MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE

K140608 · Merit Medical Systems, Inc. · DQX · Sep 12, 2014 · Cardiovascular

Device Facts

• Record ID: K140608
• Device Name: MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 12, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Device Story

Diagnostic guide wire used to facilitate placement of devices during diagnostic and interventional procedures. Device consists of PTFE-coated coil, internal core wire, and safety wire; Benzalkonium Heparin coating applied over PTFE. Core wire provides stiffness; safety wire ensures component integrity. Available in 0.035 or 0.038 inch diameters, various tip configurations (straight/J-tip), and lengths (70cm-180cm). Supplied in loop flush dispenser (hoop) with female Luer connection for hydration. Modification involves replacing PFOA with GenX as processing aid in PTFE coating manufacture. Used by clinicians in interventional settings.

Clinical Evidence

Bench testing only. No clinical data. Testing included surface analysis, coating adherence/integrity (fracture, flexing, coil lubricity), catheter compatibility, and biocompatibility. Results met predetermined acceptance criteria and were comparable to predicate devices.

Technological Characteristics

Materials: PTFE-coated coil, core wire, safety wire, Benzalkonium Heparin coating. Dimensions: 0.035-0.038 inch OD, 70-180cm length. Standards: ISO 11070:1998 (introducers), ISO 11135-1:2007 (sterilization), ASTM F1980-07 (aging), ISO 10993-1:2009 (biocompatibility). Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for use in patients undergoing diagnostic and interventional procedures to facilitate the placement of medical devices.

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

• InQwire® (K822586)
• InQwire® (K133230)

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

September 12, 2014

Merit Medical, Inc. c/o Ms. Siobhan King Regulatory Affairs Specialist II Parkmore Business Park West Galway, Ireland

Re: K140608

Trade/Device Name: InOwire® Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: August 14, 2014 Received: August 18, 2014

Dear Ms. King:

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

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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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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## Section 4 Indications for Use Statement

510(k) Number (if known):

Device Name: Merit Heparin-coated InQwire® Diagnostic Guide Wire

Indications for Use:

Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## Section 5 510(k) Summary

| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Registration Number: 1721504<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: 9616662 | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>([phone] (3061)<br>([phone]<br>Mark Mullaney<br>Correspondent Name: Merit Medical Ireland Ltd.<br>Parkmore Business Park West<br>Galway, Ireland<br>([phone] (3052)<br>([phone]<br>Siobhan King<br>06/03/2014 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Subject<br>Device | Trade Name: | InQwire®<br>Common/Usual Name:Merit Medical Guide Wire<br>Classification Name: 21 CFR 870.1330 Catheter guide wire |
| Predicate | Premarket Notification Predicate#1: | |
| | Trade Name:<br>Premarket Notification: K822586<br>Manufacturer: | InQwire®<br>Classification Name: 21 CFR 870.1330 Catheter guide wire<br>Merit Medical Systems, Inc. |
| Device | Premarket Notification Predicate#2:<br>Trade Name:<br>Premarket Notification: K133230<br>Manufacturer: | InQwire®<br>Classification Name: 21 CFR 870.1330 Catheter guide wire<br>Merit Medical Systems, Inc. |
| Classification | Class II<br>21 CFR 870.1330 Catheter guide wire<br>FDA Product Code: DQX | Review Panel: Division of Cardiovascular Devices |

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Image /page/4/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a red square with white lines on the left, followed by the word "MERIT" in red and the word "MEDICAL" in white with a red outline. The logo is simple and professional, and it is likely used to represent the company in a variety of contexts.

Merit Heparin-coated InQwire® Diagnostic Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The quide wires have a continuous PTFE (Polytetrafluoroethylene) coated coil, inside core wire and a safety wire. The core wire is fixed at the proximal end only and extends to a specified distance from the distal end. The distal segment of the core wire has a profiled taper. The core wire enhances the stiffness of the guide wire. The safety wire extends the full length of the guide wire and is welded at both the distal and proximal end. The safety wire is designed to provide integrity and ensures that the guide wire components remain together. A Benzalkonium Heparin coating is applied over the PTFE coating.

The Heparin-coated InQwire® Diagnostic Guide Wires are offered in 0.035 inch or 0.038 inch outer diameter with different tip configurations (straight or J-tip), single ended or double ended (either end of the wire can be placed into the patient), standard or firm shaft, and are available in lengths from 70cm to 180cm. The wire is placed inside a loop flush dispenser, also referred to as a hoop. The dispenser has a female Luer connection which facilitates solution flushing through the hoop to hydrate the guide wire. The guidewires are secured in the hoop dispenser by a locking J-tip straightener.

## Device

Description

This modification details a supplier process change relating to removal of perfluorooctanoic acid (PFOA), used in the manufacture of the PTFE (Polytetrafluoroethylene) coating. More specifically PFOA is a processing aid used for the polymerization process of PTFE, which is flashed off during the oven curing process and therefore not part of the finished Heparin-coated InQwire® Diagnostic Guidewire. The PTFE coating formulation has changed - PFOA has been removed as a processing aid and replaced with GenX. The oven curing process which cures the coating and flashes off the PFOA remains unchanged. The manufacturing process within Merit has not changed. Due to environmental concerns relating to PFOA, the U.S. Environmental Protection Agency has instructed that all processors of PTFE no longer make, buy or use PFOA(2010/2015 PFOA Stewardship Program). PFOA material is used in the manufacture of both the intermediate layer and top layer of the PTFE(Polytetrafluoroethylene) coating. The removal of PFOA from Merit's non Heparin-coated InQwire® Diagnostic Guide Wires was previously assessed under Special 510(k) Premarket Notification, K133230. The only difference between the Heparin-coated InQwire® Guidewires and the non-Heparin coated InQwire® Guidewires, K133230, is the addition of a Benzalkonium Heparin coating applied over the PTFE coating. No changes have been made to the actual heparin coating. The same design and material characteristics that were qualified in K133230, also apply to the heparin-coated InQwire® Diagnostic Guidewires.

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Image /page/5/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a red square with a stylized white "M" inside, followed by the words "MERIT MEDICAL" in red, with the "MEDICAL" portion slightly smaller and to the right of "MERIT". The logo has a clean and professional design.

Technological characteristics of the subject Merit Medical Heparin-coated InQwire® Diagnostic Guide Wire are substantially equivalent to Predicate Device#1, the Merit Medical Heparin-coated InQwire® Diagnostic Guidewire [K822586] and Predicate Device#2, the Merit Medical non Heparin-coated InQwire® Diagnostic Guidewire [K133230]. The difference between the subject device and Predicate Device# 1 relates to the removal of perfluorooctanoic acid (PFOA), used in the manufacture of the PTFE (Polytetrafluoroethylene) guide wire coating. The guide wire Comparison design and indications remain unchanged. Other than the addition of a to Predicate Benzalkonium Heparin coating applied over the PTFE coating, the subject device and Predicate Device#2 are identical. The guide wire design and indications remain unchanged. Predicate Device#2, the Merit Medical non Heparin-coated InQwire® Guidewire is the predicate for the performance testing parameters.

> No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Merit Heparin-coated InQwire® Diagnostic Guide Wire was conducted based on risk analysis. A battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.

> Where appropriate, the tests were based on the requirements of the following documents:

- FDA guidance Coronary and Cerebrovascular Guide Wire . Guidance January 1995.
- ISO 11070:1998, Sterile Single-Use Intravascular Catheter ● Introducers.
- ISO 11135-1:2007 Sterilization of health care products-Ethylene . oxide- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile ● Barrier Systems for Medical Devices
- ISO 10993-1:2009. Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.

The Merit Heparin-coated InQwire® Diagnostic Guide Wire was compared to the predicate device(s) for various performance attributes that support substantial equivalence of the device. The difference in coating between the modified device and the cleared device, the Merit Medical Heparin-coated InQwire® Diagnostic Guidewire, [K822586] has raised no new issues. Performance testing was based on Predicate Device#2, the Merit Medical non Heparin-coated InQwire® Diagnostic Guidewire, [K133230].

The following is a list of all significant testing that was successfully

Safety & Performance Tests

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Image /page/6/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a red square with a white stylized "M" inside, followed by the words "MERIT MEDICAL" in red. The word "MERIT" is solid red, while the word "MEDICAL" is outlined in red.

completed:

- Surface .
- Coating Adherence/Integrity .
- o Fracture Test
- o Flexing Test
- Coil Lubricity Test o
- Catheter Compatibility ●
- Biocompatibility .

All test results were comparable to the predicate devices and the subject Merit Heparin-coated InQwire® Diagnostic Guide Wire met the predeterminded acceptance criteria applicable to the safety and effectiveness of the device. This has demonstrated the subject device is substantially equivalent to predicate devices.

## Summary of Substantial Equivalence

Based on the Indications for Use, design, safety and performance testing, the subject Merit Medical Heparin-coated InQwire® Diagnostic Guide Wire is substantially equivalent to the predicate devices, the cleared Merit Medical Heparin-coated InQwire® Guidewire, K822586, and the Merit Medical non Heparin-coated InQwire® Diagnostic Guide Wire, K133230.