ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J

K072705 · Asahi Intecc Co., Ltd. · DQX · Oct 23, 2007 · Cardiovascular

Device Facts

• Record ID: K072705
• Device Name: ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The ASAHI PTCA Guide Wire, Fielder FC J 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. Device features stainless steel core wire, soldered coil, and radiopaque distal tip in pre-shaped J configuration. Distal section includes polyurethane and hydrophilic coating; proximal section features PTFE coating. Silicone oil applied to spring-coil gap. Operated by physicians in clinical settings (e.g., cath lab) to navigate coronary or peripheral vasculature. Provides mechanical support and guidance for interventional catheters; aids in vessel access and lesion crossing. Benefits include improved trackability and navigation through tortuous anatomy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel core wire; soldered coil; radiopaque distal tip; polyurethane and hydrophilic coating (distal); PTFE coating (proximal); dimethylpolysiloxane (silicone oil) lubricant. 0.014 inch diameter. Manual operation. No software or electronic components.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) to facilitate 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)
• Asahi PTCA Guide Wire, Fielder FC (K063819)

Submission Summary (Full Text)

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#### 9.0 510(K) SUMMARY

K072705

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<br><br>OCT 23 2007 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL<br>CORRESPONDENT | Yoshi Terai<br>President, CEO<br>Asahi Intecc USA, Inc.<br>2500 Red Hill Avenue, Suite 210<br>Santa Ana, CA 92705<br>Tel: [phone]<br>FAX [phone]<br>e-mail: [e-mail] |
| TRADE NAME: | Asahi PTCA Guide Wire, Fielder FC J |
| COMMON NAME: | Guide Wire |
| CLASSIFICATION<br>NAME: | Catheter Guide Wire |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX |
| PRIMARY<br>PREDICATE DEVICE: | Asahi PTCA Guide Wire, Fielder - K052022<br>Asahi PTCA Guide Wire, Fielder FC- K063819 |

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Asahi PTCA Guide Wire, Fielder FC J is a 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 made soft and easily bendable with the vessel curve, and is provided in a pre-shaped J configuration. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire and dimethylpolysiloxane (silicone oil - not contacting blood) is applied to gape space in spring-coil in the tip part. The proximal section of this guide wire is coated with PTFE.

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# K072705

### INDICATION FOR USE:

The ASAHI PTCA Guide Wire, Fielder FC J 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 J 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 PTCA Guide Wire, Fielder FC J performs as intended.

#### SUMMARY/CONCLUSION:

The ASAHI PTCA Guide Wire, Fielder FC J 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 3 2007

Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705

Re: K072705

ASAHI PTCA Guide Wire, Fielder FC J Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DOX Dated: September 10, 2007 Received: September 24, 2007

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 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. 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.

M. G. Helvenner

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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2.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K072705

Device Name: ASAHI PTCA Guide Wire, Fielder FC J

Indications for Use:

The ASAHI PTCA Guide Wire, Fielder FC J 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_X (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)

W.g. Hillebrand

Division of Čardiovascular Devices

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510(k) Number_K072709

000015