Codman Hakim Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.

Codman Hakim Shunt Systems are available with or without CODMAN BACTISEAL Catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.

Codman Hakim Shunt Systems are also available with or without SIPHONGUARD. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

Device Description

The Codman Hakim Shunt System incorporates all the possible shunt system features commercially available in the Codman Hakim line of products. The proposed device is adding a dimensional modification to the predicate valves listed above that are part of the Codman Hakim Shunt System.

AI/ML Overview

The provided text describes a 510(k) summary for the Codman Hakim Shunt Systems. It focuses on adding a dimensional modification (a silicone platform) to existing predicate valves within the system.

Here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as formal acceptance criteria.	"Bench testing has been completed and supports the safety and effectiveness of the proposed device for its intended use."
Implicit acceptance criterion: Technological characteristics of the proposed device are the same as the predicate devices, with the addition of a dimensional modification.	"The technological characteristics of the proposed device are the exact same as the predicate device." (This refers to the core function and technology, not the new dimensional modification itself.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified. The study type is "bench testing," which typically involves laboratory testing of the device itself rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The study was bench testing, not a clinical study requiring expert ground truth for patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This was bench testing, not a clinical study involving adjudication of interpretations.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (shunt system), not an AI-powered diagnostic tool for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical medical device, not an algorithm. Bench testing would assess the device's performance in a standalone laboratory environment.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For bench testing, the "ground truth" would be engineering specifications, performance standards, or established physiological parameters that the device is designed to meet. The document states that the testing "supports the safety and effectiveness of the proposed device for its intended use," implying adherence to established performance benchmarks for shunt systems.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI algorithm that requires a training set.

Summary

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SECTION 11 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

A. Submitter Information

A. Submitter Information
	Submitter's name:	Codman & Shurtleff, Inc.
	Address:	325 Paramount Drive
		Raynham, MA 02767
	Telephone:	508-828-3571
	Fax:	508-828-2777
	Contact Person:	Brian A. Kanerviko
	Date of Submission:	December 1, 2005
	B. Trade/Device Name:	Codman Hakim Shunt Systems.
	Common Name:	Shunt
	Classification Name:	Central Nervous System Fluid Shunt and Component
	Regulation Number:	882.550
	C. Predicate Device:	Codman Hakim Shunt Systems (K020667).
		Codman Hakim Programmable Valve (K974739)

D. Device Description: The Codman Hakim Shunt System incorporates all the possible shunt system features commercially available in the Codman Hakim line of products. The proposed device is adding a dimensional modification to the predicate valves listed above that are part of the Codman Hakim Shunt System.
Codman Hakim Precision Valve (K944222)
E. Intended Use: Codman Hakim Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
Codman Hakim Shunt Systems are available with or without CODMAN BACTISEAL Catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.

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F. Summary of technological characteristics of the proposed to the predicate device. The technological characteristics of the proposed device are the exact same as the predicate device.

G. Performance Data

Bench testing has been completed and supports the safety and effectiveness of the proposed device for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

Mr. Brian A. Kanerviko Senior Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K053350

Trade/Device Name: Codman Hakim Shunt Systems Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: December 22, 2005 Received: December 23, 2005

Dear Mr. Kanerviko:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Kanerviko

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchner

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):K053350

Device Name: Codman Hakim Shunt Systems: Addition of a silicone platform to the base of the Codman Hakim Programmable and Precision Valve

Indications For Use:

Codman Hakim Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Darbar Buelind to mykl

Division of General, Restorative, and Neurological Devices

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510(k) Number K053350

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).