Raider Guidewire

K173532 · Vascular Solutions, Inc. · DQX · Dec 15, 2017 · Cardiovascular

Device Facts

• Record ID: K173532
• Device Name: Raider Guidewire
• Applicant: Vascular Solutions, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

Raider guidewire is a stainless steel core guidewire (0.014" diameter) used in percutaneous procedures to facilitate catheter and interventional device placement in coronary and peripheral vasculature. Device features a shapeable distal tip with radiopaque coil, polymer jacket, hydrophilic distal coating, and PTFE proximal coating. Available in 190 cm and 300 cm lengths; compatible with guidewire extensions. Operated by physicians in clinical settings (e.g., cath lab) to navigate vasculature. Output is physical guidance for interventional tools. Benefits include precise device delivery during minimally invasive procedures.

Clinical Evidence

Bench testing only. Performance verified via tensile strength, torque strength, torqueability, tip flexibility, coating adherence, catheter compatibility, dimensional analysis, radiopacity, and corrosion testing. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, hemolysis, complement activation, and thrombogenicity.

Technological Characteristics

Stainless steel core; 0.014" diameter; 190/300 cm lengths. Distal portion: radiopaque coil, polymer jacket, hydrophilic coating. Proximal portion: PTFE coating. Mechanical device; no energy source or software. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients undergoing percutaneous procedures requiring catheter or interventional device positioning within 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

• Spectre Guidewire (K163444)

Reference Devices

• Hi-Torque Pilot 200 (K101116)
• R350 Guidewire (K151234)

Submission Summary (Full Text)

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December 15, 2017

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

Re: K173532

Trade/Device Name: Raider Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: November 13, 2017 Received: November 15, 2017

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 Mav 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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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 mediation-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)

K173532

Device Name Raider guidewire

Indications for Use (Describe)

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

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

---

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(K) SUMMARY

[As required by 21 CFR 807.92]

Date Prepared: October 20, 2017

510(k) Number: __K173532

# Submitter's Name / Contact Person

#### Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812

#### Contact Person

Beka Vite Sr. Regulatory Product Specialist Tel: [phone] Fax: [phone]

## General Information

| Trade Name | Raider guidewire |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name | Guidewire |
| Classification Name | 21 CFR 870.1330 |
| Predicate Device | Spectre Guidewire (K163444 - Vascular Solutions, Inc.; January 6, 2017) |
| Reference Device | Hi-Torque Pilot 200 (K101116 – Abbott Vascular; June 23, 2010)<br>R350 Guidewire (K151234 - Vascular Solutions, Inc.; November 18, 2015) |

#### Device Description

The Raider guidewire is a stainless steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 190 cm and 300 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.

#### Intended Use

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

# Technological Characteristics Comparison

The table below compares the technological characteristics of the Raider guidewire and the predicate device.

| Characteristic | Raider Guidewire | Predicate Device |
|--------------------|-----------------------------------------------|-----------------------------|
| Maximum Diameter | 0.014" | Same |
| Lengths | 190 cm, 300 cm | Same |
| Core Wire Material | Stainless Steel with Distal<br>Polymer Jacket | Nitinol and Stainless Steel |
| Distal Tip | Radiopaque Coil | Same |

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| Characteristic | Raider Guidewire | Predicate Device |
|---------------------|-----------------------------------------|------------------|
| Lubricious Coatings | Hydrophilic (Distal)<br>PTFE (Proximal) | Same |

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of substantial equivalence for the Raider guidewire. The device design has been verified through the following tests:

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

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

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

The Raider guidewire is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The minor technological and material differences between the Raider guidewire and the predicate device raise no new questions of safety or effectiveness. Performance data demonstrate that the Raider guidewire is as safe, as effective, and performs as well as the predicate device. Therefore, it can be concluded that the Raider guidewire is substantially equivalent to the predicate device.