MEDTRONIC STRATAVARIUS

K041992 · Medtronic Neurosurgery · JXG · Jan 28, 2005 · Neurology

Device Facts

• Record ID: K041992
• Device Name: MEDTRONIC STRATAVARIUS
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Jan 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

StrataVarius is intended for use by physicians, to non-invasively identify the Strata-type valve Performance Level (PL) setting and display that information numerically in terms of PL level and the equivalent pressure reading in millimeters of water (mm H2O). The StrataVarius allows the user to change the pressure setting of the valve non-invasively without the need for radiographic confirmation.

Device Story

Battery-powered, handheld instrument; used by physicians to manage Strata-type adjustable CSF valves. System includes StrataVarius unit, adjustment tool, valve identification cards, and templates. Device senses valve location and orientation; displays current Performance Level (PL) setting and equivalent pressure (mm H2O). Physician uses adjustment tool to change valve pressure setting non-invasively, eliminating need for radiographic confirmation. Benefits patient by enabling precise, non-invasive valve adjustment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered (two 1.5V AA alkaline batteries) handheld instrument. Sensing/actuation principle involves magnetic orientation to adjust valve settings. System includes electronic unit, adjustment tool, and valve identification cards. Connectivity is standalone.

Indications for Use

Indicated for use by physicians to non-invasively identify and adjust the pressure settings of Strata-type CSF flow control valves.

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 Strata Adjustment Kit (K012052, K040943)

Submission Summary (Full Text)

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#### SAFETY AND EFFECTIVENESS SUMMARY IX. Medtronic StrataVarius

K04/1992

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

| Establishment Registration Numer: | 2021898 |
|---------------------------------------|-----------------------------------------------------------------------------------|
| Address of Manufacturer: | Medtronic Neurosurgery<br>125 Cremona Drive<br>Goleta, CA 93117<br>[phone] |
| Contact Person: | Jeffrey Henderson |
| Date: | January 26, 2005 |
| Trade or Proprietary Name: | Medtronic StrataVariusTM |
| Common, Usual or Classification Name: | CSF Flow control Shunts and Accessories<br>(21 CFR 882.5550) |

Medtronic Strata Adjustment Kit (K012052, K040943) Predicate Device Identification:

# Device Description:

Device Description.
Medtronic Neurosurgery's StrataVarius" System is a battery-powered, handheld instrument that Medironic Neurosurgery S Otratavanas - Systement contained in PS Medical " Strata-type senses the location and onemation of the Ridgher of the StrataVarius Adjustment
adjustable valves. The StrataVarius" works in conjunction with the StrataVarius Adjustmant adjustable valves. The Gratavanas - works in conjuntalse Level (PL) setting as
Tool to change the magnet orientation, and thus the valve auctors includes Tool to change the magnet onemation, and this the Strativanius system includes and determined by the Cilifican. The complete oyetem in Cards (Smart Cards), a
the StrataVarius, an Adjustment Tool, two (or more) Valve Identification 1 First (AA) alkaling the Stratavanus, an Agusthent 150, two (61 more) Premplates, and two 1.5 volt (AA) alkaline batteries.

### Intended Use:

Intended Use.
StrataVarius is intended for use by physicians, to non-invasively in terms of PL (ovel of Stratavanus is intended for use by pryolounter to formation numerically in terms of PL level and Performance Level (FL) Setting and display that inform (mm H2O). The StrataVarius allows the same the equivalent pressure reading in millinocers of water (inn. He s).
user to change the pressure setting of the valve non-invasively without the need for radiographic confirmation.

# Intended Use of Predicate Device:

Intended Use of Predicate Device.
The Adjustment tool allows the user to change the pressure setting of the valve non-invasively.

# Technological Comparison:

l echnological Companson.
The StrataVarius is equivalent to the Strata Adjustment Kit (K012052, K040943). Substantial The Stratavanus is equivalent to the Otrata Aljastment will (1) (1) in the Strations and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

JAN 2 8 2005

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: K041992

Trade/Device Name: Medtronic StrataVarius™ Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: January 20, 2005 Received: January 21, 2005

Dear Mr. Henderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and nave decemined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device American Frank Draw commerce phor to May 20, 1978, as vice with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do nov requesable to the general controls provisions of the Act. The 1 ou may, therefore, thanker the act include requirements for annual registration, listing of general controls provisions of the rice, 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 il your device is classified (see above) mes existing major regulations affecting your device can may be subject to sueli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar regerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that 1177 s losaultes of our device complies with other requirements of the Act that FDA has made a determinations administered by other Federal agencies. You must of any I cacal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements, while and manufacturing practice requirements as set CFR Part 6077; adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality byticlins (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)
The success of the first of a first of a least of your device to a legal This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA midning of substantal equivalian of 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
r and and the may and 115 and 115 and particles and the requiries and the r If you desire specific advice for your de vice on our s. Also, please not the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the r contact the Office of Complance at (210) 270 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -"Misbranding by reference to premarks. Iountedator. < < < e Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) other general information on your responsion its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (index html Manufacturers, international and Consumer Assistance arovedrh/industry/support/index.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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# Indications for Use

K041992 510(k) Number (if known):

Device Name:

Medtronic StrataVarius™

Indications For Use:

"StrataVarius is intended for use by physicians, to non-invasively identify the Strata-type Stratavance Level (PL) setting and display that information numerically in terms valve i enormance Lever (r E) Southig and adding in millimeters of water (mm H2O). The of FL level and the equivalent prossure roading in the valve non-invasively without the need for radiographic confirmation."

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

Over-The-Counter Use (Part 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

Muriam C. Provost

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

1641992 510(k) Number.

StrataVarius™ 510(K) K041992 Amend 1 01/20/05