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 14 Soft Tip neurovascular guide wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) 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 neurovascular guide wire (K141751). The distal end of the guide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire. This change introduces a soft tip version of the round curve tip configuration.

AI/ML Overview

The acceptance criteria and study proving the device meets them are described for the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Black 14 Soft Tip, a catheter guide wire used in neurovasculature.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria Description	Reported Device Performance/Conclusion
Tensile Strength	Established by evaluation of predicate devices and ASAHI's established tensile strength specifications. (Specific numeric values are not provided in the document).	All test articles met established acceptance criteria.
Torque Strength	Established by evaluation of predicate devices and ASAHI's established torque strength specifications. (Specific numeric values are not provided in the document).	All test articles met established acceptance criteria.
Torqueability	Established by evaluation of predicate devices and ASAHI's established torqueability specifications. (Specific numeric values are not provided in the document).	All test articles met the acceptance criteria.
Tip Flexibility	Established by evaluation of predicate devices and ASAHI's established tip flexibility specifications. (Specific numeric values are not provided in the document).	All test articles met established Tip Flexibility acceptance criteria.
Bench (Simulated) Testing	Guide wire should reach the target area, and the microcatheter should be successfully advanced over the guide wire to the target site multiple times. (This is a functional acceptance criterion).	Test results on all test articles confirmed guide wire performance. Guidewire reached target area and microcatheter was successfully advanced over guidewire to target site. Performance was similar to the predicate device.

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

The document states "All test articles met established acceptance criteria" for Tensile Strength, Torque Strength, Torqueability, and Tip Flexibility tests, and "Test results on all test articles confirmed guide wire performance" for the Bench (Simulated) Testing. However, the exact sample size ("N") for the test set is not explicitly specified in the provided text. It refers to "all test articles" without quantifying them.
Data provenance (country of origin, retrospective/prospective): Not explicitly stated in the provided text. The applicant is ASAHI INTECC CO., LTD. in Japan, so the testing was likely conducted by or for them. The nature of these bench tests suggests they are prospective (i.e., conducted specifically for this submission).

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 in the context of this device and these tests. The tests are purely performance-based bench tests comparing the physical properties and functional performance of the device against predefined specifications and predicate devices. There is no "ground truth" established by human experts in the way it would be for, say, an AI diagnostic algorithm.

4. Adjudication method for the test set:

This information is not applicable for these types of bench tests. Adjudication methods like 2+1 or 3+1 are typically used for subjectively interpreted data or ground truth establishment by multiple human readers, which is not the case here. The results are objective measurements of physical properties.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in the provided text. This type of study is more relevant for diagnostic devices that involve human interpretation of images or data, where AI might assist. The device described is a physical guide wire.

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

Not applicable. This device is a physical medical instrument (a guide wire), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply.

7. The type of ground truth used:

The "ground truth" for the performance tests relies on pre-established specifications and comparative performance to predicate devices and industry standards (FDA guidance document). For example:
- Tensile strength is measured against "ASAHI's established tensile strength specifications."
- Bench testing evaluates whether the guide wire "reached target area and microcatheter was successfully advanced."
- The overall conclusion states, "Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate device."
There's no external "gold standard" ground truth like pathology or outcomes data mentioned for these specific physical performance tests.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument, not a machine learning model that requires a training set.

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

Not applicable. As it's not an AI/ML device, there's no training set or associated ground truth establishment process.

Summary

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

October 14, 2016

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

Re: K161912

Trade/Device Name: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Black 14 Soft Tip Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: September 15, 2016 Received: September 16, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 and Part 809), 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) K161912

Device Name

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Black 14 Soft Tip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Ref. 21 CFR 201. Subpart D)
	Over-The-Counter Use (21 CFR 201. Subpart C)

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 14 Soft Tip

DATE PREPARED:	September 15, 2016
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 14 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 (K141751)

510(k) K161912

Intended Use/Indications for Use

Device Description:

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The distal end of the guide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire.

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

COMPARISON WITH PREDICATE DEVICES:

Comparisons of the ASAHI CHIKAI Black 14 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 14Soft Tip)	ASAHI Neurovascular GuideWire (ASAHI CHIKAI black)
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	Round Curve
		ANGLED 90°
Overall length	200 cm	200-300 cm
Outer coil length	30cm
Outer Coil Outer Diameter	0.36mm
Distal Outer Coating		Hydrophilic
Outer Coil	Radiopaque Coil

Non Clinical testing / Performance Data:

The substantial equivalence of the ASAHI CHIKAI black line extension was evaluated in bench 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 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.

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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 establishedacceptance criteria. Acceptancecriteria determined by evaluation ofpredicate devices and ASAHI'sestablished tensile strengthspecifications.
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. Acceptancecriteria determined by evaluation ofpredicate devices and ASAHI'sestablished torque strengthspecifications.
Torqueability	To determine torque response, guidewireis inserted through catheter & intoRotational Response model. Proximalend is rotated and the torque responseat distal end is measured.	All test articles met the acceptancecriteria. Acceptance criteriadetermined by evaluation of predicatedevices and ASAHI's establishedtorqueability specifications.
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.

Table 2 ASAHI CHIKAI series Bench Test Summary

Bench(Simulated)Testing	To simulate clinical use, guidewire isinserted through guide catheter placed insimulated model and advanced to targetarea. Microcatheter is inserted overguidewire & advanced to target cerebralartery multiple times.	Test results on all test articlesconfirmed guide wire performance.Guidewire reached target area andmicrocatheter was successfullyadvanced over guidewire to targetsite.
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T 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.

BIOCOMPATIBILITY:

The ASAHI CHIKAI Black 14 Soft Tip was compared to the predicate device. Based on the identical materials and manufacturing process used in the subject device to its predicate, the biocompatibility of the ASAHI CHIKAI Black 14 Soft Tip was verified to be the same as those of the predicate.

Conclusion:

The ASAHI CHIKAI Black 14 Soft Tip 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 devices. Performance data demonstrates that the device functions as intended. Therefore, the ASAHI CHIKAI Black 14 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.