Radifocus Glidewire Advantage Track

K163004 · Ashitaka Factory of Terumo Coporation · DQX · Jan 30, 2017 · Cardiovascular

Device Facts

• Record ID: K163004
• Device Name: Radifocus Glidewire Advantage Track
• Applicant: Ashitaka Factory of Terumo Coporation
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

Device Story

Manual guide wire; used by physicians in peripheral vasculature diagnostic/interventional procedures. Input: manual manipulation by physician to navigate vasculature. Transformation: wire core (stainless steel proximal, NiTi distal) provides track for catheter advancement; hydrophilic/PTFE coatings reduce friction. Output: physical access to target lesion/site. Benefit: facilitates catheter placement in peripheral vessels. Used in clinical settings; physician-operated.

Clinical Evidence

No clinical data. Bench testing only, including surface, corrosion, radio-detectability, fracture, flexing, tensile, torque, tip flexibility, coating integrity, particulate, and friction testing per ISO 11070 and in-house standards. Biocompatibility verified per ISO 10993-1.

Technological Characteristics

Guide wire with stainless steel proximal core and NiTi distal core. Coatings: distal hydrophilic (polyurethane/tungsten/hydrophilic polymer), proximal PTFE. Distal radiopaque gold coil. Diameter 0.014/0.018", length 180/300 cm. Sterilization: Ethylene oxide (ISO 11135).

Indications for Use

Indicated for directing catheters to desired anatomical locations in peripheral vasculature during diagnostic or interventional procedures. Not for neurovascular or coronary use.

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

• Radifocus Glidewire Advantage (K122590)
• Radifocus Glidewire Advantage (K063372)

Reference Devices

• V-18 (K033742)
• V-14 (K112745)
• Miracle (K052339)
• Command (K122573)
• Spartacore (K152709)

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

January 30, 2017

Terumo Medical Corporation Mr. Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921

Re: K163004

Trade/Device Name: Radifocus Glidewire Advantage Track Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 25, 2016 Received: November 2, 2016

Dear Mr. Lu:

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 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.

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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,

Fernando Aguel
Fernando Aguel
-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) K163004

Device Name Radifocus Glidewire Advantage Track

Indications for Use (Describe)

The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

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

| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CER 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the Terumo logo. The logo consists of a red, curved line above the word "TERUMO" in green, block letters. The red line appears to be a stylized representation of a bird's wing or a swoosh, adding a dynamic element to the design.

# 510(K) SUMMARY

#### A. SUBMITTER INFORMATION (807.92(a)(1))

| Prepared by: | Liang Lu |
|--------------|--------------------------------------|
| | Senior Regulatory Affairs Specialist |
| | Terumo Medical Corporation |
| | Tel. [phone] |
| | Fax [phone] |

#### Prepared for: Owner/Operator

Terumo Corporation 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo Japan 151-0072 Owner/Operator Number: 8010026

#### Manufacturer and Sterilization Facility (Applicant)

Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 9681834

#### Contact Person: Liang Lu

Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Tel. [phone] Fax [phone] E-mail: [e-mail]

Date prepared: January 23, 2016

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Image /page/4/Picture/1 description: The image shows the Terumo logo. The logo consists of a red angled line above the word "TERUMO" in green. The red line is positioned above and to the left of the word, creating a sense of forward movement.

# B. DEVICE NAME (807.92(a)(2))

| Proprietary Name: | Radifocus Glidewire Advantage Track |
|-----------------------|-------------------------------------|
| Common Name: | Guide Wire |
| Classification Name: | Wire, Guide, Catheter |
| Classification Panel: | Cardiovascular |
| Regulation: | 21CFR870.1330 |
| Product Code: | DQX |
| Classification: | Class II |

## C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device(s) to which substantial equivalence is claimed are:

- K122590 and K063372 Radifocus Glidewire Advantage manufactured by . Ashitaka Factory of Terumo Corporation.

| 510(K) No. | Competitor's product | Competitor's name |
|------------|----------------------|-------------------|
| K033742 | V-18 | Boston Scientific |
| K112745 | V-14 | Boston Scientific |
| K052339 | Miracle | ASAHI INTECC |
| K122573 | Command | Abbott Vascular |
| K152709 | Spartacore | Abbott Vascular |

The following competitors' devices were used as reference devices:

## D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the Radifocus Glidewire Advantage Track, manufactured by Ashitaka Factory of Terumo Corporation, for the modifications on the previously cleared predicate device (K122590 and K063372) manufactured by the same factory.

The proposed Radifocus Glidewire Advantage Track is identical to the predicate Radifocus Glidewire Advantage (K122590 and K063372) with the exception of the following:

- . The proximal core wire material of the predicate device (K063372 and K122590 Radifocus Glidewire Advantage) is being modified from NiTi (Nickel Titanium alloy) to Stainless Steel;

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Image /page/5/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.

- . The angle of the angle-shape wire distal tip is being modified from 45° to 35°;
- . The labeling for the proposed Radifocus Glidewire Advantage Track is being slightly modified

#### E. DEVICE DESCRIPTION (807.92(a)(4))

#### Principle of Operation Technology

The Radifocus Glidewire Advantage Track is operated by manual process.

#### Design/Construction

The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into a needle or catheter.

During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.

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Image /page/6/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word.

# Materials

The materials for the Radifocus Glidewire Advantage Track are provided in Table 1 below.

| Part | | Raw material |
|--------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Core wire*(Proximal portion from junction) | | Stainless steel |
| Core wire*(Distal portion from junction) | | Nickel-Titanium alloy |
| First coating* | | Polyurethane containing tungsten |
| Second coating on distal portion of wire*<br>(Hydrophilic polymer) | | -Hydrophilic polymer<br>Half-ester methyl vinyl ether-maleic<br>anhydridecopolymer<br>-Under coat<br>Polyvinyl chloride |
| PTFE spiral<br>coating on<br>proximal portion<br>of wire | Under coating<br>Top coating*<br>Spiral coating* | Polytetrafluoroethylene (PTFE) |
| Edge protection<br>part | Metal part*<br>Solder* | Platinum/ Iridium (Pt/Ir)<br>Tin/Silver (Sn/Ag) |
| | Third coating on edge protection part*<br>(Hydrophilic polymer) | Dimethyle acrylamideglycidyl<br>methacrylate copolymer |
| Tip coil marker | | Gold (Au) |

| Table 1: List of Materials | |
|----------------------------|--|
|----------------------------|--|

* Blood contacting material

# Specifications

The specifications for the Radifocus Glidewire Advantage Track are provided in the Table 2 below.

| Part | Specification |
|-----------------------------|------------------------|
| Diameter of Wire | 0.014 and 0.018" |
| Length of Wire | 180 and 300 cm* |
| Shapes of Wire (distal tip) | Angled (Tip angle 35°) |

* tolerance: ± 20 mm

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Image /page/7/Picture/1 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is curved and positioned above and to the left of the word.

# F. INDICATIONS FOR USE (807.92(a)(5))

The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

Note: The indications for use are identical to the predicate device, Radifocus Glidewire Advantage (K122590 and K063372).

## G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

The Radifocus Glidewire Advantage Track, subject of this traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:

- Predicate Device: K063372 and K122590 Radifocus Glidewire Advantage, . manufactured by Ashitaka Factory of Terumo Corporation.
A comparison of the technological characteristics is summarized in Table 3 below.

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Image /page/8/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and slightly to the left of the word.

| Table 3:<br>Comparison of<br>Device<br>Characteristics | New Device:<br>Radifocus Glidewire Advantage Track | Predicate Device:<br>Radifocus Glidewire<br>Advantage (K063372) | Predicate Device:<br>Radifocus Glidewire<br>Advantage (K122590) |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Ashitaka Factory of Terumo Corp. | Same | Same |
| Intended<br>Use/Indication<br>for<br>Use | Designed to direct a catheter to the<br>desired anatomical location in the<br>peripheral vasculature during diagnostic<br>or interventional procedures. This device<br>is not intended for neurovascular or<br>coronary interventions. | Same | Same |
| Operation Principle | Manual | Same | Same |
| Design/<br>Construction | The Radifocus Glidewire Advantage<br>Track consists of a Nickel Titanium alloy<br>(distal) and stainless steel (proximal) core<br>wire.<br><br>A polyurethane and hydrophilic coating is<br>applied to the distal portion of the wire<br>while a PTFE coating is applied to the<br>proximal portion. The wire distal<br>segment comes in angled configuration.<br>The wire contains a distal radiopaque<br>gold coil.<br><br>The wire is packed in a plastic holder<br>contained within an individual package. A<br>guide wire inserter is contained within the<br>individual package to assist with the | The Radifocus Glidewire<br>Advantage consists of a<br>Nickel Titanium alloy core<br>wire<br><br>Same (the distal radiopaque<br>gold coil is for the 0.018"<br>only). | The Radifocus Glidewire<br>Advantage consists of a<br>Nickel Titanium alloy core<br>wire.<br><br>Same |
| | | Same unless mentioned below: | Same as K063372 unless mentioned below: |
| Materials | Core wire (Proximal portion from junction): Stainless steel (Distal portion from junction): Nickel-Titanium alloy First coating: Polyurethane containing tungsten Second coating on distal portion of wire (Hydrophilic polymer): Half-ester methyl vinyl ether-maleic anhydridecopolymer Under coat: Polyvinyl chloride PTFE spiral coating on proximal portion of wire: Polytetrafluoroethylene (PTFE) Edge protection part Metal part: Platinum/ Iridium (Pt/Ir) Solder: Tin/Silver (Sn/Ag) Third coating on edge protection part (Hydrophilic polymer): Dimethyle acrylamideglycidyl methacrylate copolymer Tip coil marker: Gold (Au) available for 0.014" and 0.018" | Core wire: Nickel-Titanium alloy First coating: Polyurethane containing tungsten Tip coil marker: Gold (Au) only available for 0.018" | Tip coil marker: Gold (Au) only available for 0.014" |
| Package | Individual package on which the product label and the peel-off labels are attached 1 unit per package | Same | Same |
| Specifications | Diameter of Wire: 0.014 and 0.018" Length of Wire: 180 and 300 cm<br>* tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 35°) Accessory Devices: Guide wire inserter | Diameter of Wire: 0.018 - 0.038" Length of Wire: 150 - 300 cm<br>* tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 45°), straight, J shaped Accessory Devices: Guide wire inserter | Diameter of Wire: 0.014" Length of Wire: 180 and 300 cm<br>* tolerance: ± 20 mm Shapes of Wire (distal tip): Angled (Tip angle 45°) Accessory Devices: Guide wire inserter |
| Sterilization | Ethylene oxide | Same | Same |
| Shelf Life | 24 months | Same | Same |

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Image /page/9/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red, curved line above the word "TERUMO" in green, block letters. The red line is positioned above and to the left of the word, creating a sense of motion or direction.

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Image /page/10/Picture/1 description: The image contains the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the word. The swoosh starts above the "T" and extends to the right.

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# H. NON CLINICAL TESTS (807.92(b)(1))

#### Performance Testing

Performance testing was conducted to demonstrate substantial equivalence to the predicate device, to verify conformity to applicable external and internal standards, and verify that aging does not affect the Radifocus Glidewire Advantage Track. All testing met acceptance criteria. Table 4 below provides a list of the performance tests that were performed on the proposed Radifocus Glidewire Advantage Track.

| Test | Standard |
|---------------------------------------------------|-----------------------------------|
| Surface | ISO 11070: 2014 Section 4.3 |
| Corrosion resistance | ISO 11070: 2014 Section 4.4 |
| Radio-detectability | ISO 11070: 2014 Section 4.5 |
| Size designation | ISO 11070: 2014 Section 8.2 |
| Fracture test | ISO 11070: 2014 Section 8.4 |
| Flexing test | ISO 11070: 2014 Section 8.5 |
| Peak tensile force of guidewire | ISO 11070: 2014 Section 8.6 |
| Torque strength | FDA Guidance<br>In-house Standard |
| Torqueability<br>(Torque control) | FDA Guidance<br>In-house Standard |
| Tip Flexibility<br>(Tip impact) | FDA Guidance<br>In-house Standard |
| Coating Adherence<br>/Integrity | FDA Guidance<br>In-house Standard |
| Particulate test | FDA Guidance<br>In-house Standard |
| Ease of removing from the holder | In-house Standard |
| Sliding friction<br>(hydrophilic coating portion) | In-house Standard |
| Sliding friction<br>(PTFE coating portion) | In-house Standard |
| Proximal shaft stiffness | In-house Standard |

Table 4: Summary of Performance Testing

The Radifocus Glidewire Advantage Track met the predetermined acceptance criteria. Based on the results of the performance testing, the proposed Radifocus Glidewire Advantage Track is substantially equivalent to the predicate.

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Image /page/12/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The swoosh is positioned above and to the left of the word "TERUMO."

### Biocompatibility

In accordance with ISO 10993-1, the Radifocus Glidewire Advantage Track is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours). This is the same classification as the predicate.

The finished device's patient contacting parts were tested in accordance with the tests recommended in the Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff issued on June 16, 2016. Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product.

The Table 5 below provides a list of biocompatibility tests conducted on the proposed Radifocus Glidewire Advantage Track.

| Non-aged, sterile, whole device |
|-----------------------------------------------------|
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Acute Systemic Toxicity |
| Pyrogenicity |
| Hemolysis |
| Thrombogenicity |
| Complement Activation (Immunology) |
| Physicochemical Profile (Physicochemical and FT-IR) |
| Accelerated-aged (2 years), sterile, whole device |
| Cytotoxicity |
| Hemolysis |
| Physicochemical Profile (Physicochemical and FT-IR) |

Table 5: Summary of ISO 10993 Biocompatibility Testing

Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.

## Sterilization

The sterility of the device is assured using a sterilization method validated in

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Image /page/13/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red angled line above the company name, which is written in green, block letters. The red line is above and to the left of the company name.

accordance with ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) will meet requirements for limited exposure devices (contact up to 24 hours) prior to use based on ISO 10993-7, Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals.

Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device after 24 hours of aeration.

#### Risk Analysis

A Product Risk Analysis was conducted in accordance with ISO 14971: 2007, taking into account the modifications to the previous device, and it was determined that there were no new issues of safety or effectiveness.

## I. CLINICAL TESTS (807.92(b)(2))

This 510(k) does not include data from clinical tests.

## J. CONCLUSION (807.92(b)(3))

In summary, the Radifocus Glidewire Advantage Track, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device:

- . K122590 and K063372 – Radifocus Glidewire Advantage, manufactured by Ashitaka Factory of Terumo Corporation