(87 days)
K944555, K853215A
No
The device description details a purely mechanical valve system that regulates pressure based on physical principles (spring tension, ball-in-cone design) and pre-set manufacturing parameters. There is no mention of software, algorithms, or adaptive learning capabilities.
Yes.
The device drains CSF for the management of hydrocephalus and other conditions where CSF flow is impaired, which is a therapeutic intervention.
No
The device is described as an implantable valve that regulates intraventricular pressure and drains CSF, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, implantable device made of stainless steel and silicone rubber with mechanical components (spring, ball-in-cone valve seat). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage hydrocephalus and other conditions by providing constant intraventricular pressure and drainage of CSF. This is a therapeutic and physiological function performed within the body.
- Device Description: The description details an implantable mechanical valve system designed to regulate fluid pressure and flow in vivo. It does not describe a device used to examine specimens derived from the human body in vitro to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
Therefore, the CODMAN HAKIM™ Micro Precision Valve System is a therapeutic implantable device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CODMAN HAKIM™ Micro Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus and other conditions in which CSF flow and absorption are impaired.
Product codes (comma separated list FDA assigned to the subject device)
84 JXG
Device Description
The CODMAN HAKIM™ Micro Precision Valve incorporates a flat 316L stainless steel spring. Intraventricular pressure is maintained at a constant level by the synthetic ruby ball-in-cone valve seat design. Depending on the cerebrospinal (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.
The silicone rubber housing of the CODMAN HAKIM™ Micro Precision Valve has a flat bottom to better stabilize the position of the valve underneath the scalp. The flat underside of the valve should be placed against the bone.
The operating pressures of the valve are set and verified at the time of manufacture. The valve is classified by the operating pressure, not by the opening and closing pressures. The total pressure of the valve is controlled by the inlet valve. The CODMAN HAKIM™ Micro Precision Valve is available in five pressure settings:
Very Low 10 ± 10 mm H2O
Low 40 ± 10 mm H2O
Medium 70 ± 10 mm H2O
Medium High 100 ± 10 mm H2O
High 130 ± 10 mm H2O
The materials of the CODMAN HAKIM™ Micro Precision Valve are the same materials that are used in the currently marketed Codman-Medos Shunt Valve System (K944222). The only difference in materials is in the accessories. The stainless steel connector described in K944555 has been replaced with a nylon connector that was cleared in the Accu-Flo Pressure Valve submission (K853215A).
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)
Not Found
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.
K944555, K853215A
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
DEC 2 9 1997
510(k) Summary CODMAN HAKIM™ Micro Precision Valve
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
1. Contact Person:
Janet G. Johnson, Assoc. Regulatory Affairs Specialist, (508) 828-3466
2. Device Name:
| Proprietary Name: | CODMAN HAKIM™ Micro Precision Valve |
|---|---|
| Common Name: | Hydrocephalus Shunt |
| Classification Name: | Central Nervous System Fluid Shunt and Components |
| Regulatory Class: | • Class II by 21 CFR §882.5550 |
| Product Code: | • 84 JXG |
| Owner/ Operator # | 9001269 |
Device Classification: 3.
Classification for CODMAN HAKIM™ Micro Precision Valve has been placed in Class II by 21 CFR §882.5550.
Statement of Substantial Equivalence: 4.
The safety and effectiveness of the CODMAN HAKIM™ Micro Precision Valve is substantially equivalent in terms of intended use, materials, design, manufacturing and function to the Codman-Medos Shunt Valve System (K944222).
Indications for Use: 5.
The CODMAN HAKIM™ Micro Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus and other conditions in which CSF flow and absorption are impaired.
Physical Description: 6.
The CODMAN HAKIM™ Micro Precision Valve incorporates a flat 316L stainless steel spring. Intraventricular pressure is maintained at a constant level by the synthetic ruby ball-in-cone valve seat design. Depending on the cerebrospinal (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.
1
The silicone rubber housing of the CODMAN HAKIM™ Micro Precision Valve has a flat bottom to better stabilize the position of the valve underneath the scalp. The flat underside of the valve should be placed against the bone.
The operating pressures of the valve are set and verified at the time of manufacture. The valve is classified by the operating pressure, not by the opening and closing pressures. The total pressure of the valve is controlled by the inlet valve. The CODMAN HAKIM™ Micro Precision Valve is available in five pressure settings:
| Very Low | 10 ± 10 mm H2O |
|---|---|
| Low | 40 ± 10 mm H2O |
| Medium | 70 ± 10 mm H2O |
| Medium High | 100 ± 10 mm H2O |
| High | 130 ± 10 mm H2O |
The materials of the CODMAN HAKIM™ Micro Precision Valve are the same materials that are used in the currently marketed Codman-Medos Shunt Valve System (K944222). The only difference in materials is in the accessories. The stainless steel connector described in K944555 has been replaced with a nylon connector that was cleared in the Accu-Flo Pressure Valve submission (K853215A).
Similarities and Differences Matrix
| | CODMAN
HAKIMI Micro
Precision Valve | Codman-Medos
Shunt Valve System
(K944222) |
|-----------------------------------|-------------------------------------------|-------------------------------------------------|
| DESIGN: | | |
| Ball-in-cone: | Yes | Yes |
| Inlet Spring: | Flat | Flat |
| Operating Pressures: | | |
| $10 \pm 10$ mm H2O (Very Low) | Yes | Yes |
| $40 \pm 10$ mm H2O (Low) | Yes | Yes |
| $70 \pm 10$ mm H2O (Medium) | Yes | Yes |
| $100 \pm 10$ mm H2O (Medium High) | Yes | Yes |
| $130 \pm 10$ mm H2O (High) | Yes | Yes |
| Pressure Determinant | Inlet Valve | Inlet Valve |
| Pressure Identification | Dot Code | Color Code |
| Housing Bottom | Flat | Blended to Round |
| Pumping Chamber | No | Yes |
| Outlet | No | Yes |
| Inlet Valve | Yes | Yes |
| Anti-Reflux Mechanism | Inlet Valve | Outlet |
| Priming Adapter | Yes | No |
| Pre-chamber | With and Without | With and Without |
2
| | CODMAN
HAKIM™ Micro
Precision Valve | Codman-Medos
Shunt Valve System
(K944222) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------|
| AVAILABILITY: | | |
| Valve System | Yes | Yes |
| Valve unit alone | Yes | Yes |
| System components alone | Yes | Yes |
| | | |
| INTENDED USE: | | |
| The CODMAN HAKIM™ Micro Precision Valve
System is an implantable device that provides
constant intraventricular pressure and drainage of CSF
for the management of hydrocephalus and other
conditions in which CSF flow and absorption are
impaired. | Yes | Yes |
| | | |
| PACKAGING: | | |
| Double Peel Blister Tray | Yes | Yes |
| STERILIZATION: | EtO | EtO |
and the course would
approximated for a firm a firm a comments of the country of
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and the comments of the comments of the comments of
and the same of the same of the same of the same
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 29 1997
Ms. Janet G. Johnson Associate Regulatory Affairs Specialist Johnson & Johnson Professionals. Incorporated 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K973774
Trade Name: Codman Hakim Micro Precision Value Regulatory Class: II Product Code: JXG Dated: October 2, 1997 Received: October 3, 1997
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP 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 does not affect any obligation you might have under sections 531 through 542 of the Act for
4
Page 2 - Ms. Johnson
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 vours.
Sincerely yours,
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
5
大973974
Indications For Use for the CODMAN HAKIM™ Micro Precision Valve System
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Indications for Use _
The CODMAN HAKIM™ Micro Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus and other conditions in which CSF flow and absorption are impaired.
Division Sign-Off)
Division of General Restorative Devices
510(k) Number K923774
Prescription Use
(Per 21 CFR 801.109)