LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE

K042611 · Cook, Inc. · DQX · Nov 12, 2004 · Cardiovascular

Device Facts

• Record ID: K042611
• Device Name: LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
• Applicant: Cook, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Lunderquist Extra Stiff Double Curved Exchange Wire Guide is 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 Extra Stiff Double Curved Exchange Wire Guide is a manual cardiovascular instrument used by physicians during diagnostic and interventional procedures. It consists of a .035-inch diameter, 260 cm long TFE-coated stainless steel wire. The device features a double-curved distal tip with 4 cm of flexibility and a tapered, soft proximal end to facilitate introduction. The wire provides structural support and low surface friction to assist in the exchange of catheters or other interventional devices within the vasculature. It is a non-powered, single-use manual tool.

Clinical Evidence

Bench testing only. Testing included 4-point bend testing, flexing/straightening force, and tensile testing to ensure design and performance conformance.

Technological Characteristics

Materials: TFE-coated stainless steel. Dimensions: .035 inch outer diameter, 260 cm length. Features: Double-curved distal tip (4 cm flexible segment), tapered soft proximal end. Energy source: None (manual). Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing complex diagnostic and interventional cardiovascular procedures requiring a wire guide with increased 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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K04261d

NOV 12 2004

# COOK®

Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: [phone] www.cookgroup.com

# 510(k) Summary

#### Submitted By:

WILLIAM COOK EUROPE APS Sandet 6, dk-4632 Bjaeverskov, DENMARK

#### Contact:

Earl E. Knight III, MPA Regulatory Affairs Phone: [phone] Fax: [phone]

### Date Prepared:

September 23, 2004

#### Device:

| Trade Name: | Lunderquist Extra Stiff Double Curved Exchange Wire Guide |
|--------------------------|-----------------------------------------------------------|
| Proposed Classification: | 870.1330 DQX Class II, Cardiovascular |

#### Predicate Devices:

The Lunderquist Extra Stiff Double Curved Exchange Wire Guide is 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 Extra Stiff Double Curved Exchange Wire Guide has an outer diameter of .035 inches and is 260 cm long. The Lunderquist is a TFE-coated stainless steel wire guide with a double curved tip design, and a tapered, soft proximal end to ease device introduction. The double curved distal tip has 4 cm of tip flexibility.

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## Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Fins device will of manis device will undergo packaging similar to the devices currently Assurance I rogram. This aoWolliam Cook Europe. This device will undergo sterilization marketod and distributed ourrently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

#### Test Data:

The Lunderquist Extra Stiff Double Curved Exchange Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- 4-Point Bend Testing 1.
- Flexing/Straightening Force 2.
- Tensile Testing 3.

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a guide wire.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three wing-like shapes extending from its back.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

Cook Incorporated c/o Mr. Earl E. Knight III, MPA Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489

Re: K042611

K042011
Trade/Device Name: Lunderquist Extra Stiff Double Curved Exchange Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: October 22, 2004 Received: October 25, 2004

Dear Mr. Knight:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren or clay fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to togens and ment date of the Medical Device Amendments, or to commerce provision of May 20, 1978, as encordance with the provisions of the Federal Food, Drug, de vices mat have been recuire approval of a premarket approval application (PMA). and Costinetter (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, mererore, mans of the Act include requirements for annual registration, listing of general controls pro first ring 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 may or subject to back as a subations, 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 r hat 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. Earl E. Knight III, MPA

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR) (21) (2006) (2006) (21 CFR (21 (2) 21 CFR 1000-1050 forth in the quality systems (QS) regulation (21 -51 -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 1-542 of the Action Section 5 product radiation control provisions (Scetions 35 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 article of your device of your device to a legally
premarket notification. The FDA finding of sybstantial equiracy and the premarket notification. The FDA iniding of substantial 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 If you desire specific advice for your ac vice on one of the regulation entitled.
contact the Office of Compliance at [phone]. Also, please note confact the Office of Colliphance at (240) 276 - 1207 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by relefence to premarket notified.com the Division of Small
other general information on your responsibilities under the Act from the (800) 638-200 other general information on your responsible in toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-Kdamamain html Manufacturers, International and Consultion in Losswate agos/cdrh/dsma/dsmamain.html

Sincerely yours,

Dianne D. Lochner

GA 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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## Indications for Use

510(k) Number (if known): K042611

Device Name: Lunderquist Extra Stiff Double Curved Exchange Wire Guide

Indications For Use:

The Lunderquist Extra Stiff Double Curved Exchange Wire Guide is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed.

Prescription Use __ × (Part 21 CFR 801 Subpart D) 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)

umma D. bechmel

(Division Sign-Off) Division of Cardiovascular Devices

510(K) Number_K042611