CARDIODRIVE CATHETER ADVANCEMENT SYSTEM

K051374 · Stereotaxis, Inc. · DQX · Jun 23, 2005 · Cardiovascular

Device Facts

• Record ID: K051374
• Device Name: CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
• Applicant: Stereotaxis, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only the Stereotaxis Tangent® Electrophysiology Catheter (part #001-001223-1) of 7F shaft diameter and 8F tip. The Cardiodrive® is intended to advance the Stereotaxis Tangent® Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent® Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.

Device Story

Cardiodrive® is a remote catheter advancement system for electrophysiology (EP) procedures. It consists of an electrical controller, motor assembly, and user interface (UI) located at the patient table or control room. The system mechanically advances or retracts a compatible Stereotaxis Tangent® EP catheter through a hemostasis introducer. It is operated by a clinician to navigate the catheter within the right heart chambers. The device aims to provide remote control of catheter positioning, potentially improving procedural efficiency and reducing manual handling. The system includes a horizontal patient mounting bracket, flexible drive shaft, and hemostasis introducer adapter.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing and pre-clinical performance data demonstrating the modified device performs equivalently to the predicate.

Technological Characteristics

System includes electrical controller, motor assembly, user controls, sterile single-use advancer unit, horizontal patient mounting bracket, flexible drive shaft, and hemostasis introducer adapter. Electromechanical actuation. Designed for use with 7F shaft/8F tip catheters.

Indications for Use

Indicated for automatic advancement and retraction of the Stereotaxis Tangent® Electrophysiology Catheter (7F shaft, 8F tip) within the right side of the heart. Contraindicated for use in 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® (K021802)

Submission Summary (Full Text)

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| Appendix 1 - 510(k) Summary of Safety and<br>Effectiveness | JUN 2 3 2005 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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] catheter, through a hemostasis introducer, remotely<br>via a User Interface (UI) located either at the patient table or in the control<br>room. |
| Intended use | The Stereotaxis Cardiodrive® is intended for automatically advancing and<br>retracting only the Stereotaxis Tangent® Electrophysiology Catheter (part<br>#001-001223-1) of 7F shaft diameter and 8F tip. The Cardiodrive® is<br>intended to advance the Stereotaxis Tangent® Electrophysiology Catheter in<br>the right side of the heart only. It is not intended to advance the Tangent®<br>Electrophysiology Catheter through the coronary vasculature nor the coronary<br>sinus. |
| Technological<br>characteristics | The Stereotaxis Cardiodrive® consists of an electrical controller, motor<br>assembly, and user controls, plus sterile, single-use advancer unit, horizontal<br>patient mounting bracket, flexible drive shaft, and hemostasis introducer<br>adapter. |
| Device<br>comparisons | The modified Stereotaxis Cardiodrive® consists of minor design<br>modifications of the currently marketed Stereotaxis Cardiodrive®. The new<br>Cardiodrive® has a modified Hemostasis Introducer Adapter and a new<br>horizontal patient mounting bracket to better accommodate the use of larger<br>guiding sheaths. |

Continued on next page

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| Stereotaxis, Inc. | |
|---------------------------------------------------------|--|
| Special 510(k): Cardiodrive® and Disposable Accessories | |

May 23, 2005 Page 50

| | Appendix 1 - 510(k) Summary of Safety and<br>Effectiveness, Continued | JUN 2 3 2005 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Physical testing | The Stereotaxis Cardiodrive® was designed and tested in compliance with<br>Stereotaxis design control procedures. The device met design input criteria<br>and was substantially equivalent to the currently marketed predicate device. | |
| Performance<br>data | Bench testing and pre-clinical testing demonstrate that the Stereotaxis<br>Cardiodrive® performs in an equivalent manner to the currently marketed<br>Cardiodrive® predicate device. | |
| Clinical<br>performance<br>data | No clinical studies were needed to support the modifications described herein. | |
| Conclusion | The modified Cardiodrive® is substantially equivalent to the Cardiodrive®<br>(K021802) predicate device. The modifications described herein do not affect<br>the intended use of the device or alter the fundamental scientific technology<br>associated with the device. | |
| Contact | Kelly Rowland<br>Regulatory Affairs Specialist | |
| Date | May 6, 2005 | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2005

Stereotaxis, Inc. c/o Ms Kelly Rowland Regulatory Affairs Specialist 4041 Forest Park Avenue St Louis, MO 63108

Re: K051374

Trade Name: Cardiodrive Catheter Advancement System Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: May 24, 2005 Received: May 26, 2005

Dear Ms. Rowland:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of 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 encreaty to togens and ment date of the Medical Device Amendments, or to commence price to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). allo Cosmetic Act (71ct) that do not require to the general controls provisions of the Act. The I ou may, dicrerore, manel and 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 is classified (600 above) of ols. Existing major regulations affecting your device can inay oc subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Overnments concerning your device in the Federal Register.

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Page 2 – Ms Kelly Rowland

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loas be actived 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 or any 1 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 Of It 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) I market notification. The FDA finding of substantial equivalence of your device to a legally promated 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 it you dobil o specific at 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 other general informational 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,

A. Wesley B. Boan

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

510(k) Number (if known): K__________________________________________________________________________________________________________________________________________________

Device Name: Cardiodrive® Catheter Advancement System (CAS)

Indications for Use: The Stereotaxis Cardiodrive® is intended for automatically advancing and retracting only the Stereotaxis Tangent® Electrophysiology Catheter of 7F shaft diameter and 8F tip. The Cardiodrive® is intended to advance the Stereotaxis Tangent® Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent® Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.

ズ AND/OR Prescription Use _ (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)

Rhummer
(Division Sign-Off)

Division of Cardiovascular Devices

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510(k) Number K051374

The information herein is considered CONFIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and expectations of 21 CFR §20.61, 21 CFR §812.38, and 21 CFR §814.9