STEREOTAXIS ENDOVASCULAR GUIDE WIRE

K042854 · Stereotaxis, Inc. · DQX · Feb 8, 2005 · Cardiovascular

Device Facts

• Record ID: K042854
• Device Name: STEREOTAXIS ENDOVASCULAR GUIDE WIRE
• Applicant: Stereotaxis, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Stereotaxis Cronus® Guide Wires are intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures. Contraindications: This guide wire is not intended for use without the Stereotaxis Magnetic Navigation System. The device is not intended for use in the cerebral vasculature. Rotational atherectomy devices, and any ferromagnetic interventional devices, are contraindicated for use with Stereotaxis Cronus® Guide Wires.

Device Story

Steerable endovascular guide wire (0.014 in diameter; 180-300 cm length) designed for use with Stereotaxis Magnetic Navigation System. Features tapered distal tip with embedded magnet for magnetic navigation; hydrophilic coating on distal portion; PTFE coating on proximal end. Operated by physician in interventional suite. Magnetic navigation allows precise control through vasculature to deliver catheters/therapeutic devices. Benefits include enhanced steerability and navigation in complex vascular anatomy. Not for cerebral use; incompatible with rotational atherectomy or ferromagnetic devices.

Clinical Evidence

No clinical studies performed. Substantial equivalence supported by bench testing and preclinical animal performance data (swine and canine models).

Technological Characteristics

0.014 inch diameter; 180-300 cm length. Materials: core wire, hydrophilic distal coating, PTFE proximal coating. Principle: magnetic actuation via embedded magnet for navigation within Stereotaxis Magnetic Navigation System. Sterilization: 100% ethylene oxide. Mechanical design: pushable shaft for axial force transmission.

Indications for Use

Indicated for patients undergoing PTCA or other intravascular interventional procedures requiring introduction and positioning of over-the-wire catheters/devices in coronary and peripheral vasculature. Contraindicated for use without Stereotaxis Magnetic Navigation System, in cerebral vasculature, or with rotational atherectomy/ferromagnetic devices.

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

• Stereotaxis Endovascular Guide Wire (K021363)

Submission Summary (Full Text)

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Page 21

## Appendix 1: 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. The Stereotaxis Cronus Guide Wires are steerable guide wires that have a Device nominal diameter of 0.014 in/ 0.36mm and nominal lengths from 180 cm to description 300 cm. The guide wires are designed only for use in conjunction with the Stereotaxis Magnetic Navigation System. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. A hydrophilic coating covers the distal portion of the wires, and a PTFE coating covers the proximal end of the wires. This device is sterilized with 100% ethylene oxide. The Cronus Guide Wires are conventional 0.014" hydrophilically coated Technological endovascular guide wire modified to accommodate magnetic actuation and characteristics control. It is designed to navigate within the vasculature to deliver a suitable catheter or interventional device to a desired site. The finished length of the guide wire is 180cm to 300cm. A taper runs proximal to the distal tip. The pushable shaft is a continuous wire that allows axial force, applied at the proximal end, to be transmitted to the tip of the guide wire. The guide wire is used with an introducer sheath to access the human vasculature. Indications for Use: The Stereotaxis Cronus Guide Wires are intended to Intended use introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures. Contraindications: This guide wire is not intended for use without the Stereotaxis Magnetic Navigation System. The device is not intended for use in the cerebral vasculature. Rotational atherectomy devices, and any ferromagnetic interventional devices, are contraindicated for use with the Stereotaxis Cronus Guide Wires.

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.

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| Special 510(k): Cronus Guide Wires<br>Stereotaxis, Inc. | October 11, 2004<br>Page 22 |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>comparisons | The Stereotaxis Cronus Guide Wires are minor design modifications of the<br>currently marketed Stereotaxis Endovascular Guide Wire. The new wires<br>have modified tapers to the core wire profile, have a different hydrophilic<br>coating on the distal end, and carry a PTFE coating on the proximal end. |
| Physical testing | The Stereotaxis Cronus Guide Wires were designed and tested in compliance<br>with the FDA "Coronary and Cerebrovascular Guidewire Guidance" dated<br>January 1995. The devices met design input criteria and were substantially<br>equivalent to the currently marketed predicate device. |
| Preclinical<br>animal<br>performance<br>data | Testing of the Stereotaxis Cronus Guide Wires in swine and canine animal<br>models demonstrated substantial equivalence to the currently marketed<br>predicate device. |
| Clinical<br>performance<br>data | No clinical studies were needed to support the modifications. |
| Substantial<br>equivalence | The Cronus CSS, Cronus CMS, and Cronus CCS guidewires are substantially<br>equivalent modifications of the Stereotaxis Endovascular Guide Wire<br>originally cleared under K021363. The modifications described herein do not<br>affect the intended use of the device or alter the fundamental scientific<br>technology associated with the device. |
| Contact | Gary M. Rauvola, RAC<br>Director, Compliance & Regulatory Affairs<br>Stereotaxis, Inc.<br>4041 Forest Park Avenue<br>St. Louis, Missouri 63108<br>Ph. 314-615-6913<br>Fax [phone] |
| Date | October 11, 2004 |

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Image /page/2/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 with three curved lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 8 2005

Mr. Gary M. Rauvola Director, Regulatory Affairs for Disposable Products Stereotaxis, Inc. 4041 Forest Park Avenue St. Louis, MO 63108

K042854 Re:

> Trade/Device Name: Cronus® Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: January 14, 2005 Received: January 18, 2005

Dear Mr. Rauvola:

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 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

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Page 2 – Mr. Gary M. Rauvola

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21) and 11 (2000) (2006) (21) and 11 (21 af the Agt): 21 CFR 1000-1050, forth in the quality systems (QS) regulation (21 -51 x 61 x 60 x 10 x 10 x 10 x 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050 product radiation control provisions (Scetions 35 device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin marketing your aviroe of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The PDA Inding of substantul equive 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
rs and the many of the may of the mace of a 100 - Also, mass note the regul If you desire specific advice for your device on our noomig the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation of contact the Office of Collipilance at (210) 270 - 120 - 120 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by reference to premarks. Inonifeation (con the Division of Small)
other general information on your responsibilities under (sizes number (800) 638-204 other general information on your responsionities and its toll-free number [phone] or Manufacturers, International and Consumer Assistance article of the councilindustry/support/index.html.

Sincerely yours,

Danna R. Kirchner

(A 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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Special 510(k): Cronus Guide Wire Amendment 2 Stereotaxis, Inc.

## Revised Indications for Use Form

| Indications for<br>Use Statement | 510(k) Number K042854: |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Name: Cronus® Guide Wires |
| | Indications for Use: Stereotaxis Cronus® Guide Wires are intended to<br>introduce and position over-the-wire catheters and other over-the-wire<br>therapeutic devices within the coronary and peripheral vasculature during<br>PTCA or other intravascular interventional procedures. |
| | Contraindications: This guide wire is not intended for use without the<br>Stereotaxis Magnetic Navigation System. The device is not intended for use<br>in the cerebral vasculature. Rotational atherectomy devices, and any<br>ferromagnetic interventional devices, are contraindicated for use with<br>Stereotaxis Cronus® Guide Wires. |

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)

Page _ I of l

Dura P. Vaches
(Division Sign-Off)

Division of Cardiovascular Devices The information န္တရုပ္မႈ FIDENTIAL to STEREOTAXIS, Inc. in accordance with the provisions and \$20.61, 21 CER \$812.38, and 21 CFR §814.9.