The Codman HAKIM Programmable Valves (CHPV) are implantable devices that provide constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

The SIPHONGUARD device can be used as a component of hydrocephalus shunt systems to shunt CSF from the ventricles of the brain into the peritoneal cavity or right atrium of the heart. 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 Programmable Valve (CHPV) is a variable pressure setting hydrocephalus valve, that provides constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus and other conditions in which CSF flow and absorption are impaired. The valve settings can be changed non-invasively by applying an external programming system.

An accessory to the Codman HAKIM Programmable Valve is the SIPHONGUARD CSF Control Device. This flow regulating antisiphon device can be used as an integral component of the Codman HAKIM Programmable Valve shunt system.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/software devices.

This document is a 510(k) Summary for a medical device: the Codman® HAKIM™ Programmable Valve and SIPHONGUARD™ CSF Control Device. This is a physical, implantable device (a hydrocephalus shunt system), not an AI or software-driven diagnostic tool.

The "Performance Data" section explicitly states:

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

This indicates that standard engineering bench tests were conducted to ensure the physical device functions as intended. However, it does not provide:

A table of specific acceptance criteria.
Reported device performance metrics (e.g., sensitivity, specificity, accuracy) like those found in AI studies.
Details about sample sizes for test sets in a clinical or image-based context.
Data provenance (country of origin, retrospective/prospective).
Number or qualifications of experts for ground truth.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth (pathology, outcomes data).
Sample size for training sets.
How ground truth for training sets was established.

Therefore, based on the provided text, I cannot complete the requested table and answer the specific questions related to AI/software device performance criteria and studies. The device described is a physical medical device, and its clearance relies on bench testing and substantial equivalence to predicate devices, not on the kind of performance studies you're inquiring about for AI.

Summary

{0}------------------------------------------------

Kas3107

510(k) Summary of Safety and Effectiveness

A. Submitter Information

A. Submitter InformationSubmitter's Name:Address:Telephone:Fax:Contact Person:Date of Submission:	Codman & Shurtleff, Inc.325 Paramount DriveRaynham, MA 02767508-880-8097508-828-2777Susan KaganNovember 2, 2005
B. Trade Name/Device Name:	Codman® HAKIM™ Programmable ValveHAKIM™ Micro Programmable ValveSIPHONGUARD™ CSF Control Device
Common Name:	Hydrocephalus Shunt System
Classification:	Central Nervous System Fluid Shunt and Components
Regulation Number:	21 CFR § 882.5550
C. Predicate Device:	K041296, HAKIM Precision Valve System, ProgrammableValve System, Micro-Programmable Valve System andSIPHONGUARD--Epoxy changeK020667, HAKIM Programmer and TransmitterK992173, SIPHONGUARD CSF Control DeviceK980778, HAKIM Micro Programmable ValveK974739, HAKIM Programmable Valve
D. Device Description:	The Codman HAKIM Programmable Valve (CHPV) is avariable pressure setting hydrocephalus valve, thatprovides constant intraventricular pressure and drainage ofcerebrospinal fluid for the management of hydrocephalusand other conditions in which CSF flow and absorption areimpaired. The valve settings can be changed non-invasively by applying an external programming system.An accessory to the Codman HAKIM Programmable Valveis the SIPHONGUARD CSF Control Device. This flowregulating antisiphon device can be used as an integralcomponent of the Codman HAKIM Programmable Valveshunt system.
E. Intended use:	The Codman HAKIM Programmable Valve is animplantable device that provides constant intraventricularpressure and drainage of CFS for the management ofhydrocephalus and other conditions in which CSF flow andabsorption are impaired.

$\vec{F}$ 1 of 2

{1}------------------------------------------------

F. Summary of technological characteristics of the proposed to the predicate device.
There have been no changes made to the technological characteristics of the device.

G. Performance Data:

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

Ms. Susan Kagan Senior Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K053107

KUS3107
Trade/Device Name: HAKIM® Programmable Valve with/without SIPHONGUARD™ Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: December 19, 2005 Received: December 21, 2005

Dear Ms. Kagan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocaren a seen fre device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the energeness of 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, de rices that have been 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 adviscd 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.

{3}------------------------------------------------

Page 2 - Ms. Kagan

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 yours,

Karbarz Bruckup

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

Enclosure

{4}------------------------------------------------

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division D.O. f/t:DXY:rrr: 01/13/06

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K053107

Device Name: Codman® HAKIM® Programmable Valve

Indications For Use:

The Codman HAKIM Programmable Valves (CHPV) are implantable devices that provide constant intraventricular pressure and drainage of CSF 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)

ncurrence of CDRH, Office of Device Evaluation (ODE)

Vaucluz Vaucluz

Division of General, Restorative, and Neurological Devices

510(k) Number K053107

Page 1 of 2

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K053107

Device Name: SIPHONGUARD CSF Control Device

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Oa. Dave Buell

Restorative. and Neurological Devices

Page 2 of 2

510(k) Number K053107

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).