SHEATHLESS EAUCATH CORONARY GUIDE CATHETER

K132556 · Asahi Intecc Co., Ltd. · DQY · Oct 24, 2013 · Cardiovascular

Device Facts

• Record ID: K132556
• Device Name: SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.

Device Story

SheathLess Eaucath Coronary Guide Catheter provides pathway for introduction of therapeutic/diagnostic devices (e.g., balloon catheters, guide wires) into coronary vascular system. Device consists of catheter tube, proximal hub/connector, strain relief/protector, and dilator. Available in 6.5Fr and 7.5Fr sizes. Used by clinicians in interventional cardiology procedures. Operates as percutaneous guide catheter; facilitates access to coronary vasculature. Benefits include providing stable conduit for interventional instruments.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including corrosion resistance, force at break, leakage testing, kinking, coating integrity, radiopacity, dimensional verification, and comprehensive biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, thromboresistance, coagulation, complement activation, pyrogenicity).

Technological Characteristics

Percutaneous guide catheter system comprising catheter and dilator. Available in 6.5Fr and 7.5Fr. Materials and design consistent with standard coronary guide catheters. Sterilization via ethylene oxide. Standalone device.

Indications for Use

Indicated for use in the coronary vascular system to provide a pathway for the introduction of therapeutic and diagnostic devices. Not for use in the 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

• 6F Launcher Guide Catheter (K021256)
• 7F Launcher Guide Catheter (K022764)
• 8F Launcher Guide Catheter (K023402)
• ACS Viking Catheter (K972484)
• ASAHI ZenyteEX Guiding Catheter (K091188)
• Heartrail III Guiding Catheter (K092372)
• Pinnacle Destination (K051601)

Submission Summary (Full Text)

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K132556

OCT 2 4 2013

Premarket Notification SheathLess Eaucath Coronary Guide Catheter

# ASAHI INTECC CO.,LTD.

1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel.[phone] Fax.[phone] Branch office : Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore,Beijing Research Facilities and Factories : Osaka, Seto. Thailand, Hanoi

#### 510(k) Summary [as required by 21 CFR 807.92(c)]

### SheathLess Eaucath Coronary Guide Catheter

510(k) _____

APPLICANT

Asahi Intecc Co., Ltd. 1703 Wakita-cho, Moriyama-ku Nagoya, Aichi 463-0024 Japan

Owner/Operator Number: 3003775027

OFFICIAL Correspondent

Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705 Tel: [phone] FAX [phone] e-mail: [e-mail]

SheathLess Eaucath Coronary Guide Catheter

Trade Name:

Common Name: Guide Catheter

Class 2 per 21 CFR §870.1250 DEVICE

Classification:

CLASSIFICATION Catheter, Percutaneous NAME:

PRODUCT CODE DQY

PREDICATE DEVICES:

K021256 6F Launcher Guide Catheter (Medtronic Vascular) K022764 7F Launcher Guide Catheter (Medtronic Vascular) K023402 8F Launcher Guide Catheter (Medtronic Vascular) K972484 ACS Viking Catheter (Guidant Corp.) K091188 ASAHI ZenyteEX Guiding Catheter (ASAHI Intecc Co., Ltd. K092372 Heartrail III Guiding Catheter (Terumo Medical Corp.)

- K051601 Pinnacle Destination (Terumo Medical Corp.)
Date Prepared: July 25, 2013

Asahi Intecc Co., Ltd

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### INTENDED USE:

The SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.

#### DESCRIPTION:

The SheathLess Eaucath Coronary Guide Catheter is intended for use in coronary 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.

The SheathLess Eaucath Coronary Guide Catheter consists of a "Catheter" and · "Dilator". The catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector. This product is being offered in two sizes: 6.5Fr and 7.5Fr.

### Comparison Table With Predicate Devices:

Comparisons of the SheathLess Eaucath Coronary Guide Catheter and predicate devices show that the technological characteristics of the SheathLess Eaucath such as intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the current marketed predicate devices.

# Non Clinical Testing / Performance Data:

Non clinical laboratory testing was performed on the SheathLess Eaucath Coronary Guide Catheter to determine substantial equivalence. The following testing/assessments were performed:

Performance test/evaluation summary:

- Corrosion resistance .
- . Force at break
- Liquid leakage under pressure test .
- . Air leakage into hub assembly during aspiration
- . Kinking short term test
- . Coating integrity / Particulate Evaluation
- . Radiopacity
- Dimensional Verification .

Biocompatibility:

- Cytotoxicity .
- Intracutaneous / Irritation .
- Sensitization .
- Systemic Toxicity .

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Premarket Notification SheathLess Eaucath Coronary Guide Catheter

- . In Vitro Hemolysis
- . In Vivo Thromboresistance
- Plasma Recalcification Time Coagulation .
- . C3a Complement Activation
- . SC5b-9 Complement Activation
- Pyrogen .

Package integrity:

- . Visual inspection
- . Seal strength test

Sterilization:

- Ethylene oxide sterilization evaluation .
- EO residuals .
- Endotoxin .

### CONCLUSION:

The SheathLess Eaucath Coronary Guide Catheter has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and is as safe and effective as its predicate.

Therefore, the SheathLess Eaucath Coronary Guide Catheter is substantially equivalent to the predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with a modern, abstract design, consisting of three curved lines. The text is written in a bold, sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 24, 2013 -

Asahi Intecc Co., Ltd. C/O Semih Oktay CardioMed LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K132556

> Trade/Device Name: SheathLess Eaucath Coronary Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 23, 2013 Received: August 26, 2013

Dear Semih Oktay:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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- Semih Oktay

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

M. A. Zillicherm

for 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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Premarket Notification SheathLess Eaucath Coronary Guide Catheter

## Indications for Use

| 510(k) Number (if known): | K132556 |
|---------------------------|--------------------------------------------|
| Device Name: | SheathLess Eaucath Coronary Guide Catheter |
| Indications for Use: | |

The SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.

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)

M.A. Lillehemann

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Asahi Intecc Co., Ltd