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 ASAHI® PTCA Guide Wire ASAHI SION black consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire, and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI SION black. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE. The ASAHI® PTCA Guide Wire ASAHI SION black is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available ASAHI INTECC extension wire.

AI/ML Overview

This document describes the premarket notification for the ASAHI® PTCA Guide Wire ASAHI SION black. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or a study that proves the device meets acceptance criteria related to AI/ML device performance can be extracted.

The document discusses non-clinical laboratory testing performed on the guide wire to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-based one. The types of tests conducted are standard for guide wires (e.g., tensile strength, torqueability, tip flexibility, etc.) and the conclusion is that the device met all acceptance criteria and performed similarly to predicate devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 5, 2018

Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 3168 Braverton Street. Suite 200 Edgewater, Maryland 21037

Re: K173277

Trade/Device Name: ASAHI® PTCA Guide Wire ASAHI SION black Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 4, 2018 Received: June 5, 2018

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 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 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);

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Page 2 - Ms. Cederman

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Gregory O'Connell 2018.07.05 07:54:27 -04'00'

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) K173277

Device Name ASAHI® PTCA Guide Wire ASAHI SION black

Indications for Use (Describe)

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

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K173277 PAGE 1 of 3

ASAHI INTECC CO.,LTD.

3-100 Akatsuki-cho, Seto, Aichi 489-0071 Japan Tel. +81-561-48-5551 Fax. +81-561-48-5552 Branch office: Tokyo, Nagoya, Osaka, Hong, EU, Singapore, Beijing, India, Middle Eastern Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

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

ASAHI® PTCA Guide Wire ASAHI SION black 510(k) K173277

DATE PREPARED:	July 2, 2018
APPLICANT	ASAHI INTECC CO., LTD.3-100 Akatsuki-choSeto, Aichi 489-0071, Japan
CONTACT	Yoshi TeraiPresident/CEOASAHI INTECC USA, Inc.3002 Dow Ave, Suite 212Tustin, CA 92780Tel: (949) 756-8252, FAX: (949) 756-8165e-mail: ASAHI.ra-fda@ASAHI-intecc.com
TRADE NAME:	ASAHI® PTCA Guide Wire ASAHI SION black
DEVICE CLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATION NAME:	Catheter, Guide, Wire
PRODUCT CODE	DQX- Catheter Guide Wire
PREDICATE DEVICES:	ASAHI® PTCA Guide Wire ASAHI® SION® (K163426)
REFERENCE DEVICES:	ASAHI® PTCA Guide Wire ASAHI® SION® (K100578, K122469) ASAHI® Fielder XT-A (K153106, K163426) ASAHI® Fielder XT (K072431) ASAHI® Fielder FC (K063819, K072705, K163426) ASAHI® ULTIMATEbros 3 (K101986, K163426) ASAHI® Gaia (K133865, K163426) ASAHI® Neurovascular Guide Wire ASAHI CHIKAI black (K141751)

Intended Use/Indications for Use ASAHI® PTCA Guide Wire ASAHI SION black

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous

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transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

Device Description:

Comparison with Predicate device:

Comparisons of the ASAHI® PTCA Guide Wire ASAHI SION black and predicate and reference devices show that the technological characteristics of the subject device 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 of the subject device and its predicate/reference devices are the same.

	ASAHI® PTCAGuide WireASAHI SION blackSubject	ASAHI® PTCAGuide WireASAHI SIONPredicate	ASAHI® PTCAGuide WireASAHI Fielder XT-AReference
510(k)	K173277	K163426	K153106 K163426
Intended Use andIndications	ASAHI PTCA Guide Wiresare intended to facilitatethe placement of balloondilatation catheters duringpercutaneous transluminalcoronary angioplasty(PTCA) and percutaneoustransluminal angioplasty(PTA). The ASAHI PTCAGuide Wires are not to beused in theneurovasculature.	ASAHI PTCA Guide Wiresare intended to facilitatethe placement of balloondilatation catheters duringpercutaneous transluminalcoronary angioplasty(PTCA) and percutaneoustransluminal angioplasty(PTA). The ASAHI PTCAGuide Wires are not to beused in theneurovasculature.	ASAHI PTCA Guide Wiresare intended to facilitatethe placement of balloondilatation catheters duringpercutaneous transluminalcoronary angioplasty(PTCA) and percutaneoustransluminal angioplasty(PTA). The ASAHI PTCAGuide Wires are not to beused in theneurovasculature.
Target Location	Coronary and Peripheral vasculature
Nominal OD	0.36mm (0.014 inch)
Overall Lengths	190cm and 300cm	180cm and 300cm	190cm and 300cm
Outer Coil Material	Platinum-Nickel, Stainless Steel		Platinum-Nickel
Inner Coil Material	Stainless Steel
Core Wire Material	Stainless Steel
Undercoating	Polyurethane	NA	Polyurethane
Outer Distal Coating	Hydrophilic coating
Proximal Coating	PTFE
Sterilization	Provided sterile via Ethylene Oxide to SAL10-6
Shelf Life	3 years

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Non Clinical testing / Performance Data:

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

Dimensional Verification ●
Tensile Strength ●
Torque Strength .
. Torqueability
. Tip Flexibility
Coating Adhesion ●
Catheter Compatibility
Coating Lubricitv ●
Radiopacity ●
Particulate Testing / Coating Integrity ●

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

BIOCOMPATIBILITY:

The ASAHI® PTCA Guide Wire ASAHI SION black was compared to the predicate and reference devices. Based on similarities of the materials used in the subject device to its predicates / reference devices, biocompatibility testing of the ASAHI® PTCA Guide Wire ASAHI SION black was not completed.

CONCLUSION:

The ASAHI® PTCA Guide Wire ASAHI SION black 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 and reference devices. Performance data demonstrates that the device functions as intended.

Therefore, the ASAHI® PTCA Guide Wire ASAHI SION black 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.