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 (ASAHI® CHIKAI® X 010) consists of a core wire and a coil assembly. The coil assembly consists of a stainless steel distal safety wire and an outer coil, soldered to the core wire. The outer coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010). The coil and taper core wire of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) is soft in order to easily bend in accordance with the vessel curve. Accessories such as a Torque device. Shaping device and Inserter are included in the packaging of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010).

AI/ML Overview

The provided text describes the 510(k) premarket notification for the ASAHI Neurovascular Guide Wire (ASAHI CHIKAI X 010). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets a set of performance criteria through a study with human readers or AI algorithms. As such, the information typically requested for AI/human reader studies (e.g., sample size for test/training sets, expert qualification, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable to this document. This submission relies on non-clinical bench testing to demonstrate performance and similarity to predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical laboratory testing performed to demonstrate substantial equivalence. The "acceptance criteria" are generally based on meeting established specifications derived from predicate device performance and the manufacturer's own standards.

Test	Test Method Summary	Acceptance Criteria / Reported Device Performance
Tensile Strength	Determine maximum allowable tensile load between connections by pulling until failure.	Acceptance Criteria: Determined by evaluation of predicate devices and ASAHI's established tensile strength specifications. Performance: All test articles met established tensile strength acceptance criteria.
Torque Strength	Distal end inserted & advanced through simulated model. Distal tip held stationary while proximal end rotated until failure.	Acceptance Criteria: Determined by evaluation of predicate devices and ASAHI's established torque strength specifications. Performance: All test articles met the acceptance criteria.
Torqueability	Guide wire inserted through catheter & into Rotational Response model. Proximal end rotated from 0° to 720°. Torque response at distal end measured at each 90° angle.	Acceptance Criteria: Met by test articles. Performance: Torque response is similar or better than predicate.
Tip Flexibility	Force to deflect the guide wire 45° and 90° at 5, 10, and 20 mm from distal tip measured by a force analyzer.	Acceptance Criteria: Established by evaluation of predicate devices and ASAHI's established Tip Flexibility specifications. Performance: All test articles met established Tip Flexibility acceptance criteria.
Coating Adherence	Integrity of coated outer coil & core wire determined before, and after, pretreatment and manipulation in excess of that expected in clinical use.	Acceptance Criteria (Implied): Coating integrity maintained. Performance: Test results confirmed that the integrity of the coating was maintained during simulated clinical use in all test articles.
Coating Integrity / Particulate Characterization	Total quantity and size of the particulates generated during the simulated use of the device is measured.	Acceptance Criteria (Implied): Similar to predicate. Performance: Test results are similar to the predicate.
Catheter Compatibility	Evaluated by measuring the force to withdraw the guide wire after insertion through a test catheter.	Acceptance Criteria: Met by test articles. Performance: Resistance to catheter withdrawal is similar or better than predicate.
Bench Testing (Simulated)	Guide wire inserted through guide catheter placed in simulated model and advanced to target area. Interventional catheter inserted over guide wire & advanced to target cerebral artery multiple times.	Acceptance Criteria (Implied): Device functions as intended, similar to predicate. Performance: The in vitro bench tests demonstrated that the device 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.

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

Sample Size: The document does not specify the exact sample size for each test. It consistently states "All test articles met..." or "The total quantity and size of the particulates generated...". This implies that for each test, a sufficient number of device samples were tested to provide statistical confidence, though the exact 'n' is not detailed.
Data Provenance: The testing appears to be laboratory-based, non-clinical bench testing conducted by the manufacturer, ASAHI INTECC CO., LTD., which is based in Japan. This is not clinical data from patients.

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

Not Applicable. This submission is for a medical device (guide wire) and relies on engineering and material performance specifications through bench testing, not on interpretation of images or clinical outcomes that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical bench testing, there are no human readers or expert adjudications involved in establishing ground truth. The "ground truth" or "reference standard" for these tests is the quantitative measurement or observation against predetermined engineering specifications.

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

Not Applicable. An MRMC study involves human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This document concerns a physical device, not an imaging AI or a diagnostic tool that relies on human interpretation in that manner.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance

Not Applicable. There is no algorithm or AI component to this device. Its performance is based purely on its physical and mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by engineering specifications, physical measurements, and performance characteristics benchmarked against predicate devices. For example, tensile strength is measured against a specified load, and coating adherence is visually and physically assessed against a standard.

8. The Sample Size for the Training Set

Not Applicable. The device does not involve machine learning or AI, so there is no concept of a "training set."

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

Not Applicable. As there's no training set, there's no ground truth for it. The "acceptance criteria" here are established engineering and performance benchmarks, often derived from industry standards, historical data on predicate devices, and internal quality control specifications.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 29, 2019

ASAHI INTECC CO., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, Maryland 21401

Re: K183070

Trade/Device Name: ASAHI Neurovascular Guide Wire (ASAHI CHIKAI X 010) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: October 31, 2018 Received: November 5, 2018

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. 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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K183070

Device Name

ASAHI Neurovascular Guide Wire (ASAHI CHIKAI X 010)

Indications for Use (Describe)

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)

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AHI INTECC CO.,LTD.

-100 Akatsuki-cho, Seto, Aichi 489-0071, Japan Tel. +81-52-768-1211 Fax. +81-52-768-1221 Branch office: Tokyo, Nagoya, Osaka, Hong, EU, Singapore, Beijing, India, Middle Eastern Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

510(k) Summary [as required by 21 CFR 807.92(c)]

ASAHI Neurovascular Guide Wire ASAHI® CHIKAI® X 010 510(k) K183070

DATE PREPARED:	06 January 2019
APPLICANT	ASAHI INTECC CO., LTD.
	3-100 Akatsuki-cho
	Seto, Aichi 489-0071, Japan
CONTACT	Yoshi Terai
	President/CEO
	ASAHI INTECC USA, INC.
	3002 Dow Avenue, Suite 212
	Tustin, CA 92780
	Tel: (949) 756-8252, FAX: (949) 756-8165
	e-mail: ASAHI.ra-fda@ASAHI-intecc.com
TRADE NAME:	ASAHI® Neurovascular Guide Wire
	(ASAHI® CHIKAI® X 010)
DEVICE CLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATION NAME:	Catheter, Guide, Wire
PRODUCT CODE	MOF- Catheter Guide Wire
PREDICATE DEVICES:	ASAHI® Neurovascular Guide Wire ASAHI® CHIKAI® 008, ASAHI®
	CHIKAI® black 18 (K141751)
REFERENCE DEVICES:	ASAHI SION (K100578)

INTENDED USE/INDICATIONS FOR USE

DEVICE DESCRIPTION:

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COMPARISON WITH PREDICATE DEVICE:

Comparisons of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) and the predicate devices show 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 and reference device utilizes a distal safety wire similar to the reference device, whereas the predicate devices utilize an inner coil.

The intended use and indications for use statement of the subject device and its primary predicates are identical. There are specific design features of the subject device that are similar to the primary predicate but not identical.

Name of Device	ASAHI Neurovascular Guide WireASAHI® CHIKAI® X 010	ASAHI Neurovascular Guide WireASAHI® CHIKAI® 008ASAHI® CHIKAI® black 18
510(k)	Current Application	K141751
Intended Use andIndications	This guide wire is intended to be used in the neuro vasculature to facilitate theplacement and exchange of therapeutic devices such as cerebral cathetersduring intravascular therapy. This guide wire is intended for use only in theneuro vasculature.
Target Body Location	Neuro vasculature
Overall Lengths	200 cm
Nominal OD	0.010in	0.008in, 0.018in
Outer Coil Material	Platinum-Nickel	Platinum-Nickel orPlatinum-Nickel/Stainless Steel
Core Wire Material	Stainless Steel
Hydrophilic coating	Yes
Sterilization	Provided sterile via Ethylene Oxide to SAL10-6
Shelf Life	3 Years

NON CLINICAL TESTING / PERFORMANCE DATA:

Non clinical laboratory testing was performed on the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) to determine substantial equivalence. The following testing/assessments were performed:

Test	Test Method Summary	Results/Conclusions
TensileStrength	To determine maximum allowable tensileload between connections, guide wire is fixedin the Tensile Testing Machine and pulleduntil failure.	All test articles met establishedtensile strength acceptance criteria.Acceptance criteria determined byevaluation of predicate devices andASAHI's established tensilestrength specifications.
Torque Strength	To determine torque strength, distal end isinserted & advanced through simulatedmodel. Distal tip is held stationary whileproximal end is rotated until failure.	All test articles met the acceptancecriteria. Acceptance criteriadetermined by evaluation ofpredicate devices and ASAHI'sestablished torque strengthspecifications.
Torqueability	To determine torque response, guide wire isinserted through catheter & into RotationalResponse model. Proximal end is rotatedfrom 0 o to 720o. Torque response at distal endis measured at each 90o angle.	All test articles met the acceptancecriteria. Torque response is similaror better than predicate.

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Test	Test Method Summary	Results/Conclusions
Tip Flexibility	To determine flexibility of the distal end, theforce to deflect the guide wire 45° and 90° at5, 10 and 20 mm from distal tip is measuredby a force analyzer attached to a load cell.	All test articles met established TipFlexibility acceptance criteria.Acceptance criteria determined byevaluation of predicate devices andASAHI's established TipFlexibility specifications.
	CoatingAdherence	Integrity of coated outer coil & core wire isdetermined before, and after, pretreatmentand manipulation in excess of that expectedin clinical use.	Test results confirmed that theintegrity of the coating wasmaintained during simulatedclinical use in all test articles.
	Coating Integrity /ParticulateCharacterization	The total quantity and size of the particulatesgenerated during the simulated use of thedevice is measured.	Test results are similar to thepredicate.
	CatheterCompatibility	Catheter compatibility is evaluated bymeasuring the force to withdraw the guidewire that has been inserted through the testcatheter.	All test articles met the acceptancecriteria. Resistance to catheterwithdrawal is similar or better thanpredicate.
		Bench Testing(Simulated)	To simulate clinical use, guide wire isinserted through guide catheter placed insimulated model and advanced to target area.Interventional catheter is inserted over guidewire & advanced to target cerebral arterymultiple times.

The in vitro bench tests demonstrated that the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAN® X 010) 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 Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) 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 Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) was leveraged from the predicate and reference devices.

CONCLUSION:

The ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) 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 Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) 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.