ASAHI PTCA GUIDE WIRE, FIELDER FC

K063819 · Asahi Intecc Co., Ltd. · DQX · Jan 26, 2007 · Cardiovascular

Device Facts

• Record ID: K063819
• Device Name: ASAHI PTCA GUIDE WIRE, FIELDER FC
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The ASAHI PTCA Guide Wire, Fielder FC is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

Device Story

Steerable guide wire (0.014 inch diameter; 180 cm or 300 cm length) used to facilitate balloon dilatation catheter placement during PTCA/PTA procedures. Constructed with stainless steel core wire; soldered coil/core; radiopaque distal tip for visualization; polyurethane coating with hydrophilic distal section; PTFE proximal coating. Operated by clinicians in clinical settings to navigate coronary/peripheral vasculature. Provides mechanical support and guidance for interventional catheters; benefits patient by enabling precise delivery of therapeutic devices to target lesion sites.

Clinical Evidence

Bench testing only. Mechanical and functional testing performed to demonstrate device performance and substantial equivalence to predicates.

Technological Characteristics

Stainless steel core wire; soldered coil; radiopaque distal tip; polyurethane/hydrophilic distal coating; PTFE proximal coating. 0.014 inch diameter. Manual operation. No electronic components or software.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring balloon dilatation catheter placement. Contraindicated for use in cerebral blood vessels.

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

• Asahi PTCA Guide Wire, Fielder (K052022)
• JoWire Neo's PTCA Guide Wire (K022762)
• Guidant HI-Torque Floppy Guide Wire (K974773)
• Guidant ACS HI-Torque Cross IT (K990639)

Submission Summary (Full Text)

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#### 9.0 510(K) SUMMARY

9.

K063819

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

| APPLICANT | Asahi Intecc Co., Ltd.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya, Aichi 463-0024<br>Japan | JAN 26 200 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| OFFICIAL<br>CORRESPONDENT | Yoshi Terai<br>President, CEO<br>Asahi Intecc USA, Inc.<br>1301 Dove Street, Suite 350<br>Newport Beach, CA 92660<br>Tel: [phone]<br>FAX [phone]<br>e-mail: [e-mail] | |
| TRADE NAME: | ASAHI PTCA Guide Wire, Fielder FC | |
| COMMON NAME: | Guide Wire | |
| CLASSIFICATION<br>NAME: | Catheter Guide Wire | |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1330 | |
| PRODUCT CODE | DQX | |
| | PREDICATE DEVICE: Asahi PTCA Guide Wire, Fielder K052022<br>JoWire Neo's PTCA Guide Wire K022762<br>Guidant HI-Torque Floppy Guide Wire K974773<br>Guidant ACS HI-Torque Cross IT K990639 | |

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Asahi PTCA Guide Wire, Fielder FC is steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is available straight and is made soft to easily bend with the vessel curve. And there is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

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# INDICATION FOR USE:

The ASAHI PTCA Guide Wire, Fielder FC is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

# TECHNICAL CHARACTERISTICS:

The ASAHI PTCA Guide Wire, Fielder FC is of the same materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for the intended use.

## PERFORMANCE DATA:

This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI ASAHI PTCA Guide Wire, Fielder FC performs as intended.

## SUMMARY/CONCLUSION:

The ASAHI PTCA Guide Wire, Fielder FC characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.

Bench testing demonstrates that the device functions as intended.

9.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asahi Intecc USA, Inc. c/o Mr. Yoshi Terai President, CEO 1301 Dove Street, Suite 350 Newport Beach, CA 92660

JAN 2 6 2007

Re: K063819

> ASAHI PTCA Guide Wire, Fielder FC Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: December 15, 2006 Received: December 26, 2006

Dear Mr. Terai:

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 Found, Or to 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbrandijng 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, TDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Yoshi Terai

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/industry/support/index.html.

Sincerely yours.

una R. buchner

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 Statement

2.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ KO63819

Device Name: ASAHI PTCA Guide Wire, Fielder FC

Indications for Use:

The ASAHI PTCA Guide Wire, Fielder FC is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Durna R. Vohmer

Orvision Sign-Off) Jivision of Cardiovascular Devices

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510(k) Number KO638

000015

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