NITREX NITINOL GUIDEWIRE

K024021 · Ev3 Corporation · DQX · Jan 24, 2003 · Cardiovascular

Device Facts

• Record ID: K024021
• Device Name: NITREX NITINOL GUIDEWIRE
• Applicant: Ev3 Corporation
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 24, 2003
• 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

Nitrex Nitinol Guidewire consists of nitinol (nickel-titanium alloy) core extending from distal tip to proximal shaft; distal tip features helically coiled gold-plated tungsten wire. Device includes coating to facilitate smooth passage through vasculature. Used by physicians in clinical settings to navigate peripheral and coronary vasculature. Device provides mechanical support and guidance for interventional procedures.

Clinical Evidence

Bench testing only. Biocompatibility verified per ISO 10993-1. In-vitro performance testing included dimensional inspection, tensile strength, torque strength, coating performance, and simulated use testing. All results were acceptable.

Technological Characteristics

Nitinol (nickel-titanium alloy) core; distal tip is helically coiled gold-plated tungsten wire; surface coating for lubricity. Biocompatibility per ISO 10993-1. Mechanical device; no energy source or software.

Indications for Use

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

• Ultra-Select guidewire (K910280)
• FlexFinder guidewire (K893626, K943390)

Submission Summary (Full Text)

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510(k) Summary

JAN 2 4 2003

| The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92 | |
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| 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, 74 DQX) |
| SUBMITTED BY | ev3 Inc<br>4600 Nathan Lane<br>Minneapolis, MN 55442 |
| CONTACT | Phil Neururer<br>Regulatory Affairs<br>763-398-7094 |
| PREDICATE | Ultra-Select guidewire (K910280)<br>FlexFinder guidewire (K893626, K943390) |
| DEVICE<br>DESCRIPTION | The guidewire is constructed of nitinol (nickel-titanium<br>alloy). The nitinol core extends from the distal tip of the<br>guidewire to the proximal shaft end. The distal tip is a<br>helically coiled coil gold plated tungsten wire. The<br>guidewire is coated with a coating(s)to help facilitate smooth<br>passage. |
| INDICATION FOR<br>USE | The 0.035" and 0.025" Guidewire is indicated for use in the<br>peripheral vasculature. The 0.014", 0.016", and 0.018"<br>guidewires are indicated for use in the peripheral and<br>coronary vasculature. |
| TESTING | Biocompatibility of the guidewire was verified in accordance<br>with ISO 10993-1, Biological Evaluation of the Medical<br>Devices.<br><br>In-vitro performance testing of the guidewire included<br>dimensional inspection, tensile strength tests, torque strength<br>tests, coating performance test, and performance under<br>simulated conditions. All testing of the product yielded<br>acceptable results. |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The Nitrex™ Nitinol Guidewire is substantially equivalent to<br>the predicate device in intended use and principles of<br>operation. |

Image /page/0/Picture/4 description: The image shows the logo for EV3, an endovascular company. The logo consists of the letters "ev3" in a sans-serif font, with three circles arranged in a triangular formation above the letters. Below the letters, there is some text that is too small to read.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2003

EV3 Corporation c/o Mr. Phil Neururer Regulatory Affairs Associate 4600 Nathan Lane North Plymouth, MN 55442

Re: K024021

Trade Name: Nitrex™ Nitinol Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 2, 2003 Received: January 3, 2003

Dear Mr. Neururer:

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.

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Page 2 - Mr. Phil Neururer

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 (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]. 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,

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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510 (k) Number (if known): __ KO2 4 OZI

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.

(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 | K024021 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter |
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