MEDTRONIC PS MEDICAL STRATA TYPE VALUE

K060681 · Medtronic Neurosurgery · JXG · Sep 15, 2006 · Neurology

Device Facts

• Record ID: K060681
• Device Name: MEDTRONIC PS MEDICAL STRATA TYPE VALUE
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medtronic PS Medical® Strata® Valve and Strata® NSC Valve The Medtronic PS Medical® Strata® Valve and Strata® NSC Valve are shunt components designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using an external magnetic adjustment tool without the need for radiographic confirmation. Medtronic PS Medical® Strata® II Valve The Medtronic PS Medical® Strata® II Valve and shunt assemblies with and without BioGlide are shunt components designed to provide continued 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/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.

Device Story

Adjustable shunt valve for cerebrospinal fluid (CSF) management; facilitates flow from brain ventricles to right atrium or peritoneal cavity. Physician-operated; non-invasive pressure/performance adjustment performed pre- or post-implantation using external magnetic adjustment tool. Eliminates need for radiographic confirmation during adjustment. Benefits patient by allowing precise, non-surgical pressure regulation to manage hydrocephalus or related conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Adjustable shunt valve; magnetic adjustment mechanism; non-invasive pressure setting; compatible with external magnetic adjustment tools. Materials and fundamental scientific technology identical to cleared Strata-type valves.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunting from brain ventricles to the right atrium or peritoneal cavity to manage CSF flow.

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 (K012052)
• PS Medical® Strata® NSC Valve (K033850)
• Strata® Valve Adjustment and Indicator Tools (K040943)
• PS Medical® Strata® II Valve (K042465)

Submission Summary (Full Text)

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60681

## 4. 510(k) Summary

## SEP 15 2006

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.

| Establishment Registration Number: | 2021898 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address of Manufacturer: | Medtronic Neurosurgery<br>125 Cremona Drive<br>Goleta CA, 93117<br>[phone] ext. 1773<br>Fax: [phone] |
| Contact Person: | Jeffrey Henderson |
| Date: | March 10, 2006 |
| Trade or Proprietary Name: | Medtronic PS Medical® Strata® Type Valve |
| Common usual or Classification Name: | Central Nervous System Flow Control Shunts and<br>Accessories (882.5550) |
| Predicate Device Identification: | K012052 - Medtronic PS Medical® Strata® Valve<br>K033850 - PS Medical® Strata® NSC Valve<br>K040943 - Strata® Valve Adjustment and Indicator Tools<br>K042465 - PS Medical® Strata® II Valve |

Description: The Medtronic PS Medical® Strata® Type Valve is an adjustable valve designed for non-invasive pressure-flow adjustment.

Intended Use of the device and the predicate device(s) : The intended use of the Medtronic PS Medical® Strata® Type Valve in this substantially equivalent to those previously cleared under K012052, K042465, and K033850.

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

The Medtronic PS Medical® Strata® II Valve and shunt assemblies with and without BioGlide are shunt components designed to provide continued 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/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.

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Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, and the fundamental scientific technology of the Medtronic PS Medical® Strata® Type Valves are the same as the previously reviewed and cleared Stratatype valves. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Medtronic PS Medical® Strata® Type Valves compared to the predicate and currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract human profiles facing to the right, stacked on top of each other. The profiles are rendered in black against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2006

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

Re: K060681

Trade/Device Name: Medtronic Neurosurgical Implants Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: August 15, 2006 Received: August 16, 2006

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 sct

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Page 2 - Mr. Jeffrey Henderson

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.

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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II. Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

15060681

Device Name: Medtronic Neurosurgical Implants

Indications for Use:

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

## Medtronic PS Medical® Strata® II Valve

The Medtronic PS Medical® Strata® II Valve and shunt assemblies with and without BioGlide are shunt components designed to provide continued 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/performance level pre- and post-implantation by using a special 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 801 Subpart C)

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

Concurrence of CORN, Office of Device Evaluation (ODE)
K060691
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K060641 |
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