(76 days)
Not Found
No
The description focuses on mechanical and programmable valve technology for CSF drainage, with no mention of AI or ML algorithms for decision-making, analysis, or control.
Yes
The device is used for the management of hydrocephalus, which involves providing constant intraventricular pressure and drainage of CSF, directly addressing a medical condition.
No
The device is an implantable shunt system designed to manage hydrocephalus by draining CSF and regulating pressure. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the Codman HAKIM Programmable Valves (CHPV) and the SIPHONGUARD device are implantable hardware components used in hydrocephalus shunt systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Codman HAKIM Programmable Valves and the SIPHONGUARD device are implantable devices used to manage hydrocephalus by draining cerebrospinal fluid (CSF) from the brain to other parts of the body. This is a direct intervention within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing.
Therefore, this device falls under the category of an implantable medical device rather than an in vitro diagnostic.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain, peritoneal cavity or right atrium of the heart
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)
Bench testing has been completed and supports the safety and effectiveness of the proposed 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.
K041296, K020667, K992173, K980778, K974739
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
Kas3107
510(k) Summary of Safety and Effectiveness
A. Submitter Information
| A. Submitter Information
Submitter's Name:
Address:
Telephone:
Fax:
Contact Person:
Date of Submission: | Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767
508-880-8097
508-828-2777
Susan Kagan
November 2, 2005 |
|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Trade Name/Device Name: | Codman® HAKIM™ Programmable Valve
HAKIM™ Micro Programmable Valve
SIPHONGUARD™ 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, Programmable
Valve System, Micro-Programmable Valve System and
SIPHONGUARD--Epoxy change
K020667, HAKIM Programmer and Transmitter
K992173, SIPHONGUARD CSF Control Device
K980778, HAKIM Micro Programmable Valve
K974739, HAKIM Programmable Valve |
| D. 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. |
| E. Intended use: | The Codman HAKIM Programmable Valve is an
implantable device that provides constant intraventricular
pressure and drainage of CFS for the management of
hydrocephalus and other conditions in which CSF flow and
absorption are impaired. |
$\vec{F}$ 1 of 2
1
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.
- 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:
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.
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