Warrior 14 guidewire

K180128 · Vascular Solutions, Inc. · DQX · Feb 16, 2018 · Cardiovascular

Device Facts

• Record ID: K180128
• Device Name: Warrior 14 guidewire
• Applicant: Vascular Solutions, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.

Device Story

The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire used in percutaneous procedures to facilitate the placement of catheters and interventional devices within coronary and peripheral vasculature. It features a 0.009" diameter tapered distal tip with a 14-gram tip load and a straight, shapeable design. The device includes a hydrophilic coating on the distal portion and a PTFE coating on the proximal portion. It is available in 190cm and 300cm lengths, with the 190cm version offering a guidewire extension feature. The distal 2.5cm of the spring coil is radiopaque (platinum/tungsten) for visualization under fluoroscopy. The device is intended for single-use and is sterilized via ethylene oxide. It is operated by clinicians in a clinical setting to navigate vasculature, with output visualized via fluoroscopy to guide interventional procedures.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing per ISO 10993-1 confirmed the device is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, and thromboresistant. Bench verification included catheter compatibility, coating integrity, corrosion resistance, dimensional analysis, radiopacity, tensile strength, tip flexibility/shapeability, and torque strength/torqueability. All tests met acceptance criteria.

Technological Characteristics

0.014" diameter stainless steel core; 0.009" tapered distal tip; 190cm/300cm lengths; hydrophilic distal coating; PTFE proximal coating; platinum/tungsten radiopaque tip (2.5cm); 14g tip load; ethylene oxide sterilization. Mechanical device; no software or energy source.

Indications for Use

Indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

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

• Vascular Solutions Spectre guidewire (K163444)

Reference Devices

• Asahi Confianza Pro 12 guidewire (K041531)
• Vascular Solutions R350 guidewire (K151234)

Submission Summary (Full Text)

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February 16, 2018

Vascular Solutions. Inc % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K180128

Trade/Device Name: Warrior 14 guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: January 14, 2018 Received: January 17, 2018

Dear Mark Job:

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. Iisting 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 (OS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Kenneth J. Cavanaugh -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)

K180128

Device Name Warrior 14 guidewire

Indications for Use (Describe)

The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.

| 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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Image /page/3/Picture/0 description: The image shows the logo for Vascular Solutions. The logo features a tan square with a series of black squares above it that decrease in size as they move upwards, creating a visual effect similar to smoke or a rising pattern. Below the square is the word "Vascular" in a bold, serif typeface, with the word "SOLUTIONS" underneath in a smaller, sans-serif font.

# 510(k) Summary

[As required by 21 CFR 807.92]

K180128 510(k) NUMBER:

# SUBMITTER

Vascular Solutions 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Phone: [phone] Fax: [phone] Contact Person: Becky Astrup, Regulatory Product Specialist Date Prepared: December 8, 2017

# DEVICE

Name of Device: Warrior 14 guidewire Common or Usual Name: Catheter Guidewire Classification Name: Catheter Guidewire (21 CFR 870.1330) Regulatory Class: II Product Code: DQX

# PREDICATE/REFERENCE DEVICES

The legally marketed devices to which substantial equivalence is claimed is:

Vascular Solutions Spectre guidewire, K163444 (cleared January 6, 2017)

The Asahi Confianza Pro 12 guidewire, K041531 (cleared August 3, 2004) and the Vascular Solutions R350 guidewire, K151234 (cleared November 18, 2015) are included as reference devices for this submission.

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### DEVICE DESCRIPTION

The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire with a 0.009" diameter tapered distal tip. The distal 20cm of the guidewire has a spring coil, of which the distal 2.5cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. It is available in 190cm and 300cm lengths. The proximal end of the 190cm version has a guidewire extension feature. The Warrior 14 guidewire is intended for single use and sterilized with ethylene oxide.

# INDICATIONS FOR USE

The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below compares the technological characteristics of the Warrior 14 guidewire and, Spectre guidewire predicate.

| Characteristic | Subject Device:<br>Warrior 14 | Predicate Device:<br>Spectre |
|------------------------------|-------------------------------|----------------------------------------|
| Maximum Diameter | 0.014'' | Identical |
| Lengths | 190cm, 300cm | Identical |
| Tip Configuration | Straight, Shapeable | Identical |
| Lubricious Coating- Distal | Hydrophilic | Identical |
| Lubricious Coating- Proximal | PTFE | Identical |
| Core Wire Material | Stainless Steel | Similar<br>Nitinol and Stainless Steel |
| Radiopaque Material | Platinum, Tungsten | Identical |
| Radiopaque Tip Length | 2.5cm | Equivalent<br>3cm |
| Tip O.D. | 0.009" | Similar<br>0.014" |
| Tip Load | 14g | Similar<br>< 1.5g |

# PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

# Biocompatibility Testing

The biocompatibility evaluation for the Warrior 14 guidewire was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Warrior 14 guidewire is considered an externally communicating device in contact with circulating blood and tissue for a limited period of time (<24 hours) during use. The battery of tests included the following:

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- Cytotoxicity
- Sensitization .
- Irritation
- Acute Systemic Toxicity ●
- Material Mediated Pyrogenicity
- Hemolysis
- Complement Activation ●
- Thombogenicity ●

Passing results from biomaterial tests demonstrate that the Warrior 14 guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant.

# Performance Testing- Bench

The device design was verified through the following tests:

- Catheter Compatibility ●
- Coating Adherence/Integrity .
- Corrosion Resistance .
- Dimensional Analysis ●
- Radiopacity ●
- Tensile Strength ●
- Tip Flexibility ●
- Tip Shapeability .
- Torqueability ●
- Torque Strength .

The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety or effectiveness.

# CONCLUSIONS

In summary, the technological differences between the Warrior 14 guidewire, subject of this 510(k) and the predicate device do not raise different questions of safety and effectiveness. The Warrior 14 guidewire is identical to the predicate device in its indications for use and substantially equivalent in technology, materials, and performance to the predicate device. Performance data demonstrate that the Warrior 14 guidewire is as safe, as effective, and performs as well as the predicate device. Therefore, it can be concluded that the Warrior 14 guidewire is substantially equivalent to the predicate device.