MERIT HYDROPHILIC GUIDEWIRE

K141295 · Merit Medical Systems, Inc. · DQX · Dec 16, 2014 · Cardiovascular

Device Facts

• Record ID: K141295
• Device Name: MERIT HYDROPHILIC GUIDEWIRE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

Device Story

Merit Hydrophilic Guide Wire consists of jacketed core wire with hydrophilic coating; available in straight, angled, standard, and stiff configurations in various lengths. Used in peripheral vascular system to facilitate placement of diagnostic/interventional devices. Operated by clinicians in clinical settings. Device functions as mechanical guide; hydrophilic coating reduces friction during navigation through vasculature. Benefits include improved trackability and ease of device delivery. Substantial equivalence established via bench testing comparing subject device to predicate Merit Hydrophilic Guide Wires.

Clinical Evidence

Bench testing only. Testing performed on 0.018" and 0.038" diameter wires (representing min/max range) to support equivalence for intermediate sizes. Tests included coating adherence/integrity, catheter compatibility (durability), surface, fracture, flex, size/dimensions, particulate evaluation, and biocompatibility per ISO 10993-1 and FDA modified test profile.

Technological Characteristics

Jacketed core wire with hydrophilic coating. Configurations: straight, angled, standard, stiff. Diameters: 0.018" to 0.038". Standards: ISO 11070 (catheter introducers), ISO 11135-1 (EO sterilization), ASTM F1980-07 (accelerated aging), ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for use in the peripheral vascular system to facilitate device placement during diagnostic and interventional 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

• Merit Hydrophilic Guide Wire (K131710)
• Merit Hydrophilic Guide Wire (K130588)
• Merit Hydrophilic Guide Wire (K123609)
• Merit Hydrophilic Guide Wire (K120644)

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 16, 2014

Merit Medical Systems, Inc. Mr. Michael O'Sullivan RA Specialist III Parkmore Business Park West Galway, Ireland

> K141295 Trade/Device Name: Merit Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 20, 2014 Received: October 23, 2014

Dear Mr. O' Sullivan,

Re:

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

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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,

Kenneth J. Cavanaugh -S

for

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K141295

Device Name

Merit Hydrophilic Guide Wire

Indications for Use (Describe)

The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 510(k) Summary | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Submitter Name: Merit Medical Systems, Inc.<br>Address: 1600 West Merit Parkway<br>South Jordan, UT 84095<br>Telephone Number: ([phone] (Ext. 3061)<br>Fax Number: ([phone]<br>Contact Person: Mark Mullaney<br>Registration Number: 1721504<br><br>Correspondent Name: Merit Medical Ireland Ltd.<br>Address: Parkmore Business Park<br>Parkmore, Galway, Ireland<br>Telephone Number: ([phone] (Ext. 3223)<br>Fax Number: ([phone]<br>Contact Person: Michael O'Sullivan<br>Date of Preparation: 15th May 2014<br>Registration Number: 9616662 |
| Subject<br>Device | Trade Name: Merit Hydrophilic Guide Wire<br>Common/Usual Name: Hydrophilic Guide Wire<br>Classification Name: Catheter Guide Wire |
| Predicate<br>Device | Premarket Notification Predicate Device # 1:<br>Merit Hydrophilic Guide Wire K131710<br>Manufacturer: Merit Medical Systems, Inc<br>Premarket Notification Predicate Device # 2:<br>Merit Hydrophilic Guide Wire K130588<br>Manufacturer: Merit Medical Systems, Inc<br>Premarket Notification Predicate Device # 3:<br>Merit Hydrophilic Guide Wire K123609<br>Manufacturer: Merit Medical Systems, Inc<br>Premarket Notification Predicate Device # 4:<br>Merit Hydrophilic Guide Wire K120644<br>Manufacturer: Merit Medical Systems, Inc |
| Classification | Class II<br>21 CFR § 870.1330<br>Product code: DQX<br>Division of Cardiovascular Devices |
| Intended Use | The Merit Hydrophilic Guide Wire is intended to be used in the peripheral<br>vascular system to facilitate the placement of devices during diagnostic and<br>interventional procedures. |
| Device<br>Description | The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a<br>hydrophilic coating applied to the jacket. The wire will be offered in straight,<br>angled, standard and stiff configurations, in various lengths. |
| Comparison to<br>Predicate | Technological characteristics of the subject Merit Hydrophilic Guide Wire are<br>substantially equivalent to those of the predicates, the Merit Hydrophilic Guide<br>Wires [K131710], [K130588], [K123609] and [K120644]. The difference between<br>the devices relate to the process of application of the hydrophilic coating and the<br>modification of the volume quantities of some materials. The guide wire design<br>and indications remain unchanged. |
| Safety &<br>Performance<br>Tests | No performance standards have been established under section 514 of the<br>Food, Drug and Cosmetic Act for these devices. A battery of testing was<br>conducted in accordance with protocols based on requirements outlined in<br>guidance's and industry standards and these were shown to meet the<br>acceptance criteria that were determined to demonstrate substantial<br>equivalence.<br><br>Where appropriate, the tests were based on the requirements of the following<br>documents:<br>FDA guidance Coronary and Cerebrovascular Guide Wire Guidance<br>January 1995. ISO 11070: 1998, Sterile Single-Use Intravascular Catheter Introducers. ISO 11135-1: 2007 Sterilization of health care products-Ethylene oxide-<br>Part 1: Requirements for the development, validation and routine control<br>of a sterilization process for medical devices. ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier<br>Systems for Medical Devices ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1:<br>Evaluation and Testing within a risk management process, and the FDA<br>Modified ISO 10993 Test Profile FDA Memo G95-1. The Merit Hydrophilic Guide Wire was compared to the predicate device(s) for<br>various performance attributes that support substantial equivalence of the<br>device. Performance testing was performed on the 0.018" and 0.038" diameter<br>wires only, as these represent the minimum and maximum wire diameters within<br>the cleared device range and Merit believes that the testing on these (min/max)<br>diameters is sufficient to demonstrate equivalence for the intermediate diameter<br>wires of 0.025" and 0.035" also.<br><br>The following is a list of all significant testing that was successfully completed:<br>Coating Adherence/Integrity(Including Anatomical Model), Catheter Compatibility<br>(Durability), Surface, Fracture test, Flex test, Size Designation/ Dimensions,<br>Particulate Evaluation and Biocompatibility testing. |
| Summary of<br>Substantial<br>Equivalence | Based on the Indications for Use, design, safety and performance testing, the<br>subject Merit Medical Hydrophilic Guide Wire meets the requirements that are<br>considered essential for its intended use and is substantively equivalent to the<br>predicate devices, the Merit Hydrophilic Guide Wires manufactured by Merit<br>Medical Systems Inc., K131710(0.018"), K130588(0.025"), K123609(0.038")<br>and K120644(0.035"). |

## Section 5

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Merit Hydrophilic guide wire met the predeterminded acceptance criteria applicable to the safety and efficacy of the device,this has demonstrated the subject device is substantially equivalent to the predicate devices.

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