ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY

K060745 · Asahi Intecc Co., Ltd. · DQY · Jun 23, 2006 · Cardiovascular

Device Facts

• Record ID: K060745
• Device Name: ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ASAHI Tornus support catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.

Device Story

ASAHI Tornus support catheter; full metal spiral shaft; provides pushability and torqability for crossing difficult lesions in coronary/peripheral vasculature. Supplied with plastic torque assistance device; attaches to catheter connector; assists in manipulation/directional control; includes mechanism to limit rotational force. Used by physicians during intravascular procedures. Benefits: enhanced support for steerable guidewires; facilitates access to discrete vascular regions; assists in guidewire exchange.

Clinical Evidence

Bench testing only. Mechanical and functional testing demonstrated that the torque device performs as intended and meets design requirements.

Technological Characteristics

Full metal spiral shaft catheter; plastic torque assistance device. Torque device includes a rotational force limiting mechanism. Materials are similar to predicate devices. Dimensions and design ensure compatibility with the Asahi Tornus Support Catheter.

Indications for Use

Indicated for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Asahi Tornus Support Catheter (K051772)
• JS Vascular Guide Wire Vise/Torque Device (K032411)
• Boston Scientific Wireclip Torquer (K003398)

Submission Summary (Full Text)

{0}------------------------------------------------

Summary of Safety & EFFECTIVENESS

Kobo745

#### 9.0 SUMMARY OF SAFETY AND EFFECTIVENESS

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>JUN 2 3 2006 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Tornus Support Catheter with torque device |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATION<br>NAME: | Percutaneous Catheter |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| PRODUCT CODE | DQY |
| PREDICATE DEVICE: | Asahi Tornus Support Catheter K051772<br>JS Vascular Guide Wire Vise/Torque Device K032411<br>Boston Scientific Wireclip Torquer K003398 |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The ASAHI Tornus support catheter is a device that is intended to provide additional support to a steerable guidewire when accessing discrete regions of the coronary and peripheral vasculature. The Tornus Catheter contains a full metal spiral shaft that provides enhanced pushability when attempting to cross difficult lesions. The full metal shaft provides the user with a device that has excllent torqability and pushability during intravascular procedures.

The Tornus support catheter is being supplied with a torque assistance device. The torque device is a plastic device that is attached to the connector of the Tornus Support Catheter to assist in catheter manipulation and directional control. In addition to assisting in Tornus catheter manipulation the torque device contains a function mechanism that limits the rotational force exerted upon the catheter during manipulation.

000063

CONFIDENTIAL Asahi Intecc March 10, 2006

9.

{1}------------------------------------------------

### INDICATION FOR USE:

The ASAHI Tornus support catheter with torque device is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.

#### TECHNICAL CHARACTERISTICS:

The torque device accessory is also made of similar materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for thei intended use with the Asahi Tornus Support Catheter.

#### PERFORMANCE DATA:

This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Tornus support catheter torque device performs as intended.

#### SUMMARY/CONCLUSION:

The ASAHI Tornus support catheter torque device 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.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows a partial view of a seal or logo, featuring stylized lines that resemble a wave or abstract design. The text "DEPARTMENT OF HEALTH AND H..." is visible, curving along the edge of the seal. The overall impression is of a government or health-related organization's emblem, though the full context and details are not discernible due to the cropped view.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

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

Re: K060745

> ASAHI Tornus Support Catheter with Torque Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DOY Dated: May 30. 2006 Received: May 31, 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 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 (1). 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.

{3}------------------------------------------------

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.

onna R. Voliner

Image /page/3/Picture/5 description: The image shows a signature on the left and the words "Branch" and "Director" on the right. The signature appears to be a stylized initial or symbol. The text indicates a title or role, possibly within an organization or company.

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

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

Enclosure

{4}------------------------------------------------

2.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _

Device Name: ASAHI Tornus Support Catheter with torque device

Indications for Use:

The ASAHI Tornus support catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.

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)

puna R. Va (Division Sign-Off)

ivision of Cardiovascular Devices

:0(k) Number_K060745

Page of

# 000013