(87 days)
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.
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).
Based on the provided 510(k) summary (K973774) for the CODMAN HAKIM™ Micro Precision Valve, here's an analysis of the acceptance criteria and supporting information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the CODMAN HAKIM™ Micro Precision Valve does not explicitly list "acceptance criteria" in the traditional sense of performance metrics with associated thresholds that a study would then demonstrate the device meets. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Codman-Medos Shunt Valve System, K944222).
The key performance characteristics presented are the operating pressure settings. For a medical device like this, the manufacturer's specified operating pressures are inherently the "performance" that needs to be met by each manufactured unit.
| Characteristic | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Operating Pressure | Very Low: 10 ± 10 mm H2O | 10 ± 10 mm H2O (Met by design/manufacturing) |
| Operating Pressure | Low: 40 ± 10 mm H2O | 40 ± 10 mm H2O (Met by design/manufacturing) |
| Operating Pressure | Medium: 70 ± 10 mm H2O | 70 ± 10 mm H2O (Met by design/manufacturing) |
| Operating Pressure | Medium High: 100 ± 10 mm H2O | 100 ± 10 mm H2O (Met by design/manufacturing) |
| Operating Pressure | High: 130 ± 10 mm H2O | 130 ± 10 mm H2O (Met by design/manufacturing) |
| Materials | Same as predicate (K944222), with minor accessory difference (nylon connector from K853215A) | Stated to be the same, with nylon connector (cleared in K853215A) |
| Design Features | Substantially equivalent to predicate (K944222) where applicable | "Yes" for Shared Features (e.g., Ball-in-cone, Flat Inlet Spring) |
| Intended Use | Same as predicate (K944222) | Stated to be the same |
| Sterilization | Same as predicate (K944222) (EtO) | EtO |
"Study That Proves the Device Meets the Acceptance Criteria":
The 510(k) document does not describe a specific clinical or performance study to prove these acceptance criteria (operating pressures, material compatibility, etc.) are met via a trial. Instead, the approach taken is a demonstration of substantial equivalence to an already legally marketed predicate device (Codman-Medos Shunt Valve System, K944222).
The statement "The operating pressures of the valve are set and verified at the time of manufacture" indicates that the manufacturer's quality control processes are responsible for ensuring each individual valve meets its specified pressure range. This is a manufacturing process control, not a study design.
The claim of substantial equivalence is primarily based on:
- Identical intended use.
- Similar design principles: both use a ball-in-cone and flat inlet spring.
- Identical operating pressure settings.
- Same materials, with the only difference being a previously cleared nylon connector accessory.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable (N/A) in the context of this 510(k) submission. The document describes a comparison to a predicate device, not a new performance study with a distinct "test set" of patient data. The basis for clearance is substantial equivalence based on technical and performance characteristics, not a clinical trial or a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable (N/A). There was no "test set" of patient data requiring expert ground truth establishment for this 510(k).
4. Adjudication Method for the Test Set
This is not applicable (N/A). No test set requiring adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for a medical device (shunt valve), and the focus is on its physical and functional characteristics compared to a predicate, not on a diagnostic or interpretative capability requiring human readers. Therefore, there's no mention of "human readers" or "AI assistance."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established and accepted performance characteristics of the predicate device (Codman-Medos Shunt Valve System, K944222) and the engineering specifications of the new device itself. For example, the operating pressures (e.g., 10 ± 10 mm H2O) are the established performance parameters based on design and manufacturing calibration. The "truth" is that the device should operate within these specified parameters. There is no external "pathology, outcomes data, etc." referenced as a ground truth for a study here.
8. The Sample Size for the Training Set
This is not applicable (N/A). This submission is not for an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable (N/A). No training set was used.
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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.
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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
| CODMANHAKIMI MicroPrecision Valve | Codman-MedosShunt 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 |
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| CODMANHAKIM™ MicroPrecision Valve | Codman-MedosShunt 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 ValveSystem is an implantable device that providesconstant intraventricular pressure and drainage of CSFfor the management of hydrocephalus and otherconditions in which CSF flow and absorption areimpaired. | Yes | Yes |
| PACKAGING: | ||
| Double Peel Blister Tray | Yes | Yes |
| STERILIZATION: | EtO | EtO |
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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
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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
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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)
§ 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).