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 product, ASAHI PTCA Guide Wire ASAHI Gaia (hereafter ASAHI Gaia), is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The basic structure of ASAHI Gaia consists of a tapered core wire and coils. There are currently three models of the ASAHI Gaia:

ASAHI Gaia First ●
ASAHI Gaia Second ●
. ASAHI Gaia Third

Each of these models share similar design characteristics and have the same maximum outside diameter. The models differ in the distal diameter.

The ASAHI Gaia consists of a tapered core wire and two distal coils: an inner and outer coil. The outer coil is radiopaque so as to be easily confirmed of its position under radioscopy. The distal part of the ASAHI Gaia is tapered. The distal tip of the ASAHI Gaia is available straight or pre-shaped.

In addition, coatings are applied on the surface of the product. The distal part is coated with hydrophilic polymer, and the proximal part is coated with PTFE.

AI/ML Overview

The ASAHI PTCA Guide Wire ASAHI Gaia did not undergo a clinical study with human subjects to prove it meets acceptance criteria. Instead, substantial equivalence was demonstrated through non-clinical laboratory testing and comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Assessment)	Reported Device Performance (ASAHI Gaia)
Tensile Strength	Performed. Assessed to be substantially equivalent to predicate devices.
Torque Strength	Performed. Assessed to be substantially equivalent to predicate devices.
Torqueability	Performed. Assessed to be substantially equivalent to predicate devices.
Tip Flexibility	Performed. Assessed to be substantially equivalent to predicate devices.
Coating Adhesion/Integrity	Performed. Assessed to be substantially equivalent to predicate devices.
Catheter Compatibility	Performed. Assessed to be substantially equivalent to predicate devices.
Coating Integrity and Acute Particulate Characterization	Performed. Assessed to be substantially equivalent to predicate devices.
Biocompatibility	Verified to be the same as predicate devices, based on similarities of materials.
Intended Use	Same as predicate devices.
Technological Characteristics (components, design, materials, sterilization, shelf life, operating principles)	Similar to predicate devices. Combines torqueability and crossability of two predicate devices.

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

This information is not applicable as the studies were non-clinical laboratory tests, not clinical studies with human subjects. The document does not specify sample sizes for the non-clinical tests.

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

This information is not applicable as there was no test set involving expert interpretation or ground truth establishment in a clinical context. The performance was assessed through laboratory testing against established specifications or comparison to predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable as there was no test set requiring adjudication in a clinical context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. The device is a PTCA Guide Wire, not an AI-assisted diagnostic or interpretative tool, and no MRMC study was conducted.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

Engineering specifications and standards: Non-clinical laboratory tests (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adhesion/Integrity, Catheter Compatibility, Coating Integrity and Acute Particulate Characterization) would have been performed against pre-defined engineering requirements and industry standards for guide wires.
Comparison to predicate devices: The device's performance was directly compared to the established performance and safety profiles of the cited predicate devices (K101986 - ASAHI UltimateBros3 PTCA Guide Wire, K100578 - ASAHI SION PTCA Guide Wire, K122469 - ASAHI SION J PTCA Guide Wire, K041531 - ASAHI PTCA Guide Wire Confianza Pro, K043422 - ASAHI PTCA Guide Wire, J Shape series (ASAHI Confianza Pro J)). The "ground truth" for substantial equivalence was that the new device performs "as safe and effective as its predicates."

8. The Sample Size for the Training Set

This information is not applicable as there was no training set in the context of an AI/machine learning model. The device's validation was based on non-clinical testing and comparison to predicates.

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

This information is not applicable.

Summary

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Premarket Notification ASAHI PTCA Guidewire ASAHI Gaia

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 Gaia

510(k) K133865

APPLICANT	Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan
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
DEVICE NAME:	ASAHI PTCA Guide Wire ASAHI Gaia
DEVICECLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATION NAME:	Catheter, Guide, Wire
PRODUCT CODE	DQX- Catheter Guide Wire
PREDICATE DEVICES:	K101986 - ASAHI UltimateBros3 PTCA Guide WireK100578 - ASAHI SION PTCA Guide WireK122469 - ASAHI SION J PTCA Guide WireK041531 - ASAHI PTCA Guide Wire Confianza ProK043422 - ASAHI PTCA Guide Wire, J Shape series (ASAHIConfianza Pro J)
DATE PREPARED:	March 7, 2014

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Premarket Notification ASAHI PTCA Guidewire ASAHI Gaia

INTENDED USE:

DESCRIPTION:

The basic structure of ASAHI Gaia consists of a tapered core wire and coils. There are currently three models of the ASAHI Gaia:

ASAHI Gaia First ●
ASAHI Gaia Second ●
. ASAHI Gaia Third

Each of these models share similar design characteristics and have the same maximum outside diameter. The models differ in the distal diameter.

In addition, coatings are applied on the surface of the product. The distal part is coated with hydrophilic polymer, and the proximal part is coated with PTFE.

COMPARISON TO PREDICATE DEVICES:

Comparisons of the ASAHI PTCA Guide Wire ASAHI Gaia and predicate devices show that the technological characteristics of the ASAHI Gaia such as the intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate devices. The Gaia guidewire combines the torqueability and crossability of two predicate devices, therefore allowing for more choice for the physician.

NON CLINICAL TESTING / PERFORMANCE DATA:

Non clinical laboratory testing was performed on the ASAHI Gaia to determine substantial equivalence. The following testing assessments were performed:

. Tensile Strength
Torque Strength .

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Premarket Notification ASAHI PTCA Guidewire ASAHI Gaia

Torqueablity .
Tip Flexibility .
Coating Adhesion/Integrity .
. Catheter Compatibility
Coating Integrity and Acute Particulate Characterization .

BIOCOMPATIBILITY:

The ASAHI Gaia 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 Gaia was verified to be the same as those of predicates.

CONCLUSION:

The ASAHI Gaia has the same intended use and 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, and is as safe and effective as its predicates.

Therefore, the ASAHI PTCA Guide Wire is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized, flowing lines representing its body and wings.

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

March 18, 2014

Asahi Intecc USA Inc. c/o Semih Oktav, PhD President CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K133865

Trade/Device Name: ASAHI PTCA Guide Wire - ASAHI Gaia Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 18, 2013 Received: December 19, 2013

Dear Dr. Oktay:

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

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Page 2 - Semih Oktay

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Hillman

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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Premarket Notification ASAHI PTCA Guide Wire ASAHI Gaia

Indications for Use

510(k) Number (if known): K133865

Device Name:

ASAHI PTCA Guide Wire ASAHI Gaia

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Heileman

Page 1 of 1

Asahi Intecc Co., Ltd

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.