Bandit guidewire

K181647 · Vascular Solutions, Inc. · DQX · Jul 20, 2018 · Cardiovascular

Device Facts

• Record ID: K181647
• Device Name: Bandit guidewire
• Applicant: Vascular Solutions, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 20, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Bandit 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

Bandit guidewire is a 0.014" diameter stainless steel core guidewire; features 0.008" diameter tapered distal tip; available in 200 cm and 300 cm lengths. Distal portion includes radiopaque coil, polymer jacket, and hydrophilic coating; proximal portion has PTFE coating. Used in percutaneous procedures to introduce and position catheters/interventional devices within coronary and peripheral vasculature. Operated by physicians in clinical settings. Device facilitates navigation through vasculature; radiopaque tip allows visualization under fluoroscopy; coatings reduce friction. Benefits include improved trackability and positioning of interventional devices.

Clinical Evidence

Bench testing only. Verification tests included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity, catheter compatibility, dimensional analysis, radiopacity, and corrosion. Biocompatibility testing performed per ISO 10993-1 for externally communicating devices in contact with circulating blood (<24 hours), including cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, hemolysis, complement activation, and thrombogenicity. All tests met specified acceptance criteria.

Technological Characteristics

0.014" diameter stainless steel core guidewire; 0.008" tapered distal tip; radiopaque coil; hydrophilic coating (distal); PTFE coating (proximal). Lengths: 200 cm, 300 cm. Biocompatibility per ISO 10993-1. Mechanical testing: tensile, torque, flexibility, corrosion. Non-powered, manual device.

Indications for Use

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

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

• Raider guidewire (K173532)

Reference Devices

• Fielder XT guidewire (K072431)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 20, 2018

Vascular Solutions, Inc. Ms. Becky Astrup Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K181647

Trade/Device Name: Bandit Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: June 21, 2018 Received: June 22, 2018

#### Dear Ms. Astrup:

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

{1}------------------------------------------------

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); 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 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,

# Lydia S. Glaw -S 2018.07.20 15:51:10 -04'00'

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K181647

Device Name Bandit guidewire

Indications for Use (Describe)

The Bandit 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) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for Vascular Solutions. The logo features the word "Vascular" in a bold, serif font, with the word "Solutions" in a smaller, sans-serif font underneath. Above the text is a square shape with a gradient of black squares that fade out as they rise above the square. The square is a light tan color.

# 510(k) Summary

[As required by 21 CFR 807.92]

510(k) Number: _K181647

# SUBMITTER AND DEVICE

| Submitter: | Vascular Solutions, Inc.<br>6464 Sycamore Court North<br>Minneapolis, MN 55369 USA |
|------------|------------------------------------------------------------------------------------|
|------------|------------------------------------------------------------------------------------|

| Date Prepared: | June 21st, 2018 |
|----------------|-----------------|
|----------------|-----------------|

| Name of Device: | Bandit guidewire |
|-----------------|------------------|
|-----------------|------------------|

| Establishment Registration: | 2134812 |
|-----------------------------|---------|
|-----------------------------|---------|

| Common or Usual Name: | Guidewire |
|-----------------------|-----------|
|-----------------------|-----------|

| Phone: | 763-656-4300 |
|--------|--------------|
|--------|--------------|

| Classification Name: | Catheter Guidewire<br>(21 CFR 870.1330) |
|----------------------|-----------------------------------------|
|----------------------|-----------------------------------------|

| Fax: | 763-656-4253 |
|------|--------------|
|------|--------------|

| Regulatory Class: | II |
|-------------------|----|
|-------------------|----|

| Contact Person: | Becky Astrup,<br>Regulatory Product Specialist |
|-----------------|------------------------------------------------|
|-----------------|------------------------------------------------|

| Product Code: | DQX |
|---------------|-----|
|---------------|-----|

# PREDICATE DEVICE

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

## Vascular Solutions Inc., Raider guidewire, K173532 cleared December 15, 2017.

The Asahi Intecc Co., LTD Fielder XT guidewire, K072431 cleared September 26, 2007 is included as a reference device for this submission.

# DEVICE DESCRIPTION

The Bandit guidewire is a 0.014" diameter stainless steel core guidewire with a 0.008" diameter tapered distal tip. It is available in 200 cm and 300 cm lengths. The 200 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.

{4}------------------------------------------------

# INDICATIONS FOR USE

The Bandit 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 Bandit guidewire and the Raider guidewire predicate device.

| Characteristic | Subject Device:<br>Bandit | Predicate Device:<br>Raider |
|---------------------|-----------------------------------------------|-----------------------------|
| Maximum Diameter | 0.014" | Identical |
| Lengths | 200 cm, 300 cm | Similar<br>190cm, 300cm |
| Core Wire Material | Stainless Steel with Distal<br>Polymer Jacket | Identical |
| Distal Tip | Radiopaque Coil | Identical |
| Lubricious Coatings | Distal: Hydrophilic<br>Proximal: PTFE | Identical |

# PERFORMANCE DATA

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

#### Performance Testing - Bench

The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests:

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

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

{5}------------------------------------------------

#### Biocompatibility Testing

The biocompatibility evaluation for the Bandit 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 Bandit 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:

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

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

## CONCLUSION

The subject Bandit guidewire is substantially equivalent to the Raider guidewire predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The results of design verification tests do not raise new or different questions of safety and effectiveness; therefore, the Bandit guidewire is substantially equivalent to the predicate device.