NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION

K060967 · Stereotaxis, Inc. · NDQ · Oct 19, 2006 · Cardiovascular

Device Facts

• Record ID: K060967
• Device Name: NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
• Applicant: Stereotaxis, Inc.
• Product Code: NDQ · Cardiovascular
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2

Intended Use

The Niobe® MNS with Navigant™ NWS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.

Device Story

Interventional workstation for intravascular navigation; uses computer-controlled permanent magnets to orient tip of magnetically adapted devices (catheters/guidewires). System employs magnetic fields solely for tip orientation; no pre-shaping of device tip required prior to insertion. Operated by clinicians in clinical settings to navigate through tissue to designated target sites in heart, coronary, neuro, and peripheral vasculature. Provides precise tip control to facilitate access to complex anatomy; benefits patient by enabling navigation to target sites with reduced need for manual manipulation.

Clinical Evidence

Clinical study performed using Stereotaxis Telstar® MNS and Cronus® Guidewires to demonstrate safety and efficacy of magnetically guided devices in neurovasculature. Data from Telstar® MNS used to support substantial equivalence for Niobe® MNS in neurovascular applications.

Technological Characteristics

Interventional workstation; computer-controlled permanent magnets; 0.15 Tesla operating field strength. Navigates compatible magnetic devices (catheters/guidewires) via tip orientation. Hardware and mechanical function consistent with existing Niobe® MNS platform.

Indications for Use

Indicated for navigation of magnet-tipped devices through tissue to target sites in right/left heart, coronary, neuro, and peripheral vasculature. For prescription use only.

Regulatory Classification

Identification

A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

Predicate Devices

• Stereotaxis Guidewire
• Stereotaxis Telstar® Magnetic Navigation System [MNS]
• Navigant™ Navigation Workstation [2.1] [NWS2]
• Stereotaxis Niobe® Magnetic Navigation System

Reference Devices

• Cronus® Guidewires

Submission Summary (Full Text)

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Ko60967

Premarket Notification Frentarkst Notifications of Navigant™ NWS October 17, 2006 Page 1 2

# Appendix 1: 510(k) Summary per 21CFR §807.92

| Submitter's<br>information | Stereotaxis, Inc.<br>4320 Forest Park Ave, Suite 100<br>St. Louis, MO 63108<br>Contact: Dennis Pozzo, Regulatory Affairs Specialist<br>Phone: [phone]<br>March 22, 2006 | OCT 1 9 2006 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device/<br>classification<br>name | • Device Name:<br>Niobe® MNS w/Navigant™ NWS<br>• Classification/Common name:<br>Steerable Catheter Control System & Stereotaxic Instrument<br>• The marketed device(s) to which substantial equivalence is claimed:<br>- Stereotaxis Guidewire and Stereotaxis Telstar® Magnetic Navigation<br>System [MNS]<br>- Navigant™ Navigation Workstation [2.1] [NWS2]<br>- Stereotaxis Niobe® Magnetic Navigation System | |
| Device<br>description | The Stereotaxis Niobe® MNS with Navigant™ NWS is an interventional<br>workstation for the intravascular navigation of appropriately equipped,<br>magnetically adapted, devices (e.g., catheters or guidewires) through tissue to<br>designated target sites. The system uses computer-controlled permanent<br>magnets for orienting the tip of a magnetic device. It is important to note that<br>the system employs magnetic fields only to orient or steer the tip of a<br>magnetic device. | |
| Intended use | The Niobe® MNS with Navigant™ NWS is intended to navigate a magnet-<br>tipped device through tissue to designated target sites in the right and left<br>heart, coronary vasculature, neurovasculature and peripheral vasculature by<br>orienting the device tip in a desired direction. | |

Continued on next page

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60967

Premarket Notification Stereotaxis, Niobe® MNS w/Navigant™ NWS

October 17, 2006
Page 2

## Appendix 1: 510(k) Summary per 21CFR §807.92, Continued

Technological characteristics The Niobe® MNS with/Navigant™ NWS with expanded indications is substantially equivalent to the predicate Niobe® MNS with/Navigant™ NWS in that:

- 1. The mechanical function and hardware of the existing Niobe® MNS with/Navigant™ NWS, will remain as is today.
- 2. They are intended to navigate compatible magnetic devices through tissue to designated target sites in any direction, without pre-shaping the tip prior to vessel insertion.

The Niobe® MNS with/Navigant™ NWS with expanded indications is substantially equivalent to the predicate Telstar® MNS in that:

- They are intended to navigate compatible magnetic devices through tissue 1. to designated target sites in any direction, without pre-shaping the tip prior to vessel insertion.
- 2. They have the same intended use, to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.
- 3. They have the same operating field strength, 0.15 Tesla.

#### Performance data

A Clinical Study was performed using the Stereotaxis Telstar® MNS and Cronus® Guidewires to demonstrate the safety and efficacy of magnetically guided devices when used in the neurovasculature. Stereotaxis is of the position that this clinical is applicable to support substantial equivalence of the Niobe® MNS with Navigant™ NWS. The rationale for this position is based upon the success of the Telstar® MNS demonstrating clinical safety and efficacy of utilizing magnetic navigation with magnetic guidewires in the neurovasculature.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stereotaxis. Inc. % Mr. Dennis Pozzo Regulatory Affairs Specialist 4320 Forest Park Avenue, Suite 100 St. Louis, Missouri 63108

Re: K060967

Trade/Device Name: Stereotaxis® Niobe® Magnetic Navigation System (MNS) with Navigant™ Navigation Workstation (NWS) Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable catheter control system Regulatory Class: II Product Code: NDO Dated: September 28, 2006 Received: September 29, 2006

Dear Mr. Pozzo:

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 marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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, IDA way 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

### OCT 1 9 2006

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#### Page 2 -- Mr. Dennis Pozzo

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 1000-100. This letter will allow you to begin marketing your device as described in your Section 50(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 mor ohtain 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.

fu-P.dth

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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## Appendix 2: Indications for Use Statement

Statement

The indications for Use Statement:

510(k) Number: Ko660967

Device Name: Stereotaxis ® Niobe® Magnetic Navigation System (MNS) with Navigant™ Navigation Workstation (NWS)

The Niobe® MNS with Navigant™ NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.

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

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

Page

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-C Division of General, Restorative, ____________________________________________________________________________________________________________________________________________ and Neurological Devices

510(k) Number_

The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and expectations of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9.