The ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon rilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and thatator outhers wantely (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

Device Description

Asahi PTCA Guide Wiles are steerable gulde with a maximaling to wire 114 inches (0.56mm) and available in Too children wire is constructed from the more is constructed from connected to the end of the guide wille batside the body. The wild besign. The with the stight stainless steel core with varying core ichgitis and diamotors for backless of the dights innd or wire and coil are soldered or welded depending upon specific encluded at onl of ewire and coll are soldered of welded deportung upon open open on and is and is and is a radiopaque tip to achieve visibility, and is available straight and is made soft to easily bend with the vessel curve or, available as are shaped " "The ade soit to easily bend with the vooool ed to the distal portion of the guide wire. The mating (nydropmine and Silicone) is applica to the title guilter of the galler series noximal section of the galde wire is outlou with hydrophilic coating applied to the distal there is poryal and the proximal section of this guide wire is coated with PTFE.

AI/ML Overview

The provided text describes a medical device, the ASAHI PTCA Guide Wire, and its 510(k) submission to the FDA. It details the device's design, indications for use, and a summary of performance testing.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Material Equivalence	The ASAHI PTCA Guide Wires are of the same materials as the predicate devices with the exception of the modified coating material.
Dimensional Specifications and Design	The dimensional specifications and design of the device ensures compatibility for the intended use.
Mechanical and Functional Performance	Bench testing demonstrates that the ASAHI PTCA Guide Wires performs as intended.
Substantial Equivalence	The ASAHI PTCA Guide Wire characteristics with the modified PTFE coating are substantially equivalent to the currently marketed Asahi guidewires for the same indication for use.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample size used for the bench testing. It only mentions "mechanical and functional bench testing."
Data Provenance: The study was conducted by Asahi Intecc Co., Ltd. in Japan (applicant address provided). The data is retrospective in the sense that it's bench testing conducted by the manufacturer for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The testing described is mechanical and functional bench testing, not clinical studies involving expert interpretation of data or images. Therefore, the concept of "ground truth established by experts" as typically applied to AI/imaging studies does not directly apply here. The "ground truth" for this device would be its physical specifications and performance metrics against engineering standards.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Since the testing is mechanical and functional bench testing, there's no mention of an adjudication method among experts. Performance is likely measured against predefined engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document describes mechanical and functional bench testing only. This is a physical medical device (a guide wire), not a diagnostic or AI-driven system that would typically undergo MRMC studies to assess human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable/No. This device is a physical guidewire, not an algorithm or AI system. The concept of "standalone performance" for an algorithm doesn't apply. The "standalone" performance here refers to the guidewire's inherent mechanical and functional characteristics during bench testing.

7. Type of Ground Truth Used:

The ground truth for this device's performance would be engineering specifications and established performance standards for guide wires. The document states that the "dimensional specifications and design... ensures compatibility for the intended use" and that "bench testing demonstrates that the device functions as intended." This implies that the device's performance was compared against predetermined technical criteria.

8. Sample Size for the Training Set:

This information is not applicable/provided. The device is a physical guidewire, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/provided. As explained above, this device does not involve an AI model or a training set in the conventional sense.

Summary

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SUMMARY OF SAFETY & EFFECTIVENESS

510(K) SUMMARY

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

PLICANT

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

FFICIAL ORRESPONDENT Yoshi Terai 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

ASAHI PTCA Guide Wire

Class 2 per 21 CFR §870.1330

Catheter Guide Wire

TRADE NAME:

Guide Wire

DQX

COMMON NAME: CLASSIFICATION

NAME: DEVICE

CLASSIFICATION: Product Code

大 PREDICATE DEVICE:

K022762	JoWire Neo's PTCA Guide Wire
K031277	JoWire Asahi PTCA Guide Wire
K032615	Asahi PTCA Guide Wire
K041531	Asahi PTCA Guide Wire Confianza
K043422	Asahi PTCA Guide Wire, J Shape Series
K052022	Asahi PTCA Guide Wire, Fielder
K052339	Asahi PTCA Guide Wire
K062186	Asahi PTCA Guide Wire, Fielder J
K063819	Asahi PTCA Guide Wire, Fielder FC

CONFIDENTIAL Asahi Intecc March 20, 2007

K070945

July - 9 2008

K070945

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scription of the Device Subject to Premarket Notification:

ScRIPTION OF THE DEVICE GUDEOT TO H Reviment a maximum diameter of in Asan PTCA Guide Wiles are steerable gulde with a maximaling to wire 114 inches (0.56mm) and available in Too children wire is constructed from the more is constructed from connected to the end of the guide wille batside the body. The wild besign. The with the stight stainless steel core with varying core ichgitis and diamotors for backless of the dights innd
or wire and coil are soldered or welded depending upon specific encluded at onl of ewire and coll are soldered of welded deportung upon open open on and is and is
and is a radiopaque tip to achieve visibility, and is available straight and is made soft to easily bend with the vessel curve or, available as are shaped " "The ade soit to easily bend with the vooool ed to the distal portion of the guide wire. The mating (nydropmine and Silicone) is applica to the title guilter of the galler series noximal section of the galde wire is outlou with hydrophilic coating applied to the distal there is poryal and the proximal section of this guide wire is coated with PTFE.

INDICATION FOR USE:

Technical Characteristics:

The ASAHI PTCA Guide Wires are of the same materials as the predicate devices with the exception of the modified coating material. 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 PTCA Guide Wires performs as intended.

SUMMARY/CONCLUSION:

The ASAHI PTCA Guide Wire characteristics with the modified PTFE coating are substantially equivalent to the currently marketed Asahi guidewires for the same indication for use.

Bench testing demonstrates that the device functions as intended.

CONFIDENTIAL Asahi Intecc March 20, 2007

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K070945

Trade Name: Asahi PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: December 26, 2007 Received: December 27, 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.

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) 276-0120. 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 Biometrics' (OSB) 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. luchner

/ 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_

INDICATIONS FOR USE STATEMENT

10(k) Number (if known): K070945

evice Name: ASAHI PTCA Guide Wires :

ndications for Use:

The ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon lice Honnin FOA Ouring percutaneous transluminal coronary angioplasty (PTCA) and mation catherers annig lanny (PTA). The Asahi PTCA Guide Wires are not to e used in the cerebral blood vessel.

escription Use X art 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF EDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

unna P. lo. Lunes

Division Sign Division of Cardiovascular Devices

510(k) Number K070945

Page _ | _ of _ }

000018

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.