ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300

K032615 · Asahi Intecc Co., Ltd. · DQX · Sep 16, 2003 · Cardiovascular

Device Facts

• Record ID: K032615
• Device Name: ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Asahi PTCA Guide wires are intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (I'TA). The Asahi PTCA Guide wires are not to be used in the cerebral blood vessel.

Device Story

Steerable guide wire; 0.014" diameter; 180 cm or 300 cm length; stainless steel core wire; soldered core and coil; welded radiopaque distal tip; hydrophilic and silicone distal coating; PTFE proximal coating. Used by physicians during PTCA/PTA to navigate vasculature and guide balloon catheters to target lesion sites. Facilitates catheter placement; improves procedural success in coronary and peripheral angioplasty.

Clinical Evidence

Bench testing and biocompatibility testing only; no clinical data provided.

Technological Characteristics

Stainless steel core wire; soldered core/coil; welded radiopaque distal tip; hydrophilic/silicone distal coating; PTFE proximal coating. 0.014" diameter; 180/300 cm lengths. Mechanical device; no energy source or software.

Indications for Use

Indicated for facilitating balloon dilatation catheter placement during PTCA and PTA procedures. 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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K032615

SEP 1 6 2003

Asahi Intecc Co., Ltd. August 2003

Asahi PTCA Guide Wire Special 510(k)

## 510(k) Summary of Safety and Effectiveness

| Date Prepared: | August 12, 2003 |
|----------------------|-------------------------------------------------------------------------------------------|
| Submitted: | Asahi Intecc Co., Ltd.<br>1703 Wakita-cho, Moriyama-ku, Nagoya,<br>Aichi, 463-0024, Japan |
| Contact Person: | Yoshi Terai<br>Director of Asahi Intecc US Office |
| Phone Number: | Phone : [phone] |
| Fax Number: | Fax : [phone] |
| Device Trade Name: | Asahi Wire Asahi PTCA Guide Wire |
| Classification Name: | Catheter Guide Wire, Class II (21 CFR 870.1330) |
| Predicate Device: | JoWire Neo's PTCA Guide Wire K022762<br>JoWire Asahi PTCA Guide Wire K031277 |

### Device Description:

The Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered except tip which uses welding, The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic and silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

#### Intended Use:

The Asahi PTCA Guide wires are intended to facilitate the placement of balloon dilatation Catheter during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (I'TA). 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 Wires are made of the same materials, available in the same diameters and lengths, have the same design and indications for use as the predicate devices and other currently marketed PTCA Guide Wires.

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KC32615

Asahi Intecc Co., Ltd. August 2003

Asahi PTCA Guide Wire 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 Wires met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.

Conclusion:

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

Premarket Notification [510(k)] Number

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Public Health Service

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SEP 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asahi Intecc Co., LTD. c/o Yoshi Terai Director of Asahi Intecc US Office 1100 Quail St., Suite 207 Newport Beach, CA 92660

K032615 Re: Asahi PTCA Guide Wires Regulation Number: 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: August 12, 2003 Received: August 25, 2003

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 (OS) 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

V. Q
cBram D. Zuckerman, M.D.

Bram D. Zuc Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Asahi Intecc Co., Ltd. August 2003

Asahi PTCA Guide Wire Special 510(k)

510(k) Number (if known): C032615

Device Name: Asahi PTCA Guide Wires

, i

Indications for Use:

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.

The intended use and indications for use of the modified device as described in its labeling have not change. The fundamental scientific technology of the modified device has not changed.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--|--------------------------------------------------------|--|
|--|--------------------------------------------------------|--|

| Prescription Use | <div style="text-align:center;">X</div> (Per 21 CFR 801.19) |
|----------------------|-------------------------------------------------------------|
| | OR |
| Over-the Counter Use | ____________________ |

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K032615 |

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