ASAHI FUBUKI 043 / ASAHI FUBUKI

K141981 · Asahi Intecc Co., Ltd. · DQY · Mar 9, 2015 · Cardiovascular

Device Facts

• Record ID: K141981
• Device Name: ASAHI FUBUKI 043 / ASAHI FUBUKI
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.

Device Story

ASAHI FUBUKI 043 and ASAHI FUBUKI are guide catheters used in neurovascular procedures. The device consists of a tube, protector section, and connector, with a soft distal tip. The inner lumen is PTFE-lined to facilitate device movement; the tube is polymer resin reinforced with stainless steel and tungsten braid wire; the outer surface is partially coated with a hydrophilic polymer. Used by physicians in clinical settings to navigate interventional devices to neurovascular lesions or sites and to inject contrast media. The device provides a pathway for interventional tools, aiding in therapeutic delivery. It is provided sterile for single use.

Clinical Evidence

Bench testing only. Performance data included corrosion resistance, force at break, liquid/air leakage, radio-detectability, kink resistance, and dimensional verification. Biocompatibility was verified based on material similarity to predicate devices.

Technological Characteristics

Materials: polymer resin, PTFE liner, stainless steel/tungsten braid reinforcement, hydrophilic coating. Form factor: guide catheter (4.2Fr to 8Fr) and dilator kits. Energy: none (mechanical). Connectivity: none. Sterilization: Ethylene Oxide.

Indications for Use

Indicated for patients requiring percutaneous intravascular neurovascular procedures. Used to guide interventional devices to lesions or procedural sites and for contrast media injection. Contraindicated for use outside the neurovasculature.

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

• HD Guide Catheter (K090335)
• Envoy Guide Catheter (K962362)
• GUIDER Softip Guiding Catheter (K980453)

Reference Devices

• Asahi Corsair Microcatheter (K083127)
• SheathLess Eaucath Coronary Guide Catheter (K132556)
• Precious Guide Catheter (K061601)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2015

Asahi Intecc Co., Ltd. % Mr. H. Semih Oktay President CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228

Re: K141981

Trade/Device Name: ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 5, 2015 Received: February 6, 2015

Dear Mr. 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.

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

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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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S 同公

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K141981

Device Name ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters

Indications for Use (Describe)

The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.

Type of Use (Select one or both, as applicable)

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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Image /page/3/Picture/1 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features a stylized red "A" symbol on the left, followed by the company name in dark teal. The text is in a clear, sans-serif font, making it easily readable. The logo appears to be professionally designed and conveys a sense of corporate identity.

1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel.[phone] Fax.[phone] Branch offices: 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)]

# ASAHI FUBUKI 043 and ASAHI FUBUKI

## 510(k) K141981

| 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 NAMES: | ASAHI FUBUKI 043<br>ASAHI FUBUKI |
| DEVICE<br>CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION<br>NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY |
| PREDICATE<br>DEVICES: | K090335, HD Guide Catheter<br>K962362, Envoy Guide Catheter<br>K980453, GUIDER Softip Guiding Catheter |
| REFERENCE<br>DEVICES: | K083127, Asahi Corsair Microcatheter<br>K132556, SheathLess Eaucath Coronary Guide Catheter<br>K061601, Precious Guide Catheter |
| DATE PREPARED: | February 5th , 2015 |

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## INDICATION FOR USE/INTENDED USE:

## ASAHI FUBUKI Intended Use:

This product is intended to be used to guide interventional devices for Neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the Neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this product other than for use in the Neurovasculature.

#### ASAHI FUBUKI 043 Intended Use:

This catheter is intended to be used to guide interventional devices for Neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the Neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this catheter other than for use in the Neurovasculature.

#### DESCRIPTION:

ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes:

| Product Name | Outer diameter of Catheter |
|------------------|----------------------------|
| ASAHI FUBUKI 043 | 4.2 Fr |
| ASAHI FUBUKI 6Fr | 6 Fr |
| ASAHI FUBUKI 7Fr | 7 Fr |
| ASAHI FUBUKI 8Fr | 8 Fr |

The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes:

| Product Name | Outer diameter of Catheter | Outer diameter of Dilator Shaft (mm) |
|------------------------------|----------------------------|--------------------------------------|
| ASAHI FUBUKI Dilator Kit 4Fr | 6 Fr | 1.75 |
| ASAHI FUBUKI Dilator Kit 5Fr | 7 Fr | 2.00 |
| ASAHI FUBUKI Dilator Kit 6Fr | 8 Fr | 2.21 |

The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter.

The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.

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#### COMPARISON TABLE WITH PREDICATE DEVICES:

Comparisons of the ASAHI FUBUKI 043 and ASAHI FUBUKI with the predicate devices show that the technological characteristics of the ASAHI FUBUKI 043 AND ASAHI FUBUKI such as the intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate devices. A comparison of the ASAHI FUBKI 043 and the ASAHI FUBUKI to the predicate devices is provided in the table below.

| Device Name | ASAHI<br>FUBUKI 043 | ASAHI<br>FUBUKI | HD Guide<br>Catheter | Envoy | GUIDER<br>Softip<br>Guiding<br>Catheter | Device Name<br>Comparison<br>Criteria | ASAHI<br>FUBUKI 043 | ASAHI<br>FUBUKI | HD Guide<br>Catheter | Envoy | GUIDER<br>Softip<br>Guiding<br>Catheter |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------|---------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Comparison<br>Criteria | | | | | | Tip Shape | Straight | Straight<br>Angled | Unknown | Straight<br>Multipurpose<br>C<br>Multipurpose<br>D<br>Modified<br>Cerebral<br>(Burke)<br>Headhunter 1<br>Simmons 2 | 40° Angle<br>Multipurpose<br>Straight |
| Manufacturer | ASAHI INTECC<br>CO., LTD. | ASAHI INTECC<br>CO., LTD. | Concentric | Cordis | Schneider | Primary<br>catheter<br>material | Polyurethane<br>Polyamide | Polyurethane<br>Polyamide | Polyamide<br>elastomer | Nylon<br>Polyurethane | Unknown |
| Indications for<br>Use | This catheter is<br>intended to be used to<br>guide interventional<br>devices for<br>Neurovascular<br>therapy to a lesion or<br>a procedural site for a<br>percutaneous<br>intravascular<br>procedure in the<br>Neurovasculature.<br>This catheter is also<br>intended to be used<br>for injection of<br>contrast media.<br>Do not use this<br>catheter other than<br>for use in the<br>Neurovasculature. | This product is<br>intended to be used<br>to guide<br>interventional<br>devices for<br>Neurovascular<br>therapy to a lesion<br>or a procedural site<br>for a percutaneous<br>intravascular<br>procedure in the<br>Neurovasculature.<br>This catheter is also<br>intended to be used<br>for injection of<br>contrast media.<br>Do not use this<br>product other than<br>for use in the<br>Neurovasculature. | The HD Guide<br>Catheter is<br>indicated for use in<br>facilitating the<br>insertion and<br>guidance of an<br>occlusion catheter,<br>infusion catheter or<br>other appropriate<br>microcatheter into<br>a selected blood<br>vessel in the<br>peripheral,<br>coronary and<br>neurovascular<br>systems. It may<br>also be used as a<br>diagnostic<br>angiographic<br>catheter. | The Envoy<br>Guiding<br>Catheter is<br>intended to<br>use in the<br>peripheral,<br>coronary and<br>neurovasculat<br>ure for the<br>intravascular<br>introduction<br>of<br>interventional<br>/ diagnostic<br>devices. | The SCHNEIDER<br>GUIDER Softip<br>Guiding Catheter<br>are designed for<br>introduction of<br>interventional<br>devices. They are<br>intended to<br>facilitate the<br>placement of<br>interventional<br>devices into the<br>peripheral and<br>coronary systems<br>and, in additional<br>for the XF models,<br>into the<br>neurovascular<br>system. | Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene<br>Oxide | Ethylene Oxide |
| Labeled Shaft<br>Outer<br>Diameter | 4.2 Fr | 6Fr, 7Fr, 8 Fr | 3.9Fr - 5.2 Fr | 5Fr, 6Fr | 5Fr, 6 Fr, 7 Fr, 8<br>Fr, 9 Fr | | | | | | |
| Inner Diameter | 4.2 Fr : 1.10mm<br>(0.043 in) | 6Fr : 1.80mm<br>(0.071 in)<br>7Fr : 2.05mm<br>(0.081 in)<br>8Fr : 2.28mm<br>(0.090 in) | Not Provided | 5Fr : 1.4mm<br>(0.056 in)<br>6Fr : 1.8mm<br>(0.070 in) | 5 Fr : 1.35mm<br>(0.053 in)<br>6 Fr : 1.63mm<br>(0.064 in)<br>7 Fr : 1.85mm<br>(0.073 in)<br>8 Fr : 2.18 mm<br>(0.086 in)<br>9 Fr : 2.51mm<br>(0.099 in) | | | | | | |
| Catheter<br>Effective<br>Length | 1200mm - 1300mm | 800mm - 1100mm | 1150mm -<br>1360mm | 900, 1000mm | 900, 1000mm | | | | | | |

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## NON CLINICAL TESTING / PERFORMANCE DATA:

Non clinical laboratory testing was performed on the ASAHI FUBUKI 043 and ASAHI FUBUKI to determine substantial equivalence. The following testing and assessments were performed:

- Corrosion resistance ●
- Force at break
- Liquid leakage under pressure ●
- Air leakage into hub assembly during aspiration
- Leak and damage under high static pressure ●
- Radio-detectability
- Kink resistance ●
- Appearance/Dimensions .

#### BIOCOMPATIBILITY:

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The ASAHI FUBUKI 043 and ASAHI FUBUKI was compared to the predicate devices. Based on similariites of the materials used in the subject devcie to its predicates, the biocompatibiity of the ASAHI FUBUKI 043 and ASAHI FUBUKI was verified to be the same as those of the predicates.

## CONCLUSION:

The ASAHI FUBUKI 043 and ASAHI FUBUKI 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 has a safety and effectiveness profile that is similar to the predicate devices.

Therefore, the ASAHI FUBUKI 043 and ASAHI FUBUKI are substantially equivalent to the predicate devices.