MODIFICATION TO NITREX NITINOL GUIDEWIRE

K040345 · Ev3, Inc. · DQX · Mar 2, 2004 · Cardiovascular

Device Facts

• Record ID: K040345
• Device Name: MODIFICATION TO NITREX NITINOL GUIDEWIRE
• Applicant: Ev3, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.

Device Story

Nitinol (nickel-titanium alloy) guidewire; distal tip features helically coiled gold-plated tungsten wire; surface coating facilitates smooth passage. Used in peripheral and coronary vasculature to assist in catheter placement. Operated by physicians during interventional procedures. Device provides mechanical support and navigation through vascular anatomy.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed that devices utilizing the new coating formulation met original performance requirements.

Technological Characteristics

Nitinol (nickel-titanium) core; distal tip consists of helically coiled gold-plated tungsten wire; surface coating applied for lubricity. Mechanical device; no energy source or software.

Indications for Use

Indicated for use in peripheral vasculature (0.035", 0.025", 0.014", 0.016", 0.018" diameters) and coronary vasculature (0.014", 0.016", 0.018" diameters).

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

• FlexFinder Guidewire (K893626, K943390)
• Nitrex Nitinol Guidewire (K024021, K031864)
• Lake Region Manufacturing, Inc. (K022813)

Submission Summary (Full Text)

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KO40345

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PH 763.398.7000

FX 763.398.7200

4600 Nathan Lane North, Plymouth, MN 55442-2920

## 510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

| Submitter | EV3<br>4600 Nathan Lane North<br>Plymouth, MN 55442 | | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| TRADE NAME | Nitrex™ Nitinol Guidewire | | | |
| GENERIC CLASS | Guide wire | | | |
| CLASSIFICATION | Class II (21 CFR 870.1330) | | | |
| SUBMITTED BY | ev3 Inc<br>4600 Nathan Lane<br>Minneapolis, MN 55442 | | | |
| CONTACT | Carolyn Anderson<br>Regulatory Affairs Specialist<br>763-398-7487 | | | |
| PREDICATE | FlexFinder Guidewire (K893626, K943390)<br>Nitrex Nitinol Guidewire (K024021, K031864)<br>Lake Region Manufacturing, Inc. (K022813) | | | |
| DEVICE<br>DESCRIPTION | The guidewire is constructed of nitinol (nickel-titanium alloy).<br>The nitinol core extends from the distal tip of the guidewire to the<br>proximal shaft end. The distal tip is a helically coiled coil gold<br>plated tungsten wire. The guidewire is coated with a coating(s)to<br>help facilitate smooth passage. | | | |
| INDICATION FOR<br>USE | The 0.035" and 0.025" Guidewires are indicated for use in the<br>peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires<br>are indicated for use in the peripheral and coronary vasculature. | | | |
| TESTING | Verification/validation testing demonstrated that devices utilizing<br>the new coating formulation meet the original verification and<br>validation requirements. | | | |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The Nitrex™ Nitinol Guidewire is substantially equivalent to the<br>predicate device in intended use, materials, labeling and principles<br>of operation. | | | |

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Image /page/1/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 a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2004

Carolyn Anderson Regulatory Affairs Specialist ev3 Incorporated 4600 Nathan Lane North Plymouth, Minnesota 55442

Re: K040345

Trade/Device Name: Nitrex™ Nitinol Guidewire Regulatory Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: February 11, 2004 Received: February 12, 2004

Dear Ms. Anderson:

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/dsma/dsmamain.html

Sincerely yours

\$\sqrt{}\$

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

Enclosure

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## Indications for Use

| 510(k) Number (if known): | K040345 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Nitrex™ Nitinol Guidewire |
| Indications For Use: | The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature. |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |

AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K040 345

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