The ASAHI Astato 30 Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

Device Description

The Asahi peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire. The wire is constructed from a stainless steel core wire with spring. The core wire and coil are soldered together. The distal end of the guide wire has a radiopaque tip that is straight and is made soft to easily bend with the vessel curve. The hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE.

AI/ML Overview

The provided text describes a 510(k) summary for the ASAHI Astato 30 Peripheral Guide Wire. This document is for a medical device and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to demonstrating substantial equivalence to predicate devices through performance data.

Here's the breakdown of the requested information based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Material Equivalence: Device materials are the same as predicate devices.	The ASAHI Astato 30 Peripheral Guide Wire is of the same materials as the predicate devices.
Dimensional/Design Equivalence: Dimensional specifications and design ensure compatibility for intended use.	The dimensional specifications and design of the device ensures compatibility for the intended use.
Performance as Intended: Mechanical and functional bench testing demonstrates the device performs as intended.	This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Astato 30 Peripheral Guide Wire performs as intended. Summary/Conclusion: Bench testing demonstrates that the device functions as intended.
Substantial Equivalence: Characteristics are substantially equivalent to specified predicate devices and other currently marketed devices for the same indication for use.	The ASAHI Astato 30 Peripheral Guide Wire 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)

The document states "This 510(k) notice includes mechanical and functional bench testing." It does not specify:

The exact sample size for the test set of the bench testing.
The country of origin of the data.
Whether the data was retrospective or prospective (bench testing is typically considered prospective in its execution for the submission, but the source of components might be retrospectively sourced).

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 bench test of a physical device, not an AI/software device that requires expert ground truth for interpretation of medical images or data.

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

This section is not applicable as the study described is a bench test, not a study involving human interpretation with adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a physical medical device (guide wire), not an AI or software device that would assist human readers.

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

This section is not applicable. This is a physical guide wire, not an algorithm.

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

For the bench testing, the "ground truth" would be the engineering specifications and performance standards for guide wires, as well as the performance of the predicate devices. The device was tested to ensure it met those specifications and performed comparably to legally marketed predicate devices.

8. The sample size for the training set

This section is not applicable as the document describes bench testing for a physical guide wire, not a machine learning model that requires a training set.

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

This section is not applicable as the document describes bench testing for a physical guide wire, not a machine learning model.

Summary

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9.0 510(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.

APPLICANT	Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan	JUL 13 2007
OFFICIALCORRESPONDENT	Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX (949) 756-8165e-mail: yoshi@asahi-intecc.com
TRADE NAME:	ASAHI Astato 30 Peripheral Guide Wire
COMMON NAME:	Guide Wire
CLASSIFICATIONNAME:	Catheter Guide Wire
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330
PRODUCT CODE	DQX
PREDICATE DEVICE:	Asahi Treasure Guide Wire - K061984Guidant Hi-Torque Floppy Guide Wire - K974773Guidant Hi-Torque Cross-IT - K990639Guidant Hi-Torque Steel Core 18 - K982876Asahi PTCA Guide Wire - K052339

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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INDICATION FOR USE:

TECHNICAL CHARACTERISTICS:

The ASAHI Astato 30 Peripheral Guide Wire is of the same materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for the intended use.

Performance Data:

This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Astato 30 Peripheral Guide Wire performs as intended.

SUMMARY/CONCLUSION:

The ASAHI Astato 30 Peripheral Guide Wire 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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected by flowing lines. The symbol is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a sans-serif font. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2007

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

Re: K071721

Trade/Device Name: Asahi Astato 30 Peripheral Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: May 28, 2007 Received: June 25, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 Biometric's (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.

R. buchner

A Bram 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): K07172

Device Name: ASAHI Astato 30 Peripheral Guide Wire

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)

umne R. W. hussil

ivision Sign-Off) vision of Cardiovascular Devices

Number_ Ko 11721

Page _ of _

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Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.