CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)

K071029 · Stereotaxis, Inc. · DQX · Aug 24, 2007 · Cardiovascular

Device Facts

• Record ID: K071029
• Device Name: CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
• Applicant: Stereotaxis, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping and ablation 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 and ablation catheters through the coronary vasculature nor the coronary sinus.

Device Story

Cardiodrive® CAS is a motorized catheter advancement system used in conjunction with Stereotaxis Magnetic Navigation System (MNS). Device provides a user interface for physicians to automatically advance and retract compatible magnetic EP mapping and ablation catheters within the patient's heart. Operation involves mechanical movement of the catheter; system supports variable speed, stepped or continuous movement, and includes manual override and emergency stop features. Used in clinical settings by physicians to facilitate precise catheter positioning during cardiac procedures. Output is the physical movement of the catheter, allowing the physician to navigate the heart anatomy under magnetic guidance. Benefits include controlled, automated catheter manipulation, reducing manual effort during complex EP procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by objective evidence demonstrating that compatible magnetically tipped EP ablation catheters can be used safely and effectively with the Cardiodrive® CAS.

Technological Characteristics

Mechanical catheter advancement/retraction system. Features variable speed control, stepped or continuous movement, and mechanical/manual emergency stop and override. Designed for integration with Stereotaxis Magnetic Navigation System (MNS).

Indications for Use

Indicated for patients undergoing electrophysiology (EP) mapping and ablation procedures requiring the use of compatible magnetic EP catheters within the heart. Contraindicated for use in the coronary vasculature or coronary sinus.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Cardiodrive® Catheter Advancement System
• Stereotaxis Cardiodrive® Catheter Advancer System
• Stereotaxis Catheter Advancement System (CAS)

Submission Summary (Full Text)

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## 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 30, 2007 | AUG 2 4 2007 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device/<br>classification<br>name | • Device Name:<br>Cardiodrive® CAS<br>• Classification/Common name:<br>Percutaneous Catheter & Wire, Guide, Catheter<br>• The marketed device(s) to which substantial equivalence is claimed:<br>Cardiodrive® Catheter Advancement System<br>Stereotaxis Cardiodrive® Catheter Advancer System<br>Stereotaxis Catheter Advancement System (CAS) | |
| Device<br>description | The Cardiodrive® provides a User Interface to control the motorized<br>navigation of the catheter, in conjunction with the MNS magnetic fields.<br>It is a tool that provides the physician with the ability to advance and retract<br>magnetic EP catheters. The Cardiodrive® is designed only for use with<br>compatible magnetic EP mapping catheters inside the patient's heart steered<br>with a Stereotaxis MNS. | |
| Intended use | The Stereotaxis Cardiodrive® is intended for automatically advancing and<br>retracting only compatible magnetic electrophysiology [EP] mapping and<br>ablation catheters inside the patient's heart when used in conjunction with a<br>Stereotaxis Magnetic Navigation System (MNS). It is not intended to<br>advance the EP mapping and ablation catheters through the coronary<br>vasculature nor the coronary sinus.<br>Continued on next page | |

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

| Technological<br>characteristics | There have been no modifications to the Cardiodrive CAS. The table below<br>lists device characteristics. | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------|
| | Device Characteristic | Proposed<br>Cardiodrive® CAS | Predicate<br>Cardiodrive® CAS |
| | Catheter<br>Retraction/Advancement | Mechanical | Mechanical |
| | Variable Speed | Yes | Yes |
| | Catheter Movement | Stepped or Continuous | Stepped or Continuous |
| | Emergency Stop Option | Mechanical or Manual | Mechanical or Manual |
| | Manual Override | Yes | Yes |
| | Stop Switch | Yes | Yes |

Performance data

Based upon the objective evidence presented in this 510(k) it has been demonstrated that any compatible magnetically tipped EP ablation catheter can be used safely and effectively when used with the Cardiodrive® CAS.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2007

Stereotaxis. Inc. c/o Mr. Dennis Pozzo Regulatory Affairs Specialist 4320 Forest Park Ave. Suite 100 St. Louis, MO 63108

Re: K071029

Trade/Device Name: Cardiodrive Catheter Advancement System (CAS) Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DOX Dated: July 26, 2007 Received: July 27, 2007

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 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 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

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Page 2 - Mr. Dennis Pozzo

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 (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 240-276-0120. 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,

Duna R. de Luna

b

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: K_071029

Device Name: Cardiodrive® Catheter Advancement System (CAS)

The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping and ablation 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 and ablation catheters through the coronary vasculature nor the coronary sinus.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | R. W. Jones |
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| (Division Sign-Off) | |

Division of Čardiovascular Devices____________________________________________________________________________________________________________________________________________

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