ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.

Device Description

The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil 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® Peripheral Vascular Guide Wire ASAHI Meister® 16. The coil and taper core wire of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is soft in order to easily bend in accordance with the vessel curve. The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is available in various lengths and tip shapes. Accessories such as a Torque device, Shaping device and Inserter are included in the packaging of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16.

AI/ML Overview

This document is a 510(k) Summary for the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16, submitted by ASAHI INTECC CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study for a new clinical indication.

Therefore, many of the requested categories regarding acceptance criteria and study design for a new device or algorithm are not directly applicable or available in this document. This document describes the testing performed to show the new device is as safe and effective as a previously cleared device.

Here's the information extracted and organized as requested, with notes where information is not applicable or present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical laboratory testing was performed and that the device "met all acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it generally states that the device "performed similarly to the predicate devices" and "functions as intended."

Test Performed	Acceptance Criteria (Not explicitly stated as quantitative thresholds in the document)	Reported Device Performance
Tensile Strength	Performed similarly to predicate devices	Met all acceptance criteria / Performed similarly to predicate devices
Torque Strength	Performed similarly to predicate devices	Met all acceptance criteria / Performed similarly to predicate devices
Torqueability	Performed similarly to predicate devices	Met all acceptance criteria / Performed similarly to predicate devices
Tip Flexibility	Performed similarly to predicate devices	Met all acceptance criteria / Performed similarly to predicate devices
Coating Adhesion/Integrity	Performed similarly to predicate devices	Met all acceptance criteria / Performed similarly to predicate devices
Catheter Compatibility	Performed similarly to predicate devices	Met all acceptance criteria / Performed similarly to predicate devices
Biocompatibility	Similar to predicate/reference devices (for all endpoints except complement activation)	Met all acceptance criteria / Leveraged from predicate/reference devices

2. Sample size used for the test set and the data provenance

The document mentions "non clinical laboratory testing" and "in vitro bench tests." These are likely physical tests on device samples. The sample size for these tests is not specified in the provided text. The data provenance is laboratory testing (bench tests). There is no mention of patient data (country of origin, retrospective/prospective) as this is a physical device equivalence submission, not a clinical study of an AI/software device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device submission. Ground truth for physical device performance is typically established through standardized testing methods, not expert human assessment in the way it's used for AI diagnostic tools.

4. Adjudication method for the test set

This information is not applicable as there are no expert readers or interpretations for physical bench testing outcomes.

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

This information is not applicable. This document describes a physical medical device (guide wire), not an AI algorithm, and therefore, an MRMC study or AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by objective measurements and predefined pass/fail criteria based on engineering specifications and comparison to the predicate device's established performance, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable as this document does not describe an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this document does not describe an AI/ML algorithm that requires a 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.

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

October 6, 2016

Asahi Intecc Co., Ltd. % Ms. Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K161584

Trade/Device Name: ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide wire Regulatory Class: Class II Product Code: DQX Dated: September 8, 2016 Received: September 9, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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/Resourcesfor You/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 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,

Brian D. Pullin -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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Indications for Use

510(k) Number (if known) K161584

Device Name

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16

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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Image /page/3/Picture/1 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features a stylized red "A" followed by the company name in dark green, sans-serif font. The company name is written in all capital letters, with a comma between "CO" and "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® Peripheral Vascular Guide Wire ASAHI Meister® 16 510(k) K161584

DATE PREPARED:	October 4, 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® Peripheral Vascular Guide Wire ASAHI Meister® 16
DEVICE CLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATION NAME:	Catheter, Guide, Wire
PRODUCT CODE	DQX- Catheter Guide Wire
PREDICATE DEVICES:	ASAHI® Peripheral Vascular Guide Wire: ASAHI® CHIKAI® V(K113716)
REFERENCE DEVICES:	• ASAHI® PTCA Guide Wire: ASAHI Fielder (K052022, K062186)• ASAHI® PTCA Guide Wire: ASAHI Fielder FC J (K072705)• ASAHI® Neurovascular Guide Wire: ASAHI® CHIKAI® black 18 (K141751)• Boston Scientific Fathom™ Steerable Guidewires (K111485)

INTENDED USE/INDICATIONS FOR USE

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16

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DEVICE DESCRIPTION:

COMPARISON WITH PREDICATE DEVICE:

Comparisons of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 and predicate device shows 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 primary predicates are identical. The indications are very similar, with the indications for the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 being a subset of that for the ASAHI CHIKAI V. There are specific design features of the Subject device that are similar to the primary predicate but not identical.

Name of Device	ASAHI Peripheral Vascular GuideWire ASAHI Meister 16	ASAHI CHIKAI V PeripheralVascular Guide Wire
510(k)	Current Application	K113716
Intended Use andIndications	ASAHI Peripheral Vascular GuideWire is intended for use in theperipheral vasculature, to facilitate theexchange and placement of diagnosticand therapeutic devices such asvascular catheters during peripheralinterventional procedures. This guidewire is not intended for use incoronary arteries, lower limb bloodvessels, neurovasculature and carotidarteries.	ASAHI Peripheral Vascular GuideWire is intended for use in theperipheral vasculature, to facilitate theexchange and placement of diagnosticand therapeutic devices such asvascular catheters during peripheralinterventional procedures. This guidewire is not intended for use in neuro-or coronary vasculature.
Target Body Location	Peripheral
Overall Lengths	135 cm, 165 cm, and 180 cm	165, 180 cm
Nominal OD	0.016in	0.014 in
Outer Coil Material	Platinum-Nickel, Stainless Steel
Core Wire Material	Stainless Steel
Hydrophilic coating	Yes
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® Peripheral Vascular Guide Wire ASAHI Meister® 16 to determine substantial equivalence. The following testing/assessments were performed:

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

The in vitro bench tests demonstrated that the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 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® Peripheral Vascular Guide Wire ASAHI Meister® 16 was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates/reference devices, the biocompatibility of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 was leveraged from predicates/reference devices for all endpoints other than complement activation.

CONCLUSION:

The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 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® Peripheral Vascular Guide Wire ASAHI Meister® 16 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.