ENROUTE 0.014 Guidewire

K160643 · Lake Region Medical · DQX · Oct 18, 2016 · Cardiovascular

Device Facts

• Record ID: K160643
• Device Name: ENROUTE 0.014 Guidewire
• Applicant: Lake Region Medical
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature. Contraindications: ENROUTE 0.014" Guidewire is not intended for use in: - The cerebral or coronary vasculature - Patients judged not acceptable for percutaneous intervention

Device Story

Disposable 0.014" diameter stainless steel guidewire; 95cm length; PTFE-coated shaft; distal section features centreless-ground reduced diameter for flexibility; platinum-tungsten spring coil for radiopacity; hydrophilic coating on distal tip. Operated manually by physician during peripheral vascular procedures to facilitate catheter placement. Provides tactile feedback and torque response for navigation through vasculature. X-ray visualization used for guidance. Benefits patient by enabling minimally invasive access to peripheral vessels.

Clinical Evidence

Bench testing only. No clinical data. Testing included tensile strength, torque strength/response, dimensional measurements, catheter compatibility, coating integrity, particulate testing, tip stiffness, radiopacity, biocompatibility (ISO 10993-1), and shelf life.

Technological Characteristics

Stainless steel core wire; platinum-tungsten spring coil; PTFE shaft coating; hydrophilic distal coating. 0.014" diameter; 95cm length. Manual operation. Biocompatibility per ISO 10993-1. Sterilization method identical to predicates.

Indications for Use

Indicated for use in peripheral vasculature. Contraindicated for cerebral or coronary vasculature and patients ineligible for percutaneous intervention.

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

• Brivant Guidewire (Rapidwire Plus variant – previously known as SLK) (K060551)
• Nitrex Nitinol Guidewire (K040345)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, layered on top of each other.

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

October 18, 2016

Lake Region Medical Mr. Michael Dunning QA/RA Manager Parkmore West Business Park Galway G07001 Ireland

Re: K160643

Trade/Device Name: ENROUTE 0.014" Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 7, 2016 Received: September 9, 2016

Dear Mr. Dunning:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

the quality systems (OS) 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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

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

## Indications for Use

510(k) Number (if known) K160643

Device Name ENROUTE 0.014" Guidewire

#### Indications for Use (Describe) The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature.

Contraindications:

ENROUTE 0.014" Guidewire is not intended for use in:

- The cerebral or coronary vasculature
- Patients judged not acceptable for percutaneous intervention

| 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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Lake Region Healthcare. The logo consists of a stylized heart shape in red and gray, followed by the words "Lake Region" in a clean, sans-serif font. Below "Lake Region" is the word "MEDICAL" in a smaller, light gray font.

| 510(k) Summary – ENROUTE 0.014” Guidewire |
|-------------------------------------------|
| K160643 - Traditional 510(k) |

| Device Name | ENROUTE 0.014" Guidewire | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitters name | Brivant Ltd T/A Lake Region Medical International Research &<br>Development Centre,<br>Parkmore West Business Park,<br>Co. Galway,<br>Ireland. | | |
| Application<br>Correspondent | Michael Dunning<br>QA/RA Manager<br>Brivant Ltd T/A Lake Region Medical International Research &<br>Development Centre<br>Tel: [phone]<br>Fax: [phone] | | |
| Summary<br>Preparation Date | 7th September 2016 | | |
| Device Name &<br>Classification | Trade Name: | ENROUTE 0.014" Guidewire | |
| | Common Name: | Guidewire | |
| | Classification Name: | Catheter, Guidewire | |
| | Device Classification: | Class II, 21 CFR §870.1330 | |
| | Product Code: | DQX | |
| Intended Use | Intended Use: | The ENROUTE 0.014" Guidewire is intended for use in the peripheral<br>vasculature. | |
| | | Contraindications:<br>ENROUTE 0.014" Guidewire is not intended for use in:<br>● The cerebral or coronary vasculature.<br>● Patients judged not acceptable for percutaneous intervention. | |
| Device Description | The ENROUTE .014” guidewire is a disposable medical device designed for<br>single use only. It consists of a 95cm PTFE coated 0.014" diameter<br>stainless steel core wire, one end of which is reduced in diameter over<br>approximately 9.5cm in a progressive fashion through a centreless<br>grinding operation. The profile of this reduced section affords the product<br>an area of reduced stiffness. The very distal tip section is flattened to<br>further reduce stiffness and enable the tip to be shaped.<br><br>The distal section is covered with a 5cm platinum tungsten spring coil. This<br>provides for greater visibility on x-ray equipment (radiopacity). A<br>hydrophilic coating is applied to the distal section to enhance lubricity. The<br>product is available in straight configuration | | |

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

| Predicate Device | Manufacturer | 510k | Date |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------|
| | Brivant Guidewire (Rapidwire Plus variant –<br>previously known as SLK) | K060551 | 06/07/2006 |
| | Nitrex Nitinol Guidewire | K040345 | 03/02/2004 |
| Principle of Operation | The ENROUTE 0.014" guidewire is operated manually by a manual process | | |
| Comparison of Technological Characteristics | The key technological and performance similarities examined between the<br>approved devices and the proposed ENROUTE 0.014" Guidewire device<br>are as follows:<br>- Indications for use - The Indications for use for the proposed<br>device is a subset of indications for use of the predicate device as<br>proposed device, ENROUTE 0.014" is for peripheral vasculature<br>only<br>- Contraindications – The contraindications for use are very similar<br>to that of the predicate device Nitrex Nitinol Guidewire. The<br>ENROUTE 0.014" device has an additional contraindication to the<br>predicate Rapidwire Plus against use in the Coronary Vasculature.<br>- Fundamental scientific technology, including design - identical to<br>the predicate devices<br>- Operating principle - identical to the predicate devices<br>- Packaging materials - identical to the predicate device Rapidwire<br>Plus<br>- Sterility assurance level and method of sterilization - identical to<br>the predicate devices<br>- The length of the device is within the length range of the predicate<br>device; Nitrex Nitinol Guidewire<br>- The diameter of the proposed device is within the diameter range<br>of the predicate devices (0.014")<br>- The proposed device and that of the Rapidwire Plus device are<br>identical in that they are constructed with a stainless steel core<br>which is reduced in diameter at the distal end to provide flexibility<br>- The proposed device has equivalent tip stiffness characteristics to<br>that the Rapidwire Plus device<br>- The proposed device has an identical hydrophilic coating to that of<br>the Rapidwire Plus device at the distal tip<br>- All devices have a PTFE coating on the guidewire shaft<br>- The proposed device and that of the Rapidwire Plus device have<br>equivalent torque response properties | | |

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

Image /page/5/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized heart shape in red and gray, followed by the words "Lake Region" in a sans-serif font. Below "Lake Region" is the word "MEDICAL" in a smaller, light gray font. The heart shape is made up of several geometric shapes, creating a modern and professional look.

- Compatible with equivalent interventional devices

| Performance<br>Testing (non-<br>clinical) | In vitro bench tests were utilized to demonstrate equivalence with<br>reference to the FDAs guidance document "Coronary and Cerebrovascular<br>Guidewire Guidance, Jan 1995". |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

The following bench tests support the proposed product:

| Test | Leveraged from<br>Predicate<br>510(k) Data | ENROUTE 0.014"<br>510(k) data |
|----------------------------------------|--------------------------------------------|-------------------------------|
| Tensile Strength | X | |
| Torque Strength | | X |
| Dimensional measurements | X | X<br>(Overall length) |
| Torque Response | | X |
| Catheter Compatibility | | X |
| Coating Adherence/Coating<br>Integrity | X | |
| Particulate Testing | X | |
| Tip Stiffness/Flexibility | X | |
| Radiopacity | | X |
| Biocompatibility | X | |
| Shelf Life | X | |

The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed ENROUTE 0.014" Guidewire device were met. The ENROUTE 0.014" Guidewire device test data supports the claims of substantial equivalence to the predicate devices.

Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO10993-1:2009 and G95-1, FDA General Program Memorandum: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

#### Conclusions Based on safety and performance testing, technological characteristics and the indications for use for the device, the ENROUTE 0.014" Guidewire has been demonstrated to be appropriate for its intended use and is considered to be substantially equivalent to the predicate devices.