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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Codman® HAKIM® Precision and Programmable Valve System, based on the provided 510(k) summary:

Key Takeaway: This 510(k) submission is for a material formulation change to an accessory (valve introducers), not the main valve system itself. Therefore, the "acceptance criteria" and "device performance" primarily revolve around demonstrating that this material change does not negatively impact the performance of the overall system or the introducers themselves. No clinical studies proving the device's efficacy for treating hydrocephalus were performed for this specific submission, as the fundamental device design and efficacy were established by previous predicate device clearances.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Functional Properties (Introducer)	No adverse effect on the functional flex characteristics of the valve introducers due to the material change.	Functional flex testing was successfully completed, demonstrating no impact on performance.
Mechanical Properties (Introducer)	No adverse effect on the pull strength or integrity of the valve introducers due to the material change.	Pull testing was successfully completed, demonstrating no impact on performance.
Biocompatibility	The new material formulation for the valve introducers must meet established biocompatibility standards.	Biocompatibility testing was performed in accordance with ISO-10993-1 and FDA Blue Book G95-1, indicating compliance.
Overall System Performance	The material formulation change to the valve introducers must not affect the performance of the HAKIM® Precision and Programmable Valve System.	Performance data (functional flex, pull, biocompatibility testing) demonstrates that the materials formulation change to the Hakim® Precision and Programmable valve introducers has no effect on the performance of the HAKIM® Precision and HAKIM® Programmable Valve System.
Indications for Use	The material change does not alter the established indications for use of the overall valve system.	Explicitly stated that "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 change does not alter the design, performance characteristics, or principles of operation of the overall valve system or the introducers themselves.	Explicitly stated that "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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test (functional flex, pull, biocompatibility). However, these are typically engineering and materials tests, and the sample size would be determined by relevant ISO/ASTM standards or internal validation protocols.
Data Provenance: The tests were conducted internally by Codman & Shurtleff, Inc. This is prospective internal testing, not data derived from patient studies in a specific country.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable in the traditional sense. For this type of material formulation change, "ground truth" is established by adherence to recognized engineering standards (e.g., ISO, FDA Blue Book) and successful completion of specific physical and chemical tests. The "experts" would be the engineers, material scientists, and regulatory specialists within Codman & Shurtleff, Inc. who designed and oversaw the testing and analysis.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1 by multiple experts) are typically used in clinical studies or image review where subjective interpretation or complex diagnostic decisions require consensus. For material and functional bench testing, the results are quantitative and objective, and successful completion is typically determined by meeting predefined numerical or qualitative criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was not a clinical effectiveness study. The submission relates to a material change in an accessory, not a new or significantly modified device requiring a comparative clinical performance assessment.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Not applicable. This device is a physical medical device (a shunt system and its accessories), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the material change was based on established engineering standards, material science principles, and functional performance benchmarks derived from the predicate devices. This includes:
- Compliance with ISO-10993-1 (Biological evaluation of medical devices).
- Compliance with FDA Blue Book G95-1 (Biocompatibility guidance).
- Successful completion of functional flex testing and pull testing for the introducers, presumably against predetermined specifications that ensure equivalence to the predicate.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission. This is not an AI or machine learning device. The material change was evaluated through testing against standards and functional requirements.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is not relevant.

Summary

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Codman® HAKIM® Precision and Programmable Valve System

510(k) SummaryCodman® HAKIM® Precision and Programmable Valve System
Date Prepared:	July 16, 2012			AUG	3	2012
Company Name:	Codman & Shurtleff, Inc.325 Paramount DriveRaynham, MA 02767
Contact Person	Kathy StrangeRegulatory Affairs SpecialistTelephone Number: (508) 828-3257Fax 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

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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

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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.

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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.

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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).