← Product Code [JXG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG) · K041296 # MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI (K041296) _Codman & Shurtleff, Inc. · JXG · Jun 10, 2004 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K041296 ## Device Facts - **Applicant:** Codman & Shurtleff, Inc. - **Product Code:** [JXG](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG.md) - **Decision Date:** Jun 10, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 882.5550 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The Nonprogrammable Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The HAKIM™ (and HAKIM™ Micro) Programmable Valve Shunt System is an implantable device that provides 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 designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart. ## Device Story Implantable CSF shunt systems; manage hydrocephalus via constant intraventricular pressure regulation and drainage. SiphonGuard™ component reduces risk of excessive pressure drop when patient is upright. Devices surgically implanted; function passively to shunt CSF from lateral ventricles to peritoneal cavity or right atrium. Modification involves substitution of epoxy material (Stycast 1267 replaced by Loctite M-31CL). No change to device function, operation, or clinical application. ## Clinical Evidence Bench testing and biocompatibility testing only; no clinical data provided. ## Technological Characteristics Implantable CSF shunt valves. Materials: Epoxy (Loctite M-31CL). Passive mechanical pressure regulation. No energy source, software, or connectivity. ## Regulatory 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. ## Predicate Devices - HAKIM™ Precision Valve System ([K041296](/device/K041296.md)) - HAKIM™ Programmable Valve System ([K041296](/device/K041296.md)) - HAKIM™ Micro Programmable Valve System ([K041296](/device/K041296.md)) - SiphonGuard™ CSF Control Device ([K041296](/device/K041296.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Codman & Shurtleff, Inc. Special 510(k): Device Mouilication Special 310(K). Device Moutheaton CODMAN® HAKIM™ Precision, Programmable, Micro Programmable Valve Systems; and the SiphonGuard™ CSF Control Device Page 1 of 2 # K041296 #### (JUN 1 0 2004 #### 510(k) Summary - Codman and Shurtleff, Inc. Submitter: 325 Paramount Drive Raynham, MA 02780 Kathryn Wunder Contact Person: Phone Number: (508) 880-8351 Fax Number: (508) 828-3212 May 13, 2004 Date Prepared: Classification Name: Central Nervous System Fluid Shunt and Components Item 1: HAKIM™ Precision Valve System Proprietary Name: Item 2: HAKIM™ Programmable Valve System Item 3: HAKIM™ Micro Programmable Valve System Item 4: SiphonGuardTM CSF Control Device Item 1: HAKIM™ Precision Valve System Predicate Device: Item 2: HAKIM™ Programmable Valve System Item 3: HAKIM™ Micro Programmable Valve System Item 4: SiphonGuard™ CSF Control Device HAKIM™ Precision Valve System: Intended Use: The Nonprogrammable Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. HAKIM™ (and HAKIM™ Micro) Programmable Valve Shunt System: The HAKIM™ Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. SiphonGuard™ CSF Control Device: The SiphonGuard™ device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart. {1}------------------------------------------------ | | 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 erect
position. | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Materials: | All materials remain the same for the indicated devices, with the
exception of an alternate epoxy. The current epoxy is Stycast
1267. The proposed alternative is Loctite M-31CL. | | Device
Description: | The devices that are the subject of this Special 510(k): Device
Modification are identical to their respective predicate
predecessors, with the exception of one material component. The
proposed alternative epoxy is the single difference in the devices. | | Performance
Data: | This submission relied upon appropriate bench and
biocompatibility testing necessary to support the device for its
intended use. | {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person with outstretched arms. The seal is black and white and appears to be a logo or emblem. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # 'JUN 1 0 2004 Ms. Kathryn Wunder Regulatory Affairs Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767 Re: K041296 K041296 Trade/Device Name: HAKIM™ Precision Valve Shunt System Trade/Device Name: HAKIM™ 20075550 Regulation Number: 21 CFR 882.5550 Regulation Number. 21 CFR 862.9596 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: May 13, 2004 Received: May 14, 2004 Dear Ms. Wunder: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section >10(t) prematic is substantially equivalent (for the indications referenced above and have determined the device marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally marked the of the Medical Device Amendments, or to commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior to May 28, 1970, the enaculier and other of the Federal Food, Drug, devices that have been reclassified in accordance was are askets on oval application (PMA). and Cosmetic Act (Act) that do not requires and control controlsions of the Act. and Cosmetic Act (Act) that do not require approvations provisions of the Act. The You may, therefore, market the device, subject to the general constructions of the Act. You may, therefore, market the device, subject to the gentlal registration, listing of general controls provisions of the Act include requirements for annual registranding an general controls provisions of the Act mender requirements of the manufacturing and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more controls it (spealations affecting your device can may be subject to such additional controls. Existing major regulations affec may be subject to such additional controis. Existing major toganto and on addion, FDA may be found in the Code of Federal-Regulations, Title 21, Parts 800 to 898 - 11 additi be found in the Code of rederaritegalations, Friday, Friday, In the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I-DA's issuance of a subscribe only of the requirements of the Act that FDA has made a determination that your device also also annones. You must that FDA has made a determilation his your arres on other Fecderal agencies. You must or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations administered on registration and listing (21 comply with all the Act's requirements, including, but times assets requirements asst comply with all the Act s requirements, including, out manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the e CFR Part 807); labeling (21 CFR Patt 801); good mananation: and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 2001); 1000-1050 forth in the quality systems (QS) regulanon (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 {3}------------------------------------------------ Page 2 - Ms. Kathryn Wunder This letter will allow you to begin marketing your device as described in your Section 510(k) 10 Alegal This letter will allow you to begin marketing your active of your device of your device of your device to a legally premarket notification. The FDA Innding of substantial eq premarket notification. The FDA inding of substantial equive and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please r the regulation and 1104 - 1001 - 1650 - Also, please note the regulation e If you desire specific advice for your device on our accessing regulation entitled, contact the Office of Compliance at (301) 594-4659. Also, please note the Office of contact the Office of Compliance at (301) 554-407. The Part 807.97). You may obtain "Misbranding by reference to premarket notification" (21CFR Part 807.97). Your may oftai "Misbranding by reference to premarkst nonitication " (2) User from the Division of Small other general information on your responsibilities under (800) 638-204 other general information on your responsibilities and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance as and orders and human Manufacturers, International and Consumer 71355stance as no 1 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, L. Merle A. Milliken L. Merle Milliken, Ph.D., M.D. Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): Device Name: Indications For Use: K041296 SiphonGuard™ CSF Control Device The SiphonGuard™ device can be used as a The Siphon Oudrocephalus shunt systems designed component of myaross lateral ventricles of the brain to shunt OOF front of the right atrium of the heart. The SiphonGuard™ device is designed to reduce the me olphonomanas of excessive lowering of potential nazarde of exect to atmospheric intraventhoulan a patient is in an upright position. 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) > Office of Device Evaluation (ODE) Concurrence of CDRH Mark A M Page 1 of 1 (Division Sign-On) Division of General, Restorative, and Neurological Devices Re 510(k) Number K041296 {5}------------------------------------------------ K041296 510(k) Number (if known): Device Name: Indications For Use: HAKIM™ Precision Valve Shunt System The HAKIM™ Precision Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. 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) > Qffice of Device Evaluation (ODE) Concurrence of CDRH, Mark A. Millheiser Page 1 of 1 Sign-Off) (Division (Division of General, Restorative, Division of Generalive, Division of General Division and Neurological Devices 510(k) Number {6}------------------------------------------------ K041296 510(k) Number (if known): Device Name: Indications For Use: HAKIM™ Micro Programmable Valve Shunt System The HAKIM™ Micro Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. 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) > Qffice of Device Evaluation (ODE) Concurrence of CDRH, Page 1 of 1 (Division Sign-Off) Division of General, Restorative, and Neurological Devices K04/296 510(k) Number {7}------------------------------------------------ 510(k) Number (if known): Device Name: Indications For Use: K041296 HAKIM™ Programmable Valve Shunt System The HAKIM™ Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. 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) > Office of Device Evaluation (ODE) Concurrence of CDRH, Mark A. Wilkerson Page 1 of 1 __ Sign-Off) (Division (Division Sign Oct) Division of General, Restorative, Division of General Division of Schoological Devices K041296 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K041296](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXG/K041296) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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