The Asahi Corsair 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. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures.

Device Description

The ASAHI Corsair Microcatheter consists of distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The Corsair has a radiopaque marker coil is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the device is coated with sodium hyaluronate on the outer surface of shaft tube to provide a smooth transition in blood vessel. The Distal tip of the Corsair has a tapered shape and is designed to have increased flexiblility towards distal side. PTFE is applied to the inner lumen of Catheter for the purpose of smooth transition and exchange of guidewire. The Microcatheter also reinforcement wires that are knitted between hypoblast and intercellular layer to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study details for the Asahi Corsair Microcatheter, focusing on the requested categories:

This submission is a 510(k) Pre-Market Notification, which is a regulatory pathway for medical devices seeking to demonstrate substantial equivalence to a previously legally marketed device (predicate device). In this context, the "acceptance criteria" are not performance metrics of an AI algorithm, but rather the regulatory requirements for showing that the new device is as safe and effective as existing ones.

The provided text describes a traditional medical device (microcatheter), not an AI/ML powered device. Therefore, many of the requested categories (e.g., AI assistance, standalone algorithm performance, training set details) are not applicable to this document.

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

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance
Similar Indications for Use: The new device must have the same or similar intended use as the predicate device(s).	"The Asahi Corsair 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. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures." (Stated as equivalent to predicate devices)
Similar Technical Characteristics: The new device must be made of the same materials and have equivalent physical specifications to predicate devices.	"The Asahi Corsair Microcatheter is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices."
Biocompatibility: Materials coming into contact with the patient must be proven biocompatible.	"All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains biocompatibility testing conducted on the subject device."
Mechanical and Functional Performance: The device must perform as intended through bench testing.	"This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI Corsair Microcatheter performs as intended."

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

Not Applicable. This document describes a traditional medical device, not an AI/ML system evaluated on a "test set" of data. The performance was demonstrated through biocompatibility testing and mechanical/functional bench testing, which usually involves a set number of physical device units rather than a dataset of patient information. The number of devices used for these tests is not specified in this summary.

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)

Not Applicable. As this is not an AI/ML system, there is no "ground truth" established by experts in the context of a test set for diagnostic accuracy. The evaluation revolves around the physical and material properties of the microcatheter.

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

Not Applicable. There is no "adjudication method" described for a test set, as this is not an AI/ML system with diagnostic outputs that require expert consensus.

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

Not Applicable. This is not an AI-assisted device. Therefore, no MRMC study or AI assistance effect size is relevant or reported.

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

Not Applicable. This device is a physical medical instrument, not an AI algorithm.

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

Not Applicable. For a physical device like a microcatheter, the "ground truth" used for evaluation is based on established engineering standards for mechanical performance, material science for biocompatibility, and regulatory criteria for safety and effectiveness compared to predicate devices. It's not about diagnostic accuracy.

8. The sample size for the training set

Not Applicable. This is not an AI/ML system. There is no "training set" in the context of data for model development.

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

Not Applicable. As no training set exists for an AI/ML model, there's no ground truth established in this context.

Summary

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9.0 510(K) Summary

<.831^{27}

510(K) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

3/09

APPLICANT

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

OFFICIAL Correspondent

Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705 Tel: (949) 756-8252 FAX (949) 756-8165 e-mail: yoshi@asahi-intecc.com

TRADE NAME:	Asahi Corsair Microcatheter
COMMON NAME:	Microcatheter
CLASSIFICATION NAME:	Percutaneous Catheter
DEVICE CLASSIFICATION:	Class 2 per 21 CFR §870.1250
PRODUCT CODE	DQy
PREDICATE DEVICE:	Asahi Stride Microcatheter – K062885Asahi Tornus Catheter - K051772Boston Scientific - Tracker Excel - 14 pre-shaped Microcatheter -K050599

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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INDICATION FOR USE:

TECHNICAL CHARACTERISTICS:

The Asahi Corsair Microcatheter is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.

Performance Data:

All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains biocompatibility testing conducted on the subject device. This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI Corsair Microcatheter performs as intended.

SUMMARY/CONCLUSION:

The Asahi Corsair Microcatheter characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the une indication for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is drawn in a simple, bold style, and the text is in a sans-serif font. The overall design is clean and professional.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB -3 2009

Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705

K083127

Re:

Trade/Device Name: Asahi Corsair Microcatheter Common Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DOY Dated: January 22, 2008 Received: January 23, 2008

Dear Mr. Terai:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Yoshi Terai

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dina D. Vicker

( 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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INDICATIONS FOR USE STATEMENT 2.0

510(k) Number (if known):

Device Name: Asahi Corsair Microcatheter

Indications for Use:

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)

unna R. Verlines

(Division Sign-Off) Division of Cardiovascular Devices

Page \ of

510(k) Number_K083127

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).