ASAHI ZENYTEEX GUIDING CATHETER

K091188 · Asahi Intecc Co., Ltd. · DQY · Feb 26, 2010 · Cardiovascular

Device Facts

• Record ID: K091188
• Device Name: ASAHI ZENYTEEX GUIDING CATHETER
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

Device Story

ASAHI ZenyteEX Guiding Catheter; percutaneous catheter for coronary/peripheral vascular access. Device provides pathway for therapeutic instruments (balloon catheters, guide wires). Construction: polyamide elastomer tube body; stainless steel braid-reinforced shaft; proximal hub/connector; strain relief. Distal portion soft for flexibility. Used in clinical settings by physicians to facilitate interventional procedures. Device enables delivery of therapeutic tools to target vasculature; benefits patient by providing stable access for minimally invasive interventions.

Clinical Evidence

Bench testing only. Includes biocompatibility testing and mechanical/functional bench testing to demonstrate performance as intended.

Technological Characteristics

Polyamide elastomer tube body; stainless steel braid-reinforced shaft; two-layer construction; proximal hub/connector; distal soft tip. Percutaneous catheter. Non-active device.

Indications for Use

Indicated for patients requiring coronary or peripheral vascular access for the introduction of therapeutic devices (e.g., balloon catheters, guide wires). Contraindicated for use in cerebral vasculature.

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

• Medtronic Launcher Guide Catheter (K023402 & K022764)
• ACS Viking Guiding Catheter (K972484)
• Precious Guide Catheter (K061601)
• Mach 1 Guide Catheter (K020028)

Submission Summary (Full Text)

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# 510(K) SUMMARY

#### 9.0 510(K) SUMMARY

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## FEB 2 6 2010

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 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL<br>CORRESPONDENT | Yoshi Terai<br>President, CEO<br>Asahi Intecc USA, Inc.<br>2500 Red Hill Avenue, Suite 210<br>Santa Ana, CA 92705<br>Tel: [phone]<br>FAX [phone]<br>e-mail: [e-mail] |
| TRADE NAME: | ASAHI ZenyteEX Guiding Catheter |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATION<br>NAME: | Catheter, Percutaneous |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| PRODUCT CODE | DQY |
| PREDICATE DEVICE: | K023402 & K022764 - Medtronic Launcher Guide Catheter<br>K972484 - ACS Viking Guiding Catheter<br>K061601 - Precious Guide Catheter<br>K020028 - Mach 1 Guide Catheter |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. The Catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector for the joint portion of the first 2 sections. The tube body section consists of soft tip, soft tube and shaft. The tube body itself is constructed of a polyamide elastomer. The shaft is reinforced by stainless steel braid, and it consists of two layers. The distal portion of the tube is made soft in order to easily bend.

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### INDICATION FOR USE:

ASAHI ZenvteEX Guiding Catheter is intended for use in coronary or peripheral vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

### TECHNICAL CHARACTERISTICS:

The ASAHI ZenyteEX Guiding Catheter is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.

#### PERFORMANCE DATA:

All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains biocompatibility testing conducted on the subject device. This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI ZenyteEX Guiding Catheter performs as intended.

#### SUMMARY/CONCLUSION:

The ASAHI ZenyteEX Guiding Catheter 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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Asahi Intecc Co., Ltd. c/o Mr Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705

FEB 2 6 2010

Re: K091188

Trade/Device Name: ASAHI ZenyteEX Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: January 20, 2010 Received: January 27, 2010

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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Dura R. Lachner

W

- 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

041188 510(k) Number (if known):

Device Name: ASAHI ZenyteEX Guiding Catheter

Indications for Use:

2.

ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

huma D. Vicher

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K 69 II

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