ENDOVASCULAR GUIDE WIRE

K021363 · Stereotaxis, Inc. · DQX · Nov 27, 2002 · Cardiovascular

Device Facts

• Record ID: K021363
• Device Name: ENDOVASCULAR GUIDE WIRE
• Applicant: Stereotaxis, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Stereotaxis Endovascular Guide Wire is 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 the Stereotaxis Endovascular Guide Wire.

Device Story

Steerable 0.014" guide wire (210-300 cm length) designed for use with Stereotaxis Magnetic Navigation System; features tapered distal tip with embedded magnet for magnetic navigation through vasculature; hydrophilic coating for lubricity. Operated by physician during intravascular interventional procedures (e.g., PTCA) to deliver catheters/therapeutic devices. Magnetic navigation allows precise control of wire tip within vasculature. Benefits include enhanced maneuverability and positioning of interventional tools. Not for use in cerebral vasculature; incompatible with rotational atherectomy or ferromagnetic devices.

Clinical Evidence

Bench testing and preclinical in-vivo testing performed. No clinical trial data provided. Testing demonstrated performance equivalent to predicate devices.

Technological Characteristics

0.014" diameter, 210-300 cm length; hydrophilic coating; tapered distal tip; embedded magnet for magnetic navigation; pushable shaft for axial force transmission; sterilized with 100% ethylene oxide.

Indications for Use

Indicated for patients undergoing PTCA or other intravascular interventional procedures requiring catheter placement in coronary and peripheral vasculature. Contraindicated for use in cerebral vasculature, with rotational atherectomy devices, or with ferromagnetic interventional 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

• BSC Choice Guide Wire (K970244)
• ACS BMW Guide Wire (K971815)

Submission Summary (Full Text)

{0}------------------------------------------------

# NOV 27 2002

# Appendix A: 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. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 Stereotaxis Endovascular Guide Wire is a steerable guide wire that has a<br>nominal diameter of 0.014 in/ 0.36mm and a nominal length of 210/300 cm.<br>The guide wire is designed only for use in conjunction with the Stereotaxis<br>Magnetic Navigation System. The wire is configured with a tapered distal tip<br>and an embedded magnet, which is used for navigating the wire through the<br>vasculature. A hydrophilic coating extends from the base of the distal coil to<br>the proximal end of the wire. This device is sterilized with 100% ethylene<br>oxide. |
| Intended use | The Stereotaxis Endovascular Guide Wire is intended to introduce and<br>position over-the-wire catheters and other over-the-wire therapeutic devices<br>within the coronary and peripheral vasculature during PTCA or other<br>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 the<br>Stereotaxis Endovascular Guide Wire. |
| Technological<br>characteristics | The Endovascular Guide Wire is a conventional 0.014" hydrophilically<br>coated endovascular guide wire modified to accommodate magnetic actuation<br>and control. It is designed to navigate within the vasculature to deliver a<br>suitable catheter or interventional device to a desired site. |
| | The finished length of the Endovascular Guide Wire is 210cm to 300cm. A<br>taper runs 30cm proximal to the distal tip. The pushable shaft is a continuous<br>wire that allows axial force, applied at the proximal end, to be transmitted to<br>the tip of the guide wire. The Endovascular Guide Wire is used with an<br>introducer sheath to access the human vasculature. |

{1}------------------------------------------------

| Performance<br>data | Bench testing and preclinical in-vivo testing demonstrate that the Stereotaxis<br>Endovascular Guide Wire performs in an equivalent manner to both the BSC<br>Choice Guide Wire and the ACS BMW Guide Wire predicate devices. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The Stereotaxis Endovascular Guide Wire is substantially equivalent to the<br>BSC Choice Guide Wire (K970244) and the ACS BMW Guide Wire<br>(K971815) predicate devices. |
| Contact | Gary M. Rauvola, Director, Regulatory Affairs for Disposable Products |
| Date | November 22, 2002 |

.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, arranged in a row.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 27 2002

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

Re: K021363

> Trade/Device Name: Stereotaxis Endovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: August 29, 2002 Received: August 30, 2002

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

{3}------------------------------------------------

Page 2 - Mr. Gary M. Rauvola

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

### Appendix L: Revised Indications For Use Statement

### Indications for Use Statement

Revised Statement Indications for Use Statement:

510(k) Number: K021363

Device Name: Stereotaxis Endovascular Guide Wire

Indications for Use: The Stereotaxis Endovascular Guide Wire is 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 the Stereotaxis Endovascular Guide Wire.

**Prescription Use**
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021363