the valve introducers that are used as accessories to the Hakim® Precision and Programmable Valve Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Performance Testing: Testing has been successfully completed and supports the safety and effectiveness of the modified valve introducers for their intended uses.
Clinical Performance Testing: The intention of this Special 510(k) is to seek clearance for a materials formulation change to the polyethylene material used on the valve introducers which are accessories to the HAKIM® Precision and Programmable Valve System. No clinical tests were required for this change.
Performance Data: Codman performed functional flex testing, pull testing, and biocompatibility testing in accordance with ISO-10993-1 and FDA Blue Book G95-1. The results of this testing demonstrate that the materials formulation change to the Hakim® Precision and Programmable valve introducers has no affect on the performance of the HAKIM® Precision and HAKIM® Programmable Valve System.
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.
K944222, K974739, K020667, K053350, K992173
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.
Not Found
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).
0
Codman® HAKIM® Precision and Programmable Valve System
| 510(k) Summary
| Codman® HAKIM® Precision and Programmable Valve System | ||||||
|---|---|---|---|---|---|---|
| Date Prepared: | July 16, 2012 | AUG | 3 | 2012 | ||
| Company Name: | Codman & Shurtleff, Inc. | |||||
| 325 Paramount Drive | ||||||
| Raynham, MA 02767 | ||||||
| Contact Person | Kathy Strange | |||||
| Regulatory Affairs Specialist | ||||||
| Telephone Number: (508) 828-3257 | ||||||
| Fax Number: (508) 977-6428 | ||||||
| Device Proprietary Name: | Codman® HAKIM Precision and Programmable Valve System | |||||
| Device Common Name: | Hydrocephalus Shunt System | |||||
| Classification Name: | Central Nervous System Fluid Shunt and Components | |||||
| Device Classification: | Class II (21 CFR§ 882.5550) (JXG) | |||||
| Type of 510(k) Submission: | Special 510(k) | |||||
| Basis for Submission: | Materials Formulation Change | |||||
| Predicate Device(s): | K944222 | Codman® Hakim® Shunt System | ||||
| K974739 | Codman® Hakim® Programmable Valve System | |||||
| K020667 | Codman® Hakim® Shunt System | |||||
| K053350 | Modification to Codman® Hakim® Shunt System | |||||
| K992173 | Codman® SiphonGuard CSF Control Device |
Device Description
The Codman HAKIM® Precision and Programmable Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
Hydrocephalus is a condition caused by the excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as the HAKIM® valve, to another body cavity where it is absorbed and subsequently excreted.
1
Both the HAKIM® Precision and Programmable valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The HAKIM® Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges: The HAKIM® Programmable valves not having fixed pressures, permit non-invasive adjustment of the valve opening pressure, in order for the surgeon to increase or decrease the valve's opening pressure, and can be adjusted to 18 different opening pressure settings.
The purpose of this Special 510(k) premarket notification is to request a material formulation change to the valve introducers that are used as accessories to the Hakim® Precision and Programmable Valve Systems.
Indications for Use
The HAKIM® Precision and Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainage of CFS for the management of hydrocephalus. The material formulation change of the valve introducers does not affect the indications for use or the intended use of the HAKIM® Precision and Programmable Valve System.
Technological Characteristics
The material formulation change of the valve introducers does not affect the design, performance characteristics, or principles of operation of the HAKIM® Precision and Programmable Valve Systems. The technological characteristics of the modified valve introducers are identical to those of the predicate valve introducer devices. No changes are being made to the HAKIM® Precision or HAKIM® Programmable valves or any other accessory components provided with the valves.
Non-Clinical Performance Testing
Testing has been successfully completed and supports the safety and effectiveness of the modified valve introducers for their intended uses.
Clinical Performance Testing
The intention of this Special 510(k) is to seek clearance for a materials formulation change to the polyethylene material used on the valve introducers which are accessories to the HAKIM® Precision and Programmable Valve System. No clinical tests were required for this change.
Performance Data
Codman performed functional flex testing, pull testing, and biocompatibility testing in accordance with ISO-10993-1 and FDA Blue Book G95-1. The results of this testing
2
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... ....
demonstrate that the materials formulation change to the Hakim® Precision and Programmable valve introducers has no affect on the performance of the HAKIM® Precision and HAKIM® Programmable Valve System.
Statement of Substantial Equivalence
The Codman® HAKIM® Precision and Programmable Valve Systems are substantially equivalent to the Codman® HAKIM® Precision and Programmable Valve Systems previously cleared by the FDA (K944222, K974739, K020667, K053350, and K992173) based on similarities in intended use, design, principles of operation, and performance specifications.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is positioned to the right of the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
3 2012 AUG
Codman & Shurtleff, Inc. c/o Ms. Kathy A. Strange Regulatory Specialist 325 Paramount Dr. Raynham, MA 02767-0350
Re: K122118
Trade/Device Name: HAKIM® Programmable and Precision Valve Introducer Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: July 16, 2012 Received: July 17, 2012
Dear Ms. Strange:
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.
4
Page 2 - Ms. Kathy A. Strange
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,
Debrah Falls
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
5
Indications for Use
510(k) Number (if known): K122118
Device Name: Codman ® HAKIM ® Precision and Programmable Valve System
Indications for Use:
The HAKIM ® Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The HAKIM ® Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Samuel Shimp
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K122118
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