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 008, ASAHI Neurovascular Guide Wire ASAHI CHIKAI black, and the ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18 (ASAHI CHIKAI series) is a line extension of the ASAHI CHIKAI (K110584) and the ASAHI CHIKAI 10 (K112979).

The ASAHI CHIKAI series of steerable guide wires are constructed from a stainless steel core wire with a coil assembly consisting of an inner and outer coil soldered to the core wire. Distal outer diameter and tip shape of the ASAHI CHIKAI series range from 0.008 inches (0.20mm) with a straight tip for the ASAHI CHIKAI 008, to 0.014 inches (0.36mm) Round Curve or Angled 90º tip for the ASAHI CHIKAI black, to 0.018 inches (0.45mm) with a Round Curve tip for the ASAHI CHIKAI 18. The ASAHI CHIKAI and ASAHI CHIKAI black 18 are 200cm long, and the ASAHI CHIKAI black is available in 200cm and 300cm lengths.

AI/ML Overview

The provided text describes a 510(k) summary for the Asahi Neurovascular Guide Wire ASAHI CHIKAI series, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing, rather than a clinical study involving human subjects or AI performance evaluation. Therefore, many of the requested categories related to AI performance, human readers, ground truth establishment for AI, and large-scale data provenance are not applicable to this submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (determined by)	Reported Device Performance
Tensile Strength	Evaluation of predicate devices and ASAHI's established tensile strength specifications.	All test articles met established tensile strength acceptance criteria.
Torque Strength	Evaluation of predicate devices and ASAHI's established torque strength specifications.	All test articles met the acceptance criteria.
Torqueability	Similar or better than predicate devices.	All test articles met the acceptance criteria. Torque response is similar or better than predicate.
Tip Flexibility	Evaluation of predicate devices and ASAHI's established Tip Flexibility specifications.	All test articles met established Tip Flexibility acceptance criteria.
Coating Adherence	Maintained integrity of the coating during simulated clinical use.	Test results confirmed that the integrity of the coating was maintained during simulated clinical use in all test articles.
Coating Integrity & Particulate Characterization	Characterization of coating integrity and particulate generation during simulated use. (No specific quantitative acceptance criteria mentioned, but the test characterized these aspects).	This testing characterized the coating integrity and particulate generation during simulated use. (This suggests the results were within acceptable ranges, though specific numbers are not given).
Catheter Compatibility	Similar or better than predicate devices regarding resistance to catheter withdrawal.	All test articles met the acceptance criteria. Resistance to catheter withdrawal is similar or better than predicate.
Bench (Simulated) Testing	Guide wire reached target area and interventional catheter was successfully advanced over guide wire to target site.	Test results on all test articles confirmed guide wire performance. Guidewire reached target area and interventional catheter was successfully advanced over guidewire to target site.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated as a number. The table mentions "All test articles" for each test. This implies that a sufficient number of devices were tested to draw conclusions, but the specific count is not provided in this summary.
Data Provenance: The data is from bench testing (simulated use), not human patient data. Asahi Intecc Co., Ltd. is based in Japan, so the testing was likely conducted in an industrial or laboratory setting, potentially in Japan or at a contract lab. It is not retrospective or prospective in the clinical sense, as it does not involve patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a bench study for a physical medical device (guide wire). There is no "ground truth" to be established by medical experts in the context of diagnostic interpretation or AI performance. The "ground truth" here is the physical performance of the device against predefined engineering and performance specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As this is a bench study, there is no need for expert adjudication like in diagnostic imaging studies. The results of the physical tests are measured directly by instruments or observed against clear criteria.

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

Not Applicable. This document describes the premarket notification for a physical medical device (a guide wire), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant here.

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

Not Applicable. This device is a manual medical instrument; there is no algorithm or AI component involved, thus no standalone algorithm performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the established engineering specifications, performance standards, and comparison to legally marketed predicate devices' performance. It is based on objective physical measurements and observations during bench testing, not medical expert consensus, pathology, or patient outcomes data.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable. No training set exists for this type of device.

Summary

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

January 30, 2015

Asahi Intecc Co., Ltd. % Mr. Semih Oktay President CardioMed Device Consultants LLC 5523 Research Park Drive Suite 205 Baltimore, Maryland 21228

Re: K141751

Trade/Device Name: Asahi Neurovascular Guide Wire ASAHI CHIKAI 008, Asahi Neurovascular Guide Wire ASAHI CHIKAI Black, and Asahi Neurovascular Guide Wire ASAHI CHIKAI Black 18 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: December 29, 2014 Received: December 31, 2014

Dear Mr. Semih 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

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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 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 yours,

Carlos L. Pena -S FD/△

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) K141751

Device Name

ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008 ASAHI Neurovascular Guide Wire ASAHI CHIKAI black ASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18

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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510(k) SUMMARY

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

Applicant:

Asahi Intecc Co., Ltd. 1703 Wakita-cho, Moriyama-ku Nagoya, Aichi 463-0024 Japan

Official Correspondent:

Yoshi Terai President. CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705 Tel: (949) 756-8252 FAX: (949) 756-8165 e-mail: asahi.ra-fda@asahi-intecc.com

Date Prepared: January 27, 2015

Device Information:

Proprietary Name:	ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008ASAHI Neurovascular Guide Wire ASAHI CHIKAI blackASAHI Neurovascular Guide Wire ASAHI CHIKAI black 18
Common/Usual Name:	Guide Wire
Regulation Name:	Neurovascular Catheter Guide Wire
Regulatory Class:	Class II
Product Code:	MOF

Predicate Devices:

Micro Therapeutics Silverspeed Hydrophilic Guidewires (K993257) ●
Micro Therapeutics Mirage Hydrophilic Guidewire (K002212) ●
ASAHI Neurovascular Guide Wire ASAHI CHIKAI (K110584) .
ASAHI Neurovascular Guide Wire ASAHI CHIKAI 10 (K112979) .
ASAHI Prowater and Marker Wire Guide Wires (JoWire Neo's PTCA Guide Wire ● K022762)
ASAHI PTCA Guide Wire Fielder (K052022) ●

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Device Description:

Indication for Use:

Comparison of Technological Characteristics

The indication, design, materials, and manufacturing methods of the ASAHI CHIKAI series are the same or similar to those used for the ASAHI CHIKAI and CHIKAI 10 neurovascular guide wires and share similarities with Micro Therapeutics' neurovascular guide wires. A summary table comparing the technological characteristics of the ASAHI CHIKAI series with the predicate neurovascular devices is shown in Table 1.

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MFR	ASAHI NeurovascularGuide Wire			ASAHI NeurovascularGuide Wire		MicroTherapeutics	MicroTherapeutics Inc
DeviceName	ASAHICHIKAI008	ASAHICHIKAIblack	ASAHICHIKAIblack 18	ASAHICHIKAI	ASAHICHIKAI 10	Inc. SilverspeedHydrophilicGuidewires	MirageHydrophilicGuidewire
510(k)	Subject 510k			K110584		K112979	K993257	K002212
IntendedUse	This guide wire is intended to beused in the neuro vasculature tofacilitate the placement andexchange of therapeutic devicessuch as cerebral catheters duringintravascular therapy. This guidewire is intended for use only inthe neuro vasculature.			ASAHI Neurovascular GuideWire is intended to be used inthe neuro vasculature tofacilitate the placement andexchange of therapeutic devicessuch as cerebral cathetersduring intravascular therapy.This guide wire is intended foruse only in the neurovasculature.		For general intravascular use to aid inthe selective placement of catheters inthe peripheral, visceral, and cerebralvasculature during diagnostic and/ortherapeutic procedures.
Class	21 CFR 870.1330, Class II			Same		Same
Devicedesign	Stainless Steel core wire with anouter and inner coils			Same		Stainless steel core wire with an outercoil
OuterCoatingMaterial	HydrophilicPTFE - proximal 300 cm lengthCHIKAI black only			HydrophilicPTFE - proximal 300cm lengthonly		Hydrophilic
OuterCoil OD	0.20mm	0.36mm	0.45mm	0.36mm	0.26mm	0.36, 0.41, & 0.45mm	0.20mm
Overalllength	200cm	200cm,300cm	200cm	200cm300cm	200cm300cm	200cm	200cm
Tip shape	Straight	RoundCurve,Angled90°	RoundCurve	Straight		Straight
SterilizingMethod/Packaging	ETO sterilized guide wire isinserted in a tube & placed inpeelable pack and then in apackaging box.CHIKAI black & black 18:Angle protector & Productfixture protective components			ETO sterilized guide wire isinserted in a tube & placed inpeelable pack and then in apackaging box.		Not available		Not available

Table 1 Comparison of ASAHI CHIKAI series to the predicate devices.

The materials used in the manufacture of the ASAHI CHIKAI series tapered core wire, coils and coating materials, and the manufacturing processes are the same as those used for ASAHI's Prowater and Marker Wire PTCA Guide Wires (K022762) and ASAHI PTCA Guide Wire Fielder (K052022), which were subject to full biocompatibility testing in accordance with ISO 10993.

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Non-clinical Performance Data:

The safety and effectiveness of the ASAHI CHIKAI series line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document: Coronary and Cerebrovascular Guidewire Guidance. Table 2 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
TensileStrength	To determine maximum allowable tensileload between connections, guide wire isfixed in the Tensile Testing Machine andpulled until failure.	All test articles met established tensilestrength acceptance criteria. Acceptancecriteria determined by evaluation ofpredicate devices and ASAHI'sestablished tensile strength 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 criteria determinedby evaluation of predicate devices andASAHI's established torque strengthspecifications.
Torqueability	To determine torque response, guidewire isinserted through catheter & into RotationalResponse model. Proximal end is rotatedand the torque response at distal end ismeasured.	All test articles met the acceptancecriteria. Torque response is similar orbetter than predicate.
Tip Flexibility	To determine flexibility of the distal end, theforce to deflect the guide wire 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 Tip Flexibilityspecifications.
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 the integrity ofthe coating was maintained duringsimulated clinical use in all test articles.
Coating Integrity& ParticulateCharacterization	Coating integrity and particulates wereevaluated. The test samples were advancedthrough a microcatheter to the targetlocation, retracted and the coating inspectedunder magnification. All particulate mattergenerated during insertion/retraction of theguidewire was counted & classified by theirparticle sizes.	This testing characterized the coatingintegrity and particulate generation duringsimulated use.
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(Simulated)Testing	To simulate clinical use, guidewire isinserted through guide catheter placed insimulated model and advanced to target area.Interventional catheter is inserted overguidewire & advanced to target cerebralartery multiple times.	Test results on all test articles confirmedguide wire performance. Guidewirereached target area and interventionalcatheter was successfully advanced overguidewire to target site.

Table 2 ASAHI CHIKAI series Bench Test Summary

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All neurovascular guide wires in the ASAHI CHIKAI series met the acceptance criteria for each of the bench tests.

Conclusion

Based on the similar indication, design and materials, and the results of the bench testing, the ASAHI CHIKAI series line extension is considered substantially equivalent to the predicate devices listed above.

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.