ASAHI PTCA GUIDE WIRE

K052339 · Asahi Intecc Co., Ltd. · DQX · Nov 30, 2005 · Cardiovascular

Device Facts

• Record ID: K052339
• Device Name: ASAHI PTCA GUIDE WIRE
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

To facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal blood vessel transluminal coronary angioplasty (PTCA) and perculaneous transluminal blood vessel in the cerebral blood vessel.

Device Story

Asahi PTCA Guide Wire is a steerable guide wire used by physicians during PTCA procedures to navigate the coronary vasculature and facilitate the placement of balloon dilatation catheters. The device consists of a 0.014" stainless steel core wire with a radiopaque distal tip designed to bend and conform to vessel curves. The wire is available in 150 cm lengths and features either a hydrophilic or PTFE coating to reduce friction. The device is used in a clinical setting (e.g., cath lab) by interventional cardiologists. By providing a track for balloon catheters, the wire enables the physician to reach and treat coronary stenoses, potentially improving blood flow and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility is supported by the use of materials with a long history of use in medical devices for vascular applications.

Technological Characteristics

0.014" diameter stainless steel core wire; 150 cm length; radiopaque distal tip; PTFE or hydrophilic coating. Manual steerable guide wire. No electronic components or software.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) 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 Confianza Pro (K041531)
• JOWIRE Asahi PTCA Guide Wire (K031277)
• JOWIRE Neo's PTCA Guide Wire (K022762)

Submission Summary (Full Text)

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#### SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

This 510(k) summary of safety and effectiveness information is being submitted in
tell in the summer of same and 1000 and 21 CEP 807 92 This 510(K) summary of Salety and Sheety and 21 CFR 807.92.

| APPLICANT | Asahi Intecc Co., Ltd.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya, Aichi 463-0024<br>Japan |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| 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 Confianza Pro K041531<br>JOWIRE Asahi PTCA Guide Wire K031277<br>JOWIRE Neo's PTCA Guide Wire K022762 |

# Description of the Device Subject to Premarket Notification:

DESCRIPTION OF THE DEVICE SUBSEVED TO TO TO LE Wires with a maximum diameter of The Asani PTCA Guide Wiles are stechable gelde is constructed from a 0.014" and available in 150 cm and oo of the guide wire has a radiopaque tip that is
stainless steel core wire. The distal end of the guide wire The coating stainless steel core wire. The distar end of the gd with the vessel curve. The coating
available straight and is made soft to easily bend with wire guide wire. The available straignt and is thade soll to casily bonion of the wire guide wire. The (Hydrophilie or onlooms) is coated with PTFE.

#### INDICATION FOR USE:

To facilitate the placement of balloon dilatation catheters during percularied and To facilitate the placement of balloon dilation sus transluminal angioplasty
transluminal coronary angioplasty (PTCA) and percutaneous transluminal blood vessel transluminal coronary angloplasty (1 YOA) and poroculared in the cerebral blood vessel.

Asahi Intecc August 14, 2005

K052339

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## TECHNICAL CHARACTERISTICS:

TECHNICAL CHARACTERISTICS:
The Asahi PTCA Guide Wire is made of the same materials that have been used in the The Asahi PTCA Guide Wire is made of the same indications are the equilie predicate Asahi products with the same incation for citications are the equivalent to specifications and the galacting cleared predicate devices.

### PERFORMANCE DATA:

PERFORMANCE DATA:
All components that come in direct contact with the patient have a long history of use in All components that come in offect bontact with the for use in the vasculature. This medical devices and are proven to be blocombilibe for ass in the demonstrates that 5 folk) notice installing performs as intended.

### SUMMARY/CONCLUSION:

The ASAHI Guide Wire characteristics are substantially equivalent to the specified The ASAHI Guide Wire characteristics are substantially oquine ame indication for use.

Bench testing demonstrates that the device functions as intended.

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Image /page/2/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

NOV 3 0 2005

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

Re: K052339 Asahi PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: October 27, 2005 Received: October 31, 2005

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

Bran D. Zuckerman, M.D.

Bram D. Zyckerman, 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

Page _1_ of _1_

510(k) Number (if known); ____________________________________________________________________________________________________________________________________________________

Device Name: ASAHI PTCA Guide Wire

Indications for Use:

2.

To facilitate the placement of balloon dilatation catheters during perculaneous I o facilitate the placement of between the perculaneous transluminal transfuminal coronary angloplasty (r 1 one ports are not to be used in the cerebral blood vessel.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-On)
Division of Cardiovascular Devices

| 510(k) Number | K052339 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use<br>(Optional Format 1-96) |
|------------------------------------------|---|----|------------------------------------------------|
|------------------------------------------|---|----|------------------------------------------------|

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