ASAHI PTCA GUIDE WIRE FIELDER

K052022 · Asahi Intecc Co., Ltd. · DQX · Aug 25, 2005 · Cardiovascular

Device Facts

• Record ID: K052022
• Device Name: ASAHI PTCA GUIDE WIRE FIELDER
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Asahi PTCA Guide Wire Fielder is intended to facilitate the placement of balloon dilatation Catheter 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; 0.36mm (0.014 inch) diameter; 180cm or 300cm length. Stainless steel core wire; soldered coil; radiopaque distal tip for visibility; flexible distal section for vessel navigation. Distal section features polyurethane and hydrophilic coating; proximal section features PTFE coating. Used by physicians during PTCA/PTA procedures to guide balloon catheters to target lesion sites. Facilitates catheter placement; improves procedural success; reduces vessel trauma via flexible tip.

Clinical Evidence

Bench testing and biocompatibility testing conducted per FDA guidance. No clinical data provided. Testing demonstrated device met acceptance criteria and performed equivalently to predicate devices.

Technological Characteristics

Stainless steel core wire; soldered coil; radiopaque distal tip. Distal section: polyurethane and hydrophilic coating. Proximal section: PTFE coating. Diameter: 0.36mm (0.014"). Lengths: 180cm, 300cm. Mechanical steerable guide wire.

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

• JoWire Neo's PTCA Guide Wire (K022762)
• JoWire Asahi PTCA Guide Wire (K031277)

Submission Summary (Full Text)

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K052022
p. 1 of 2

Asahi Intecc Co., Ltd. July 2005

AUG 25 2005

Asahi PTCA Guide Wire Fielder Special 510(k)

## 510(k) Summary of Safety and Effectiveness

| Date Prepared: | July 2005 |
|----------------------|-------------------------------------------------|
| Submitted: | Asahi Intecc Co., Ltd. |
| | 1703 Wakita-cho, Moriyama-ku, Nagoya, |
| | Aichi, 463-0024, Japan |
| Contact Person: | Yoshi Terai |
| | Director of Asahi Intecc USA Inc. |
| Address: | 1301 Dove Street, |
| | Suite #350 Newport Beach, |
| | CA, 92660, USA |
| Phone Number: | Phone: [phone] |
| Fax Number: | Fax: [phone] |
| Device Trade Name: | Asahi Wire Asahi PTCA Guide Wire Fielder |
| Classification Name: | Catheter Guide Wire, Class II (21 CFR 870.1330) |
| Predicate Device: | JoWire Neo's PTCA Guide Wire: K022762 |
| | JoWire Asahi PTCA Guide Wire: K031277 |

## Device Description:

The Asahi PTCA Guide Wire Fielder is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 180 cm and 300 cm length. 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 flexible to bend easily at the vessel curve. 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.

### Intended Use:

The Asahi PTCA Guide Wire Fielder is intended to facilitate the placement of balloon dilatation Catheter 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 Technological Characteristics and Comparison to Predicate Device:

The Asahi PTCA Guide Wire Fielder is made of the same materials and designed except polyurethane coating, available in the same diameters and lengths, and indications for use as the predicate devices and other currently marketed PTCA Guide Wires.

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11-052022 p. 202

Asahi Intecc Co., Ltd. July 2005

Asahi PTCA Guide Wire Fielder Special 510(k)

### Performance Data:

Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Fielder met the acceptance criteria and performed equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing.

#### Conclusion:

The Asahi PTCA Guide Wire Fielder is substantially equivalent to the claimed predicates devices and other currently marketed PTCA Guide Wires.

Koszo 22 Premarket Notification [510(k)] Number

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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AUG 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai Director of Asahi Intecc USA Inc. 1301 Dove Street, Suite #350 Newport Beach, CA 92660

K052022 Re:

Asahi Wire Asahi PTCA Guide Wire Fielder Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 2005 Received: July 26, 2005

Dear Mr. Terai:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(t) promation is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interestate referenced above and have decembled the devices marketed in interstate for use stated in the encrosule) to tegally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the character with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that to not require approvate of the general controls of the Act. The
You may, therefore, market the device, subject to the general magatestion, list You may, therefore, market the device, seeject of the samual registration, listing of
general controls provisions of the Act include requirements michrending and general controls provisions of the Herbaco rep adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller "Littering component" be found in the Cour of Peaces one reasons one 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,

Dilla R. Vachner

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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Asahi Intecc Co., Ltd. July 2005

Asahi PTCA Guide Wire Fielder Special 510(k)

# Indications for Use

510(k) Number (if known): K052022

Device Name: Asahi PTCA Guide Wire Fielder

Indications For Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal 10 faciliate the procement of can't 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 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K65022

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