AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)

K031303 · Aesculap, Inc. · JXG · Jun 4, 2003 · Neurology

Device Facts

• Record ID: K031303
• Device Name: AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
• Applicant: Aesculap, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jun 4, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• 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

Hydrocephalus shunt system; diverts CSF from lateral ventricles to peritoneum. Incorporates Gravity Assisted Valve (GAV); utilizes ball-in-cone valve mechanism in series with gravitational valve. Modified version of Paedi-GAV-Valve; features slightly larger dimensions and higher opening pressures. Implanted by neurosurgeons to manage intracranial pressure. Passive mechanical device; no electronic components or software.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Central nervous system fluid shunt; ball-in-cone valve mechanism; gravitational valve; passive mechanical operation; no energy source; non-software.

Indications for Use

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

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.

Predicate Devices

• Miethke Shunt System with Paedi-Gav-Valve
• Miethke Shunt System with DualSwitch Valve

Submission Summary (Full Text)

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# JUN - 4 2003

K031303

Aesculap - Miethke Shunt System

Page 1 of 1

### C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (in Accordance with SMDA of 1990)

# AESCULAP - MIETHKE SHUNT SYSTEM W/ GRAVITY ASSISTED VALVE (GAV)

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull<br>800-258-1946 x 5072 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Aesculap - Miethke Shunt System |
| COMMON NAME: | Hydrocephalus Shunt System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 84 JXG |
| CLASSIFICATION: | 882.5550 - Central Nervous System fluid shunt and<br>components. |
| REVIEW PANEL: | Neurology |

# INDICATIONS FOR 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 components of the Miethke Shunt System can include the Paedi-GAV-Valve, a "ballin-cone" valve in line with a gravitational valve. The modified device, is a slightly larger version of the Paedi-GAV-Valve and has slightly higher opening pressures. This modified device will be known as the Gravity Assisted Valve (GAV) and will also be offered as a part of the Miethke Shunt System.

#### PERFORMANCE DATA

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system.

# SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Miethke Shunt System with the GAV is substantially equivalent to our currently marketed Miethke Shunt System with Paedi-Gav-Valve and DualSwitch Valve.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

JUN - 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matthew M. Hull Senior Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K031303

Trade/Device Name: Aesculap - Miethke Shunt System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: April 23, 2003 Received: May 6, 2003

Dear Mr. Hull:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 - Mr. Matthew M. Hull

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]. 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) you may obtain. 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.

Sincerely yours,

O. Mark-N-Millman

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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#### INDICATIONS FOR USE STATEMENT B.

| 510(k) Number: | K031303 |
|----------------|---------|
|----------------|---------|

Device Name: Aesculap - 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

for

| (Division Sign-Off) | |
|-----------------------------------------------------------|--|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | |
| Prescription Use | |
| or Over-the-Counter Use | |
| (per 21 CFR 801.109) | |