MAURICE WORLDWIDE SHUNT SYSTEM

K973525 · Integra Neurocare, LLC · JXG · Dec 16, 1997 · Neurology

Device Facts

• Record ID: K973525
• Device Name: MAURICE WORLDWIDE SHUNT SYSTEM
• Applicant: Integra Neurocare, LLC
• Product Code: JXG · Neurology
• Decision Date: Dec 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maurice Worldwide Shunt System is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneal cavity. This device should only be used by a physician or qualified personnel under the direction of a physician. Care must be taken to ensure compliance with the manufacturer's instructions for use. Prescription Use Only (Per 21 CFR 801.109)

Device Story

The Maurice Worldwide Shunt System is a medical device component used to manage hydrocephalus. It functions as part of a shunt system to divert cerebrospinal fluid (CSF) from the lateral ventricles of the brain to the peritoneal cavity. The device is intended for use by physicians or qualified personnel under physician direction. By facilitating CSF drainage, the system helps manage intracranial pressure in hydrocephalic patients.

Indications for Use

Indicated for hydrocephalic patients requiring cerebrospinal fluid (CSF) shunting from lateral ventricles to the peritoneal cavity.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 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 its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lori L. Havs. MT(ASCP) Regulatory Submissions Specialist NeuroCare Group™ 8401 102nd Street, Suite 200, PO Box 390 Pleasant Prairie, Wisconsin 53158-0390

DEC I 6 1997

Re: K973525

> Trade Name: Maurice Worldwide Shunt System Regulatory Class: II Product Code: JXG Dated: September 15, 1997 Received: September 17, 1997

Dear Ms. Hays:

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 (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

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Page 2 - Ms. Lori L. Hays, MT(ASCP)

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 yours,

tcoees

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lori L. Havs. MT(ASCP) Regulatory Submissions Specialist NeuroCare Group™ 8401 102nd Street, Suite 200, PO Box 390 Pleasant Prairie, Wisconsin 53158-0390

DEC I 6 1997

Re: K973525

> Trade Name: Maurice Worldwide Shunt System Regulatory Class: II Product Code: JXG Dated: September 15, 1997 Received: September 17, 1997

Dear Ms. Hays:

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 (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

{3}------------------------------------------------

Page 2 - Ms. Lori L. Hays, MT(ASCP)

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 yours,

tcoees

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

{4}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right and appears to be in flight. The logo is simple and clean, with a focus on the eagle as a symbol of the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lori L. Havs. MT(ASCP) Regulatory Submissions Specialist NeuroCare Group™ 8401 102nd Street, Suite 200, PO Box 390 Pleasant Prairie, Wisconsin 53158-0390

DEC I 6 1997

Re: K973525

> Trade Name: Maurice Worldwide Shunt System Regulatory Class: II Product Code: JXG Dated: September 15, 1997 Received: September 17, 1997

Dear Ms. Hays:

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 (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

{5}------------------------------------------------

Page 2 - Ms. Lori L. Hays, MT(ASCP)

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 yours,

tcoees

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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## SECTION 8 - DEVICE INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Maurice Worldwide Shunt System

Indications for Use: The Maurice Worldwide Shunt System is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneal cavity.

This device should only be used by a physician or qualified personnel under the direction of a physician.

Care must be taken to ensure compliance with the manufacturer's instructions for use.

**Prescription Use Only**
(Per 21 CFR 801.109)

boole

Sign-Off) of General Restorative Devic