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 SUOH® 03 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 ASAHI® PTCA Guide Wire: ASAHI SUOH® 03. The distal portion of the guidewire has a hydrophilic coating, and the proximal portion of the guidewire is coated with PTFE. The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 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

The provided document is a 510(k) Summary for a medical device (Asahi PTCA Guide Wire Asahi SUOH 03) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, the information typically requested in an AI/ML context regarding acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this document.

The document outlines the device's technical specifications and compares them to predicate devices, along with non-clinical performance testing to ensure safety and effectiveness.

Here's a breakdown of the non-clinical performance data and acceptance criteria as presented in the document, which primarily revolve around engineering and material properties, rather than diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Performed (as listed)	Reported Device Performance
Mechanical Performance	Tensile Strength	Met all acceptance criteria and performed similarly to predicates.
	Torque Strength	Met all acceptance criteria and performed similarly to predicates.
	Torqueability	Met all acceptance criteria and performed similarly to predicates.
	Tip Flexibility	Met all acceptance criteria and performed similarly to predicates.
Material Integrity	Coating Adhesion/Coating Integrity	Met all acceptance criteria and performed similarly to predicates.
Functional Compatibility	Catheter Compatibility	Met all acceptance criteria and performed similarly to predicates.
Cleanliness/Safety	Particulate Testing / Coating Integrity	Met all acceptance criteria and performed similarly to predicates.
Biocompatibility	(Not explicitly listed as a test, but addressed)	Verified to be the same as predicates/reference devices based on material similarity.

Note: The document states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" for the listed tests. Specific numerical values for the criteria or performance are not provided in this summary but would have been part of the full 510(k) submission.

Regarding the AI/ML specific questions (2-9):

This document is for a conventional medical device (a guide wire), not an AI/ML-driven device. Therefore, the following information is not applicable and cannot be extracted from the provided text:

Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical guide wire samples for bench testing, not a dataset for an AI model.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant to guide wire physical testing.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size: Not applicable. This type of study is for evaluating human performance with/without AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used: Not applicable. The "ground truth" for a guide wire's performance is its physical properties meeting engineering standards.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

Summary

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

January 27, 2017

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

Re: K162842

Trade/Device Name: Asahi PTCA Guide Wire Asahi SUOH 03 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 29, 2016 Received: December 30, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Candace Cederman

the quality systems (OS) 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,

Fernando Agnel
Fernando Aguel-S

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) K162842

Device Name ASAHI® PTCA Guide Wire ASAHI SUOH® 03

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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® PTCA Guide Wire ASAHI SUOH® 03 510(k) __

DATE PREPARED:	October 7, 2016
APPLICANT	ASAHI INTECC CO., LTD.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024, Japan
CONTACT	Yoshi TeraiPresident/CEOASAHI INTECC USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252, FAX: (949) 756-8165e-mail: ASAHI.ra-fda@ASAHI-intecc.com
TRADE NAME:	ASAHI® PTCA Guide Wire• ASAHI SUOH® 03
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® blue (K122468)• ASAHI® SUOH® (K083904)
REFERENCE DEVICES:	ASAHI® PTCA Guide Wire:• ASAHI RG3 (K141339)ASAHI® Neurovascular Guide Wire:• ASAHI CHIKAI black, 300cm (K141751)

Intended Use/Indications for Use ASAHI® PTCA GUIDE WIRE: ASAHI SUOH® 03

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Device Description:

Comparison with predicate device:

Comparisons of the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 and predicate 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 predicates are the same.

	ASAHI® PTCA GuideWire:ASAHI SUOH 03	ASAHI® PTCAGuide Wire:ASAHI SUOH	ASAHI® PTCAGuide Wire:ASAHI SION blue
Name of Device

510(k)	Current Application	K083904	K122468
Intended Use andIndications	intended to facilitatethe placement ofballoon dilatationcatheters duringpercutaneoustransluminal coronaryangioplasty (PTCA)and percutaneoustransluminalangioplasty (PTA).The ASAHI PTCAGuide Wires are notto be used in theneurovasculature.	intended to facilitatethe placement ofballoon dilatationcatheters duringpercutaneoustransluminal coronaryangioplasty (PTCA)and percutaneoustransluminalangioplasty (PTA).The Asahi SUOHPTCA Guide Wiresare not to be used inthe cerebral bloodvessel.	intended to facilitatethe placement ofballoon dilatationcatheters duringpercutaneoustransluminal coronaryangioplasty (PTCA)and percutaneoustransluminalangioplasty (PTA).The ASAHI PTCAGUIDE WIRES arenot to be used in thecerebral bloodvessels.
Target BodyLocation	Coronary and Peripheral
Overall Lengths	190cm and 300cm	180cm and 300cm	180cm and 300cm
Nominal OD	0.014 in
Outer Coil Material	Platinum-Nickel, Stainless Steel
Core Wire Material	Stainless Steel
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 SUOH® 03 to determine substantial equivalence. The following testing/assessments were performed:

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

The in vitro bench tests demonstrated that the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 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® PTCA Guide Wire: ASAHI SUOH® 03 was compared to the predicate and reference devices. Based on similarities of the materials used the subject device to its predicates / reference devices, the in biocompatibility of the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 was verified to be the same as those of the predicates / reference devices.

CONCLUSION:

The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 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 SUOH® 03 is substantially equivalent to the predicate device.

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.