MIETHKE SHUNT SYSTEM

K020728 · Aesculap, Inc. · HCA · Apr 5, 2002 · Neurology

Device Facts

• Record ID: K020728
• Device Name: MIETHKE SHUNT SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: HCA · Neurology
• Decision Date: Apr 5, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

Device Story

Miethke Shunt System facilitates drainage of excess cerebrospinal fluid (CSF) from lateral brain ventricles to peritoneum; used for hydrocephalus management. System comprises ventricular catheter and valve components; functions as passive fluid conduit. Operated by neurosurgeons in clinical/surgical settings. Output is continuous CSF diversion; clinical decision-making relies on surgeon assessment of intracranial pressure and patient hydrocephalus status. Benefits include reduction of intracranial pressure and prevention of neurological complications associated with fluid accumulation.

Clinical Evidence

No clinical data provided. The device relies on bench testing and conformance to applicable ASTM and ISO standards to demonstrate safety and effectiveness.

Technological Characteristics

Shunt system consisting of ventricular catheter and valve components. Materials conform to applicable ASTM and ISO standards. Passive mechanical fluid diversion principle. Class II device.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunting from the lateral ventricles of the brain to the peritoneum for the management of hydrocephalus.

Regulatory Classification

Identification

A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.

Predicate Devices

• J & J Hakim Micro Programmable Valve System (K980778)
• Heyer-Schulte Novus (K961859)
• P/S Medtronic Bulton (K911410)
• P/S Medtronic Delta (K902783)
• Cordis NMT Gravity Compensating Accessory (K932429)
• Cordis NMT Hakim Standard/Pediatric Valves (K861377)

Submission Summary (Full Text)

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### APR - 5 M

Miethke Shunt System

Kolo728

Page 1 of 1

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

#### MIETHKE SHUNT SYSTEM

November 26, 2001

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Joyce Kilroy, Director of Regulatory Affairs/Quality Assurance<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>joyce.kilroy @ aesculap.com (email) |
| TRADE NAME: | Central Nervous System Fluid Shunt and Components |
| COMMON NAME: | Miethke Shunt System |
| DEVICE CLASS: | Shunt System - Class II<br>Ventricular Catheter - Class II |
| PRODUCT CODE: | Shunt System - JXG<br>Ventricular Catheter - HCA |
| CLASSIFICATION: | Shunt System - 882.5550<br>Ventricular Catheter - 882.4100 |
| REVIEW PANEL: | Neurology |

#### INTENDED USE

The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

#### DEVICE DESCRIPTION

The ventricular catheter is a part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for removal of excess CSF.

### PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new Miethke Shunt System conforms to applicable ASTM and ISO standards.

#### SUBSTANTIAL EQUIVALENCE

The Aesculap Miethke Shunt System is essentially identical to the J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K911410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429) and the Cordis NMT Hakim Standard/Pediatric Valves (K861377).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

Ms. Joyce Kilroy Director, Regulatory Affairs and Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034

2002 APR

Re: K020728

Trade/Device Name: Miethke Shunt System Regulation Number: 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: II Product Code: HCA Dated: March 4, 2002 Received: March 6, 2002

Dear Ms. Kilroy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(x) premained in substantially equivalent (for the indications for use stated in the enclosure) the devices the devices marketed in interstate for use stated in the encrosule) to regally mancted producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Food Frya commerce prior to May 28, 1770, the enactions with the provisions of the Federal Food. Drug, devices that have been reclassified in accerative will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket of the Ac and Cosmetic Act (Act) that to hot require approvide on trols provisions of the Act. The Act. The You may, therefore, market the devices, belyer to the more of registration, listing of general controls provisions of the 110th line, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into etails rates in the major regulations affecting your device can
may be subject to such additional controls. Existing major regu may be subject to such additional controller a marketing and to 898. In addition, FDA may be found in the Code of I sacka 11.5gmming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of woulderice complies with other requirements of the Act that IDA has made a decommation administered by other Federal agencies. You must of ally Federal statutes and regulations adminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercaing, and manufacturing practice requirements as set CFK Fart 807), adomig (21 CFR Part 820); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000-1050 forth in the quality systems (QD) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human figures. The image is in black and white.

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Page 2 - Ms. Joyce Kilroy

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

R. Mark N. Millican

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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Special 510(k) Premarket Notification

Miethke Shunt System

Page 1 of 1

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

020728

Device Name: Miethke Shunt System

Indication for Use:

The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

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| | | | In the control of the consisted on the commended to comments of the many of the many of the many of the many of the many world and the many would be comments of the many of t |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of General. Restorative and Neurological Devices 020728

510(k) Number***_***_

Prescription Use X or Over-the-Counter Use ***_***

(per 21 CFR 801.109)

(Optional Format 3-10-98)