Endura guidewire

K161702 · Vascular Solutions, Inc. · DQX · Dec 6, 2016 · Cardiovascular

Device Facts

• Record ID: K161702
• Device Name: Endura guidewire
• Applicant: Vascular Solutions, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Endura guidewire is a straight-tip, 0.014" diameter wire (190 cm or 300 cm lengths) used to navigate coronary and peripheral vasculature. It functions as a track for catheters and interventional devices. The device features a bi-metal stainless steel and nitinol core, a distal radiopaque coil, a distal hydrophilic coating, and a proximal PTFE coating. It is used in clinical settings (e.g., cath lab) by physicians during percutaneous interventions. The device provides mechanical support and guidance for interventional tools, facilitating access to target vascular sites. It is a sterile, single-use device.

Clinical Evidence

Bench testing only. Verification testing included tensile strength, torque strength, torque response, support profile, tip load, fracture resistance, flex resistance, coating adherence/integrity (HPC and PTFE), corrosion resistance, track force, friction force, fluoroscopy visualization, and length extension. Biocompatibility testing included cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, pyrogenicity, and hemocompatibility. All tests met acceptance criteria.

Technological Characteristics

Bi-metal stainless steel and nitinol core wire; 0.014" O.D.; 190 cm/300 cm lengths; distal radiopaque coil; hydrophilic coating (distal); PTFE coating (proximal). Sterilized via Ethylene Oxide (EO) to SAL 10^-6. Mechanical device; no software or electronics.

Indications for Use

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

• R350 guidewire (K151234)

Reference Devices

• Runthrough NS guidewire (K063695)
• MiracleBros 6 guidewire (K052339)

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

December 6, 2016

Vascular Solutions, Inc. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K161702

Trade/Device Name: Endura Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 3, 2016 Received: November 4, 2016

Dear Beka Vite:

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 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/Resourcesfor You/Industry/default.htm.

Sincerely.

Brian D. Pullin -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)

Device Name Endura guidewire

Indications for Use (Describe)

The Endura guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or 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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### 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: December 2, 2016

510(k) Number: K161702

## 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 | Endura guidewire |
| Common / Usual Name | Guidewire |
| Classification Name | 21 CFR 870.1330, Catheter Guidewire (DQX) |
| Predicate Device | K151234 - R350 guidewire (Vascular Solutions, Inc.) |
| Reference Device | K063695 - Runthrough NS guidewire (Terumo Medical Corp.)<br>K052339 - MiracleBros 6 (Asahi Intecc Co., Ltd.) |

## Device Description

The Endura guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Endura guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal end of the Endura guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.

## Intended Use

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

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#### Technological Characteristics Comparison

| Characteristic | Subject Device | Predicate Device |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| | Endura Guidewire | R350 Guidewire<br>(K151234, VSI) |
| Indications for Use | ...for use in percutaneous procedures to introduce and position catheters and other<br>interventional devices within the coronary and/or peripheral vasculature. | |
| Anatomical Location | Coronary and peripheral vasculature | |
| Dimensions | Maximum O.D.: 0.014"<br>Length: 190 cm and 300 cm | Maximum O.D.: 0.013"<br>Length: 350 cm |
| Core Wire | Nitinol and Stainless Steel | Nitinol |
| Distal Tip | 3 cm radiopaque coil | 5 cm radiopaque coil |
| Lubricious Coatings | Hydrophilic (distal end) and PTFE (proximal end) | |
| Sterility | Ethylene Oxide (EO) – Sterility Assurance Level (SAL) 10-6 | |

The table below compares the technological characteristics of the Endura guidewire.

### Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The Endura guidewire is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

- Tensile Strength ●
- Torque Strength
- Torque Response (Torqueability) ●
- Guidewire Support Profile
- Tip Load (Tip Flexibility)
- Fracture Resistance
- Flex Resistance
- Hydrophilic Coating Particulate (Coating Adherence/Integrity)
- PTFE Coating Adhesion (Coating Adherence/Integrity)
- Corrosion Resistance
- Track Force
- Friction Force (HPC and PTFE) .
- Fluoroscopy Visualization
- Length Extension

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The only evaluation that was not performed on the modified guidewire was package integrity as it is identical to the predicate device. Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

- Cytotoxicity
- Sensitization
- . Irritation/Intracutaneous Reactivity
- Systemic Toxicity
- Pyrogenicity
- Hemocompatibility

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore the Endura guidewire, a modified version of the R350, is considered substantially equivalent to the predicate device.