ASAHI PRECIOUS GUIDE CATHETER

K061601 · Asahi Intecc Co., Ltd. · DQY · Nov 17, 2006 · Cardiovascular

Device Facts

• Record ID: K061601
• Device Name: ASAHI PRECIOUS GUIDE CATHETER
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ASAHI Precious guide catheter is intended for use in coronary artery 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. These devices are not intended for use in the cerebral vasculature.

Device Story

The ASAHI Precious guide catheter is a percutaneous catheter used in coronary artery procedures. It provides a pathway for the introduction of therapeutic devices like balloon catheters and guide wires. The device consists of a tube, a proximal hub, and a joint protector. The inner lumen is coated with PTFE or Sodium hyaluronate for lubricity, while the outer surface is coated with Silicone oil. It is used by physicians in a clinical setting to facilitate coronary interventions. The device does not incorporate electronic components, software, or algorithms.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing was conducted on the device, and mechanical/functional bench testing demonstrated that the device performs as intended.

Technological Characteristics

Percutaneous catheter; materials include PTFE or Sodium hyaluronate (inner lumen) and Silicone oil (outer surface). Dimensions are equivalent to predicate devices. No electronic components, software, or energy sources.

Indications for Use

Indicated for use in coronary artery applications to provide a pathway for introducing medical instruments (e.g., balloon catheters, guide wires). Not 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

• Boston Scientific MACH 1 (Various models) (K020028)
• Boston Scientific 6F MACH 1 (K010874)

Submission Summary (Full Text)

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Kob1601

#### 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 | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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] | NOV 17 2006 |
| TRADE NAME: | Precious | |
| COMMON NAME: | Guide Catheter | |
| CLASSIFICATION<br>NAME: | Percutaneous Catheter | |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1250 | |
| PRODUCT CODE | DQY | |
| PREDICATE DEVICE: | Boston Scientific MACH 1 (Various models) (K020028)<br>Boston Scientific 6F MACH 1 (K010874) | |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The ASAHI Precious guide catheter is intended for use in coronary artery 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. These devices are not intended for use in the cerebral vasculature. This Precious guide catheter consists of a tube, a proximal hub, and protector for the joint portion of the first 2 components. The surface of inner lumen of the shaft is coated with either PTFE or Sodium hyaluronate (depending upon the specific model number) to enhance lubricity. The outer surface of the product is coated with Silicone oil,

#### INDICATION FOR USE:

The ASAHI Precious guide catheter is intended for use in coronary artery applications and is designed to provide a pathway through which medical instruments, spuch as balloon catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

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## TECHNICAL CHARACTERISTICS:

The ASAHI Precious guide 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 additional biocompatibility testing that was conducted on the actual device. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Precious guide catheter performs as intended.

## SUMMARY/CONCLUSION:

The ASAHI Precious guide catheter catheteristics 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 2006

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

Re: K061601

ASAHI Precious Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: October 2, 2006 Received: October 10, 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. 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,

Duna R. Wachner

Image /page/3/Picture/5 description: The image shows a signature. The signature appears to be a stylized combination of letters, possibly initials. The lines are fluid and connected, forming a unique design.

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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INDICATIONS FOR USE STATEMENT 2.0

510(k) Number (if known):

Device Name: Precious

Indications for Use:

The ASAHI Precious guide catheter is intended for use in coronary artery 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. These devices are 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Durna R. Schiner

sion Sign-Off) Division of Cardiovascular Devices

510(k) Number_

Page

CONFIDENTIAL Asahi Intecc May 15, 2006

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