DIAMOND II VALVE

K991429 · Phoenix Biomedical Corp. · JXG · May 19, 1999 · Neurology

Device Facts

• Record ID: K991429
• Device Name: DIAMOND II VALVE
• Applicant: Phoenix Biomedical Corp.
• Product Code: JXG · Neurology
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended as the principle pressure regulating component of a CSF shunt assembly, used in the treatment of hydrocephalus.

Device Story

Diamond II Valve functions as primary pressure-regulating component within CSF shunt assembly; manages intracranial pressure in hydrocephalus patients. Device implanted surgically by neurosurgeon; regulates flow of cerebrospinal fluid from ventricles to drainage site. Mechanical valve design; maintains pressure gradients to prevent over-drainage or under-drainage. Clinical benefit: restoration of normal CSF dynamics; reduction of intracranial pressure symptoms. Used in hospital/OR setting.

Technological Characteristics

Mechanical pressure-regulating valve for CSF shunt assembly. Specific materials and ASTM standards not provided in text.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunt systems for the treatment of hydrocephalus.

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.

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes extending from its body. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAY 1 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Courtney Smith Regulatory Affairs Manager Phoenix Biomedical Corporation 2495 General Armstead Avenue Norristown, Pennsylvania 19403

K991429 Re: Trade Name: Diamond II Valve Regulatory Class: JXG Product Code: II Dated: April 22, 1999 Received: April 26, 1999

Dear Ms. Smith:

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Courtney Smith

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 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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Page Page Ca of

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Diamond II Valve Device Name:_

...

..

Indications For Use:

This device is intended as the principle pressure This device is intended as the principle proven
regulating component of a CSF shunt assembly, used regulabing compt of hydrocephalus.

.. .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K991429 |

| Prescription Use | <div style="text-align: center;">X</div> | OR | Over-The-Counter Use |
|----------------------|------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |