CODMAN HAKIM MICRO PRECISION VALVE

K973774 · Johnson & Johnson Professionals, Inc. · JXG · Dec 29, 1997 · Neurology

Device Facts

• Record ID: K973774
• Device Name: CODMAN HAKIM MICRO PRECISION VALVE
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JXG · Neurology
• Decision Date: Dec 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Implantable hydrocephalus shunt valve; manages CSF flow and intraventricular pressure. Device utilizes synthetic ruby ball-in-cone mechanism with calibrated flat 316L stainless steel spring; spring tension adjusts valve opening based on CSF flow rate/viscosity to maintain constant pressure. Silicone rubber housing features flat bottom for scalp stabilization. Available in five pressure settings (10 to 130 mm H2O). Operated by neurosurgeons during implantation; provides passive, automatic pressure regulation. Benefits patient by preventing excessive intracranial pressure accumulation. No pumping chamber or outlet mechanism; anti-reflux provided by inlet valve.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 316L stainless steel spring, synthetic ruby ball, silicone rubber housing, nylon connector. Mechanism: Passive ball-in-cone valve with calibrated spring. Pressure settings: 10, 40, 70, 100, 130 mm H2O. Sterilization: Ethylene Oxide (EtO).

Indications for Use

Indicated for patients requiring management of hydrocephalus or conditions with impaired CSF flow and absorption. Implantable device for constant intraventricular pressure regulation and CSF drainage.

Regulatory Classification

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.

Predicate Devices

• Codman-Medos Shunt Valve System (K944222)

Reference Devices

• Accu-Flo Pressure Valve (K853215A)
• Stainless steel connector (K944555)

Submission Summary (Full Text)

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K973774

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, [phone]

#### 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

| | CODMAN<br>HAKIMI Micro<br>Precision Valve | Codman-Medos<br>Shunt Valve System<br>(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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| | CODMAN<br>HAKIM™ Micro<br>Precision Valve | Codman-Medos<br>Shunt Valve System<br>(K944222) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------|
| AVAILABILITY: | | |
| Valve System | Yes | Yes |
| Valve unit alone | Yes | Yes |
| System components alone | Yes | Yes |
| | | |
| INTENDED USE: | | |
| The CODMAN HAKIM™ Micro Precision Valve<br>System is an implantable device that provides<br>constant intraventricular pressure and drainage of CSF<br>for the management of hydrocephalus and other<br>conditions in which CSF flow and absorption are<br>impaired. | 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)