MEDTRONIC PS MEDICAL STRATA VALVE

K040943 · Medtronic Neurosurgery · JXG · Jun 15, 2004 · Neurology

Device Facts

• Record ID: K040943
• Device Name: MEDTRONIC PS MEDICAL STRATA VALVE
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Jun 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/flow performance level pre- and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation.

Device Story

Strata Valve is a CSF shunt component for hydrocephalus management; facilitates fluid drainage from brain ventricles to right atrium or peritoneal cavity. Device features adjustable pressure/flow performance levels; adjustments performed non-invasively by physicians using external magnetic handtools (Locator, Indicator, and Adjustment tools). System eliminates need for radiographic confirmation during pressure setting changes. Benefits include ability to manage changing patient needs post-implantation without surgical intervention or radiation exposure.

Clinical Evidence

Clinical study data evaluated accuracy of Indicator Tool pressure/performance level settings compared to radiographic confirmation. Results showed 98.6% correlation at discharge and 98.8% correlation during follow-up.

Technological Characteristics

CSF shunt valve with magnetic adjustment mechanism. Includes manual handtools (Locator, Indicator, Adjustment). Non-invasive magnetic actuation. Materials and dimensions identical to predicate. No software or electronic components.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunting from brain ventricles to the right atrium or peritoneal cavity for hydrocephalus management. Prescription use only.

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

• Medtronic PS Medical Strata® Valve (K040943)

Submission Summary (Full Text)

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# JUN 1 5 2004

## 510(k) Summary

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

| Establishment Registration Number: | 2021898 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Address of Manufacturer: | Medtronic Neurosurgery<br>125 Cremona Drive<br>Goleta CA, 93117<br>Telephone: [phone] ext. 1770<br>Fax: [phone] |
| Contact Person: | Jeffrey Henderson |
| Date: | April 8, 2004 |
| Trade or Proprietary Name: | Medtronic PS Medical Strata ® Valves and<br>Handtools |
| Common usual or Classification Name: | Central Nervous System Fluid Shunts and<br>Components. 21 CFR 882.5550 |

### Description:

After surgical implantation, the Strata Valve provides a non-invasive method to address changing patient needs in the management of hydrocephalus. The unique valve design allows the physician to adjust the pressure/flow performance level by using a magnetic Adjustment Tool included with the Strata® Valve adjustment kit without the need for radiographic confirmation.

The Strata® Handtools, include the Locator Tool, Indicator Tool and Adjustment Tool. Ail three tools are required to set or change the pressure/performance level setting of the Strata® Valve.

## Intended Use:

The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/flow performance level pre- and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation.

## Predicate Device Identification:

The Strata® Valve is substantially equivalent to the Medtronic PS Medical Strata® Valve based on the same intended use, materials, design and dimensions.

K040943 1/2

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K040943 2/2

## 510(k) Summary

## Device Testing:

The Strata® Valve is substantially equivalent to the Medical Strata® Valve based The Othata "Varo is oubota.histing, biocompatibility studies, and clinical study data.

Comparison of the Indicator Tool pressure/performance level setting and corresponding x-ray at time of Discharge and during follow-up, yielded the following results:

| Discharge Data | 98.6% | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| ALL IN CORRES<br>Adjustment Data | <br>98.8% | |
| Concellential<br><br>ית DJT | And An A C C C C C C . C . C . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . | SERE ENGLE EN LEE MERICAN |

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Image /page/2/Picture/2 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle.

JUN 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey Henderson Vice President, Quality & Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117-5500

Re: K040943

Trade/Device Name: PS Medical Strata® Valve Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: April 9, 2004 Received: April 20, 2004

Dear Mr. Henderson:

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. Jeffrey Henderson

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

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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# 2. Modified Indications for Use Statement

## Indications for Use

510(k) Number (if known): K040943

Device Name: PS Medical Strata® Valve

Indications For Use:

"The Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/flow ourfly - The don't and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation."

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

iriam C. Provost

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

510(k) Number_ K 040943

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