This product 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 Wires in this submission have a coil-type distal end or a plastic covered-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy.

The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. ASAHI INTECC detachable extension wire (hereafter "extension wire") (previously cleared as part of K083145 and K101985) is available to connect with the proximal end of the guide wire with a length of less than 300 cm. The total length of the system after the connection with be 300cm to 400cm. Torque device may be included in the same package.

The ASAHI Peripheral Guide Wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter range of 0.36 to 0.45 mm.

AI/ML Overview

This document is a 510(k) summary for ASAHI Peripheral Guide Wires, which includes three models: ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV. The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and study information provided:

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

The document broadly states that "The in vitro bench tests demonstrated that the ASAHI Peripheral Guide Wire met all acceptance criteria and performed similarly to the predicate devices." However, specific numerical acceptance criteria for each test (e.g., minimum tensile strength in Newtons, or maximum torque strength in N/cm) are not explicitly listed in the provided text. The performance is reported qualitatively as "met all acceptance criteria and performed similarly."

Test Performed	Acceptance Criteria (Not Explicitly Stated Numerically)	Reported Device Performance
Tensile Strength	Implied: Met predetermined standards	Met all acceptance criteria and performed similarly to predicate devices.
Torque Strength	Implied: Met predetermined standards	Met all acceptance criteria and performed similarly to predicate devices.
Torqueability	Implied: Met predetermined standards	Met all acceptance criteria and performed similarly to predicate devices.
Tip Flexibility	Implied: Met predetermined standards	Met all acceptance criteria and performed similarly to predicate devices.
Coating Adhesion/Integrity	Implied: Met predetermined standards	Met all acceptance criteria and performed similarly to predicate devices.
Catheter Compatibility	Implied: Met predetermined standards	Met all acceptance criteria and performed similarly to predicate devices.

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

The document mentions "Non clinical laboratory testing was performed," which implies a test set. However, the sample size used for the test set is not specified. The data provenance is also not specified beyond being "non clinical laboratory testing." It does not mention the country of origin of the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing of this nature.

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

This information is not applicable or provided. For medical devices undergoing bench testing against engineering specifications, ground truth is established by physical measurements and engineering standards, not typically by expert review in the same way it would be for AI model validation in image interpretation, for example.

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

This information is not applicable or provided. Adjudication methods are typically relevant for human review of data, especially in clinical studies or when establishing ground truth for AI model training/testing. For bench testing, the results are typically objectively measured against established engineering specifications.

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:

This information is not applicable or provided. The device in question is a guide wire, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

This information is not applicable or provided. The device is a physical medical device (a guide wire), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this product.

7. The type of ground truth used:

The ground truth for the bench tests would have been the engineering specifications and performance standards applicable to guide wires. These are based on industry standards, established medical device requirements, and the characteristics of the predicate devices.

8. The sample size for the training set:

This information is not applicable or provided. The document describes a physical medical device undergoing bench testing, not an AI system that requires a "training set."

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

This information is not applicable or provided for the same reason as point 8.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol featuring three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them.

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

June 30, 2015

ASAHI Intecc Co., Ltd. % Candace Cederman Senior Regulatory Affairs Consultant Cardiomed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, MD 21228

Re: K150445

Trade/Device Name: ASAHI Peripheral Guide Wires (ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 3, 2015 Received: June 4, 2015

Dear Ms. Cederman:

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 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

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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 devicerelated 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" (21 CFR 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,

Brian D. Pullin -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) K150445

Device Name

ASAHI Peripheral Guide Wires (ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV)

Indications for Use (Describe)

This product is intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.

Type of Use ( Select one or both, as applicable )
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Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

| X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 Peripheral Guide Wires

ASAHI Peripheral Guide Wire ASAHI Gladius ASAHI Peripheral Guide Wire ASAHI Halberd ASAHI Peripheral Guide Wire ASAHI Gaia PV

510(k) -

DATE PREPARED:	2/19/2015
APPLICANT	ASAHI Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024, Japan
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 Peripheral Guide Wire series• ASAHI Peripheral Guide Wire ASAHI Gladius• ASAHI Peripheral Guide Wire ASAHI Halberd• ASAHI Peripheral Guide Wire ASAHI Gaia PV
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATIONNAME:	Catheter, Guide, Wire
PRODUCT CODE	DQX- Catheter Guide Wire
PREDICATEDEVICES:	Primary Predicates:ASAHI Regalia XS 1.0 Peripheral Guide Wire (K083146)ASAHI ASTATO 30 Peripheral Guide Wire 10 (K071721)ASAHI ASTATO XS20 Peripheral Guide Wire (K103057)Reference Devices:ASAHI PTCA Guide Wire ASAHI Gaia Third (K133865)Abbott Vascular HI-TORQUE IRON MAN Guide Wire (K963702)Boston Scientific V-18 Control Wire Guidewire (K033742)ASAHI CHIKAI (K112979)

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Intended Use/Indications for Use

This product 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.

Description:

The ASAHI Peripheral Guide Wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter range of 0.36 to 0.45 mm.

COMPARISON WITH PREDICATE DEVICES:

Comparisons of the ASAHI Peripheral Guide Wire and predicate devices show that the technological characteristics of the ASAHI Peripheral Guide Wires such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.

The intended use/indications between the Subject Device and its primary predicates are identical. There are specific design features of the Subject device that are similar to the primary predicate but not identical. Additional predicate devices have been used to demonstrate equivalence for these similar features.

Name of Device	ASAHI Peripheral Guide Wire ASAHI Gladius ASAHI Halberd ASAHI Gaia PV	Regalia XS 1.0 ASTATO XS 20 ASTATO 30
510(k)	Current Application	K083146 K103057 K071721
Intended Use andIndications	This product is intended to facilitate the placement and exchange ofdiagnostic and therapeutic devices during intravascular procedures.This device is intended for peripheral vascular use only.
Sterilization	Provided sterile via Ethylene Oxide to SAL10-6
Shelf Life	3 Years
Target Body Location	Peripheral

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Traditional 510(k) Premarket Notification ASAHI Peripheral Guide Wires

Outer Distal	Yes
Hydrophilic coating
Proximal Coating	PTFE
Overall Length	180-300 cm
Nominal OD	0.36-0.45 mm (0.014-0.018inches)
Outer Coil Material	Platinum-Nickel Austenitic Stainless Steel (316 SS)
Core Wire Material	Austenitic Stainless Steel (304 SS)

Non Clinical testing / Performance Data:

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

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

The in vitro bench tests demonstrated that the ASAHI Peripheral Guide Wire met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate devices.

BIOCOMPATIBILITY:

The ASAHI Peripheral Guide Wire was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates, the biocompatibility of the ASAHI Peripheral Guide Wire was verified to be the same as those of the predicates.

Conclusion:

The ASAHI Peripheral Guide Wire has identical intended use and the same or 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.

Therefore, the ASAHI Peripheral Guide Wire 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.