TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH

K013484 · Stereotaxis, Inc. · DRF · May 2, 2002 · Cardiovascular

Device Facts

• Record ID: K013484
• Device Name: TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH
• Applicant: Stereotaxis, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The 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. The Telstar™ Bi-plane Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System. The Niobe EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart.

Device Story

System comprises Magnetic Navigation System (MNS), Telstar Bi-plane Imaging System (TIS), and Niobe EP Catheter. MNS uses computer-controlled magnetic field generator to orient distal tip of Niobe catheter containing Neodymium-Iron-Boron magnets; enables remote physician control of catheter navigation through heart/coronary vasculature. TIS provides bi-plane fluoroscopic visualization of patient and device. Niobe catheter records electrical activity and paces right heart. Used in clinical EP/angiography settings; physician operates workstation to determine magnetic vectors via computer interface. System benefits include precise, remote-controlled navigation to target sites. Output is visual fluoroscopic guidance and electrogram data, informing clinical decision-making for cardiac interventions.

Clinical Evidence

Single-site, 20-patient clinical study. Primary endpoint: successful navigation to designated target sites. Results: 198 of 200 targets reached (99% success). Comparison: conventional catheter failed to reach RV apex in one patient. Bench testing confirmed biocompatibility and physical characteristics per FDA guidance. Preclinical animal data showed equivalent steering performance and electrogram recording quality compared to predicate Steerocath.

Technological Characteristics

MNS: computer-controlled magnetic field generator. TIS: bi-plane fluoroscopic x-ray system with rotating anode and image intensifier. Niobe Catheter: 5-8F mapping catheter, Pebax body, distal Neodymium-Iron-Boron magnets. Steering: magnetic field-induced torque. Connectivity: standalone or integrated system. Compliance: 21 CFR 1020.32 for fluoroscopic equipment.

Indications for Use

Indicated for patients requiring intracardiac electrophysiological recording, pacing, or navigation of magnetic devices within the right/left heart and coronary vasculature for angiography or EP studies.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

• Catheter Research CRI Electronic Control System (K924125)
• OEC Medical Systems IMDIS (K974355)
• EP Technologies Steerocath (K900765)

Submission Summary (Full Text)

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K013484

VC

## 510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under Statement 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 Telstar™ Magnetic Navigation System [MNS] is an interventional workstation for the intravascular navigation of a magnetic device through tissue to designated target sites in the heart and coronary vasculature. It combines a bi-planar fluoroscopy system with a computer controlled magnetic field generator, to provide both visualization and control of a magnetically actuated catheter. The system employs magnetic fields to orient the catheter.

The Telstar" 14 Bi-plane Imaging System [TIS] is a digital fluoroscopic system providing bi-plane fluoroscopic clinical images of both patients and medical devices during conventional and magnetic procedures.

The Niobe™ EP Catheter is a conventional 5-8F mapping catheter modified to accommodate magnetic actuation and control. It is designed to navigate into the right heart in order to measure and record electrical activity, and to pace the heart. A separate two-conductor junction box cord is supplied to allow electrical signals to be transmitted from the sterile catheter to a nonsterile signal recorder junction box.

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

#### Magnetic Navigation System: The MNS is intended to navigate a magnetic Intended use 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.

Telstar Bi-plane Imaging System: Provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used standalone, or in conjunction with an associated Stereotaxis Magnetic Navigation System.

Niobe EP Catheter: The EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart.

The MNS, TIS, and Niobe Catheter are substantially equivalent to the Substantial equivalence following cleared medical devices:

| Stereotaxis Device | Predicate Device | Predicate 510(k) No. |
|------------------------------------|-------------------------------------------------------|----------------------|
| MNS | Catheter Research CRI<br>Electronic Control<br>System | K924125 |
| Telstar Bi-plane<br>Imaging System | OEC Medical Systems<br>IMDIS | K974355 |
| Niobe Catheter | EP Technologies<br>Steerocath | K900765 |

### Technological characteristics

The Magnetic Navigation System employs application of magnetic fields to orient the distal tip of a magnetically actuated catheter. The TIS provides visualization through standard fluoroscopy. The Niobe Catheter is an electrophysiology mapping catheter designed to accommodate magnetic actuation and control.

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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 MNS vs. the predicate device, the CRI Electronic Control System, K924125.

| Device<br>Characteristics | MNS | CRI System |
|------------------------------------------------------------------------------|-----|------------|
| Direct contact with patient tissue | No | No |
| Remote tableside physician control of steerable<br>device distal orientation | Yes | Yes |
| Electronic/computer control of steerable device<br>distal orientation | Yes | Yes |
| Conducted under fluoroscopic visualization | Yes | Yes |
| Automated advancement of the steerable device | No | Yes |

Device comparisons -Imaging

The following is a comparison of the key features of the Telstar Bi-plane Imaging System vs. the predicate device, the OEC Medical Systems IMDIS, K974355.

| Device<br>Characteristics | Bi-plane Imaging<br>System | OEC Medical Systems<br>IMDIS |
|---------------------------|----------------------------|------------------------------|
| Imaging | Fluoroscopic | Fluoroscopic & spot-film |
| Mobility | No | Yes |
| Pulsed fluoro | 7.5, 15, 30 pulses/sec | 2, 4, 8, 15 pulses/sec |
| Pulsed cardiac | 15, 30 pulses/sec | 8, 15, 30 pulses/sec |
| X-ray tube assembly | Rotating anode | Rotating anode |
| Image intensifier | Yes | Yes |
| Monitor | Quad 15" | Dual 16" |

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

Device comparisons — Catheters

The following is a comparison of the key features of the Niobe Catheter vs. the predicate device, the EP Technologies Steerocath, K900765.

| Device<br>Characteristics | Niobe EP Catheter | EP Technologies<br>Steerocath |
|--------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Direct patient contact | Yes | Yes |
| Single use | Yes | Yes |
| Catheter body size/length | 5-8 French/130 cm | 6 French/100, 130 cm |
| Catheter body<br>composition | Poly Ether Block Amide<br>(Pebax) | Nylon |
| Mechanism of catheter<br>advancement/retraction | Direct physician control via<br>physical manipulation | Direct physician control<br>via physical manipulation |
| Mechanism of distal tip<br>orientation (steering<br>control) | Physician-determined<br>magnetic vectors via a<br>computer interface | Physical manipulation via<br>a thumbwheel lever at the<br>proximal end of the<br>catheter |
| Distal tip | Contains Neodymium-Iron-<br>Boron magnets | No magnets |
| Articulation wires (stylets)<br>within catheter | No | Yes |
| Mechanism of steering<br>orientation | Magnetic field-induced<br>torque | Physically induced torque |

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

| Physical testing | Testing of the EP Catheter was performed in accordance with the FDA<br>"Electrode Recording Catheter Preliminary Guidance" (March, 1995). The<br>catheter met or exceeded all requirements for biocompatibility and physical<br>characteristics. |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Bi-plane X-ray System is designed and tested in compliance with the<br>requirements of 21 CFR §1020.32 (Fluoroscopic Equipment). |
| Preclinical<br>animal<br>performance<br>data | The MNS was used to steer the Niobe EP Catheter to designated sites within<br>the canine heart. The ability of the Niobe EP Catheter and the predicate<br>Steerocath to steer to the target sites was equivalent. Both the Niobe EP<br>Catheter and Steerocath recorded clinically acceptable, comparable,<br>intracardiac electrograms at each site. |
| Clinical<br>performance<br>data | Clinical evaluation was carried out in a single site, 20 patient study to confirm<br>the safety and effectiveness of the MNS, TIS, and Niobe Catheter. |
| | Successful navigation of the catheter was achieved to 198 of 200 designated<br>targets in the 20 patients. The conventional marketed catheter also employed<br>was not able to reach the RV apex in one of the two patients. |
| | The Stereotaxis Magnetic Navigation System, Telstar Bi-plane Imaging<br>System, and Niobe EP Catheter were demonstrated to be substantially<br>equivalent to their respective predicate devices. |
| 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 | April 29, 2002 |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 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. In the center of the logo is a stylized image of three human profiles facing to the right.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Y 1 5 2002

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

#### Re: K013484

Trade Name: Telstar™ Magnetic Navigating System, Telstar™ Bi-plane Imaging System and Niobe™ EP Catheter Regulation Number: 21 CFR 870.1290, 892.1650, and 870.1220

Regulation Name: Steerable Catheter Control System, Image-Intensified Fluoroscopic X-ray System, and Electrode Recording Catheter

Regulatory Class: Class II (two) Product Code: DXX, MQB, and DRF Dated: February 1, 2002 Received: February 4, 2002

Dear Dr. Takes:

This letter corrects our substantially equivalent letter of May 2, 2002, regarding the 510(k) number written in the Indications for Use Statement. That number was erroneously written as K01384 although it should have been K013484. Additionally, a newer product code, MQB instead of JAA, has been chosen for the Telstar™ Bi-plane Imaging System to reflect the use of solid state imagers in the device.

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). 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.

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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 Errt 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

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| Statement - MNS | Indications for Use Statement: |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Number: K013484 |
| | Device Name: Telstar™ Magnetic Navigation System [MNS] |
| | Indications for Use: The 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. |
| Statement - Bi-plane Imaging System | Indications for Use Statement: |
| | 510(k) Number: K013484 |
| | Device Name: Telstar™ Bi-plane Imaging System [TIS] |
| | Indications for Use: The Telstar™ Bi-plane Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System |
| Statement - Niobe Catheter | Indications for Use Statement: |
| | 510(k) Number: K013484 |
| | Device Name: Niobe™ EP Catheter |
| | Indications for Use: The Niobe EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart. |
| Prescription Use: | X |

Division of Cardiovascular & Respiratory Devices
510(k) Number K013484.

: