PS MEDICAL STRATA II VALVE

K042465 · Medtronic Neurosurgery · JXG · Oct 19, 2004 · Neurology

Device Facts

• Record ID: K042465
• Device Name: PS MEDICAL STRATA II VALVE
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic PS Medical Strata™ II Valve and shunt assemblies with and without BioGilde 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 the pressure/flow performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.

Device Story

The PS Medical Strata II Valve is an adjustable cerebrospinal fluid (CSF) shunt component; it facilitates fluid drainage from brain ventricles to the peritoneal cavity or right atrium. The device features a non-invasive, magnetically adjustable pressure/flow mechanism; physicians use a specialized magnetic tool to adjust performance levels pre- or post-implantation. This adjustment process eliminates the need for radiographic confirmation. The device is intended for use by neurosurgeons in a clinical setting to manage patient-specific CSF flow requirements. By allowing external, non-invasive pressure adjustments, the device enables clinicians to address changing patient needs without surgical revision.

Technological Characteristics

Adjustable CSF flow control valve; magnetic adjustment mechanism; includes shunt assemblies with/without BioGlide coating. Operates via non-invasive magnetic tool. Mechanical design for fluid regulation.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunting from the ventricles of the brain to the right atrium of the heart or the peritoneal cavity to manage hydrocephalus or related conditions requiring CSF flow control.

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 and Strata NSC Valve and Shunt Assemblies with and without BioGlide (K0120052, K040943, K033850)

Submission Summary (Full Text)

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## ATTACHMENT 2

OCT 1 9 2004

042465 1/2

## 510k Summary 4.

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: | September 10, 2004 |
| Trade or Proprietary Name: | Medtronic PS Medical® Strata II Valve™ and<br>Shunt Assemblies with and without BioGlide |
| Common usual or Classification Name: | Central Nervous System Flow Control Shunts and<br>Accessories ( 882.5550) |
| Predicate Device Identification: | Medtronic PS Medical Strata and Strata NSC<br>Valve and Shunt Assemblies with and without<br>BioGlide (K0120052, K040943, K033850) |

Description: The PS Medical Strata II Valve is an adjustable Valve designed for noninvasive pressure-flow adjustment.

Intended Use: The Medical Strata™ II Valve and shunt assemblies with and without Intended Use. The Mediforne Formsale continued CSF flow from the ventricles of the Bloodiae are shint components assigned to the peritoneal cavity. The design allows the physician to brain mo the ngm athum of the noal. offormance level pre- and post-implantation by using a non invaoly adjustment tool without the need for radiographic confirmation.

Intended Use of predicate device(s): The PS Medical Strata and Strata NSC valve are michaea ooo er provide continued CSF flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata NSC valve allows the into into non-invasively adjust the pressure/flow performance level pre- and post implantation to address the changing patient needs.

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K042465 2/2

Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the Strata II Valve and Shunts with and without BioGlide are the same as the previously reviewed and cleared Strata and Strata NSC Valve and Shunt Assemblies with and without BioGlide. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Strata products based upon the predicate and currently marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. 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 image of a bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2004

Mr. Jeffrey Henderson Vice President, Quality and Regulatory Affairs Medtronic Neurosurgery 125 Cremona Drive Goelta, California 93117

Re: K042465

Trade/Device Name: PS Medical Strata II Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: September 10, 2004 Received: September 23, 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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This letter will allow you to begin marketing your device as described in your Section 510(k) rmoreteet 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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## ATTACHMENT 1

K042465 510(k) Number (if known):

Device Name: PS Medical Strata II

Indications For Use:

The Medtronic PS Medical Strata™ II Valve and shunt assemblies with and without BioGilde are I he Meditoric i S Medical Oliata - It Valvo included CSF flow from the venticles of the brain into the shurt components dosigned to provide sonantes of the design allows the physician to non-invasively nght athum of the ficult of the portionsal very - 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 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 __ 1__

Miriam C Provost

storative. Division of G and Neurological Dev

**510(k) Number** K042465