(137 days)
Not Found
No
The device description details a purely mechanical and magnetic mechanism for adjusting valve pressure. There is no mention of algorithms, learning, or data processing that would indicate AI/ML.
Yes
The device is used for the management of hydrocephalus, which is a medical condition, by providing constant intraventricular pressure and drainage of cerebrospinal fluid.
No
The device is an implantable hydrocephalus shunt that drains cerebrospinal fluid to manage hydrocephalus, which is a treatment, not a diagnostic, function.
No
The device description clearly details a physical, implantable valve system with mechanical components (ruby ball, spring, cam, pivot) and a magnetic programming mechanism. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the HAKIM Micro Programmable (HMP) Valve System is an implantable device for the management of hydrocephalus by draining cerebrospinal fluid. This is a therapeutic and mechanical function performed within the body.
- Device Description: The description details a mechanical valve system with a spring, ball, and cam that physically regulates fluid pressure. This is a physical mechanism, not a test performed on a sample outside the body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device does not perform such tests.
The HAKIM Micro Programmable Valve System is a Class III implantable medical device.
N/A
Intended Use / Indications for Use
The HAKIM Micro Programmable (HMP) Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The HMP Valve System is a hydrocephalus shunt designed to allow the surgeon to change the valve opening pressure without surgical intervention. Intraventricular pressure is maintained at a constant level by the device's ruby ball-in-cone valve seat design. The center of a flat spring is attached to a fixed fulcrum, with one end resting on the ruby ball and the other end resting on an eighteen position spiral staircase shaped cam that rotates on a titanium pivot. When the cam rotates the tension on the spring changes as the distal end of the spring moves up or down the cam. The opening pressure of the valve is thereby adjusted. During programming, the programmer transmits a coded magnetic signal to the device, causing the cam to rotate. The device has 18 pressure settings, ranging from 30mm to 200mm H20, in 10mm increments.
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)
Performance testing was conducted to confirm device functionality for its intended use as a hydrocephalus shunt. Results of all testing demonstrate that the HAKIM Micro Programmable Valve System is equivalent to currently marketed products in its performance as a hydrocephalus shunt.
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.
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
EXHIBIT E
510K Summary HAKIM Micro Programmable Valve System
February 26, 1998
Submitter 1.
Johnson & Johnson Professional, Inc. 325 Paramount Drive Ravnham, MA 02767 。 Diane Minear, Senior Regulatory Consultant, (508) 828-3532
2. Device Name
| Proprietary Name: | HAKIM Micro Programmable Valve System |
|---|---|
| Common Name: | Hydrocephalus Shunt |
| Classification Name: | Central Nervous System Fluid Shunt and |
| Components | |
| Regulatory Class: | Class II by 21 CFR §882.5550 |
3. Intended Use
The HAKIM Micro Programmable (HMP) Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.
4. Device Description
The HMP Valve System is a hydrocephalus shunt designed to allow the surgeon to change the valve opening pressure without surgical intervention. Intraventricular pressure is maintained at a constant level by the device's ruby ball-in-cone valve seat design. The center of a flat spring is attached to a fixed fulcrum, with one end resting on the ruby ball and the other end resting on an eighteen position spiral staircase shaped cam that rotates on a titanium pivot. When the cam rotates the tension on the spring changes as the distal end of the spring moves up or down the cam. The opening pressure of the valve is thereby adjusted. During programming, the programmer transmits a coded magnetic signal to the device, causing the cam to rotate. The device has 18 pressure settings, ranging from 30mm to 200mm H20, in 10mm increments.
1
Predicate Device Comparison 5.
The HMP Valve System is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the CODMAN HAKIM Micro Precision Valve System (K973774). Both devices utilize the same ball-in-cone Frecision valve oyotom (traventricular pressure. Depending on the CSF flow rate and/or viscosity, the ball moves up or down within the cone under the control of the calibrated flat stainless steel spring. The cross section of the valve through which CSF flows automatically increases or decreases, therefore maintaining the selected pressure.
While the pressure regulating mechanism is identical in both devices, the variable pressure setting feature is only available with the HMP Valve System, while the HAKIM Micro Precision Valve System is available in five fixed pressure ranges.
Device Testing Summary 6.
Performance testing was conducted to confirm device functionality for its intended use as a hydrocephalus shunt. Results of all testing demonstrate that the HAKIM Micro Programmable Valve System is equivalent to currently marketed products in its performance as a hydrocephalus shunt.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA," which is arranged in a circular pattern around the left side of the logo.
JUL 1 7 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diane Minear ·Senior Regulatory Affairs Consultant Johnson & Johnson Professionals, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K980778 Trade Name: Hakim Micro Programmable Valve System Regulatory Class: II Product Code: JXG Dated: June 15, 1998 Received: June 16, 1998
Dear Ms. Minear:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desirent the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls) or class
regulations affecting your device as no found in the final controls. Existing major regulations affecting your device can be for attend in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) and that,
such assumptions Failure to comply with the CMD such assumptions. Failure to comply with the GMP regulation may result in regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Flectronic nave under sections 531 through 542 of the Act for
regulations. regulations.
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Page 2 - Ms. Diane Minear
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Witt, Ph.D., M.P.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Hakim Micro Programmable Valve System INDICATIONS FOR USE
The HAKIM Micro Programmable Valve System is an implantable device that provides The HARM Micro Programmatic Introller of cerebrospinal fluid (CSF) for the management of hydrocephalus
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K980778
Prescription Use
(Per 21 CFR §801.109)
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Over-the-Counter Use
1980718
(Optional Format 1-2-96)