ACCURA ELITE SHUNT SYSTEM

K024040 · Phoenix Biomedical Corp. · JXG · Jan 27, 2003 · Neurology

Device Facts

• Record ID: K024040
• Device Name: ACCURA ELITE SHUNT SYSTEM
• Applicant: Phoenix Biomedical Corp.
• Product Code: JXG · Neurology
• Decision Date: Jan 27, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accura Elite Shunt System is intended for use as the principle of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.

Device Story

Accura Elite Shunt System functions as a component of a cerebrospinal fluid (CSF) shunt assembly; used for hydrocephalus treatment. Device facilitates drainage of excess CSF from the ventricles to an appropriate drainage site. Used in clinical/surgical settings by neurosurgeons. System design aims to manage intracranial pressure; provides therapeutic benefit by preventing complications associated with hydrocephalus.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics.

Technological Characteristics

Central Nervous System Fluid Shunt and Components (21 CFR 882.5550); Class II; Product Code JXG. Mechanical shunt assembly components.

Indications for Use

Indicated for the treatment of hydrocephalus in patients requiring a cerebrospinal fluid shunt assembly.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 2 7 2003

Ms. Courtney Smith Regulatory Affairs Manger Phoenix Biomedical Corporation P.O. Box 80390 Valley Forge, Pennsylvania 19484

Re: K024040

Trade Name: Accura Elite Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: II Product Code: JXG Dated: January 2, 2003 Received: January 2, 2003

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Courtney Smith

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN) : K024040

DEVICE NAME : ACCURA ELITE SHUNT SYSTEM

INDICATIONS FOR USE:

## Accura Elite Shunt System

## Intended Use/ Indications:

- The Accura Elite Shunt System is intended for use as the principle ● I ne Accura Lifte Bhant Bystent of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Muriam C. Provost

Vivision of General, Restorative nd Neurological Devices

Number K024040