TORAYGUIDE GUIDEWIRE

K042370 · Toray Industries (America), Inc. · DQX · Dec 17, 2004 · Cardiovascular

Device Facts

• Record ID: K042370
• Device Name: TORAYGUIDE GUIDEWIRE
• Applicant: Toray Industries (America), Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The TORAYGUIDE guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.

Device Story

TORAYGUIDE Guidewire is a 304 stainless steel wire, 0.65 mm diameter, 175-230 cm length, featuring a distal stainless steel spring core. Used by clinicians during percutaneous procedures to facilitate the introduction and positioning of catheters and interventional devices within the heart and peripheral vasculature. Device is single-use and ethylene oxide sterilized. It functions as a mechanical guide to navigate the vasculature; it does not provide diagnostic data or automated outputs.

Clinical Evidence

Bench testing only. Performance characteristics were evaluated in accordance with FDA guidance, with all samples meeting acceptance criteria.

Technological Characteristics

Material: 304 stainless steel. Diameter: 0.65 mm. Length: 175-230 cm. Features: Distal spring core. Sterilization: Ethylene oxide. Single-use. Mechanical device; no software or energy source.

Indications for Use

Indicated for percutaneous procedures to introduce and position catheters and interventional devices within the heart and peripheral vasculature. Contraindicated for use in coronary arteries.

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

• Guidewire (K982559)

Submission Summary (Full Text)

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K042370

#### 510(k) SUMMARY DEC 17 2004

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

Submitter's Name: Toray Industries (America), Inc. 461 Fifth Avenue, 9th Floor New York, NY 10017 Telephone: [phone] Contact person: Mr. Koji Hagimoto, Director, Medical and Pharmaceutical

Date of Summary: November 12, 2004

Device Name: TORAYGUIDE™ Guidewire

Device Classification Name: Catheter Guide Wire (74 DQX); 21 CFR, Part 870.1330

Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is the Guidewire (K982559) manufactured by Galt Medical Corporation, determined to be substantially equivalent to a legally marketed (preAmendment) device on February 1, 1999.

Device Description: The TORAYGUIDE™ Guidewire is manufactured of 304 stainless steel, which is consistent with guidewires presently in commercial distribution and with the same intended use. The device diameter is 0.65 mm, and is supplied in lengths ranging from 175 to 230 cm. The guidewire has a spring core at the distal end, also of stainless steel. The device is ethylene oxide sterilized and intended for single use only.

Intended Use: The TORAYGUIDE guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.

Descriptive Summary of Technological Characteristics and Those of Predicate Device: The TORAYGUIDE Guidewire has the same indications for use and is otherwise technically identical to the legally marketed predicate device.

Performance Data: Applicable testing was conducted on the TORAYGUIDE guidewire in accordance with the FDA guidance. All samples met the acceptance criteria. The test results establish that the TORAYGUIDE Guidewire possesses performance characteristics that make it acceptable for its intended use.

Conclusion: The information and data provided in this 510(k) Notification establish that the TORAYGUIDE Guidewire is substantially equivalent to the legally marketed predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 17 2004

Toray Industries (America), Inc c/o Ms. Lisa S. Jones Regulatory Affairs Consultant 461 Fifth Avenue, 9th Floor New York, NY 10017

K042370 Re: Torayguide™ Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 12, 2004 Received: November 16, 2004

#### Dear Ms. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use statu in the encrosule) to regars and the Medical Device Amendments, or to commence prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have occh recuire in assee approval of a premarket approval application (PMA). and Costine Act (1107 that to hovice, subject to the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of gencral controls provisions of the tice, 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 If your device is classince (600 a00 rols. Existing major regulations affecting your device can may be subject to sublications, 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 - Ms. Lisa S. Jones

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,

Durna R. Lockines

( A 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): K042370

Device Name: TORAYGUIDE Guidewire

Indications For Use: The TORAYGuide guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral The device is not intended for use in the vasculature. coronary arteries.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Richard

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_K042370

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