ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

K160659 · Asahi Intecc Co., Ltd. · MOF · Apr 7, 2016 · Cardiovascular

Device Facts

• Record ID: K160659
• Device Name: ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: MOF · Cardiovascular
• Decision Date: Apr 7, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Indications for Use

ASAHI CHIKAI Neurovascular 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

Steerable guide wire; 0.014-inch diameter; 200-300 cm lengths. Used in neurovasculature to facilitate placement/exchange of cerebral catheters during intravascular therapy. Operated by physicians in clinical settings. Device features stainless steel core wire with platinum-nickel and stainless steel coil assembly; distal radiopaque tip with round curve configuration; hydrophilic coating on distal portion; PTFE coating on proximal section (300 cm model). Physician manually manipulates wire to navigate vessel curves; provides trackability for therapeutic devices. Benefits include improved navigation through vessel curves via rounded tip design.

Clinical Evidence

Bench testing only. In vitro assessments included tensile strength, torque strength, torqueability, and tip flexibility. Results demonstrated the device met all acceptance criteria and performed similarly to the predicate device.

Technological Characteristics

Materials: stainless steel core, platinum-nickel and stainless steel coils. Dimensions: 0.014" diameter, 200-300 cm length. Features: hydrophilic distal coating, PTFE proximal coating (300 cm), radiopaque distal tip. Sterilization: Ethylene Oxide (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 Neurovascular Guide Wire (K110584)

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

April 7, 2016

ASAHI Intecc Co., Ltd. % Ms. Candace Cederman Senior Regulatory Affairs Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228

Re: K160659

Trade/Device Name: ASAHI CHIKAI Neurovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: March 7, 2016 Received: March 8, 2016

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. Isting 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), 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/^

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) K160659

Device Name ASAHI CHIKAI Neurovascular Guide Wire

Indications for Use (Describe)

ASAHI CHIKAI Neurovascular Guide Wire is intended to be used in the neuro vasculate 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)

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary (as required by 21 CFR 807.92)

# II INTECC CO. L

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 Round Curve

| DATE PREPARED: | March 7, 2016 |
|------------------------|-------------------------------------------------|
| APPLICANT | ASAHI Intecc Co., Ltd. |
| | 1703 Wakita-cho, Moriyama-ku |
| | Nagoya, Aichi 463-0024, Japan |
| OFFICIAL CORRESPONDENT | Carroll Councilman |
| | Sr. RA Manager |
| | ASAHI Intecc USA, Inc. |
| | 2500 Red Hill Avenue, Suite 210 |
| | Santa Ana, CA 92705 |
| | Tel: [phone] |
| | FAX: [phone] |
| | e-mail: [e-mail] |
| TRADE NAME: | ASAHI CHIKAI Neurovascular Guide Wire |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Wire, Guide, Catheter, Neurovasculature |
| PRODUCT CODE | MOF- Catheter Guide Wire |
| PREDICATE DEVICES: | ASAHI CHIKAI Neurovascular Guide Wire (K110584) |

## 510(k) [K160659]

# Intended Use/Indications for Use

ASAHI CHIKAI Neurovascular 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 Neurovascular Guide Wire (Round Curve) is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200 cm and 300 cm lengths. The guide 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

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Special 510(k) Premarket Notification ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Round Curve

assembly is soldered to the core wire. The coil assembly construction is identical to the 510(k) cleared ASAHI CHIKAI Neurovascular Guide Wire (K110584).

The distal end of the quide wire has a radiopaque tip to achieve visibility. This change introduces a rounded tip configuration designed to bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.

#### COMPARISON WITH PREDICATE DEVICES:

Comparisons of the CHIKAI Round Curve 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 shape variations between the Subject and predicate device.

| Name of Device | ASAHI CHIKAI Neurovascular<br>Guide Wire (Round Curve) | ASAHI CHIKAI Neurovascular<br>Guide Wire |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 510(k) | Current Application | K110584 |
| Intended Use and<br>Indications | ASAHI Neurovascular Guide Wire is intended to be used in the<br>neuro vasculature to facilitate the placement and exchange of<br>therapeutic devices such as cerebral catheters during<br>intravascular therapy. This guide wire is intended for use only in<br>the neuro vasculature. | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 Years | |
| Target Body Location | Neuro Vascular | |
| Outer Distal Hydrophilic<br>coating | Yes | |
| Proximal Coating | PTFE (300cm only) | |
| Outer Coil Material | Stainless Steel<br>Platinum-Nickel | |
| Core Wire Material | Stainless Steel | |
| Inner Coil Material | Stainless Steel | |
| Distal Tip Shape | Round Curve | Straight |
| Overall Length | 200-300 cm | |
| Outer coil length | 30cm | |
| Outer Coil Outer Diameter | 0.36mm | |
| Distal Outer Coating | Hydrophilic | |
| Outer Coil | Radiopaque Coil | |

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## Non Clinical testing / Performance Data:

Confirmatory non clinical laboratory testing was performed on the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) to determine substantial equivalence.

The following testing/assessments were performed:

- Tensile Strength
- Torque Strength ●
- Torqueability ●
- . Tip Flexibility

The in vitro bench tests demonstrated that the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate devices.

#### BIOCOMPATIBILITY:

The ASAHI CHIKAJ Neurovascular Guide Wire (Round Curve) 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 Neurovascular Guide Wire (Round Curve) was verified to be the same as those of the predicate.

#### Conclusion:

The ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) 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 Neurovascular Guide Wire (Round Curve) is substantially equivalent to the predicate device.