ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16

K161584 · Asahi Intecc Co., Ltd. · DQX · Oct 6, 2016 · Cardiovascular

Device Facts

• Record ID: K161584
• Device Name: ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.

Device Story

Guide wire for peripheral vascular interventional procedures; facilitates exchange/placement of diagnostic and therapeutic catheters. Device comprises core wire and coil assembly (platinum-nickel/stainless steel); distal portion radiopaque for visualization under fluoroscopy. Surface coated with polyurethane and hydrophilic polymer to reduce friction. Operated by physician in clinical setting; manual manipulation using included torque/shaping devices and inserter. Provides mechanical support and steerability for catheter navigation through peripheral vasculature. Benefits patient by enabling minimally invasive access to target peripheral sites.

Clinical Evidence

Bench testing only. Tests included tensile strength, torque strength, torqueability, tip flexibility, coating adhesion/integrity, and catheter compatibility. Results demonstrated device met all acceptance criteria and performed similarly to predicate devices. Biocompatibility leveraged from predicate/reference devices.

Technological Characteristics

Core wire (stainless steel) and coil assembly (platinum-nickel, stainless steel). Coated with polyurethane and hydrophilic polymer. Available in various lengths; 0.016 inch nominal OD. Sterilized via Ethylene Oxide (SAL 10^-6). Manual operation; no electronic components or software.

Indications for Use

Indicated for patients requiring peripheral vascular interventional procedures to facilitate placement of diagnostic/therapeutic devices. Contraindicated for use in coronary arteries, lower limb blood vessels, neurovasculature, and carotid arteries.

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 V (K113716)

Reference Devices

• ASAHI Fielder (K052022, K062186)
• ASAHI Fielder FC J (K072705)
• ASAHI CHIKAI black 18 (K141751)
• Boston Scientific Fathom Steerable Guidewires (K111485)

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 6, 2016

Asahi Intecc Co., Ltd. % Ms. Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K161584

Trade/Device Name: ASAHI Peripheral Vascular Guide Wire ASAHI Meister 16 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide wire Regulatory Class: Class II Product Code: DQX Dated: September 8, 2016 Received: September 9, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

# Brian D. Pullin -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161584

Device Name

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16

Indications for Use (Describe)

ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.

| 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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Image /page/3/Picture/1 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features a stylized red "A" followed by the company name in dark green, sans-serif font. The company name is written in all capital letters, with a comma between "CO" and "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

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

## ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 510(k) K161584

| DATE PREPARED: | October 4, 2016 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT | ASAHI INTECC CO., LTD.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya, Aichi 463-0024, Japan |
| CONTACT | Yoshi Terai<br>President/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® Peripheral Vascular Guide Wire ASAHI Meister® 16 |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Catheter, Guide, Wire |
| PRODUCT CODE | DQX- Catheter Guide Wire |
| PREDICATE DEVICES: | ASAHI® Peripheral Vascular Guide Wire: ASAHI® CHIKAI® V<br>(K113716) |
| REFERENCE DEVICES: | • ASAHI® PTCA Guide Wire: ASAHI Fielder (K052022, K062186)<br>• ASAHI® PTCA Guide Wire: ASAHI Fielder FC J (K072705)<br>• ASAHI® Neurovascular Guide Wire: ASAHI® CHIKAI® black 18 (K141751)<br>• Boston Scientific Fathom™ Steerable Guidewires (K111485) |

#### INTENDED USE/INDICATIONS FOR USE

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16

ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.

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#### DEVICE DESCRIPTION:

The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16. The coil and taper core wire of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is soft in order to easily bend in accordance with the vessel curve. The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is available in various lengths and tip shapes. Accessories such as a Torque device, Shaping device and Inserter are included in the packaging of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16.

#### COMPARISON WITH PREDICATE DEVICE:

Comparisons of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 and predicate device shows that the technological characteristics of the Subject device such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.

The intended use of the Subject Device and its primary predicates are identical. The indications are very similar, with the indications for the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 being a subset of that for the ASAHI CHIKAI V. There are specific design features of the Subject device that are similar to the primary predicate but not identical.

| Name of Device | ASAHI Peripheral Vascular Guide<br>Wire ASAHI Meister 16 | ASAHI CHIKAI V Peripheral<br>Vascular Guide Wire |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Current Application | K113716 |
| Intended Use and<br>Indications | ASAHI Peripheral Vascular Guide<br>Wire is intended for use in the<br>peripheral vasculature, to facilitate the<br>exchange and placement of diagnostic<br>and therapeutic devices such as<br>vascular catheters during peripheral<br>interventional procedures. This guide<br>wire is not intended for use in<br>coronary arteries, lower limb blood<br>vessels, neurovasculature and carotid<br>arteries. | ASAHI Peripheral Vascular Guide<br>Wire is intended for use in the<br>peripheral vasculature, to facilitate the<br>exchange and placement of diagnostic<br>and therapeutic devices such as<br>vascular catheters during peripheral<br>interventional procedures. This guide<br>wire is not intended for use in neuro-<br>or coronary vasculature. |
| Target Body Location | Peripheral | |
| Overall Lengths | 135 cm, 165 cm, and 180 cm | 165, 180 cm |
| Nominal OD | 0.016in | 0.014 in |
| Outer Coil Material | Platinum-Nickel, Stainless Steel | |
| Core Wire Material | Stainless Steel | |
| Hydrophilic coating | Yes | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 Years | |

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#### NON CLINICAL TESTING / PERFORMANCE DATA:

Non clinical laboratory testing was performed on the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 to determine substantial equivalence. The following testing/assessments were performed:

- Tensile Strength ●
- Torque Strength ●
- Torqueability
- Tip Flexibility ●
- Coating Adhesion/Integrity
- Catheter Compatibility

The in vitro bench tests demonstrated that the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 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® Peripheral Vascular Guide Wire ASAHI Meister® 16 was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates/reference devices, the biocompatibility of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 was leveraged from predicates/reference devices for all endpoints other than complement activation.

#### CONCLUSION:

The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 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 and reference devices. Performance data demonstrates that the device functions as intended.

Therefore, the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is substantially equivalent to the predicate device.