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 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. 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.

AI/ML Overview

The provided text describes the ASAHI Corsair Pro, a percutaneous catheter, and its substantial equivalence to predicate devices (ASAHI Corsair Microcatheter K151103, K083127). The document outlines the testing performed to demonstrate that the device meets acceptance criteria.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states that "The in vitro bench tests demonstrated that the ASAHI Corsair Pro met all acceptance criteria." However, specific numerical acceptance criteria for each test (e.g., "Force at Break > X N") are not explicitly provided in this document. The table below lists the tests performed and the general statement of performance.

Test Performed	Reported Device Performance
Appearance/Dimensions	Met all acceptance criteria and performed similarly to predicate devices.
Radio-Detectability	Met all acceptance criteria and performed similarly to predicate devices.
Slide Durability	Met all acceptance criteria and performed similarly to predicate devices.
Kink Resistance	Met all acceptance criteria and performed similarly to predicate devices.
Force at Break	Met all acceptance criteria and performed similarly to predicate devices.
Flexibility	Met all acceptance criteria and performed similarly to predicate devices.
Torque Transmission	Met all acceptance criteria and performed similarly to predicate devices.
Liquid Leakage under Pressure	Met all acceptance criteria and performed similarly to predicate devices.
Leak and Damage under High Static Pressure	Met all acceptance criteria and performed similarly to predicate devices.
Air Leakage	Met all acceptance criteria and performed similarly to predicate devices.
Corrosion Resistance	Met all acceptance criteria and performed similarly to predicate devices.
Torque Durability	Met all acceptance criteria and performed similarly to predicate devices.
Biocompatibility	All materials used are identical to the predicate device, demonstrating comparable biocompatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the non-clinical tests.
The data provenance is from in vitro bench tests conducted by ASAHI Intecc Co., Ltd. The company is based in Nagoya, Aichi, Japan, with various branch offices and research facilities globally. The specific location where these tests were performed is not detailed. The tests are prospective in nature, as they are conducted on the new device to demonstrate its performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the study described is a series of non-clinical, in vitro bench tests. These tests assess physical and mechanical properties of the device against predefined engineering specifications, not clinical outcomes requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the described study involves non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of medical images or data to establish a ground truth or resolve discrepancies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The provided document pertains to the regulatory submission for a medical device (a microcatheter), and the studies described are non-clinical bench tests. It is not an AI-based diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this content.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical instrument (microcatheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical bench tests, the "ground truth" refers to predefined engineering specifications and performance standards. The device's performance in each test is measured and compared against these established criteria, which are derived from industry standards, regulatory requirements, and the performance characteristics of the predicate device. There is no biological or clinical "ground truth" derived from expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

This section is not applicable. The document describes non-clinical testing of a physical medical device, not a machine learning model or algorithm that typically requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as #8.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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. +81-52-768-1211 Fax. +81-52-768-1221 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.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024, Japan
CONTACT	Yoshi TeraiPresident/CEOASAHI INTECC USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252, FAX: (949) 756-8165e-mail: ASAHI.ra-fda@ASAHI-intecc.com
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:

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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.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).