NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500

K032937 · Stereotaxis, Inc. · DXX · Jul 1, 2004 · Cardiovascular

Device Facts

• Record ID: K032937
• Device Name: NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
• Applicant: Stereotaxis, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2

Intended Use

The Navigant™ Navigation Workstation 2.1 [NWS2] is a component of the Niobe® MNS. The Niobe® MNS with NWS2 is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.

Device Story

Niobe Magnetic Navigation System (MNS) is an interventional workstation for steering magnetically-adapted catheters or guidewires. System uses two computer-controlled permanent magnets (up to 0.10 T) to orient device tips via magnetic fields. Navigant Navigation Workstation 2.1 (NWS2) is a software-based subsystem providing an enhanced navigation interface for physician control. Operated by physicians in a control room or at the patient table side; requires integration with a digital fluoroscopy system for visualization. System enables remote, computer-assisted steering of devices through heart and coronary vasculature. Benefits include precise, physician-directed navigation of interventional devices to target sites.

Clinical Evidence

No clinical data or animal testing was required for this modification. Substantial equivalence is supported by performance testing and data provided in previous submissions (K013484 and K021555).

Technological Characteristics

System uses two mechanically positioned permanent magnets to generate magnetic fields up to 0.10 T. Operates as a workstation subsystem requiring digital fluoroscopy integration. Software-based navigation interface for physician control of magnetic catheters/guidewires. No direct patient tissue contact.

Indications for Use

Indicated for navigation of compatible magnetic devices through tissue to target sites in the right and left heart and coronary vasculature by orienting the device tip. For use by physicians.

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

• Niobe® Magnetic Navigation System (K021555)
• Telstar® Magnetic Navigation System [TMNS] (K013484)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness, K032937

| Statement | Information supporting claims of substantial equivalence, as defined under<br>the Federal Food, Drug and Cosmetic Act, regarding safety and effectiveness<br>is summarized below. This summary is formatted in accordance with the<br>Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR<br>Part 807) and can be used to provide a substantial equivalence summary to<br>anyone requesting it from the Agency. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>description | The Niobe® Magnetic Navigation System [NMNS] is an interventional<br>workstation for the navigation of appropriately equipped, magnetically<br>adapted, devices (e.g., catheters or guidewires) through tissue to designated<br>target sites. The system uses computer-controlled permanent magnets for<br>orienting the tip of a magnetic device. |
| | The system employs magnetic fields to orient or steer the tip of a magnetic<br>device. |
| | The Navigant Navigation Workstation 2.1 [NWS2] is a modification to the<br>Niobe® Magnetic Navigation System (K021555). The changes introduce a<br>new software design and mode of operation, but maintain the existing<br>technology for orientation of magnetically-adapted devices and clinical<br>utility. |
| | The NWS2 is a subsystem of the MNS, and requires both an MNS and a<br>digital fluoroscopy system to function properly. |
| Intended use | The Navigant™ Navigation Workstation 2.1 [NWS2] is a component of the<br>Niobe® MNS. The Niobe® MNS with NWS2 is intended to navigate<br>compatible magnetic devices through tissue to designated target sites in the<br>right and left heart and coronary vasculature by orienting the device tip in a<br>desired direction. The Navigant™ feature provides an enhanced navigation<br>interface for the physician to control the MNS. |
| Substantial<br>equivalence | The Niobe® MNS with NWS2 is substantially equivalent to the Telstar®<br>Magnetic Navigation System [TMNS] (K013484), and the NMNS<br>(K021555). |
| | Continued on next page |

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# 510(k) Summary of Safety and Effectiveness, K032937,

Continued

## Technological characteristics

The Niobe® Magnetic Navigation System employs application of magnetic fields to orient the distal tip of a magnetically-adapted device (e.g., catheter or guidewire).

#### Device comparisons steering control

The following is a comparison of the key features of the Niobe® MNS with NWS2 vs. the predicate device, the Niobe® MNS, K021555.

| Device<br>Characteristics | New Device-<br>Niobe® MNS with<br>NWS2 | Predicate Device-<br>Niobe® MNS |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | To navigate compatible<br>magnetic devices<br>through tissue to<br>designated target sites<br>in the right and left<br>heart and coronary<br>vasculature by orienting<br>the device tip in a<br>desired direction. | To navigate a magnetic<br>device through tissue to<br>designated target sites<br>in the right and left<br>heart and coronary<br>vasculature by orienting<br>the device tip in a<br>desired direction. |
| Direct contact with<br>patient tissue | No | No |
| Remote physician<br>control of steerable<br>device distal orientation | Yes | Yes |
| Computer control of<br>steerable device distal<br>orientation | Yes | Yes |
| Conducted under<br>fluoroscopic<br>visualization | Yes | Yes |
| Guided magnetic device<br>employed | Specially designed<br>magnetic<br>catheters/guidewires | Specially designed<br>magnetic<br>catheters/guidewires |
| Steering control | Via magnetic fields,<br>from a control room or<br>at patient table side | Via magnetic fields,<br>from a control room or<br>at patient table side |

Continued on next page

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## 510(k) Summary of Safety and Effectiveness, K032937, Continued

#### Device comparisons – steering control (continued)

| | Device<br>Characteristics | New Device-<br>Niobe® MNS with<br>NWS2 | Predicate Device-<br>Niobe® MNS | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------|--|
| | System command | Physician-directed | Physician-directed | |
| | | computer command | computer command | |
| | Magnetic field source | Two permanent | Two permanent | |
| | | magnets - positioned | magnets - positioned | |
| | Operating field strength | mechanically<br>Up to 0.10 T | mechanically<br>Up to 0.10 T | |
| | | | | |
| Physical testing | Performance testing has demonstrated substantial equivalence of the new<br>device to the predicate device. | | | |
| Preclinical<br>animal and<br>clinical<br>performance<br>data | The Navigant™ Navigation Workstation 2.1 [NWS2] is a modification of the<br>predicate Niobe® MNS. Animal and clinical data are not necessary to support<br>the modifications. Application data (animal and clinical) for magnetic<br>navigation were provided in K013484 & K021555. | | | |
| Contact | Peter A. Takes, Ph.D., RAC<br>Director, Clinical & Regulatory Affairs<br>Stereotaxis, Inc.<br>4041 Forest Park Avenue<br>St. Louis, Missouri 63108<br>Ph. 314-615-6964<br>Fax [phone]<br>[e-mail] | | | |
| Date | June 28, 2004 | | | |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 2004

Stereotaxis, Inc. c/o Peter A. Takes, Ph.D., RAC Director Clinical and Regulatory Affairs 4041 Forest Park Avenue St. Louis, Missouri 63108

Re: K032937

Trade Name: Navigant™ Navigation Workstation 2.1 (NWS2) Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: 74 DXX Dated: May 6, 2004 Received: May 7, 2004

Dear Dr. Takes:

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 I'DA'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);

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## Page 2 - Peter A. Takes, Ph.D., RAC

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. 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 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 vours.

Neil R. O'Brien

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):_______K032937

Device Name: Navigant™ Navigation Workstation 2.1 [NWS2]

Indications For Use:

The Navigant™ Navigation Workstation 2.1 [NWS2] is a component of the Niobe® MNS. The Niobe® MNS with NWS2 is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.

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)

| (Division Sign-Off) | <img alt="signature" src="signature.png"/> |
|------------------------------------|--------------------------------------------|
| | <i>for BDZ</i> |
| Division of Cardiovascular Devices | |
| 510(k) Number | K032937 |

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