STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM

K021555 · Stereotaxis, Inc. · DXX · Jan 15, 2003 · Cardiovascular

Device Facts

• Record ID: K021555
• Device Name: STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
• Applicant: Stereotaxis, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Jan 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Niobe MNS is intended to navigate a magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction.

Device Story

Niobe Magnetic Navigation System (MNS) is an interventional workstation for navigating magnetically-adapted devices (catheters/guidewires) through tissue. System uses computer-controlled permanent magnets to generate magnetic fields that orient/steer the distal tip of the magnetic device. Operated by a physician in a clinical setting; used under fluoroscopic visualization. Provides remote tableside control of device orientation. Benefits include precise navigation to target sites in heart and coronary vasculature. No direct patient contact.

Clinical Evidence

No clinical data provided; clinical data for magnetic navigation was previously established in K013484. Performance of the Niobe MNS was demonstrated via three canine studies.

Technological Characteristics

System utilizes computer-controlled permanent magnets to generate magnetic fields for steering magnetically-adapted catheters or guidewires. Operates as an interventional workstation. Connectivity and software details not specified. Class II device (21 CFR 870.1290).

Indications for Use

Indicated for navigation of magnetic devices (catheters/guidewires) through tissue to target sites in the right and left heart and coronary vasculature.

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

• Telstar Magnetic Navigation System (K013484)

Submission Summary (Full Text)

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JAN 1 5 2003 K021555

## 510(k) Summary of Safety and Effectiveness

| Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | The Niobe Magnetic Navigation System [MNS] is an interventional workstation for the navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer-controlled permanent magnets for orienting the tip of a magnetic device. |
| | The system employs magnetic fields to orient or steer the tip of a magnetic device. |
| Intended use | The Niobe MNS is intended to navigate a magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. |
| Substantial equivalence | The Niobe MNS is substantially equivalent to the Telstar Magnetic Navigation System [MNS], K013484. |
| 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). |
| | Continued on next page |

//}

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

Device comparisons steering control The following is a comparison of the key features of the Niobe MNS vs. the predicate device, the Telstar MNS, K013484.

| Device<br>Characteristics | New Device-<br>Niobe MNS | Predicate Device-<br>Telstar MNS |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | To navigate a magnetic device<br>through tissue to designated<br>target sites in the right and left<br>heart and coronary vasculature<br>by orienting the device tip in a<br>desired direction. | To navigate a magnetic<br>device through tissue to<br>designated target sites in<br>the right and left heart and<br>coronary vasculature by<br>orienting the device tip in<br>a desired direction. |
| Direct contact<br>with patient<br>tissue | No | No |
| Remote tableside<br>physician control<br>of steerable<br>device distal<br>orientation | Yes | Yes |
| Computer control<br>of steerable<br>device distal<br>orientation | Yes | Yes |
| Conducted under<br>fluoroscopic<br>visualization | Yes | Yes |

Continued on next page

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

| 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 Niobe MNS is a modification of the predicate Telstar MNS. Clinical<br>data are not necessary to support the modifications. Clinical application data<br>for magnetic navigation were provided in K013484. Performance of the<br>Niobe MNS was demonstrated in three canine studies. |
| 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] |
| Date | January 14, 2003 |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2003

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

Re: K021555

Trade Name: NiobeTM Magnetic Navigation System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: DXX Dated: December 6, 2002 Received: December 9, 2002

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.

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

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 (OS) 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 may be obtained 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.

R. R. Zadeh M.D.

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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### Appendix 2: Indications for Use Statement

Statement

Indications for Use Statement:

510(k) Number: K_O 2 / رك كـ كــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Device Name: Niobe Magnetic Navigation System [MNS]

Indications for Use: The Niobe MNS is intended to navigate a magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction.

(Division Sig
Division of
510(k) number K021355

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