ASAHI PTCA Guide Wire ASAHI SION black

K173277 · Asahi Intecc Co., Ltd. · DQX · Jul 5, 2018 · Cardiovascular

Device Facts

• Record ID: K173277
• Device Name: ASAHI PTCA Guide Wire ASAHI SION black
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

Device Story

ASAHI SION black is a PTCA guide wire used to facilitate balloon dilatation catheter placement in coronary and peripheral vasculature. Device consists of core wire, inner/outer coil assembly, and safety wire. Distal portion is radiopaque for visualization under fluoroscopy. Surface features include polyurethane undercoating, hydrophilic coating on distal portion, and PTFE coating on proximal portion. Used in clinical settings (e.g., cath lab) by physicians. Device provides mechanical support and navigation for catheters; aids in successful angioplasty procedures; benefits patients by enabling minimally invasive treatment of vascular stenoses.

Clinical Evidence

Bench testing only. Performance evaluations included dimensional verification, tensile strength, torque strength, torqueability, tip flexibility, coating adhesion, catheter compatibility, coating lubricity, radiopacity, and particulate/coating integrity testing. Results demonstrated the device met all acceptance criteria and performed similarly to predicate devices.

Technological Characteristics

Guide wire with core wire and coil assembly (Platinum-Nickel, Stainless Steel). Coatings: Polyurethane undercoating, hydrophilic distal coating, PTFE proximal coating. Nominal OD 0.36mm (0.014 inch). Lengths 190cm and 300cm. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring balloon dilatation catheter placement. Contraindicated for use in the neurovasculature.

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 PTCA Guide Wire ASAHI SION (K163426)

Reference Devices

• ASAHI PTCA Guide Wire ASAHI SION (K100578, K122469)
• ASAHI Fielder XT-A (K153106, K163426)
• ASAHI Fielder XT (K072431)
• ASAHI Fielder FC (K063819, K072705, K163426)
• ASAHI ULTIMATEbros 3 (K101986, K163426)
• ASAHI Gaia (K133865, K163426)
• ASAHI Neurovascular Guide Wire ASAHI CHIKAI black (K141751)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 5, 2018

Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 3168 Braverton Street. Suite 200 Edgewater, Maryland 21037

Re: K173277

Trade/Device Name: ASAHI® PTCA Guide Wire ASAHI SION black Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 4, 2018 Received: June 5, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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# Page 2 - Ms. Cederman

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Gregory O'Connell 2018.07.05 07:54:27 -04'00'

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) K173277

Device Name ASAHI® PTCA Guide Wire ASAHI SION black

Indications for Use (Describe)

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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K173277 PAGE 1 of 3

# ASAHI INTECC CO.,LTD.

3-100 Akatsuki-cho, Seto, Aichi 489-0071 Japan Tel. [phone] Fax. [phone] Branch office: Tokyo, Nagoya, Osaka, Hong, EU, Singapore, Beijing, India, Middle Eastern Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

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

# ASAHI® PTCA Guide Wire ASAHI SION black 510(k) K173277

| DATE PREPARED: | July 2, 2018 | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| APPLICANT | ASAHI INTECC CO., LTD.<br>3-100 Akatsuki-cho<br>Seto, Aichi 489-0071, Japan | | |
| CONTACT | Yoshi Terai<br>President/CEO<br>ASAHI INTECC USA, Inc.<br>3002 Dow Ave, Suite 212<br>Tustin, CA 92780<br>Tel: [phone], FAX: [phone]<br>e-mail: [e-mail] | | |
| TRADE NAME: | ASAHI® PTCA Guide Wire ASAHI SION black | | |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 | | |
| CLASSIFICATION NAME: | Catheter, Guide, Wire | | |
| PRODUCT CODE | DQX- Catheter Guide Wire | | |
| PREDICATE DEVICES: | ASAHI® PTCA Guide Wire ASAHI® SION® (K163426) | | |
| REFERENCE DEVICES: | ASAHI® PTCA Guide Wire ASAHI® SION® (K100578, K122469) ASAHI® Fielder XT-A (K153106, K163426) ASAHI® Fielder XT (K072431) ASAHI® Fielder FC (K063819, K072705, K163426) ASAHI® ULTIMATEbros 3 (K101986, K163426) ASAHI® Gaia (K133865, K163426) ASAHI® Neurovascular Guide Wire ASAHI CHIKAI black (K141751) | | |

# Intended Use/Indications for Use ASAHI® PTCA Guide Wire ASAHI SION black

ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous

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transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

## Device Description:

The ASAHI® PTCA Guide Wire ASAHI SION black consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire, 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 the ASAHI® PTCA Guide Wire ASAHI SION black. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE. The ASAHI® PTCA Guide Wire ASAHI SION black is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available ASAHI INTECC extension wire.

#### Comparison with Predicate device:

Comparisons of the ASAHI® PTCA Guide Wire ASAHI SION black and predicate and reference devices show 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 predicate/reference devices are the same.

| | ASAHI® PTCA<br>Guide Wire<br>ASAHI SION black<br>Subject | ASAHI® PTCA<br>Guide Wire<br>ASAHI SION<br>Predicate | ASAHI® PTCA<br>Guide Wire<br>ASAHI Fielder XT-A<br>Reference |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K173277 | K163426 | K153106<br>K163426 |
| Intended Use and<br>Indications | ASAHI PTCA Guide Wires<br>are intended to facilitate<br>the placement of balloon<br>dilatation catheters during<br>percutaneous transluminal<br>coronary angioplasty<br>(PTCA) and percutaneous<br>transluminal angioplasty<br>(PTA). The ASAHI PTCA<br>Guide Wires are not to be<br>used in the<br>neurovasculature. | ASAHI PTCA Guide Wires<br>are intended to facilitate<br>the placement of balloon<br>dilatation catheters during<br>percutaneous transluminal<br>coronary angioplasty<br>(PTCA) and percutaneous<br>transluminal angioplasty<br>(PTA). The ASAHI PTCA<br>Guide Wires are not to be<br>used in the<br>neurovasculature. | ASAHI PTCA Guide Wires<br>are intended to facilitate<br>the placement of balloon<br>dilatation catheters during<br>percutaneous transluminal<br>coronary angioplasty<br>(PTCA) and percutaneous<br>transluminal angioplasty<br>(PTA). The ASAHI PTCA<br>Guide Wires are not to be<br>used in the<br>neurovasculature. |
| Target Location | Coronary and Peripheral vasculature | | |
| Nominal OD | 0.36mm (0.014 inch) | | |
| Overall Lengths | 190cm and 300cm | 180cm and 300cm | 190cm and 300cm |
| Outer Coil Material | Platinum-Nickel, Stainless Steel | | Platinum-Nickel |
| Inner Coil Material | Stainless Steel | | |
| Core Wire Material | Stainless Steel | | |
| Undercoating | Polyurethane | NA | Polyurethane |
| Outer Distal Coating | Hydrophilic coating | | |
| Proximal Coating | PTFE | | |
| 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® PTCA Guide Wire ASAHI SION black to determine substantial equivalence. The following testing/assessments were performed:

- Dimensional Verification ●
- Tensile Strength ●
- Torque Strength .
- . Torqueability
- . Tip Flexibility
- Coating Adhesion ●
- Catheter Compatibility
- Coating Lubricitv ●
- Radiopacity ●
- Particulate Testing / Coating Integrity ●

The in vitro bench tests demonstrated that the ASAHI® PTCA Guide Wire ASAHI SION black met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and has a profile that is similar to the predicate devices.

## BIOCOMPATIBILITY:

The ASAHI® PTCA Guide Wire ASAHI SION black was compared to the predicate and reference devices. Based on similarities of the materials used in the subject device to its predicates / reference devices, biocompatibility testing of the ASAHI® PTCA Guide Wire ASAHI SION black was not completed.

## CONCLUSION:

The ASAHI® PTCA Guide Wire ASAHI SION black 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® PTCA Guide Wire ASAHI SION black is substantially equivalent to the predicate devices.