LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE

K061670 · William Cook Europe Aps · DQX · Jan 19, 2007 · Cardiovascular

Device Facts

• Record ID: K061670
• Device Name: LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE
• Applicant: William Cook Europe Aps
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Lunderquist Wire Guide and the Lunderquist DC Wire Guide are intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed.

Device Story

The Lunderquist Wire Guide and Lunderquist DC Wire Guide are stainless steel wire guides with PTFE coating, designed to facilitate complex diagnostic and interventional procedures. The devices feature a 0.035-inch outer diameter and lengths ranging from 90 to 300 cm. Certain models include a radiopaque gold coil at the flexible distal tip to assist in visualization. The distal tips are available in straight or J-curve configurations with varying degrees of flexibility. These wire guides are used by clinicians in interventional settings to navigate vasculature or anatomical structures. The device provides mechanical support and guidance for catheters or other interventional tools, benefiting the patient by enabling access during complex procedures.

Clinical Evidence

Bench testing only. Testing included tensile testing, flexibility testing, functional testing, corrosion testing, and radiodetectability assessment to ensure design and performance conformance.

Technological Characteristics

Materials: PTFE-coated stainless steel; radiopaque gold coil on distal tip. Dimensions: 0.035-inch outer diameter; 90-300 cm lengths. Design: Straight or J-curve tip configurations with 3-7.5 mm radii. Sterilization: Standardized process controls. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients undergoing complex diagnostic and interventional procedures requiring increased wire guide body, flexibility, and low surface friction.

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.

Submission Summary (Full Text)

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K061670

# COOK®

William Cook Europe ApS Sandet 6, 4632 Bjaeverskov DENMARK Phone: [phone] Fax: [phone] CVR No. 83 74 23 13 www.cookgroup.com

JAN 1 9 2007

510(k) Summary

#### Submitted By:

Tina H. Andersen WILLIAM COOK EUROPE APS Sandet 6. DK-4632 Bjaeverskov, DENMARK [phone]

June 09, 2006

Device:

Trade Name: Proposed Classification: Lunderquist Wire Guide/Lunderquist DC Wire Guide 870.1330 DQX Class II, Cardiovascular

# Predicate Devices:

The Lunderquist Wire Guide and Lunderguist DC Wire Guide are similar in terms of intended use, materials of construction and technological characteristics to predicate devices designed for diagnostic and interventional procedures.

# Device Description:

The Lunderquist Wire Guide is a PTFE-coated stainless steel wire guide with an outer diameter of .035 inches and comes in 90 to 300 cm lengths. For lengths 260-300 cm , a radiopaque gold coil is provided on the flexible distal tip. The distal tip has 4 or 7 cm of flexibility comes straight or as a J-curve with a 3 or 7.5 mm radius.

The Lunderquist DC Wire Guide is a PTFE-coated stainless steel wire guide with an outer diameter of .035 inches and comes in 260-300 cm lengths. A radiopaque gold coil is provided on the flexible distal tip. The Lunderquist DC Wire Guide is a PTFE-coated stainless steel wire guide with a double curved tip design. The double curved distal tip has 4 cm of tip flexibility.

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# Substantial Equivalence:

These devices will be manufactured according to specified process controls and a Quality Assurance Program. These devices will undergo packaging similar to the devices currently marketed and distributed by William Cook Europe ApS. These devices will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meets the requirements for section 510(k) substantial equivalence.

# Test Data:

The Lunderquist Wire Guide and Lunderquist DC Wire Guide were subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- Tensile Testing 1.
- 2. Flexible Testing
- 3. Functional Testing
- 4. Corrosion Testing
- 5. Radiodetectability

The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their use as guide wires.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

William Cook Europe ApS c/o Ms. Tina H. Andersen Regulatory Affairs Coordinator Sandet 6. 4632 Bjaeverskov DENMARK

JAN 1 9 2007

Re: K061670

Trade/Device Name: Lunderquist Wire Guide and Lunderquist DC Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: January 8, 2007 Received: January 10, 2007

Dear Ms. Andersen:

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 cither 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 (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.

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Page 2 – Ms. Tina H. Andersen

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/industry/support/index.html.

Sincerely yours,

Duna R. Vochner

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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# Instructions for Use

510(k) Number (if known):

K061670

Device Name:

Lunderquist Wire Gulde and Lunderquist DC Wire Guide

Indications for Use:

The Lunderquist Wire Guide and the Lunderquist DC Wire Guide are intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed.

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. Va. Aumes

Division Sign-Off) livision of Cardiovascular Devices

10(k) Number_K0616 40