CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)

K042850 · Stereotaxis, Inc. · DQY · Aug 9, 2006 · Cardiovascular

Device Facts

• Record ID: K042850
• Device Name: CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
• Applicant: Stereotaxis, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System [MNS]. It is not intended to advance the EP mapping catheter through the coronary vasculature nor the coronary sinus.

Device Story

Cardiodrive® is an automated catheter advancement system for electrophysiology (EP) mapping. It consists of an electrical controller, motor assembly, user interface (UI), and sterile, single-use advancer unit. Operated by a clinician at the patient table or in a control room, the device remotely advances or retracts compatible magnetic EP mapping catheters. It functions as an accessory to the Stereotaxis Magnetic Navigation System (MNS). By automating catheter movement, it assists clinicians in navigating the heart during EP procedures, potentially improving procedural efficiency and precision. The system includes a patient mounting bracket, flexible drive shaft, and hemostasis valve adapter to facilitate integration with standard mapping catheters.

Clinical Evidence

Bench testing only.

Technological Characteristics

System includes electrical controller, motor assembly, user controls, sterile single-use advancer unit, patient mounting bracket, flexible drive shaft, and hemostasis valve adapter. Operates as an electromechanical accessory for remote catheter manipulation within the heart.

Indications for Use

Indicated for automatic advancement and retraction of compatible magnetic electrophysiology (EP) mapping catheters within the heart, used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). Contraindicated for use in coronary vasculature or coronary sinus.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Stereotaxis Catheter Advancer System (CAS) (021802)

Submission Summary (Full Text)

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## K042850

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## Appendix 1 – 510(k) Summary of Safety and Effectiveness

| Statement | Information supporting claims of substantial equivalence, as defined under<br>the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness<br>is summarized below.<br><br>For the convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule "...510(k) Summaries and 510(k)<br>Statements..." (21 CFR §807) and can be used to provide a substantial<br>equivalence summary to anyone requesting it from the Agency. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>description | The Cardiodrive® advances or retracts a compatible magnetic<br>electrophysiology [EP] mapping catheter, through a hemostasis introducer,<br>remotely via a User Interface (UI) located either at the patient table or in the<br>control room. |
| Intended use | The Stereotaxis Cardiodrive® is intended for automatically advancing and<br>retracting only compatible magnetic electrophysiology [EP] mapping<br>catheters. It is not intended to advance the EP mapping catheter through the<br>coronary vasculature nor the coronary sinus. |
| Technological<br>characteristics | The Stereotaxis Cardiodrive® consists of an electrical controller, motor<br>assembly, and user controls, plus sterile, single-use advancer unit, patient<br>mounting bracket, flexible drive shaft, and hemostasis valve adapter. |
| Performance<br>data | Bench testing demonstrates that the Stereotaxis Cardiodrive® performs in an<br>equivalent manner to the Stereotaxis Catheter Advancer System (CAS)<br>predicate device. |
| Conclusion | The Stereotaxis Cardiodrive® is substantially equivalent to the Stereotaxis<br>Catheter Advancer System (CAS) (021802) predicate device. |
| Contact | Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products |
| Date | September 20, 2004 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2006

Stereotaxis, Inc. c/o Mr. Gary Rauvola, RAC Director, Regulatory Affairs - Disposable Products 4320 Forest Park Avenue Suite 100 St. Louis, MO 63108

K042850 Re:

Trade/Device Name: Stereotaxis Cardiodrive® Catheter Advancer System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: June 12, 2006 Received: June 13, 2006

Dear Mr. Rauvola:

We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave review your see determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) it itgans)
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to econiner of the 1125 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de nees that have been receasing t require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, diciere, mailes of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device 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 1 Toast of advised that 1197 5 results over device complies with other requirements of the Act that I DA has made a detel regulations administered by other Federal agencies. You must

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#### Page 2 - Mr. Gary Rauvola, RAC

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 (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/industry/support/index.html.

Sincerely yours,

Bhimmarfor

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

The indications for Use Statement:

510(k) Number: K042850_______________________________________________________________________________________________________________________________________________________

Device Name: Stereotaxis Cardiodrive®

Stereotaxis Cardiodrive®:

The Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System [MNS]. It is not intended to advance the EP mapping catheter through the coronary vasculature nor the coronary sinus.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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S.K. McComber

Julsion Sign-Off) Division of Cardlovascular Devloes 510(k) Number

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