ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation 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

As a basic structure, the Fielder XT-A, Fielder XT-R, consists of a taper core wire and 2 types coils (a tapered outer coil and an inner rope coil). The taper core wire and the coils are soldered together. The coil is radiopaque so as to easily confirm its position under radioscopy.

The coil and distal part of tapered core wire of the products are coated with polyurethane and then covered with hydrophilic polymer. The proximal end of the tapered core wire is coated with PTFE.

The nominal outer diameter of both the Fielder XT-A and Fielder XT-R is 0.36mm. with a distal diameter of 0.26mm. Both the Fielder XT-A and Fielder XT-R are available in 190cm and 300cm, total length. The tip shape is straight.

AI/ML Overview

The provided document does not contain an acceptance criteria table with reported device performance for a medical device. Instead, it is an FDA 510(k) summary for the ASAHI Fielder XT-A and ASAHI Fielder XT-R guide wires, demonstrating substantial equivalence to predicate devices. The document outlines general testing performed but does not provide specific quantitative acceptance criteria or detailed results.

However, based on the information provided, here's a breakdown of what is available regarding testing and equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The in vitro bench tests demonstrated that the ASAHI Fielder XT-A and ASAHI Fielder XT-R met acceptance criteria and performed similarly to the predicate devices."

It does not provide a table with specific quantitative acceptance criteria or the numerical results of the device's performance against those criteria. It only lists the types of tests performed.

Acceptance Criteria (General)	Reported Device Performance (General)
Device functions as intended	Met acceptance criteria and performed similarly to predicate devices.
Safety profile similar to predicate devices	Verified to be the same as those of the predicates.
Effectiveness profile similar to predicate devices	Verified to be the same as those of the predicates.
Specific detailed criteria (e.g., tensile strength in Newtons)	Not provided in the document.
Specific numerical performance (e.g., actual tensile strength)	Not provided in the document.

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

Sample Size for Test Set: The document does not specify the exact sample size for each bench test performed (Dimensional Verification, Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adhesion, Catheter Compatibility, Coating Integrity / Particulate testing).
Data Provenance: The tests were "Non clinical laboratory testing" performed by "ASAHI INTECC CO.,LTD" (applicant). The company is based in Nagoya, Aichi, Japan, with research facilities and factories in Osaka, Seto, Thailand, and Hanoi, suggesting the testing likely occurred in one of these locations. The data is retrospective for the purpose of this 510(k) submission.

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

This information is not applicable and therefore not provided. The testing described is bench testing of physical device characteristics, not clinical studies requiring expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the testing involves objective physical measurements and comparisons to predicate devices, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done. The device is a PTCA guide wire, and its performance is evaluated through bench testing and comparison to existing predicate devices, not through a comparative clinical effectiveness study with human readers interpreting imaging.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This question is not applicable. The device is a physical medical device (guide wire), not an algorithm or AI system. Its performance is inherent to the device itself.

7. Type of Ground Truth Used:

The "ground truth" for the bench tests was based on predetermined acceptance criteria for physical and mechanical properties, likely derived from engineering specifications and performance characteristics of functionally equivalent predicate devices. For example, a certain tensile strength or torqueability range would be considered acceptable based on established standards for guide wires.

8. Sample Size for the Training Set:

This information is not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

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

This information is not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

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

June 21, 2016

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

Re: K153106

Trade/Device Name: Asahi Fielder XT-A, ASAHI Fielder XT-R Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 9, 2016 Received: May 10, 2016

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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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.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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,

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)

K153106

Device Name ASAHI Fielder XT-A, ASAHI Fielder XT-R

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 Wires ASAHI Fielder XT-A ASAHI Fielder XT-R

510(k)

DATE PREPARED:	October 16, 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 PTCA Guide Wires:• ASAHI Fielder XT-A• ASAHI Fielder XT-R
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATIONNAME:	Catheter Guide Wire
PRODUCT CODE	DQX - Wire, Guide, Catheter
PREDICATEDEVICES:	ASAHI PTCA Guide Wire ASAHI Gaia First (K133865)ASAHI PTCA Guide Wire ASAHI Fielder FC (K063819, K072705)ASAHI PTCA Guide Wire ASAHI Fielder XT (K072431)

Intended Use/Indications for Use

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

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DESCRIPTION:

The coil and distal part of tapered core wire of the products are coated with polyurethane and then covered with hydrophilic polymer. The proximal end of the tapered core wire is coated with PTFE.

COMPARISON WITH PREDICATE DEVICES:

Comparisons of the Fielder XT-A and Fielder XT-R and predicate devices show that the technological characteristics of the Subject devices 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 the same as the primary predicates.

Name of Device	ASAHI Fielder XT-AASAHI Fielder XT-R	ASAHI Gaia First	ASAHI Fielder FCASAHI Fielder XT
510(k)	Current Application	K133865	K063819, K072705 K072431
Intended Use andIndications	ASAHI PTCA Guide Wires are intended to facilitate the placement ofballoon dilation catheters during percutaneous transluminal coronaryangioplasty (PTCA) and percutaneous transluminal angioplasty(PTA).The ASAHI PTCA Guide Wires are not to be used in theneurovasculature.
Sterilization	Provided sterile via Ethylene Oxide to SAL10-6
Shelf Life	3 Years
Target Body Location	Coronary and Peripheral
Inner coil	Yes		No
Undercoating	Polyurethane	NA	Polyurethane
Outer Distal coating	Hydrophilic
Proximal Coating	PTFE
Overall Length	190, 300 cm		180, 300 cm (FC)190, 300 cm (XT)
Nominal OD	0.36 mm (0.014 inches)
Outer Coil Material		Platinum-Nickel	Platinum-Nickel andStainless Steel (FC),Platinum-Nickel (XT)
Core Wire Material	Stainless Steel

ASAHI Intecc Co., Ltd.

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Non Clinical testing / Performance Data:

Non clinical laboratory testing was performed on the ASAHI Fielder XT-A and ASAHI Fielder XT-R to determine substantial equivalence. The following testing/assessments were performed:

Dimensional Verification ●
Tensile Strenath ●
Torque Strength ●
Torqueability ●
. Tip Flexibility
Coating Adhesion
Catheter Compatibility ●
Coating Integrity / Particulate testing ●

The in vitro bench tests demonstrated that the ASAHI Fielder XT-A and ASAHI Fielder XT-R met 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 Fielder XT-A and ASAHI Fielder XT-R were compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates, the biocompatibility of the ASAHI Fielder XT-A and ASAHI Fielder XT-R was verified to be the same as those of the predicates.

Conclusion:

The ASAHI Fielder XT-A and ASAHI Fielder XT-R have identical intended uses 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 devices function as intended.

Therefore, the ASAHI Fielder XT-A and ASAHI Fielder XT-R 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.