The ASAHI Stride 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 guidewire for another. The Asahi Stride Microcatheter is also intended to assist in the delivery of diagnostic agents, such as contrast media and therapeutic agents, such as occlusion coils into the coronary and peripheral vasculature.

Device Description

Asahi Stride Microcatheter consists of catheter (soft tip tube and shaft tube), protector tube, strain relief, hub connector, and radiopaque marker in the soft tip tube. The proximal shaft is reinforced with a stainless steel braid wire to enhance pushability. The device is provided in a 2.2 Fr size with lengths ranging from 105 cm to 150 cm. The device also comes with both straight and angled tips.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Asahi Stride Microcatheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria or improvements with AI.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device are not applicable to this submission. The document emphasizes bench testing and biocompatibility testing to show the device performs as intended and is safe, focusing on equivalence to existing devices.

Here's an analysis based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the way one might expect for a new AI-powered diagnostic tool. Instead, it refers to:

Area of Performance	Acceptance Criteria (Implied)	Reported Device Performance
Technical Characteristics	Equivalent to predicate devices; made of similar materials.	"made of the same materials that have been used in other predicate devices" and "dimensional specifications are equivalent to those listed for the currently cleared predicate devices."
Biocompatibility	Safe for patient contact (non-toxic, non-irritating, etc.).	"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." and "submission contains biocompatibility testing conducted on the subject device."
Mechanical & Functional Bench Testing	Performs as intended (e.g., pushability, deliverability, ability to facilitate guidewire placement and deliver agents).	"mechanical and functional bench testing that demonstrates that the ASAHI Stride Microcatheter performs as intended."
Overall Equivalence	Substantially equivalent to predicate devices for stated indications.	"The ASAHI Stride Microcatheter characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use."

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

This information is not provided in the document as it refers to bench and biocompatibility testing, not clinical studies with "test sets" in the context of an AI/ML device.

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 information is not provided and is not applicable to the type of testing described (bench and biocompatibility).

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

This information is not provided and is not applicable.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not the nature of the Stride Microcatheter.

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

This information is not applicable as the Stride Microcatheter is a physical medical device, not a standalone algorithm.

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

For the biocompatibility testing, the "ground truth" would be established by scientific standards for material safety and patient interaction. For mechanical and functional bench testing, the "ground truth" would be established by engineering specifications and performance benchmarks against predicate devices, based on objective physical measurements.

8. The sample size for the training set

This information is not provided and is not applicable.

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

This information is not provided and is not applicable.

Summary

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X 062885

JUN 1 8 2007

9.0 510(K) SUMMARY

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

Asahi Intecc Co., Ltd. APPLICANT 1703 Wakita-cho, Moriyama-ku Nagoya, Aichi 463-0024 Japan OFFICIAL Yoshi Terai Correspondent President, CEO Asahi Intecc USA. Inc. 1301 Dove Street, Suite 350 Newport Beach, CA 92660 Tel: (949) 756-8252 FAX (949) 756-8165 e-mail: yoshi@asahi-intecc.com Trade Name: Stride Microcatheter COMMON NAME: Microcatheter Classification NAME: . Percutaneous Catheter DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Boston Scientific Tracker Excel - 14 (K050599) Cordis Transit/Rapid Transit/Spedster/Prowler (K972518) ASHAI Tomus Support Catheter (K051772)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

Indication for Use:

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TECHNICAL CHARACTERISTICS:

The ASAHI Stride 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:

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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 Stride Microcatheter performs as intended.

SUMMARY/CONCLUSION:

The ASAHI Stride Microcatheter characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.

Bench testing demonstrates that the device functions as intended.

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Public Health Service

U
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asahi Intecc USA, Inc. c/o Mr. Yoshi Terai President, CEO 1301 Dove Street, Suite 350 Newport Beach, CA 92660

JUN 1 8 2007

Re: K062885 Stride Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DQY Dated: March 20, 2007 Received: March 30, 2007

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.

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Page 2 - Mr. Yoshi Terai

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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 wours,

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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2.0 INDICATIONS FOR USE STATEMENT

11062885 510(k) Number (if known): _

Device Name: Stride Microcatheter

Indications for Use:

The ASAHI Stride Microcatheter 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 guidewire for another. The Asahi Stride Microcatheter is also intended to assist in the delivery of diagnostic agents, such as contrast media and therapeutic agents, such as occlusion coils into the coronary and peripheral vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K062885

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CONFIDENTIAL Asahi Intecc September 12, 2006

NEEDED)

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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).