The ASAHI Treasure 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 Treasure peripheral guide wire is a steerable guide wire with a diameter of 0.018" and available in 180 cm and 300 cm lengths. 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 nod of the guide wire has a radiopaque tip that is straight and is 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

This is a medical device 510(k) summary for a guide wire, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific performance metrics is not available in the provided text. The submission focuses on substantial equivalence to predicate devices based on materials, dimensional specifications, and bench testing.

Here's an analysis of what is provided, in relation to your questions, and why AI/ML specific information is absent:

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

Acceptance Criteria: Not explicitly stated as a table with numerical targets. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices and performing "as intended" through bench testing.
Reported Device Performance: The document states:
- "The ASAHI Treasure guide wire 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."
- "mechanical and functional bench testing that demonstrates that the ASAHI Treasure guide wire performs as intended."
- "Bench testing demonstrates that the device functions as intended."
Table (Reconstructed from text, but not explicit in the document):

Acceptance Criteria Category	Reported Device Performance
Material Composition	Same materials as predicate devices with similar indications, proven biocompatible.
Dimensional Specifications	Equivalent to cleared predicate devices. (0.018" diameter, 180cm/300cm lengths mentioned in description)
Functional Performance (Bench Testing)	Functions as intended (details of specific tests or quantitative results are not provided in this summary, only the conclusion that it performs).
Biocompatibility	Components have a long history of use and are proven biocompatible.

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. The study is described as "mechanical and functional bench testing" which typically involves laboratory testing of physical samples of the device itself, rather than data from human patients. Therefore, concepts like data provenance or retrospective/prospective don't apply in the same way.

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. "Ground truth" in the context of this device's evaluation would refer to the established performance standards or safety profiles against which the bench test results are compared. There is no mention of experts establishing a "ground truth" for the test set, as this is a physical device evaluation, not an image analysis or diagnostic AI tool.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images). This document describes bench testing, which is objective and mechanistic.

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 device.

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

Not applicable. This is not an AI device.

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

For this type of device, the "ground truth" is implicitly defined by the regulatory standards and the performance of the legally marketed predicate devices. The device is being evaluated against established engineering specifications and historical performance of similar devices. There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for its performance.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. This is not an AI device, so there is no "training set."

Summary of why AI/ML specific information is absent:

The document describes a conventional medical device (a guide wire) seeking 510(k) clearance based on "substantial equivalence" to existing predicate devices. This regulatory pathway primarily focuses on comparing material composition, dimensional specifications, and fundamental functional performance through bench testing. It does not involve AI/ML technology, imaging analysis, or diagnostic capabilities that would necessitate the study design and evaluation metrics typically associated with AI/ML device submissions.

Summary

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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.

OCT = 5 2006

APPLICANT	Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan
OFFICIALCORRESPONDENT	Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.1301 Dove Street, Suite 350Newport Beach, CA 92660Tel: (949) 756-8252FAX (949) 756-8165e-mail: yoshi@asahi-intecc.com
TRADE NAME:	Treasure
COMMON NAME:	Guide Wire
CLASSIFICATIONNAME:	Catheter Guide Wire
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330
PRODUCT CODE	DQX
PREDICATE DEVICE:	Boston Scientific V-18 guide wire (K033724)HI-Torque Steelcore 18 guide wire (K982876)JOMED JoWire (K022762)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

Indication for Use:

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TECHNICAL CHARACTERISTICS:

The ASAHI Treasure guide wire 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 reference to a predicate ASAHI devices that uses the same materials as used in the subject device. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Treasure guide wire performs as intended.

Summary/Conclusion:

The ASAHI Treasure 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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006

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

Re: K061984

Treasure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 20, 2006 Received: September 26, 2006

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 yours.

R. Vuchner

Image /page/3/Picture/5 description: The image shows a black and white drawing of a signature. The signature is illegible, but it appears to be a stylized version of the letters 'S' and 'W'. The signature is drawn with thick lines and has a slightly messy appearance. The signature is located in the center of the image.

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

510(k) Number (if known): KO61984

Device Name: Treasure

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)

R. lochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K6661984

Page of of J

CONFIDENTIAL Asahi Intecc June 20, 2006

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.