ASAHI TORNUS SUPPORT CATHETER

K051772 · Asahi Intecc Co., Ltd. · DQY · Sep 26, 2005 · Cardiovascular

Device Facts

• Record ID: K051772
• Device Name: ASAHI TORNUS SUPPORT CATHETER
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 26, 2005
• Decision: SESE
• Submission Type: Traditional
• 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

The Tornus Support Catheter is an intravascular device designed to assist in accessing discrete regions of the coronary and peripheral vasculature. It features a full metal spiral shaft, which provides high torqability and pushability, allowing clinicians to navigate and cross difficult lesions. The device is used in conjunction with a steerable guidewire to provide additional support during intravascular procedures and to facilitate guidewire exchange. It is operated by physicians in a clinical setting. By providing enhanced mechanical support, the device assists in successful navigation through complex vascular anatomy.

Clinical Evidence

Bench testing only. The submission includes mechanical and functional bench testing to demonstrate that the device performs as intended. Biocompatibility of materials is supported by a long history of use in similar medical devices.

Technological Characteristics

The device features a full metal spiral shaft construction. Materials used have a history of biocompatibility in vascular applications. The device is designed for compatibility with steerable guidewires. No electronic, software, or energy-based components are present.

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

• XTRAK Support Catheter (K032660)
• ILT Support Catheter (K012169)

Submission Summary (Full Text)

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#### SUMMARY OF SAFETY AND EFFECTIVENESS 9.0

O

This 510(k) summary of safety and effectiveness information is being submitted in
t and except and encome and essee - LCM CED 807 02 This 510(K) summary of Sarety 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: | Tornus Support Catheter |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATION<br>NAME: | Percutaneous Catheter |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| PRODUCT CODE | DQY |
| PREDICATE DEVICE: | XTRAK Support Catheter (K032660)<br>ILT Support Catheter (K012169) |

# Description of the Device Subject to Premarket Notification:

DESCRIFTION or rests support catheter is a device that is intended to provide additional The ASAN Tomas Support Satheton in accessing discrete regions of the coronary and support to a stochable galactine in the catheter contains a full metal spiral shaft that penpheral vasculature. The formas ettempting to cross difficult lesions. The full metal provides the user with a device that has excllent torqability and pushability during intravascular procedures.

#### INDICATION FOR USE:

The ASAHI Tornus support catheter is intended to be used in conjunction with a The AOAl If Torniao Support cathere regions of the vasculature and for guidewire exchange.

### TECHNICAL CHARACTERISTICS:

The Asahi Tornus support catheter is made of the same materials that have been used in other Asahi products that are labeled for use in the vasculature. The dimensional in other Asam producte that wire use compatibility specifications are the equivalent to those listed for the currently cleared predicate devices.

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## Performance Data:

9

PERFORMANCE DATA:
All components that come in direct contact with the patient have a long history of use in All components that come in be biocompatible for use in the vasculature. This medical devices and are proven to be blocompatible for about with the first of the comment of that
510(k) notice includes mechanical and functional bench that demonstrates th 510(K) notice includes meonamour and forms as intended.

# SUMMARY/CONCLUSION:

SUMMARY/CONCLUSION.
The ASAHI Tornus support catheteristics are substantially equivalent to the specified The ASAH Tornus support catheteristics are Substantially of the same indication for use.
predicate devices and other currently marketed devices for the same indication for us

Bench testing demonstrates that the device functions as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a symbol with three stylized human figures, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

SEP 26 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051772

> Tornus Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: September 14, 2005 Received: September 14, 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 Please be advised that FDA s issualice of a succession requirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decermination and Jointinered by other Federal agencies. You must or any Federal statutes and regulations daminders. by J not limited to: registration and listing (21 comply will an the Act 3 requirements, morealing, were and acturing practice requirements as set CFK Part 807), labeling (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (section (over device as described in your Section 510(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket notification. THC PDA miding of caseballians 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 If you desire spoonie aarree 10. J 276-0120. Also, please note the regulation entitled, Contact the Office of Compullier as (21 ) = 1 minimation" (21CFR Part 807.97). You may obtain Misoraliung by reference to promantee no promantee act from the Division of Small biller gelleral information on Jour response 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,

Donna R. Vachner

Br.
Di

\ 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):

Device Name: ASAHI Tornus Support Catheter

Indications for Use:

2.

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.

中

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)

Donna R. Vachner

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K051772

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