STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635

K082127 · Medtronic Neurosurgery · JXG · Aug 27, 2008 · Neurology

Device Facts

• Record ID: K082127
• Device Name: STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Aug 27, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Strata NSC Burr Hole Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata NSC Burr Hole Valve 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 in order to address changing patient needs.

Device Story

Adjustable non-siphon control valve for CSF shunting; used to divert fluid from brain ventricles to right atrium or peritoneal cavity. Device consists of silicone elastomer and polypropylene components. Physician operates device using special magnetic adjustment tool to non-invasively modify valve pressure/performance levels pre- or post-implantation. Eliminates need for radiographic confirmation during adjustments. Benefits patient by allowing clinical management of CSF flow without repeated surgical intervention.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison and identical materials to predicate devices.

Technological Characteristics

Adjustable non-siphon control valve; materials: silicone elastomer and polypropylene; magnetic adjustment mechanism; form factor: burr hole valve and shunt assembly.

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) shunting from brain ventricles to the right atrium or peritoneal cavity. Allows non-invasive pressure/flow adjustment to address changing patient needs.

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 NSC Valve and Shunt Assemblies (K038850)
• Medtronic PS Medical Strata II Valves and Shunt Assemblies with and without BioGlide (K042465)
• CSF-Flow Control Valve, Burr Hole (K831678)

Submission Summary (Full Text)

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Kof2127

# AUG 2 7 2008

## 4. 510(k) Summary

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]<br>Fax: [phone] |
| Contact Person: | Jeffrey Henderson |
| Date: | July 28, 2008 |
| Trade or Proprietary Name: | PS Medical® Strata® NSC Burr Hole<br>Valves and Shunt Assemblies |
| Common Usual or Classification Name: | Central nervous system fluid shunt and<br>components (882.5550) |
| Predicate Device Identification: | • Medtronic PS Medical Strata NSC Valve<br>and Shunt Assemblies (K038850)<br>• Medtronic PS Medical Strata II Valves and<br>Shunt Assemblies with and without<br>BioGlide (K042465)<br>• CSF-Flow Control Valve, Burr Hole<br>(K831678) |

### Description:

The PS Medical® Strata® NSC Burr Hole Valve is an adjustable non-siphon control valve. The valve is manufactured of silicone elastomer and polypropylene. The valve is used as a shunt component. The adjustable valve is designed for non-invasive pressure flow adjustment.

#### Intended Use:

- · The Strata NSC Burr Hole Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata NSC Burr Hole Valve 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 in order to address changing patient needs.
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## Intended Use of Predicate Device(s):

- The Strata NSC Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata NSC Valve 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 in order to address changing patient needs.
- · The Strata II Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata II Valve 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 in order to address changing patient needs.
- · The CSF-Flow Control Burr Hole 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.

#### Technological Comparison:

Medtronic Neurosurgery submits that the Strata NSC Burr Hole Valves and Shunt Assemblies included in this submission are manufactured of identical materials, and have the same intended use and fundamental scientific technology as the previously reviewed and cleared:

- Medtronic PS Medical Strata NSC Valve and Shunt Assemblies (K038850) .
- Medtronic PS Medical Strata II Valves and Shunt Assemblies with and without . BioGlide (K042465)
- . PS Medical CSF Flow Control Valve, Burr Hole (K831678).

Based upon the summary above, Medtronic Neurosurgery has determined that the proposed Strata NSC Burr Hole Valves and Shunt Assemblies are safe and effective and substantially equivalent 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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2008

Medtronic Neurosurgery % Mr. Jeffrey Henderson VP, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117

Re: K082127

Trade/Device Name: PS Medical® Strata® NSC Burr Hole Valves and Shunt Assemblies Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: July 28, 2008 Received: July 29, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N Milliman

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):

K082127

Device Name: PS Medical® Strata® NSC Burr Hole Valves and Shunt Assemblies

Indications for Use:

The Strata NSC Burr Hole Valves and Shunt Assemblies 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 the peritoneal cavity. The Strata NSC Burr Hole Valve allows the physician to non-invasively adjust the pressure/ flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs.

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 CDRH, Office of Device Evaluation (ODE)

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510(k) Number