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), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary chronic total occlusions (CTO).
This device should not be used in neurovasculature.

Device Description

The ASAHI® PTCA Guide Wires and ASAHI® Corsair® / ASAHI® Corsair® Pro Microcatheters covered by this submission are existing marketed devices. There have been no physical changes to the subject devices as compared to the currently marketed predicate devices except for a change in indication and related clinical information added to the labeling. The designs and performance of the guidewires are unchanged.
The ASAHI® PTCA Guide Wires consist of a core wire and a coil assembly. Depending on the model, the coil assembly could consist of an outer coil soldered to the core wire, or an inner coil and an outer coil, with or without a safety wire, 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 Wires. The coil and distal portion of the quidewire have a hydrophilic outer coating. The proximal portion of the guidewires are coated with PTFE. The ASAHI® PTCA Guide Wires are available in various lengths and tip shapes. The shorter length devices are designed for use with a commercially available Asahi Intecc extension wire.
The ASAHI Corsair / ASAHI Corsair Pro Microcatheter consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. No accessories are part of this device. The ASAHI Corsair has a radiopaque marker coil that is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the devices have a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the ASAHI Corsair / ASAHI Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheters for the purposes of a smooth transition and exchange of guidewires.
The microcatheters also contain wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Performance Goal)	Reported Device Performance (Original MI Definition)	Reported Device Performance (SCAI MI Definition)
Procedure Success Rate	63.1%	73.0% (119/163)	84.7% (138/163)
Lower Bound of One-Sided 95% CI (Procedure Success)	63.1% (implied)	67.3%	80.0%
Successful Re-canalization	N/A (reported as part of success)	89.0% (145/163)	89.0% (145/163)
Absence of In-hospital MACE	N/A (reported as part of success)	81.0% (132/163)	93.9% (153/163)

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

Sample Size: 163 subjects
Data Provenance: Prospective, multi-center, single-arm study. The document does not specify the country of origin of the data, but the applicant's address is in Japan and the US office is in California.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). However, the "absence of in-hospital MACE" (Major Adverse Cardiac Events) and "Successful re-canalization" metrics imply adjudication by medical professionals typically involved in cardiac care and angiography. The "Expert Consensus Document from the Society for Cardiovascular Angiography and Interventions (SCAI) published in 2013" is referenced for an alternative MI definition, suggesting expertise from this society would be relevant.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method like 2+1 or 3+1 for establishing ground truth. The MACE definition includes "cardiac death, target lesion revascularization, or postprocedural myocardial infarction (MI)," which would typically involve clinical review and diagnosis by treating physicians or a clinical events committee. The re-canalization success is based on "angiographic visualization," which would involve interpretation by interventional cardiologists.

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

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported. This study evaluates the performance of medical devices (guide wires and microcatheters) directly in human subjects, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This study is a clinical trial evaluating the performance of physical medical devices in a clinical setting with human operators, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth is based on clinical outcomes and angiographic visualization, as determined by medical professionals during and after the procedures. Specifically:

Angiographic visualization of guide wire crossing the target lesion for "successful re-canalization."
Clinical assessment for "in-hospital major adverse cardiac events (MACE)," which includes cardiac death, target lesion revascularization, and post-procedural myocardial infarction (MI), with two different definitions for MI cited.

8. The Sample Size for the Training Set

This document describes a clinical trial for physical medical devices. There is no mention of a training set as would be applicable to an AI model.

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

As this is not an AI model, there is no training set and therefore no ground truth established for it.

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 logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

February 12, 2018

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

Re: K171933

Trade/Device Name: ASAHI PTCA Guide Wires (ASAHI Gaia First, Gaia Second, Gaia Third; ASAHI Fielder XT: ASAHI Fielder XT-A, Fielder XT-R: ASAHI Miraclebros3, Miraclebros4.5. Miraclebros6. Miraclebros12: ASAHI Ultimate bros3. ASAHI Confianza; ASAHI Confianza Pro, Confianza Pro 12), ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter Regulation Number: 21 CFR 870.1330; 21 CFR 870.1250 Regulation Name: Catheter Guide Wire: Percutaneous Catheter Regulatory Class: Class II Product Code: DOX: DOY Dated: January 9, 2018 Received: January 11, 2018

Dear Candace 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

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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 (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.

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.

For comprehensive regulatory information about mediation-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,

Kenneth J. Cavanaugh -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171933

Device Name

ASAHI® PTCA Guide Wire

•ASAHI Gaia First, Gaia Second, Gaia Third, •ASAHI Fielder XT, •ASAHI Fielder XT-A, •ASAHI Miraclebros3, Miraclebros4.5, Miraclebros12, •ASAHI Ultimate bros3, •ASAHI Confianza, •ASAHI Confianza Pro, Confianza Pro 12

Indications for Use (Describe)

The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171933

Device Name

• ASAHI Corsair Microcatheter

· ASAHI Corsair Pro Microcatheter

Indications for Use (Describe)

This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.

This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary chronic total occlusions (CTO).

This device should not be used in neurovasculature.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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ΛՏΛΗΙ 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® Corsair® / ASAHI® Corsair® Pro Microcatheter 510(k) __

DATE PREPARED:	June 26, 2017
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 Gaia First, Gaia Second, Gaia Third• ASAHI Fielder XT• ASAHI Fielder XT-A, Fielder XT-R• ASAHI MIRACLEbros 3, MIRACLEbros 4.5, MIRACLEbros 6, MIRACLEbros 12• ASAHI ULTIMATEbros 3• ASAHI Confianza• ASAHI Confianza Pro, Confianza Pro 12ASAHI® Corsair® / ASAHI® Corsair® Pro Microcatheter• ASAHI Corsair• ASAHI Corsair Pro
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330 – Guide wiresClass 2 per 21 CFR §870.1250 - Catheter
CLASSIFICATIONNAME:	Catheter guide wirePercutaneous catheter
PRODUCT CODE	DQX - Wire, Guide, CatheterDQY – Catheter, Percutaneous
PREDICATE DEVICES:	ASAHI® PTCA Guide Wire• ASAHI Gaia First, Gaia Second, Gaia Third (K133865)• ASAHI Fielder XT (K072431)• ASAHI Fielder XT-A, Fielder XT-R (K153106)• ASAHI MIRACLEbros 3, MIRACLEbros 4.5, MIRACLEbros 6 (K022762, K031277)• ASAHI MIRACLEbros 12 (K052339)• ASAHI ULTIMATEbros 3 (K101986)• ASAHI Confianza (K022762, K031277)• ASAHI Confianza Pro (K041531)

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ASAHI® Corsair® / ASAHI Corsair® Pro Microcatheter
ASAHI Corsair (K083127, K151103)
ASAHI Corsair Pro (K161126)

Intended Use/Indications for Use

ASAHI PTCA Guide Wires:

The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

ASAHI Corsair Microcatheter / ASAHI Corsair Pro Microcatheter:

This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.

This device should not be used in neurovasculature.

Device Description:

The ASAHI® PTCA Guide Wires consist of a core wire and a coil assembly. Depending on the model, the coil assembly could consist of an outer coil soldered to the core wire, or an inner coil and an outer coil, with or without a safety wire, 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 Wires. The coil and distal portion of the quidewire have a hydrophilic outer coating. The proximal portion of the guidewires are coated with PTFE. The ASAHI® PTCA Guide Wires are available in various lengths and tip shapes. The shorter length devices are designed for use with a commercially available Asahi Intecc extension wire.

The ASAHI Corsair / ASAHI Corsair Pro Microcatheter consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. No accessories are part of this device. The ASAHI Corsair has a radiopaque marker coil that is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the devices have a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the ASAHI Corsair / ASAHI

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Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheters for the purposes of a smooth transition and exchange of guidewires.

The microcatheters also contain wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

Comparison with Predicate device:

The devices included in this submission are unchanged from the predicate devices. The technological characteristics of the Subject devices such as the components, design, materials, sterilization method, shelf life and operating principle are identical to the currently marketed predicate devices. This submission covers only the inclusion of additional language in the Indications for Use.

Name of Device	ASAHI PTCA Guide wire	ASAHI PTCA Guide wire(Predicate)
510(k)	Current Application	K022762, K031277, K041531,K052339, K072431, K101986,K133865, K153106
Intended Use andIndications	ASAHI PTCA Guide Wires areintended to facilitate theplacement of balloon dilatationcatheters during percutaneoustransluminal coronaryangioplasty (PTCA) andpercutaneous transluminalangioplasty (PTA), includinguse in crossing or assisting incrossing de novo coronarychronic total occlusions (CTO).The ASAHI PTCA Guide Wiresare not to be used in theneurovasculature.	ASAHI PTCA Guide Wires areintended to facilitate theplacement of balloon dilatationcatheters during percutaneoustransluminal coronaryangioplasty (PTCA) andpercutaneous transluminalangioplasty (PTA). The ASAHIPTCA Guide Wires are not tobe used in theneurovasculature.
Sterilization	Identical	Identical
Shelf Life	Identical	Identical
Target Body Location	Identical
Outer Coil Material	Identical
Core Wire Material	Identical
Inner Coil Material	Identical
Distal Tip Shape	Identical
Overall length	Identical
Outer coil length	Identical
Outer Coil OuterDiameter	Identical
Distal Outer Coating	Identical
Proximal Coating	Identical

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Name of Device	ASAHI Corsair MicrocatheterASAHI Corsair ProMicrocatheter	ASAHI Corsair MicrocatheterASAHI Corsair Pro Microcatheter
510(k)	Current Application	K083127, K151103, K161126
Intended Use andIndications	This product is intended toprovide support to facilitate theplacement of guide wires in thecoronary and peripheralvasculatures, and can be used toexchange one guide wire foranother.This product is also intended toassist in the delivery of contrastmedia into the coronary,peripheral and abdominalvasculatures, and to assist incrossing de novo coronarychronic total occlusions (CTO).This device should not be used inneurovasculature.	The ASAHI Corsair is intended toprovide support to facilitate theplacement of guide wires in thecoronary and peripheral vasculature,and can be used to exchange oneguide wire for another. The ASAHICorsair is also intended to assist inthe delivery of contrast media in thecoronary, peripheral, and abdominalvasculature.The ASAHI Corsair Pro is intended toprovide support to facilitate theplacement of guide wires in thecoronary and peripheral vasculature,and can be used to exchange oneguide wire for another. The ASAHICorsair Pro is also intended to assistin the delivery of contrast media in thecoronary, peripheral, and abdominalvasculature.This device should not be used inneurovasculature.
Sterilization	Identical
Shelf Life	Identical
Target Body Location	Identical
Overall length	Identical
Nominal Outer Diameter	Identical
Coating Length	Identical
Distal Tip Outer Diameter	Identical
Distal Tip Inner Diameter	Identical
Shaft Tube OuterDiameter	Identical
Shaft Tube Inner Diameter	Identical
Materials	Identical

Non Clinical testing - Performance Data / Biocompatibility / Packaging and STERILIZATION TESTING:

There have been no physical changes to the subject devices as compared to the predicate devices. Comparisons of bench, biocompatibility, packaging, and sterilization testing are not necessary. The subject and predicate devices are identical and bench testing, biocompatibility, packaging, and sterilization for the subject devices are therefore substantially equivalent to their respective predicate devices.

CLINICAL TESTING:

A prospective, multi-center, single-arm study of 163 subjects was performed to evaluate the safety and effectiveness of the ASAHI series of Guide Wires and/or Corsair Microcatheter (study devices) in patients with symptomatic ischemic heart disease attributed to a chronic total occlusion (CTO) in a native coronary artery. The primary objective of the trial was to evaluate placement of any guide wire beyond the CTO in the true vessel lumen in subjects in which at least one of the

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study devices were used. Procedure success was defined as (1) angiographic visualization of any guide wire crossing the target lesion and (2) absence of inhospital major adverse cardiac events (MACE), defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or postprocedural myocardial infarction (MI). For this study the definition of MI also included any CK-MB reading > 3xULN.

Primary Endpoint Results and Analysis

The procedure success rate for this study was 73.0% (p=0.0044). The Investigators successfully re-canalized the vessel in 89.0% of procedures. The absence of inhospital MACE was 81.0%. Study success was defined as meeting the primary endpoint of a successful re-canalization rate and absence of in-hospital MACE above 63.1% with a one-sided lower 95% confidence bound of 67.3%. A summary of primary endpoint procedure success is provided in the table below.

Parameter	Result	Two-Sided 95% CI	Performance Goal	Lower Bound of One-Sided 95% CI	P-value
Procedure Success	73.0% (119/163)	(66.2%, 79.8%)	63.1%	67.3%	0.0044
Successful re-canalization	89.0% (145/163)	---	---	---	---
Absence of in-hospital MACE	81.0% (132/163)	---	---	---	---

Repeating this same data, using the criteria for a clinically relevant MI as recommended in the Expert Consensus Document from the Society for Cardiovascular Angiography and Interventions (SCAI) published in 2013.

Parameter	Result	Two-Sided95% Cl	PerformanceGoal	LowerBound ofOne-Sided95% Cl	P-value
ProcedureSuccess	84.7%(138/163)	(79.1%,90.2%)	63.1%	80.0%	<0.0001
Successfulre-canalization	89.0%(145/163)
Absence ofin-hospitalMACE	93.9%(153/163)

CONCLUSION:

The results of this clinical trial demonstrate that the study ASAHI PTCA Guide Wires, including the Gaia Series, Fielder XT, Fielder XT-A, Fielder XT-R, MIRACLEbros Series, ULTIMATEbros 3, Confianza, and Confianza Pro Series, and the ASAHI Corsair Microcatheter, exceeded the pre-specified safety and effectiveness performance criteria for crossing CTOs and re-canalizing the target vessel in this subject population. The primary and secondary endpoints of the study

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were met. The data support a CTO indication for these wires. No new safety or effectiveness issues were raised during the study, and therefore, the ASAHI® PTCA Guide Wires and ASAHI® Corsair® Microcatheter are 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.