Merit Hydrophilic Guide Wire

K170933 · Merit Medical Systems, Inc. · DQX · Jun 22, 2017 · Cardiovascular

Device Facts

• Record ID: K170933
• Device Name: Merit Hydrophilic Guide Wire
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 22, 2017
• Decision: SESE
• Submission Type: Special
• 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; jacketed core wire with hydrophilic coating; used in peripheral vascular system to facilitate placement of diagnostic/interventional devices. Operated by physicians in clinical settings. Device provides trackability and access within vasculature. Coating modification (Gantrez AN-169 BF) replaces previous version. Performance verified via bench testing (surface, flex, fracture, lubricity, particulate, coating integrity) and biocompatibility testing. Output is physical guidance for catheter/device navigation; assists clinicians in reaching target anatomy; improves procedural efficiency and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data. Testing included surface, flex, fracture, size/dimensions, coating adherence/integrity, catheter compatibility, particulate evaluation, lubricity, and comprehensive biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, hemocompatibility). Testing performed on min/max diameters (0.018" and 0.038") and 0.035" variant for biocompatibility. All results met predetermined acceptance criteria.

Technological Characteristics

Jacketed core wire with hydrophilic coating (Gantrez AN-169 BF). Available in straight, angled, standard, and stiff configurations. Complies with ISO 11070:2014, ISO 11135:2014 (sterilization), ISO 10993-1:2009 (biocompatibility), and ASTM F1980-07 (aging). Sterilized via ethylene oxide.

Indications for Use

Indicated for use in the peripheral vascular system to facilitate device placement during diagnostic and interventional procedures in patients requiring such vascular access.

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 (K141295)

Submission Summary (Full Text)

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Public Health Service

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June 22, 2017

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

Merit Medical Systems, Inc. Mr. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland

Re: K170933

Trade/Device Name: Merit Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 23, 2017 Received: May 24, 2017

Dear Mr. O'Sullivan:

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

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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.

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,

Fernando
Aguel-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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## Indications for Use

510(k) Number (if known) K170933

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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:120%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|

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| K170993 | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary | | |
| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>([phone] (Ext. 3061)<br>([phone]<br>Mark Mullaney<br>1721504 |
| | Correspondent Name:<br>Address: | Merit Medical Ireland Ltd.<br>Parkmore Business Park<br>Parkmore, Galway, Ireland |
| | Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | ([phone] (Ext. 3223)<br>([phone]<br>Michael O'Sullivan<br>23 May 2017<br>9616662 |
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Merit Hydrophilic Guide Wire<br>Hydrophilic Guide Wire<br>Catheter Guide Wire |
| Predicate<br>Device | Predicate Device:<br>Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Merit Hydrophilic Guide Wire<br>21 CFR 870.1330 Catheter guide wire<br>K141295<br>Merit Medical Systems, Inc |
| Classification | Class II<br>21 CFR 870.1330 Catheter guide wire<br>FDA Product Code: DQX<br>Review Panel: 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 predicate, the Merit Hydrophilic Guide<br>Wires [K141295]. The only difference between the devices relate to the Material<br>Formulation of the Gantrez™ AN-169 that is used in the Hydrophilic coating<br>process, which has changed to a "Benzene Free" Version of that same material,<br>Gantrez™ AN-169 BF. The guide wire design and indications for use remain<br>unchanged. | |
| | 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<br>substantial<br>equivalence. | |
| Safety &<br>Performance<br>Tests | 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.<br>• ISO 11070:2014, Sterile Single-Use Intravascular Catheter Introducers.<br>• ISO 11135:2014 Sterilization of health care products-Ethylene oxide-:<br>Requirements for the development, validation and routine control of a<br>sterilization process for medical devices.<br>• ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier<br>Systems for Medical Devices<br>• 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.<br>• ISO 11607-1:2006, Packaging for terminally sterilized medical devices -<br>Part 1: Requirements for materials, sterile barrier systems and<br>packaging systems | |
| | The Merit Hydrophilic Guide Wire was compared to the predicate device for<br>various performance attributes that support substantial equivalence of the<br>device. Most of the performance testing was performed on the 0.018" and 0.038"<br>diameter wires only, as these represent the minimum and maximum wire<br>diameters within the cleared device range and Merit believes that the testing on<br>these (min/max) diameters is sufficient to demonstrate equivalence for the<br>intermediate diameter wires of 0.025" and 0.035" also. The exception to this is | |

## K170993

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The following is a list of all testing that was successfully completed:

| 1) | Surface | 2) | Flex | 3) | Fracture | 4) | Size<br>Designation/<br>Dimensions |
|----|--------------------------------------------------------------------------|----|-------------------------------------------|----|---------------------------|----|------------------------------------|
| 5) | Coating<br>Adherence/<br>Integrity<br>(Including<br>Anatomical<br>Model) | 6) | Catheter<br>Compatibility<br>(Durability) | 7) | Particulate<br>Evaluation | 8) | Lubricity |
| 9) | Biocompatibility | | | | | | |

Biocompatibility, where the 0.035" OD variant of the wire was chosen for testing.

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| Cytotoxicity - ISO MEM Elution Assay: MEM Extraction Sensitization - ISO Guinea Pig Max. Sensitization Test: Sodium Chloride and Sesame Oil Extraction Irritation - ISO I.C. Reactivity Test: Sodium Chloride and Sesame Oil Extraction Acute Systemic Toxicity - ISO Acute Systemic Toxicity Test: Sodium Chloride and Sesame Oil Extractions Pyrogenicity - Material Mediated Pyrogen Test: Sodium Chloride Extraction Genotoxicity - Ames Bacterial Reverse Mutation Assay: Saline and Ethanol Extractions Hemocompatibility - ISO Complement Activation: Direct Contact, C3a and SC5b-9 ASTM Hemolysis – Direct and Indirect Contact: Phosphate Buffered Saline Extraction ISO 4-Hour Thrombo. Study in Canine |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| As all test results were comparable to the predicate device and the subject Merit Hydrophilic guide wire met the predeterminded acceptance criteria. This has demonstrated the subject device is substantially equivalent to the predicate devices. |
| <b>Summary of Substantial Equivalence</b><br>Based on the Indications for Use, design, safety and performance testing, the subject Merit Medical Hydrophilic Guide Wire meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit Hydrophilic Guide Wire manufactured by Merit Medical Systems Inc., K141295. |