(27 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a material change, not technological advancements related to AI/ML.
Yes
The device is used for the management of hydrocephalus, by providing constant intraventricular pressure and drainage of CSF, which is a therapeutic intervention.
No
The device description indicates that the HAKIM™ Precision Valve System, HAKIM™ Programmable Valve Shunt System, and SiphonGuard™ CSF Control Device are implantable devices designed to manage hydrocephalus by regulating intraventricular pressure and draining CSF. These are therapeutic devices, not diagnostic ones.
No
The device description explicitly states that the devices are "implantable devices" and mentions a "material component" and "alternative epoxy," indicating they are physical hardware devices, not software-only.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use/Indications for Use: The descriptions clearly state that these are implantable devices used for the management of hydrocephalus by draining CSF. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description focuses on the physical components and materials of the implantable devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. These devices do not fit that description.
N/A
Intended Use / Indications for Use
HAKIM™ Precision Valve System: 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
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)
This submission relied upon appropriate bench and biocompatibility testing necessary to support the device for its intended use.
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.
HAKIM™ Precision Valve System, HAKIM™ Programmable Valve System, HAKIM™ Micro Programmable Valve System, SiphonGuard™ CSF Control Device
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 & 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:
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
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
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:
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
510(k) Number