R350 guidewire

K151234 · Vascular Solutions, Inc. · DQX · Nov 18, 2015 · Cardiovascular

Device Facts

• Record ID: K151234
• Device Name: R350 guidewire
• Applicant: Vascular Solutions, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

Device Story

The R350 guidewire is a 350 cm long, 0.013" O.D. device used to facilitate the placement of catheters and interventional devices within coronary and peripheral vasculature. It consists of a nitinol alloy mandrel with a radiopaque gold-coated tungsten coil distal tip. The proximal 150 cm features a PTFE coating, while the distal 200 cm has a hydrophilic coating to reduce friction. The device is used by physicians in clinical settings during percutaneous procedures. It provides a track for interventional devices, aiding in navigation through the vasculature. The radiopaque tip allows for visualization under fluoroscopy, assisting the clinician in precise positioning. The device benefits patients by enabling minimally invasive access to target vascular sites.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including mechanical performance (torque, flex, fracture, tensile strength, tip deflection) and biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, platelet/leukocyte count, PTT, and in vivo thrombogenicity).

Technological Characteristics

Nitinol alloy mandrel; gold-coated tungsten coil distal tip; PTFE coating (proximal 150 cm); hydrophilic coating (distal 200 cm). Dimensions: 350 cm length, 0.013" max O.D. Mechanical properties verified via torque, flex, fracture, and tensile testing. Biocompatibility per ISO 10993-1 and ASTM standards for hemolysis and platelet/leukocyte count.

Indications for Use

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

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 (K021990)
• Asahi RG3 guidewire (K141339)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2015

Vascular Solutions, Inc. Beka Vite Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55639

Re: K151234

Trade/Device Name: R350 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: October 16, 2015 Received: October 19, 2015

Dear Ms. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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.

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" (21CFR 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 yours.

M.A. Hillebrenner
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) K151234

Device Name R350 Guidewire

Indications for Use (Describe)

The R350 guidewire is indicated 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)

#### 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 [e-mail]

"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}------------------------------------------------

# 510(k) Summary [As required by 21 CFR 807.92] Date Prepared: May 06, 2015 510(k) Number: K151234

## Submitter's Name / Contact Person

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

#### Contact Person

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

## General Information

| Trade Name | R350 guidewire |
|---------------------|---------------------------------------------------------------------------------------------------------|
| Common / Usual Name | Guidewire |
| Classification Name | 21 CFR 870.1330, DQX – catheter guidewire |
| Predicate Devices | K021990 – R350 guidewire (Galt Medical Corp.)<br>K141339 - Asahi RG3 guidewire (Asahi Intecc Co., Ltd.) |

## Device Description

The R350 guidewire is 350 cm in length with a 0.013" maximum outer diameter (O.D) (0.012″ nominal O.D.). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a PTFE coating, while the distal 200 cm has a hydrophilic coating.

## Indications for Use

The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

## Technological Characteristics Comparison

The R350 guidewire is similar in design and intended use to the predicate devices as they are all guidewires intended for use in percutaneous procedures. The R350 guidewire and predicate devices are similar in size, and all have a radiopaque tip and lubricous coating.

## Substantial Equivalence and Summary of Studies

The technological differences between the R350 guidewire and predicate devices were evaluated through biocompatibility and mechanical tests, and results did not raise new questions of safety or effectiveness.

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

The R350 guidewire is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The R350 guidewire design has been verified through the following tests and inspections:

- Hydrophilic Coating Particulate ●
- Hydrophilic Coating Delamination Inspection (after Fracture Test) .
- Fluoroscopy Visualization ●
- Guidewire O.D. ●
- Guidewire Length
- Component Alignment .
- Interface with Other Devices .
- Torqueability
- Torque ●
- Flex .
- . Fracture
- Tip Deflection Force ●
- Tip Load
- Distal Solder Joint Tensile ●
- . Proximal Solder Joint Tensile
- Corrosion

Device samples passed the following biocompatibility tests per ISO 10993-1:

- . Cytotoxicity
- . Sensitization
- Irritation ●
- Acute Systemic Toxicity ●
- Material Mediated Pyrogenicity .
- ASTM Hemolysis
- Complement Activation .
- ASTM Platelet and Leukocyte Count Assay ●
- Partial Thromboplastin Time .
- In Vivo Thrombogenicity

The results of the design verification and validation tests met the specified acceptance criteria and did not raise new questions of safety and effectiveness. Therefore, the R350 guidewire is substantially equivalent to the predicate devices.