ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip

K161912 · Asahi Intecc Co., Ltd. · MOF · Oct 14, 2016 · Cardiovascular

Device Facts

• Record ID: K161912
• Device Name: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: MOF · Cardiovascular
• Decision Date: Oct 14, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended 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 Black 14 Soft Tip is a steerable neurovascular guide wire (0.014" diameter, 200cm length). It consists of a stainless steel core wire with platinum-nickel and stainless steel coils; distal end features a radiopaque round curve tip for visualization and a hydrophilic coating. Used by physicians in clinical settings to navigate neurovasculature; facilitates placement/exchange of cerebral catheters during intravascular procedures. Device provides mechanical support and steerability for catheter delivery. Benefits include improved access to target cerebral arteries and procedural efficiency.

Clinical Evidence

Bench testing only. Testing included tensile strength, torque strength, torqueability, tip flexibility, and simulated clinical use in a model. All test articles met established acceptance criteria based on predicate device performance and manufacturer specifications.

Technological Characteristics

Stainless steel core wire; platinum-nickel and stainless steel outer coils; stainless steel inner coil. 0.014" (0.36mm) diameter; 200cm length. Hydrophilic coating on distal portion. Radiopaque tip. Sterilized via Ethylene Oxide to SAL 10^-6.

Indications for Use

Indicated for use in the neurovasculature to facilitate placement and exchange of therapeutic devices, such as cerebral catheters, during intravascular therapy.

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

• ASAHI CHIKAI black (K141751)

Submission Summary (Full Text)

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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 [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,

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)

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) | 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. [phone] Fax. [phone] 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.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya, Aichi 463-0024, Japan |
| CONTACT | Yoshinori Terai, President and CEO<br>ASAHI Intecc USA, Inc.<br>2500 Red Hill Avenue, Suite 210<br>Santa Ana, CA 92705<br>Tel: [phone], FAX: [phone]<br>e-mail: [e-mail] |
| TRADE NAME: | ASAHI Neurovascular Guide Wire:<br>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:<br>ASAHI CHIKAI black (K141751) |

#### 510(k) K161912

#### Intended Use/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 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).

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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 Guide<br>Wire (ASAHI CHIKAI Black 14<br>Soft Tip) | ASAHI Neurovascular Guide<br>Wire (ASAHI CHIKAI black) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) | Current Application | K141751 |
| Intended Use and<br>Indications | This guide wire is intended to be used in the neuro vasculature to<br>facilitate the placement and exchange of therapeutic devices such<br>as cerebral catheters during intravascular therapy. This guide wire<br>is 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 Steel<br>Platinum-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 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>acceptance criteria. Acceptance<br>criteria determined by evaluation of<br>predicate devices and ASAHI's<br>established tensile strength<br>specifications. |
| Torque<br>Strength | To determine torque strength, distal end<br>is inserted & advanced through<br>simulated model. Distal tip is held<br>stationary while proximal end is rotated<br>until failure. | All test articles met established<br>acceptance criteria. Acceptance<br>criteria determined by evaluation of<br>predicate devices and ASAHI's<br>established torque strength<br>specifications. |
| Torqueability | To determine torque response, guidewire<br>is inserted through catheter & into<br>Rotational Response model. Proximal<br>end is rotated and the torque response<br>at distal end is measured. | All test articles met the acceptance<br>criteria. Acceptance criteria<br>determined by evaluation of predicate<br>devices and ASAHI's established<br>torqueability specifications. |
| Tip Flexibility | To determine flexibility of the distal end,<br>the force to deflect the guide wire is<br>measured by a force analyzer attached<br>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. |

Table 2 ASAHI CHIKAI series Bench Test Summary

| 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<br>area. Microcatheter is inserted over<br>guidewire & advanced to target cerebral<br>artery multiple times. | Test results on all test articles<br>confirmed guide wire performance.<br>Guidewire reached target area and<br>microcatheter was successfully<br>advanced over guidewire to target<br>site. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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.