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 CHIKAI black 18 soft tip neurovascular guide wire is a steerable quide wire with a maximum diameter of 0.018 inches (0.45mm) and length of 200cm. The quide wire is constructed from a stainless steel core wire with 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 coil assembly construction is similar to that of the 510(k) cleared ASAHI CHIKAI black 18 neurovascular guide wire (K141751). The distal end of the quide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire. Like the predicates, the ASAHI CHIKAI black 18 soft tip is packaged with accessories: a torque device, shaping device, and inserter. This change introduces a soft tip version of the round curve tip configuration.

AI/ML Overview

This document describes the premarket notification (510(k)) for the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip. The core of the document focuses on demonstrating substantial equivalence to a predicate device (ASAHI CHIKAI black 18, K141751) through non-clinical performance testing. This is a medical device, not an AI/ML model, so the typical AI/ML acceptance criteria and study designs (like MRMC, training/test sets, expert consensus for ground truth) are not applicable in this context.

However, I can extract the information relevant to device performance acceptance criteria and proof based on the provided text, re-framing it to fit the spirit of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" for a medical device.

Here's the breakdown:

Understanding the Device and Context:

Device Name: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip
Device Type: Catheter Guide Wire (Class II)
Intended Use: To be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy.
Purpose of Submission: Demonstrate substantial equivalence to a predicate device (ASAHI CHIKAI black 18, K141751) due to a minor modification (introduction of a soft tip version). This is a device modification, not a brand new AI/ML model being deployed.

Acceptance Criteria and Device Performance (Adapted for Medical Device Testing):

Since this is a physical medical device, the "acceptance criteria" are based on engineering specifications and performance benchmarks established from the predicate device and internal standards, rather than metrics like sensitivity/specificity for an AI model.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Determined by)	Reported Device Performance (Results/Conclusions)
Tensile Strength	Maximum allowable tensile load before failure. Determined by: - Evaluation of predicate devices - ASAHI's established tensile strength specifications	All test articles met established acceptance criteria.
Torque Strength	Torque strength before failure (distal tip stationary, proximal end rotated). Determined by: - Evaluation of predicate devices - ASAHI's established torque strength specifications	All test articles met established acceptance criteria.
Torqueability	Torque response at the distal end (proximal end rotated). Determined by: - Evaluation of predicate devices - ASAHI's established torqueability specifications	All test articles met the acceptance criteria.
Tip Flexibility	Force to deflect the guide wire. Determined by: - Evaluation of predicate devices - ASAHI's established tip flexibility specifications	All test articles met established Tip Flexibility acceptance criteria.
Simulated Use Testing	Successful navigation to target area and successful advancement of microcatheter over guidewire to target site (in a simulated model). Determined by: - Evaluation of predicate devices - ASAHI's established simulated use specifications	Test results on all test articles confirmed guide wire performance. Guidewire reached target area and microcatheter was successfully advanced over guidewire to target site.

Overall Conclusion on Performance: "The in vitro performance tests demonstrated that the ASAHI CHIKAI black 18 soft tip met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate device."

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

Sample Size: The document repeatedly uses the phrase "All test articles" or "Test results on all test articles." While a specific numerical sample size (e.g., N=X units for each test) is not explicitly stated, it implies that a predefined number of units were manufactured and tested for each performance characteristic.
Data Provenance: This is not a clinical study involving patient data, but rather in-vitro performance testing of a physical device. Therefore, concepts like country of origin of data or retrospective/prospective do not apply. The tests were conducted according to the FDA's "Coronary and Cerebrovascular Guidewire Guidance."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as this is not an AI/ML study requiring expert annotation for ground truth. The "ground truth" here is the physical performance of the device against predefined engineering specifications and the performance of the predicate device. The "experts" are the engineers and technicians conducting the tests and the designers establishing the specifications.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of classifications or interpretations. Performance is measured against objective, quantifiable metrics (e.g., force, torque, successful navigation).

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 is a physical medical device, not an AI system assisting human readers. Therefore, an MRMC study is not relevant.

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

Not applicable. This is a physical medical device, not an algorithm. The performance tests ("Non Clinical testing / Performance Data") effectively serve as a "standalone" assessment of the device's physical properties and functionality.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:
- Engineering Specifications: Pre-defined quantifiable ranges for physical properties (e.g., tensile strength, torque strength).
- Predicate Device Performance: Performance data from the previously cleared ASAHI CHIKAI black 18 guidewire (K141751) serves as a benchmark for "similarity."
- Clinical Experience: ASAHI's established specifications are also based on clinical experience with similar devices.
- FDA Guidance: Adherence to recommendations in the FDA guidance document: "Coronary and Cerebrovascular Guidewire Guidance."

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the AI/ML sense. The "training" for the device design and manufacturing processes comes from decades of engineering knowledge, materials science, and previous device iterations (like the predicate device).

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

Not applicable for the same reasons as point 8. The "ground truth" for developing the device itself resides in the established scientific and engineering principles, material properties, and performance benchmarks derived from prior device development and regulatory clearances.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a design that suggests flowing hair or fabric.

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

July 1, 2017

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

Re: K171613

Trade/Device Name: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: May 30, 2017 Received: June 2, 2017

Dear Ms. 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. 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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/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

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Indications for Use

510(k) Number (if known)

K171613

Device Name

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (as required by 21 CFR 807.92) SAHI 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 Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip

DATE PREPARED:	June 22, 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 Neurovascular Guide Wire:ASAHI CHIKAI black 18 soft tip
DEVICE CLASSIFICATION:	Class 2 per 21 CFR §870.1330
CLASSIFICATION NAME:	Wire, Guide, Catheter, Neurovasculature
PRODUCT CODE	MOF- Catheter Guide Wire
PREDICATE DEVICES:	ASAHI Neurovascular Guide Wire:ASAHI CHIKAI black 18 (K141751)

510(k) K171613

Indications for Use

Device Description:

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The distal end of the quide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire. Like the predicates, the ASAHI CHIKAI black 18 soft tip is packaged with accessories: a torque device, shaping device, and inserter.

This change introduces a soft tip version of the round curve tip configuration.

Comparison with Predicate Devices:

Comparisons of the ASAHI CHIKAI black 18 soft tip to its predicate device 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. There are only minor dimensional variations in the core wire taper and inner coil between the Subject and predicate device.

Name of Device	ASAHI Neurovascular GuideWire (ASAHI CHIKAI black 18soft tip)	ASAHI Neurovascular GuideWire (ASAHI CHIKAI black 18)
510(k)	Current Application	K141751
Intended Use andIndications	This guide wire is intended to be used in the neuro vasculature tofacilitate the placement and exchange of therapeutic devices suchas cerebral catheters during intravascular therapy. This guide wireis intended for use only in the neuro vasculature.
Sterilization	Provided sterile via Ethylene Oxide to SAL10-6
Shelf Life	3 Years
Target Body Location	Neuro Vascular
Outer Coil Material	Stainless SteelPlatinum-Nickel
Core Wire Material	Stainless Steel
Inner Coil Material	Stainless Steel
Distal Tip Shape	Round Curve
Overall length	200 cm
Outer coil length	34cm
Outer Coil Outer Diameter	0.45mm
Distal Outer Coating	Hydrophilic
Distal Outer Coil	Radiopaque Coil

Non Clinical testing / Performance Data:

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

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Test	Test Method Summary	Results/Conclusions
TensileStrength	To determine maximum allowabletensile load between connections, guidewire is fixed in the Tensile TestingMachine and pulled until failure.	All test articles met establishedacceptance criteria. Acceptance criteriadetermined by evaluation of predicatedevices and ASAHI's established tensilestrength specifications.
TorqueStrength	To determine torque strength, distal endis inserted & advanced throughsimulated model. Distal tip is heldstationary while proximal end is rotateduntil failure.	All test articles met establishedacceptance criteria. Acceptance criteriadetermined by evaluation of predicatedevices and ASAHI's established torquestrength specifications.
Torqueability	To determine torque response,guidewire is inserted through catheter &into Rotational Response model.Proximal end is rotated and the torqueresponse at distal end is measured.	All test articles met the acceptancecriteria. Acceptance criteria determinedby evaluation of predicate devices andASAHI's established torqueabilityspecifications.
Tip Flexibility	To determine flexibility of the distal end,the force to deflect the guide wire ismeasured by a force analyzer attachedto a load cell.	All test articles met established TipFlexibility acceptance criteria.Acceptance criteria determined byevaluation of predicate devices andASAHI's established tip flexibilityspecifications.
SimulatedUse Testing	To simulate clinical use, guidewire isinserted through guide catheter placedin simulated model and advanced totarget area. Microcatheter is insertedover guidewire & advanced to targetcerebral artery multiple times.	Test results on all test articles confirmedguide wire performance. Guidewirereached target area and microcatheterwas successfully advanced overguidewire to target site. Acceptancecriteria determined by evaluation ofpredicate devices and ASAHI'sestablished simulated usespecifications.

The in vitro performance tests demonstrated that the ASAHI CHIKAI black 18 soft tip met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate device.

Conclusion:

The ASAHI CHIKAI black 18 soft tip has identical intended use and indications, and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended. Therefore, the ASAHI CHIKAI black 18 soft tip 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.