ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR

K141751 · Asahi Intecc Co., Ltd. · MOF · Jan 30, 2015 · Cardiovascular

Device Facts

• Record ID: K141751
• Device Name: ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: MOF · Cardiovascular
• Decision Date: Jan 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Indications for Use

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 Story

ASAHI CHIKAI series are steerable neurovascular guide wires; used by physicians in clinical settings to navigate neurovasculature; facilitate placement/exchange of therapeutic devices like cerebral catheters. Device consists of stainless steel core wire with inner/outer coil assembly; distal diameters range 0.008-0.018 inches; lengths 200-300cm. Hydrophilic coating reduces friction. Physician manually manipulates proximal end to steer distal tip through vasculature under imaging guidance. Output is mechanical support and track for catheter delivery. Benefits include improved access to distal neurovascular sites for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data presented. Performance evaluated via simulated use models, tensile strength, torque strength, torqueability, tip flexibility, coating adherence, and particulate characterization. All test articles met established acceptance criteria based on predicate device performance and manufacturer specifications.

Technological Characteristics

Stainless steel core wire; inner and outer coil assembly; hydrophilic coating. Diameters: 0.008", 0.014", 0.018". Lengths: 200cm, 300cm. Tip shapes: straight, round curve, angled 90°. Sterilization: ETO. Biocompatibility per ISO 10993.

Indications for Use

Indicated for use in the neuro vasculature to facilitate placement and exchange of therapeutic devices (e.g., cerebral catheters) during intravascular therapy. No specific age or gender restrictions provided.

Regulatory Classification

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.

Special Controls

*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.

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 (K022762)
• ASAHI PTCA Guide Wire Fielder (K052022)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] FAX: [phone] e-mail: [e-mail]

Date Prepared: January 27, 2015

## Device Information:

| Proprietary Name: | ASAHI Neurovascular Guide Wire ASAHI CHIKAI 008<br>ASAHI Neurovascular Guide Wire ASAHI CHIKAI black<br>ASAHI 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:

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.

## Indication for Use:

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.

## 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 Neurovascular<br>Guide Wire | | | ASAHI Neurovascular<br>Guide Wire | | Micro<br>Therapeutics | Micro<br>Therapeutics Inc | | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|---------------|--|
| Device<br>Name | ASAHI<br>CHIKAI<br>008 | ASAHI<br>CHIKAI<br>black | ASAHI<br>CHIKAI<br>black 18 | ASAHI<br>CHIKAI | ASAHI<br>CHIKAI 10 | Inc. Silverspeed<br>Hydrophilic<br>Guidewires | Mirage<br>Hydrophilic<br>Guidewire | | |
| 510(k) | Subject 510k | | | K110584 | | K112979 | K993257 | K002212 | |
| Intended<br>Use | This guide wire is intended to be<br>used in the neuro vasculature to<br>facilitate the placement and<br>exchange of therapeutic devices<br>such as cerebral catheters during<br>intravascular therapy. This guide<br>wire is intended for use only in<br>the neuro vasculature. | | | ASAHI Neurovascular Guide<br>Wire is intended to be used in<br>the neuro vasculature to<br>facilitate the placement and<br>exchange of therapeutic devices<br>such as cerebral catheters<br>during intravascular therapy.<br>This guide wire is intended for<br>use only in the neuro<br>vasculature. | | For general intravascular use to aid in<br>the selective placement of catheters in<br>the peripheral, visceral, and cerebral<br>vasculature during diagnostic and/or<br>therapeutic procedures. | | | |
| Class | 21 CFR 870.1330, Class II | | | Same | | Same | | | |
| Device<br>design | Stainless Steel core wire with an<br>outer and inner coils | | | Same | | Stainless steel core wire with an outer<br>coil | | | |
| Outer<br>Coating<br>Material | Hydrophilic<br>PTFE - proximal 300 cm length<br>CHIKAI black only | | | Hydrophilic<br>PTFE - proximal 300cm length<br>only | | Hydrophilic | | | |
| Outer<br>Coil OD | 0.20mm | 0.36mm | 0.45mm | 0.36mm | 0.26mm | 0.36, 0.41, & 0.45mm | 0.20mm | | |
| Overall<br>length | 200cm | 200cm,<br>300cm | 200cm | 200cm<br>300cm | 200cm<br>300cm | 200cm | 200cm | | |
| Tip shape | Straight | Round<br>Curve,<br>Angled<br>90° | Round<br>Curve | Straight | | Straight | | | |
| Sterilizing<br>Method/<br>Packaging | ETO sterilized guide wire is<br>inserted in a tube & placed in<br>peelable pack and then in a<br>packaging box.<br>CHIKAI black & black 18:<br>Angle protector & Product<br>fixture protective components | | | ETO sterilized guide wire is<br>inserted in a tube & placed in<br>peelable pack and then in a<br>packaging 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 |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tensile<br>Strength | To determine maximum allowable tensile<br>load between connections, guide wire is<br>fixed in the Tensile Testing Machine and<br>pulled until failure. | All test articles met established tensile<br>strength acceptance criteria. Acceptance<br>criteria determined by evaluation of<br>predicate devices and ASAHI's<br>established tensile strength specifications. |
| Torque Strength | To determine torque strength, distal end is<br>inserted & advanced through simulated<br>model. Distal tip is held stationary while<br>proximal end is rotated until failure. | All test articles met the acceptance<br>criteria. Acceptance criteria determined<br>by evaluation of predicate devices and<br>ASAHI's established torque strength<br>specifications. |
| Torqueability | To determine torque response, guidewire is<br>inserted through catheter & into Rotational<br>Response model. Proximal end is rotated<br>and the torque response at distal end is<br>measured. | All test articles met the acceptance<br>criteria. Torque response is similar or<br>better than predicate. |
| Tip Flexibility | To determine flexibility of the distal end, the<br>force to deflect the guide wire is measured<br>by a force analyzer attached to a load cell. | All test articles met established Tip<br>Flexibility acceptance criteria.<br>Acceptance criteria determined by<br>evaluation of predicate devices and<br>ASAHI's established Tip Flexibility<br>specifications. |
| Coating<br>Adherence | Integrity of coated outer coil & core wire is<br>determined before, and after, pretreatment<br>and manipulation in excess of that expected<br>in clinical use. | Test results confirmed that the integrity of<br>the coating was maintained during<br>simulated clinical use in all test articles. |
| Coating Integrity<br>& Particulate<br>Characterization | Coating integrity and particulates were<br>evaluated. The test samples were advanced<br>through a microcatheter to the target<br>location, retracted and the coating inspected<br>under magnification. All particulate matter<br>generated during insertion/retraction of the<br>guidewire was counted & classified by their<br>particle sizes. | This testing characterized the coating<br>integrity and particulate generation during<br>simulated use. |
| Catheter<br>Compatibility | Catheter compatibility is evaluated by<br>measuring the force to withdraw the guide<br>wire that has been inserted through the test<br>catheter. | All test articles met the acceptance<br>criteria. Resistance to catheter<br>withdrawal is similar or better than<br>predicate. |
| Bench<br>(Simulated)<br>Testing | To simulate clinical use, guidewire is<br>inserted through guide catheter placed in<br>simulated model and advanced to target area.<br>Interventional catheter is inserted over<br>guidewire & advanced to target cerebral<br>artery multiple times. | Test results on all test articles confirmed<br>guide wire performance. Guidewire<br>reached target area and interventional<br>catheter was successfully advanced over<br>guidewire 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.