ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

Device Description

The product, ASAHI PTCA Guide Wire ASAHI RG3 (hereinafter ASAHI RG3 and ASAHI RG3 Soft), is intended to facilitate the insertion of an inflatable balloon catheter and other devices for treating narrowing and obstruction of the blood vessels.

The basic structure of the ASAHI RG3 and ASAHI RG3 Soft consists of a taper core wire and a coil. The taper core wire and the coil are soldered. The coil is radiopaque in part length so its position can be easily confirmed under radioscopy. In addition to this, coatings are applied on the surface of the product. The distal end of ASAHI RG3 and ASAHI RG3 Soft are coated with hydrophilic polymer. On the other hand, the proximal end of the taper core of ASAHI RG3 and ASAHI RG3 Soft wire is coated with silicone oil.

AI/ML Overview

This document is a 510(k) premarket notification for the ASAHI PTCA Guidewire System, ASAHI RG3. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic device's performance study is not applicable to this submission. This document describes a medical device, a guidewire, and the testing conducted is for its physical and biocompatibility properties, not diagnostic accuracy.

However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence:

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

The document does not explicitly state quantitative "acceptance criteria" alongside specific "reported device performance values" in a table format as would be typical for a diagnostic algorithm. Instead, it lists the types of non-clinical tests performed to demonstrate that the device functions as intended and is as safe and effective as predicate devices. The implicit acceptance criterion for these tests is that the device performs comparably to the predicate devices or within established engineering specifications for guidewires.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Tensile Strength	Performed, demonstrated substantial equivalence.
Torque Strength	Performed, demonstrated substantial equivalence.
Torqueability	Performed, demonstrated substantial equivalence.
Tip Flexibility	Performed, demonstrated substantial equivalence.
Coating Adhesion/Integrity	Performed, demonstrated substantial equivalence.
Catheter Compatibility	Performed, demonstrated substantial equivalence.
Biocompatibility	Verified to be the same as predicate devices based on material similarities.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical test. The tests were performed on "the ASAHI RG3." As it's a physical device performance test, the "data provenance" would be a laboratory setting, not related to patient data or country of origin in the context of diagnostic performance. These would be prospective laboratory tests on the manufactured guidewires.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical device performance and safety study, not a diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. This is a non-clinical device performance and safety study.

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 a non-clinical device performance and safety study for a guidewire, not a diagnostic AI tool.

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

Not applicable. This is a non-clinical device performance and safety study for a guidewire, not a diagnostic algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be the established engineering specifications for guidewire performance and safety, and direct measurement of the physical properties (e.g., tensile strength, torque, flexibility) of the ASAHI RG3 guidewire, compared against those of the predicate devices.

8. The sample size for the training set

Not applicable. This is a non-clinical device performance and safety study, not a machine learning model.

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

Not applicable. This is a non-clinical device performance and safety study, not a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 3, 2014

Asahi Intecc Co., Ltd. % Candace Cederman Senior Regulatory Affairs Consultant CardoMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228

Re: K141339

Trade/Device Name: ASAHI PTCA Guidewire System, ASAHI RG3 Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire System Regulatory Class: Class II Product Code: DQX Dated: September 25, 2014 Received: September 26, 2014

Dear Candace Cederman:

This letter corrects our substantially equivalent letter of September 25, 2014.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For 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

510(k) Number (if known):

Device Name:

ASAHI PTCA Guidewire ASAHI RG3

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)

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ASAHI INTECC CO.,LTD.

1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel.+81-52-768-1211 Fax.+81-52-768-1221 Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

510(k) Summary [as required by 21 CFR 807.92(c)]

ASAHI PTCA Guide Wire ASAHI RG3

510(k)

APPLICANT	Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan
OFFICIALCORRESPONDENT	Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX: (949) 756-8165e-mail: asahi.ra-fda@asahi-intecc.com
TRADE NAME:	ASAHI PTCA Guidewire System, ASAHI RG3
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATIONNAME:	Catheter, Guide, Wire
PRODUCT CODE	DQX- Catheter Guide Wire
PREDICATEDEVICES:	K031277, Asahi Prowater Guidewire, Asahi Grand SlamK133865, ASAHI PTCA Guide Wire ASAHI Gaia
DATE PREPARED:	May 16th, 2014

INTENDED USE:

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DESCRIPTION:

COMPARISON TABLE WITH PREDICATE DEVICES:

Comparisons of the ASAHI PTCA Guide Wire ASAHI RG3 and predicate devices show that the technological characteristics of the ASAHI RG3 such as the intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate devices. The ASAHI PTCA Guide Wire ASAHI RG3 has an overall length of 330 cm and a nominal outer diameter of 0.26 mm.

NON CLINICAL TESTING / PERFORMANCE DATA:

Non clinical laboratory testing was performed on the ASAHI RG3 to determine substantial equivalence. The following testing/assessments were performed:

Tensile Strength ●
Torque Strength
o Torqueablity
Tip Flexibility ●
Coating Adhesion/Integrity ●
Catheter Compatibility ●

BIOCOMPATIBILITY:

The ASAHI RG3 Guidewire was compared to the predicate devices. Based on similariites of the materials used in the subject devcie to its predicates, the biocompatibiity of the ASAHI RG3 was verified to be the same as those of the predicates.

CONCLUSION:

The ASAHI RG3 GuideWire has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and is as safe and effective as the predicate devices.

Therefore, the ASAHI PTCA Guide Wire ASAHI RG3 is substantially equivalent to the predicate devices.

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.