ASAHI Silverway

K183062 · Asahi Intecc Co., Ltd. · DQX · Jul 1, 2019 · Cardiovascular

Device Facts

• Record ID: K183062
• Device Name: ASAHI Silverway
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

Device Story

ASAHI Silverway is a catheter guide wire used to facilitate the percutaneous introduction of catheters. The device consists of a one-piece stainless steel core wire and a coil assembly (inner and outer coils) soldered to the core. The distal and proximal sections feature a silicone coating, while the intermediate section features a hydrophilic coating. It is available in a 0.89mm (0.035in) diameter and lengths ranging from 150cm to 300cm. The device is operated by a clinician during interventional or diagnostic procedures to navigate the vasculature. By providing a track for catheter advancement, it assists in reaching desired anatomical locations. The device is provided sterile via ethylene oxide.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included dimensional verification, tensile strength, torque strength, torqueability, tip flexibility, coating adhesion, catheter compatibility, radiopacity (ISO 11070), and corrosion (ISO 11070). Biocompatibility testing performed per ISO 10993, ASTM F756, and ASTM F2382.

Technological Characteristics

Materials: Stainless steel core wire and coils. Dimensions: 0.89mm (0.035in) OD, 150-300cm length. Coatings: Silicone (distal/proximal) and hydrophilic (intermediate). Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 11070 (radiopacity/corrosion), ISO 10993 (biocompatibility), ASTM F756 (hemolysis), ASTM F2382 (PTT).

Indications for Use

Indicated for percutaneous introduction of catheters in patients requiring peripheral vascular access. Contraindicated for use in coronary arteries or intracranial vessels.

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

• EMERALD Guidewire (K935170)

Reference Devices

• RADIFOCUS Glidewire (K863138)
• ASAHI CHIKAI (K110584)
• ASAHI CHIKAI black (K141751)
• ASAHI SOFT (K022762)
• ASAHI Gladius Mongo (K180784)
• ASAHI Gladius (K150445)

Submission Summary (Full Text)

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July 1, 2019

Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 1783 Forest Drive, #254 Annapolis, Maryland 21401

Re: K183062

Trade/Device Name: ASAHI Silverway Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 31, 2019 Received: June 3, 2019

Dear 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/ training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Kenneth Cavanaugh, Ph.D. Director (Acting) DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183062

Device Name ASAHI® Silverway®

Indications for Use (Describe)

This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

Type of Use (Select one or both, as applicable)

| <div><span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|

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510(k) Summary

(as required by 21 CFR 807.92)

Image /page/3/Picture/2 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features the company name in a bold, sans-serif font, with the first letter 'A' stylized in red. Below the logo, the company's address is printed: 3-100 Akatsuki-cho, Seto, Aichi 489-0071, Japan.

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

### ASAHI® Silverway® 510(k) K183062

| Date Prepared: | 28 June 2019 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Avenue, Suite 212<br>Tustin, CA 92780<br>Tel: [phone], FAX: [phone]<br>e-mail: [e-mail] |
| Trade Name: | ASAHI® Silverway® |
| Device Classification: | Class 2 per 21 CFR §870.1330 |
| Classification Name: | Catheter, Guide, Wire |
| Product Code: | DQX - Catheter Guide Wire |
| Primary Predicate Device: | EMERALD Guidewire, K935170 |
| Reference Devices: | RADIFOCUS Glidewire, K863138<br>ASAHI CHIKAI, K110584<br>ASAHI CHIKAI black, K141751<br>ASAHI SOFT, K022762<br>ASAHI Gladius Mongo, K180784<br>ASAHI Gladius, K150445 |

### INTENDED USE/INDICATIONS FOR USE:

This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

### DEVICE DESCRIPTION:

The ASAHI Silverway consists of a one-piece core wire and a coil assembly that extends the entire length of the device. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. In addition, coatings are applied on the surface of the ASAHI Silverway. The distal and proximal sections are coated with silicone. The intermediate section is coated with hydrophilic coating. The ASAHI Silverway has a nominal outer diameter of

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0.89mm (0.035in) and is available in various lengths from 150cm to 300cm and tip shapes.

## COMPARISON WITH PREDICATE DEVICES:

Comparisons of the ASAHI® Silverway® and predicate / 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 similar to the currently marketed predicate and reference devices. The ASAHI Silverway and predicate device are constructed with a core wire covered by a coil. The available lengths and tip shapes of the ASAHI Silverway are within the ranges of the predicate and reference devices. Currently, the ASAHI Silverway is available in an 0.035" diameter which is within the range of the sizes available for the predicate and reference devices. The ASAHI Silverway has both a hydrophilic and hydrophobic (silicone) coating, whereas the predicate and reference devices have either a hydrophilic or hydrophobic coating. The intended use of the subject device and its predicates are the same.

| Name of Devices | ASAHI Silverway | EMERALD<br>Guidewire | RADIFOCUS<br>Glidewire |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Subject<br>K183062 | Predicate<br>K935170 | Reference<br>K863138 |
| Intended Use and<br>Indications | This product is<br>intended for use in<br>the percutaneous<br>introduction of<br>catheters. Not for use<br>in the coronary<br>arteries or intracranial<br>vessels. | Cordis Guidewires<br>are intended for use<br>in the percutaneous<br>introduction of<br>catheters. | The Glidewire is<br>designed to direct a<br>catheter to the<br>desired anatomical<br>location during<br>diagnostic or<br>interventional<br>procedures. |
| Nominal OD | 0.89mm<br>(0.035in) | 0.46~1.65mm<br>(0.018~0.065in) | 0.46~0.97mm<br>(0.018~0.038in) |
| Overall Length | 150~300cm | 80~260cm | 30~300cm |
| Outer Coil | Stainless Steel | Stainless Steel | NA |
| Tapered Core Wire | Stainless Steel | Stainless Steel | Ni-Ti |
| Inner Structure | Stainless Steel<br>Coil | Stainless Steel<br>Safety Wire | NA |
| Tip Shape | Angle<br>J-tip | Straight<br>J-tip | Straight<br>Angle<br>J-Tip |
| Coating | Silicone<br>Hydrophilic | PTFE | Hydrophilic |
| Sterilization | Provided sterile via<br>Ethylene Oxide to<br>SAL 10-6 | Provided sterile via<br>Ethylene Oxide | Provided sterile via<br>Ethylene Oxide |

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## NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical laboratory testing was performed on the ASAHI® Silverway® to determine substantial equivalence. The following testing/assessments were performed:

Non-clinical laboratory testing was performed on the ASAHI Silverway to determine substantial equivalence. The following testing/assessments were performed:

- Dimensional Verification ●
- Tensile Strength ●
- . Torque Strength
- Torqueability ●
- Tip Flexibilitv .
- Coating Adhesion ●
- . Catheter Compatibility
- Radiopacity, ISO 11070
- Corrosion, ISO 11070 ●

The in vitro bench tests demonstrated that the ASAHI Silverway 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 Silverway was tested in accordance with ISO 10993 and found to be biocompatible. The following tests were performed.

| Cytotoxicity | ISO 10993-5: Tests for <i>in vitro</i> cytotoxicity |
|--------------------------------------|--------------------------------------------------------------------------|
| Intracutaneous Reactivity/Irritation | ISO 10993-10: Tests for irritation and skin sensitization |
| Sensitization | ISO 10993-10: Tests for irritation and skin sensitization |
| Acute Systemic Toxicity | ISO 10993-11: Tests for systemic toxicity |
| Material Mediated Pyrogenicity | USP, General Chapter <151>,<br>ISO 10993-11: Tests for systemic toxicity |
| Hemolysis | ASTM F756<br>ISO 10993-4: tests for interactions with blood |
| Partial Thromboplastin Time | ASTM F2382 |
| Thrombogenicity | ISO 10993-4: tests for interactions with blood |
| SC5b-9 Complement Activation | ISO 10993-4: tests for interactions with blood |

### CONCLUSION:

The ASAHI® Silverway® 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.

Therefore, the ASAHI Silverway is substantially equivalent to the predicate devices.