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.

ASAHI Peripheral Guide Wires:

ASAHI Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

ASAHI Guide Wire Extension:

The ASAHI Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.

Device Description

This modification details a change relating to the removal of perfluorooctanoic acid (PFOA) used by suppliers in the manufacture of PTFE (polytetrafluoroethylene) coating used on the ASAHI family of guidewires including ASAHI PTCA guide wires and ASAHI peripheral guidewires. All of these wires are steerable guide wires, constructed with a core wire with coil assembly. The distal ends of the guide wires have a radiopaque tip to achieve visibility. Various coatings are applied to the distal and proximal portions of the guidewires.

This submission covers the addition of an alternate type of PTFE coating material. The designs and performance of the guidewires are unchanged.

AI/ML Overview

The provided document is a 510(k) premarket notification for ASAHI PTCA Guide Wires, ASAHI Peripheral Guide Wires, and ASAHI Guide Wire Extension. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices, meaning they do not require extensive novel clinical trials to demonstrate safety and effectiveness as a brand new device would.

The document does not describe a study involving an AI/Machine Learning device, nor does it pertain to a device that would typically have "accuracy," "sensitivity," or "specificity" as acceptance criteria in the traditional sense of diagnostic or prognostic AI. Instead, it describes acceptance criteria for a physical medical device (guidewires) based on material changes (specifically, a change in the PTFE coating to remove PFOA) and proves it meets those criteria through non-clinical (bench) testing and biocompatibility assessments.

Therefore, I cannot provide the information requested in points 2-9, nor can I create a table with "accuracy," "sensitivity," and "specificity" as these metrics are not relevant to this type of device and study.

However, I can extract the acceptance criteria and the "reported device performance" as presented in the non-clinical testing section for this specific medical device.

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)

Test	Acceptance Criteria (Implied by Test Method Summary and Intent)	Reported Device Performance (Results/Conclusions)
Coating Adherence	Integrity of the coated core wire maintained after pretreatment and manipulation in excess of expected clinical use.	Test results confirmed that the coating adhesion was maintained during simulated clinical use in all test articles.
Coating Integrity & Particulate Characterization	Coating integrity maintained and particulate generation characterized during simulated use (advancing/retracting through a clinically relevant model).	This testing characterized the coating integrity and particulate generation during simulated use. The test results confirmed that the coating integrity was maintained during simulated clinical use of the test articles.

Biocompatibility Testing (All acceptance criteria are "Passed" based on the results)

Test	Acceptance Criteria (Implied by Test Method Summary and Intent - typically "Pass" based on recognized standards)	Reported Device Performance (Results/Conclusions)
Cytotoxicity	No evidence of causing cell lysis or toxicity.	Passed. No evidence of causing cell lysis or toxicity.
Intracutaneous Irritation	Difference between test article and control less than 1.0.	Passed. Difference between test article and control less than 1.0.
Sensitization	No evidence of causing delayed dermal contact sensitization.	Passed. No evidence of causing delayed dermal contact sensitization.
Systemic Toxicity	No mortality or evidence of systemic toxicity.	Passed. No mortality or evidence of systemic toxicity.
Material Mediated Pyrogenicity	Test article judged as non-pyrogenic.	Passed. Test article judged as non-pyrogenic.
Hemocompatibility - Hemolysis	Hemolytic index within acceptable limits (e.g., < 2.0% for non-hemolytic).	Passed. Hemolytic index was 0.0%.
Hemocompatibility - Complement Activation (SC5b-9, C3a)	Not considered a potential activator of the complement system.	Passed. Test article is not considered to be a potential activator of the complement system.
Hemocompatibility - PTT	"Considered activator" or "not considered activator" as per standard (context needed for specific acceptance value).	Passed. Test article is considered activator. (Note: This might mean it activates PTT, which could be an expected or acceptable characteristic depending on the material and intended use, or simply that the test was completed and the result recorded).
Hemocompatibility – in vivo Thromboresistance	Considered thromboresistant.	Passed. Test article is considered thromboresistant.

Regarding the other requested information (points 2-9):

This document describes a 510(k) submission for a physical medical device (guidewires) with a material change, not an AI/Machine Learning device. Therefore, the following points are not applicable in the context of this document:

Sample size used for the test set and the data provenance: Not an AI device using data sets in this manner. Testing involved physical samples of guidewires.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth for this device is established through internationally recognized physical and biological testing standards (e.g., ISO, ASTM, USP).
Adjudication method for the test set: Not applicable for physical/biocompatibility testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is not an AI diagnostic/prognostic device for human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable to a physical guidewire.
The type of ground truth used: For physical/biocompatibility testing, the "ground truth" is defined by the established and validated test methods and passing criteria of the relevant standards (e.g., ISO 10993 series for biocompatibility).
The sample size for the training set: Not applicable to a physical guidewire.
How the ground truth for the training set was established: Not applicable to a physical guidewire.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

April 3, 2017

ASAHI INTECC CO., LTD. % Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228

Re: K163426

Trade/Device Name: ASAHI PTCA Guide Wires, ASAHI Peripheral Guide Wires, ASAHI Guide Wire Extension Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 1, 2017 Received: March 3, 2017

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

{1}------------------------------------------------

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,

Carlos L. Pena-S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163426

Device Name

ASAHI PTCA Guide Wires, ASAHI Peripheral Guide Wires, ASAHI Guide Wire Extension

Indications for Use (Describe)

ASAHI PTCA Guide Wires:

ASAHI Peripheral Guide Wires:

ASAHI Guide Wire Extension:

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)

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."

{3}------------------------------------------------

510(k) Summary

(as required by 21 CFR 807.92)

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

ASAHI PTCA Guide Wires ASAHI Peripheral Guide Wires ASAHI Guide Wire Extension

510(k) K163426

DATE PREPARED:	March 29, 2017
APPLICANT	ASAHI INTECC CO., LTD.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024, Japan
CONTACT	Yoshinori Terai, President and 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 WiresASAHI Peripheral Guide WiresASAHI Guide Wire Extension
DEVICE CLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATION NAME:	Catheter Guide Wire
PRODUCT CODE	DQX - Wire, Guide, Catheter
PREDICATE DEVICES:	• ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531,K043422, K052022, K052339, K062186. K063819, K072431,K072705, K083904, K100578, K101986, K122468, K122469,K133865, K153106)• ASAHI Peripheral Guide Wires (K061984, K071721, K083146,K103057, K110553, K150445, K153443)• ASAHI Guide Wire Extension (K083145, K101985)

{4}------------------------------------------------

INTENDED USE/INDICATIONS FOR USE

The intended use of these wires are unchanged:

ASAHI PTCA Guide Wires:

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous translyminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

ASAHI Peripheral Guide Wires:

ASAHI Guide Wire Extension

DEVICE DESCRIPTION:

This submission covers the addition of an alternate type of PTFE coating material. The designs and performance of the guidewires are unchanged.

COMPARISON WITH PREDICATE DEVICES:

The technological characteristics of the subject guide wires are substantially equivalent to those of the predicate guidewires. The differences between the devices relates to the guide wire proximal coating. The guide wire design and indications remain unchanged.

Comparisons of the revised ASAHI guide wires to the predicate devices show that the technological characteristics of the Subject device such as the product performance, intended use/indications, components, materials, sterilization method, shelf life, manufacturing process, and operating principle are identical to the currently marketed predicate devices. The only difference is in the PTFE coating applied to the proximal portion of the device. The new PTFE is manufactured by a supplier without the use of PFOA.

Name of Device
510(k)	ASAHI PTCA Guide wireASAHI Peripheral Guide wireASAHI Guide wire Extension	ASAHI PTCA Guide wireASAHI Peripheral Guide wireASAHI Guide wire Extension
	Current Application	Multiple
Intended Use and Indications	Unchanged

{5}------------------------------------------------

Name of Device	ASAHI PTCA Guide wireASAHI Peripheral Guide wireASAHI Guide wire Extension	ASAHI PTCA Guide wireASAHI Peripheral Guide wireASAHI Guide wire Extension
Sterilization	Unchanged
Shelf Life	Unchanged
Target Body Location	Unchanged
Outer Coil Material	Unchanged
Core Wire Material	Unchanged
Inner Coil Material	Unchanged
Distal Tip Shape	Unchanged
Overall length	Unchanged
Outer coil length	Unchanged
Outer Coil Outer Diameter	Unchanged
Distal Outer Coating	Unchanged
Proximal Coating	PTFE(with or without PFOA used inprocessing)Alternate PTFE(without PFOA used inprocessing)	PTFE(with or without PFOA used inprocessing)

NON CLINICAL TESTING / PERFORMANCE DATA:

Confirmatory non clinical laboratory testing was performed to determine substantial equivalence.

The following testing/assessments were performed:

Test	Test Method Summary	Results/Conclusions
CoatingAdherence	Integrity of the coated core wire isdetermined before and after pretreatmentand manipulation in excess of thatexpected in clinical use.	Test results confirmed that the coatingadhesion was maintained duringsimulated clinical use in all test articles.
CoatingIntegrity &ParticulateCharacterization	Coating integrity and particulategeneration were evaluated. The testsamples were advanced through aclinically relevant simulated use model tothe target location, retracted and thecoating inspected under magnification.All particulate matter generated duringinsertion/retraction of the guidewire wascharacterized.	This testing characterized the coatingintegrity and particulate generationduring simulated use. The test resultsconfirmed that the coating integrity wasmaintained during simulated clinical useof the test articles.

The in vitro bench tests demonstrated that the devices with the modified coating 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.

{6}------------------------------------------------

BIOCOMPATIBILITY:

Test	Test Method Summary	Results/Conclusions
Cytotoxicity	Testing was conducted in accordance with ISO 10993-5	Passed. No evidence of causing cell lysis or toxicity.
Intracutaneous Irritation	Testing was conducted in accordance with ISO 10993-10	Passed. Difference between test article and control less than 1.0.
Sensitization	Testing was conducted in accordance with ISO 10993-10	Passed. No evidence of causing delayed dermal contact sensitization
Systemic Toxicity	Testing was conducted in accordance with ISO 10993-11	Passed. No mortality or evidence of systemic toxicity
Material MediatedPyrogenicity	Testing was conducted in accordance with ISO 10993-11, USP<151>	Passed. Test article judged as non-pyrogenic.
Hemocompatibility -Hemolysis	Testing was conducted in accordance with ISO 10993-4, ASTM F756	Passed. Hemolytic index was 0.0%.
Hemocompatibility -Complement Activation(SC5b-9, C3a)	Testing was conducted in accordance with ISO 10993-4	Passed. Test article is not considered to be a potential activator of the complement system.
Hemocompatibility -PTT	Testing was conducted in accordance with ASTM F2382	Passed. Test article is considered activator.
Hemocompatibility – invivo Thromboresistance	Testing was conducted in accordance with ISO 10993-4	Passed. Test article is considered thromboresistant.

Testing was performed to assess biocompatibility of the modified coating material.

CONCLUSION:

The ASAHI guidewires with the alternate coating have the identical intended use and the same technological characteristics such as components, design, sterilization method, shelf life and operating principles as the predicate devices. Data demonstrate that the device performance is unchanged.

Therefore, the ASAHI guidewires 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.