NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000

K050772 · Image-Guided Neurologics, Inc. · HAW · Apr 21, 2005 · Neurology

Device Facts

• Record ID: K050772
• Device Name: NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
• Applicant: Image-Guided Neurologics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Apr 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Navigus Reusable Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation.

Device Story

Navigus Reusable Passive Probe functions as a component of stereotaxic surgical navigation systems; used with Navigus trajectory guides and Medtronic StealthStation Treatment Guidance System. Device facilitates patient registration and navigation during neurosurgical procedures. Operated by neurosurgeons or trained clinical staff in an OR setting. Provides spatial tracking data to the navigation system to assist in guiding surgical instruments to target anatomical sites. Benefits include enhanced precision in stereotaxic procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Passive probe for stereotaxic navigation; reusable design. Interfaces with Medtronic StealthStation system for spatial tracking. Materials and sterilization methods consistent with standard reusable surgical instruments for neurosurgical applications.

Indications for Use

Indicated for use in conjunction with Navigus trajectory guides and Medtronic StealthStation Treatment Guidance System for patient registration and navigation during stereotaxic surgical procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Reference Devices

• Medtronic StealthStation Treatment Guidance System

Submission Summary (Full Text)

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APR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 208!50

Mr. David M. Lee Vice President of Quality and Regulatory Affairs Image-Guided Neurologics, Inc. 2290 West Eau Gallie Boulevard Melbourne, Florida 32935

Re: K050772

Trade/Device Name: Navigus Reusable Passive Probe Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 24, 2005 Received: March 25, 2005

Dear Mr. Lee:

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 10 taller work or 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 cormply 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. David M. Lee

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to ough finding of substantial equivalence of your device to a legally premarket notification: "The 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 If you desire specific acrise ion your as [phone] . Also, please note the regulation entitled, Colliation of Companyers of Company of College of (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responer 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,

Ratha

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050772

Ravi.sed

Indications for Use

510(k) Number (if known): K050772

Device Name: Navigus Reusable Passive Probe

Indications For Use:

Intended Use: The Navigus Reusable Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation.

Prescription Use __ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

tive

K050772

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