CRX DIAMOND VALVE

K974096 · Phoenix Biomedical Corp. · JXG · Dec 8, 1998 · Neurology

Device Facts

• Record ID: K974096
• Device Name: CRX DIAMOND VALVE
• Applicant: Phoenix Biomedical Corp.
• Product Code: JXG · Neurology
• Decision Date: Dec 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use as the principle regulating component of a CSF flow and pressure requirement, used in the treatment of hydrocephalus.

Device Story

CRX Diamond Valve functions as a flow and pressure regulation component in cerebrospinal fluid (CSF) shunt systems. Used in the treatment of hydrocephalus; device manages intracranial pressure by regulating CSF drainage. Operated by neurosurgeons during surgical implantation. Device acts as a mechanical valve to maintain physiological pressure levels; prevents over-drainage or under-drainage of CSF. Clinical benefit includes management of hydrocephalus symptoms through controlled fluid diversion.

Technological Characteristics

Mechanical valve for CSF flow and pressure regulation. Specific materials and ASTM standards not disclosed in provided text.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) flow and pressure regulation 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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8 1998 DEC

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Courtney Smith Clinical and Requlatory Specialist Phoenix Biomedical Corporation P.O. Box 80390 19484 Vallev Forge, Pennsylvania

K974096 Re: CRX Diamond Valve Trade Name: Requlatory Class: II Product Code: JXG September 8, 1998 Dated: September 9, 1998 Received:

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 The general controls provisions of the Act 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 Requlations, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 diaqnostic 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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K974096/A'

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510(k) Number (if known): K974096

Device Name: CRX DIAMOND VALJE

Indications For Use:

This device is intended for use as the principle This device is Intended For the regulating component of a CSF ITOW and pressure regaremently, used in the treatment of hydrocephalus.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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