This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

Device Description

The ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (hereafter "CHIKAI X 014 soft") is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200cm length. The extension wire is connected to the end of the guide wire outside the body for 200cm wire. The guide wire is constructed from a stainless steel core wire with a platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The coil assembly construction is similar to the 510(K) cleared ASAHI Neurovascular Guide Wire CHIKAI with K110584.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the "ASAHI Neurovascular Guide Wire (CHIKAI X 014 soft)". It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to previously cleared predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary table of non-clinical bench testing. The acceptance criteria for each test were established by prior comparative testing with predicate devices, ASAHI's established guide wire specifications, and clinical experience. The reported device performance indicates that all tested articles met these criteria.

Test	Test Method Summary	Acceptance Criteria Basis	Reported Device Performance (Results / Conclusions)
Tensile Strength	To determine maximum allowable tensile load between connections, guide wire is fixed in the Tensile Testing Machine and pulled until failure.	Determined by evaluation of predicate devices and ASAHI's established tensile strength specifications.	All test articles met established acceptance criteria.
Torque Strength	To determine torque strength, distal end is inserted and advanced through simulated model. Distal tip is held stationary while proximal end is rotated until failure.	Determined by evaluation of predicate devices and ASAHI's established torque strength specifications.	All test articles met established acceptance criteria.
Torqueability	To determine torque response, guidewire is inserted through catheter and into Rotational Response model. Proximal end is rotated from 0° to 720°. Torque response at distal end is measured at each 90° angle.	Determined by evaluation of predicate devices and ASAHI's established torqueability specifications.	All test articles met the acceptance criteria.
Tip Flexibility	To determine flexibility of the distal end, the force to deflect the guide wire 45° and 90° at 5, 10, and 20mm from distal tip is measure by a force analyzer attached to a load cell.	Determined by evaluation of predicate devices and ASAHI's established tip flexibility specifications.	All test articles met established Tip Flexibility acceptance criteria.
Coating Adherence	Integrity of coated outer coil and core wire is determined before, and after, pretreatment and manipulation in excess of that expected in clinical use.	(Implicitly, the coating should remain intact and adherent after simulated use. No explicit numerical criteria provided, but the conclusion confirms integrity.)	Test results confirmed the integrity of the coating was maintained during simulated clinical use in all test articles.
Catheter Compatibility	Catheter compatibility is evaluated by measuring the force to withdraw the guide wire that has been inserted through the test catheter.	(Implicitly, the resistance should be similar to or better than the predicate. No explicit numerical criteria provided.)	All test articles met the acceptance criteria. Resistance to catheter withdrawal is similar or better than predicate.
Bench Testing	To simulate clinical use, guidewire is inserted through guide catheter placed in simulated model and advanced to target area. Microcatheter is inserted over guidewire and advanced to target cerebral artery multiple times.	(Implicitly, the guidewire should reach the target area and allow successful advancement of the interventional catheter. No explicit numerical criteria beyond functional success.)	Test results on all test articles confirmed guidewire performance. Guidewire reached target area and interventional catheter was successfully advanced over guide wire to target site.

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

Sample Size: The document does not specify an exact numerical sample size for each test. It uses phrases like "All test articles" or refers to "multiple times" for the bench testing. This typically implies a statistically relevant number of units were tested to ensure consistency and reliability, but the precise numbers are not disclosed.
Data Provenance: The tests are described as non-clinical bench testing which are performed in a controlled laboratory environment. There is no mention of human subject data, country of origin related to human data, or whether it was retrospective or prospective, as it's a device performance study, not a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this type of device clearance. The "ground truth" here is the physical performance criteria and specifications of the device, which are established through engineering design, industry standards, and comparison to predicate devices, not through expert human readings or interpretations.

4. Adjudication Method for the Test Set:

Not applicable. As stated above, this involves physical bench testing against predefined engineering specifications and predicate performance, not human adjudication of observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This device is a physical medical instrument (guide wire), not an AI/imaging diagnostic tool that would typically undergo an MRMC study.

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

Not applicable. This is a hardware device, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation is based on:
- Prior comparative testing with predicate devices: Directly comparing the new device's performance to that of legally marketed and accepted similar devices.
- ASAHI's established guide wire specifications: Internal engineering and design specifications for their devices.
- Clinical experience: Implicitly, the understanding of performance requirements derived from the real-world use of similar guide wires.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model that requires a "training set."

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

Not applicable. As above, no training set for an AI model is involved.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION".

July 26, 2019

ASAHI INTECC CO., LTD % Cynthia Valenzuela Director, Regulatory Affairs ASAHI INTECC USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, California 92780

Re: K191714

Trade/Device Name: ASAHI Neurovascular Guide Wire (CHIKAI X 014 soft) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: June 26, 2019 Received: June 26, 2019

Dear Cynthia Valenzuela:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Xiaolin Zheng, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K191714

Device Name

ASAHI Neurovascular Guide Wire (CHIKAI X 014 soft)

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.

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 21CFR § 807.92(c)]

Image /page/3/Picture/1 description: The image shows the logo and contact information for ASAHI INTECC CO., LTD. The logo is in red and black. Below the logo is the text "Global Headquarters and R&D Center", followed by the address "3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan". The phone number is +81-561-48-5551, the fax number is +81-561-48-5552, and the website is http://www.asahi-intecc.co.jp/.

ASAHI Neurovascular Guide Wire CHIKAI X 014 soft

DATE PREPARED:	27JUN2019
APPLICANT:	ASAHI INTECC CO., LTD3-100 Akatsuki-cho, SetoAichi 489-0071, Japan
PRIMARY CONTACT:	Mrs. Cynthia ValenzuelaDirector, Regulatory AffairsASAHI INTECC USA, INC.3002 Dow Avenue, Suite 212Tustin, California 92780Phone: (714) 442 0575Fax: (949) 377 3255Cell Phone: (949) 413 0071Email: cynthiav@asahi-intecc-us.com
ALTERNATE CONTACT:	Mr. Yoshi TeraiPresident, CEOASAHI INTECC USA, INC.Tustin, CA 92780 USAPhone: (949) 756 8901Fax: (949) 377 3255Email: yoshi@asahi-intec-us.com
TRADE NAME:	ASAHI Neurovascular Guide Wire (CHIKAI X014 soft)
DEVICE CLASSIFICATION:	Class II, 21CFR § 870.1330
CLASSIFICATION NAME:	Wire, Guide, Catheter, Neurovascular
PRODUCT CODE:	MOF - Catheter Guide Wire
PREDICATE DEVICE(S):	Primary Predicate:ASAHI Neurovascular Guide Wire CHIKAI(K110584)Reference Device:ASAHI Neurovascular Guide Wire CHIKAIblack(K141751)

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

Intended Use/Indications for Use

This quide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

Description:

Comparison with Predicate Device(s):

Predicate Device:	Reference Device:
ASAHI Neurovascular Guide Wire CHIKAI (K110584)	ASAHI Neurovascular Guide Wire CHIKAI black(K141751)

Comparisons of the CHIKAI X 014 soft and predicate devices show that the technological characteristics of the CHIKALX 014 soft such as components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate device. A tabular comparison of the specific technological characteristics between the predicate device and subject device is provided below.

Name of Device	ASAHI Neurovascular GuideWire CHIKΑΙ Χ 014 soft	ASAHI Neurovascular GuidewireCHIKAI
510(K)	K191714	K110584
Intended Use and Indications	The guide wire is intended to be used in the neuro vasculature to facilitatethe placement and exchange of therapeutic devices such as cerebralcatheters during intravascular therapy. This guide wire is intended for useonly in the neuro vasculature.
Sterilization	Ethylene Oxide to SAL 10-6
Shelf Life	1 Year	3 Years
Target Body Location	Neurovascular
Outer Coil Material	Stainless-Steel	Stainless-SteelPlatinum-Nickel Alloy
Core Wire Material	Stainless-Steel	Stainless-Steel
Inner Coil Material	Platinum-Nickel Alloy	Stainless-Steel
Distal Tip Shape	Straight	Straight
Overall Length	200cm	200cm, 300cm

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

Distal Section Coating length	1700mm	1700mm
Outside Diameter of Wire	0.36mm	0.36mm

Non Clinical Testing / Performance Data:

The substantial equivalence of the CHIKAI X 014 soft line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary and Cerebrovascular Guidance, January 1995. Only those tests impacted by the device modifications were repeated. The table below provides a summary of the bench test methods, results and conclusions. Acceptance criteria for each of the tests were determined by prior comparative testing with predicate devices, ASAHI's established guide wire specifications, and clinical experience.

Test	Test Method Summary	Results / Conclusions
Tensile Strength	To determine maximum allowabletensile load between connections, guidewire is fixed in the Tensile TestingMachine and pulled until failure.	All test articles met establishedacceptance criteria. Acceptancecriteria determined by evaluation ofpredicate devices and ASAHI'sestablished tensile strengthspecifications.
Torque Strength	To determine torque strength, distal endis inserted and advanced throughsimulated model. Distal tip is heldstationary while proximal end is rotateduntil failure.	All test articles met establishedacceptance criteria. Acceptancecriteria determined by evaluation ofpredicate devices and ASAHI'sestablished torque strengthspecifications.
Torqueability	To determine torque response,guidewire is inserted through catheterand into Rotational Response model.Proximal end is rotated from 0° to720°. Torque response at distal end ismeasured at each 90° angle.	All test articles met the acceptancecriteria. Acceptance criteriadetermined by evaluation ofpredicate devices and ASAHI'sestablished torqueabilityspecifications.
Tip Flexibility	To determine flexibility of the distal end,the force to deflect the guide wire 45°and 90° at 5, 10, and 20mm from distaltip is measure by a force analyzerattached to a load cell.	All test articles met established TipFlexibility acceptance criteria.Acceptance criteria determined byevaluation of predicate devices andASAHI's established tip flexibilityspecifications.
Coating Adherence	Integrity of coated outer coil and corewire is determined before, and after,pretreatment and manipulation inexcess of that expected in clinical use.	Test results confirmed the integrity ofthe coating was maintained duringsimulated clinical use in all testarticles.
Catheter Compatibility	Catheter compatibility is evaluated bymeasuring the force to withdraw theguide wire that has been insertedthrough the test catheter.	All test articles met the acceptancecriteria. Resistance to catheterwithdrawal is similar or better thanpredicate.
Bench Testing	To simulate clinical use, guidewire isinserted through guide catheter placedin simulated model and advanced totarget area. Microcatheter is insertedover guidewire and advanced to targetcerebral artery multiple times.	Test results on all test articlesconfirmed guidewire performance.Guidewire reached target area andinterventional catheter wassuccessfully advancedover quidewire to target site.

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

The in vitro bench tests demonstrated that the CHIKAI X 014 soft 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 device.

BIOCOMPATIBILITY:

There have been no changes in materials of the Subject device as compared to the Predicate device. For this reason, no additional biocompatibility information is required for this Special 510(K).

CONCLUSION:

The CHIKAI X 014 soft 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 device. Performance data demonstrates that the device functions as intended.

Therefore, the CHIKAI X 014 soft 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.