ASAHI Caravel

K152447 · Asahi Intecc Co., Ltd. · DQY · Jan 22, 2016 · Cardiovascular

Device Facts

• Record ID: K152447
• Device Name: ASAHI Caravel
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures. Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

Device Story

ASAHI Caravel is a microcatheter used in interventional procedures to support guide wire placement and deliver contrast media in coronary and peripheral vasculatures. Device features a tapered distal tip with increased flexibility, a shaft reinforced with internal wires for physician control, a hydrophilic outer coating for smooth navigation, and a PTFE-lined inner lumen for guide wire exchange. Operated by physicians in clinical settings. Device provides mechanical support for wire navigation and a conduit for contrast media, facilitating vessel visualization and interventional access. Benefits include improved trackability and control during complex vascular procedures.

Clinical Evidence

Bench testing only. Performance data included appearance/dimensions, corrosion resistance, force at break, liquid/air leakage, radio-detectability, slide durability, kink resistance, and shaft flexibility. Biocompatibility testing conducted per ISO 10993, including cytotoxicity, sensitization, systemic toxicity, hemolysis, and thromboresistance. All tests met acceptance criteria.

Technological Characteristics

Microcatheter construction: Polyamide, polyamide-elastomer, and polyurethane shaft; PTFE-lined inner lumen; hydrophilic outer coating. Distal tip reinforced with wires. Dimensions: 1350–1500 mm length; 0.62 mm distal OD, 0.85 mm proximal OD. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients requiring guide wire placement or contrast media delivery within coronary and peripheral vasculatures.

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

• ASAHI Corsair Microcatheter (K151103)

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.

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

January 22, 2016

Asahi Intecc Co. Ltd. c/o Candace Cederman CardioMed Device Consultants LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K152447

Trade/Device Name: Asahi Caravel Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: December 18, 2015 Received: December 22, 2015

Dear Candace Cederman:

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. Iisting 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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 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,

Kenneth J. Cavanaugh -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K152447

Device Name ASAHI Caravel

Indications for Use (Describe)

This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.

This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463 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 Caravel

#### 510(k) K152447

| DATE PREPARED: | August 26, 2015 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT | ASAHI Intecc Co., Ltd.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya, Aichi 463-0024, Japan |
| OFFICIAL 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 Caravel |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY- Catheter, Percutaneous |
| PREDICATE DEVICES: | ASAHI Corsair Microcatheter (K151103) |

#### Intended Use/Indications for Use

This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.

This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

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## DESCRIPTION:

The ASAHI Caravel consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Caravel has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.

The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

#### COMPARISON WITH PREDICATE DEVICES:

Comparisons of the ASAHI Caravel and predicate devices show that the technological characteristics of the ASAHI Caravel such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.

The intended use/indications of the Subject Device are a subset of the primary predicates. There are specific design features of the Subject device that are similar to the primary predicate but not identical. Additional reference devices have been used to demonstrate equivalence for these similar features.

| Name of Device | ASAHI Caravel | ASAHI Corsair Microcatheter |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Current Application | K151103 |
| Intended Use and<br>Indications | This microcatheter is intended to<br>provide support to facilitate the<br>placement of guide wires in the<br>coronary<br>and peripheral<br>vasculatures, and can be used to<br>exchange one guide wire for<br>another.<br>This microcatheter is also intended<br>to assist in the delivery of contrast<br>media into the coronary and<br>peripheral vasculatures.<br>Do not use this microcatheter other<br>than for use in the coronary and<br>peripheral vasculatures. | The ASAHI Corsair Microcatheter is<br>intended to provide support to<br>facilitate the placement of Guide<br>wires in the coronary and peripheral<br>vasculatures and can be used to<br>exchange one guide wire for<br>another.<br>The Corsair Microcatheter is also<br>intended to assist in the delivery of<br>contrast media into the coronary,<br>peripheral,<br>and<br>abdominal<br>vasculatures. |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Target Body<br>Location | Peripheral, Coronary | Coronary, Peripheral<br>Abdominal (contrast media only) |
| Hydrophilic<br>coating | Yes | |
| Effective Length | 1350 – 1500 mm | 900 - 1500mm |
| Nominal OD | Distal : 0.62mm, Proximal : 0.85<br>mm | Distal : 0.75mm, Proximal : 1.0mm |
| Catheter Shaft<br>Mat'l | Polyamide<br>Polyamide-elastomer Polyurethane | Polyamide-elastomer |

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# Non Clinical testing / Performance Data:

Non clinical laboratory testing was performed on the ASAHI Caravel to determine substantial equivalence. The following testing/assessments were performed:

- Appearance/Dimensions ●
- Corrosion Resistance ●
- Force at Break ●
- Liquid Leakage under Pressure ●
- Air Leakage ●
- Leak and Damage under High Static Pressure ●
- Radio-Detectability
- Slide Durability ●
- Kink Resistance ●
- Shaft Flexibility ●

The in vitro bench tests demonstrated that the ASAHI Caravel met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.

#### BIOCOMPATIBILITY:

The ASAHI Caravel was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed: Cytotoxicity

- Intracutaneous Study ●
- Sensitization ●
- o Systemic Toxicity
- Hemolysis
- o In Vivo Thromboresistance
- Partial Thromboplastin Time ●
- C3a Complement Activation ●
- Sc5b-9 Complement Activation ●
- USP Pyrogen o

## CONCLUSION:

The ASAHI Caravel has identical intended use, a subset of the indications, and the same or 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. Therefore, the ASAHI Caravel is substantially equivalent to the predicate devices.