ASAHI Corsair Pro

K161126 · Asahi Intecc Co., Ltd. · DQY · Aug 25, 2016 · Cardiovascular

Device Facts

• Record ID: K161126
• Device Name: ASAHI Corsair Pro
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ASAHI Corsair Pro is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature, and can be used to exchange one guide wire for another. The ASAHI Corsair Pro is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. This device should not be used in neurovasculature.

Device Story

Microcatheter designed for interventional procedures in coronary and peripheral vasculature; facilitates guide wire placement/exchange; assists contrast media delivery. Device comprises distal tip, shaft tube, and vascular connector. Distal tip features tapered shape with increased flexibility; shaft tube reinforced with wires for physician control; inner lumen lined with PTFE for smooth wire transition; outer surface features hydrophilic coating. Operated by physicians in clinical settings. Physician inserts device into vasculature; manipulates via connector; delivers contrast media through lumen. Output is physical support for guide wires and conduit for contrast media. Benefits include improved device control and navigation during complex vascular interventions.

Clinical Evidence

Bench testing only. Performance assessments included appearance/dimensions, radio-detectability, slide durability, kink resistance, force at break, flexibility, torque transmission/durability, liquid leakage under pressure, leak/damage under high static pressure, air leakage, and corrosion resistance. Results demonstrated device met all acceptance criteria and performed similarly to predicate devices.

Technological Characteristics

Percutaneous catheter; hydrophilic-coated shaft; PTFE-lined inner lumen; wire-reinforced distal tip and shaft. Dimensions: 135 cm/150 cm length, 0.93 mm nominal OD. Sterilization: Ethylene Oxide (SAL 10^-6). Single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring guide wire placement or exchange in coronary and peripheral vasculature, and delivery of contrast media in coronary, peripheral, and abdominal vasculature. Contraindicated for use in 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

• ASAHI Corsair Microcatheter (K151103, K083127)

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 features a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

Auqust 25, 2016

ASAHI Intecc Co., Ltd. % Candace Cederman Senior Regulatory Affairs Consultant Cardiomed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K161126 Trade/Device Name: ASAHI Corsair Pro Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 26, 2016 Received: July 27, 2016

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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.

Mude Jellman
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

510(k) Number (if known) K161126

Device Name ASAHI Corsair Pro

Indications for Use (Describe)

The ASAHI Corsair Pro is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature and can be used to exchange one guide wire for another. The ASAHI Corsair Pro is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. This device should not be used in neurovasculature.

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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Image /page/3/Picture/1 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features a stylized red "A" followed by the company name in a dark green sans-serif font. The company name is written in all caps, with a comma between "CO." and "LTD."

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 Corsair Pro Microcatheter

## 510(k) 161126

| DATE PREPARED: | July 26, 2016 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT | ASAHI Intecc Co., Ltd.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya, Aichi 463-0024, Japan |
| CONTACT | 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], FAX: [phone]<br>e-mail: [e-mail] |
| TRADE NAME: | ASAHI Corsair Pro |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY- Catheter, Percutaneous |
| PREDICATE DEVICES: | ASAHI Corsair Microcatheter (K151103, K083127) |

### INTENDED USE/INDICATIONS FOR USE

The ASAHI Corsair Pro is intended to provide support to facilitate the placement of quide wires in the coronary and peripheral vasculature, and can be used to exchange one guide wire for another. The ASAHI Corsair Pro is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. This device should not be used in neurovasculature.

### Description:

The ASAHI Corsair Pro 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 Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. The inner lumen of the catheter is PTFE for the purposes of a smooth transition and exchange of guidewires.

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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 Corsair Pro and predicate device show that the technological characteristics of the Subject device such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to currently marketed predicate devices. The minor differences between the Subject and predicate devices do not raise any new questions of safety or effectiveness.

The intended use/indications between the Subject Device and its primary predicate are identical except of last sentence has been added for clarity.

| Name of Device | ASAHI Corsair Pro | ASAHI Corsair Microcatheter |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Current Application | K083127, K151103 |
| Indications for Use | The ASAHI Corsair Pro is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature, and can be used to exchange one guide wire for another. The ASAHI Corsair Pro is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. This device should not be used in neurovasculature. | The ASAHI Corsair Microcatheter is intended to provide support to facilitate the placement of Guide wires in the coronary and peripheral vasculature and can be used to exchange one guide wire for another. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Target body location | Peripheral, Coronary | |
| Shelf Life | 3 Years | |
| Overall Length | 135 cm/ 150 cm | 90 cm / 135 cm/ 150 cm |
| Nominal OD | 0.93 mm | 0.93 mm |
| Coating Length | 600 mm | |
| Coating material | Hydrophilic | |
| Marker? | No | Yes |
| Single use | Yes | |

# Non Clinical testing / Performance Data:

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

- Appearance/Dimensions
- Radio-Detectability ●
- Slide Durability
- Kink Resistance
- Force at Break
- Flexibility
- . Torque Transmission
- . Liquid Leakage under Pressure

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- Leak and Damage under High Static Pressure ●
- Air Leakage
- Corrosion Resistance ●
- . Torque Durability

The in vitro bench tests demonstrated that the ASAHI Corsair Pro 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 Corsair Pro was compared to the predicate devices. All of materials used for the ASAHI Corsair Pro are identical to the ASAHI Corsair Microcatheter predicate except that there is no marker in the Subject device.

#### Conclusion:

The ASAHI Corsair Pro has identical intended use, similar indications, and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life, performance, and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended.

Therefore, the ASAHI Corsair Pro is substantially equivalent to the predicate devices.