Inqwire Diagnostic Guide Wire

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. April 6, 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: K170700 Trade/Device Name: InOwire Amplatz Super Stiff Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 6, 2017 Received: March 7, 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 {1}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Fernando Aguel 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170700 #### Device Name InQwire Amplatz Super Stiff Guide Wire Indications for Use (Describe) Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures. 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. 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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 PRAStaff@fda.hhs.gov "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}------------------------------------------------ | 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>(+353) 91 703700 (3061)<br>(+353) 91 680 104<br>Mark Mullaney<br>1721504 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Correspondent Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Ireland Ltd.<br>Parkmore Business Park West<br>Galway, Ireland<br>(+353) 91 703700 (3223)<br>(+353) 91 680 104<br>Michael O'Sullivan<br>5/Apr//2017<br>9616662 | | Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | InQwire® Amplatz<br>Merit Medical Guide Wire<br>21 CFR 870.1330 Catheter guide wire | | Predicate<br>Device | Premarket Notification Predicate #1: (Primary Predicate)<br>Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer:<br><br>Premarket Notification Reference Device<br>Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | InQwire®<br>21 CFR 870.1330 Catheter guide wire<br>K163575<br>Merit Medical Systems, Inc.<br><br>Amplatz Super Stiff Guidewire<br>21 CFR 870.1330 Catheter guide wire<br>K843012<br>Boston Scientific Corporation | | 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 | Merit Medical guide wires are used to facilitate the placement of devices during<br>diagnostic and interventional procedures. | | | Device<br>Description | Merit InQwire® Amplatz Super Stiff Guide Wires are intended to facilitate the<br>placement of devices during diagnostic and interventional procedures. The guide<br>wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with<br>an inside core wire. The core wire enhances the "Super Stiff" characteristic of<br>the guide wire.<br>The core wire extends the full length of the coil and is welded to the coil at three<br>(3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm<br>from the distal end. These welds are designed to provide integrity and ensure<br>that the guide wire components remain together The outside coil is PTFE coated | | | The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch<br>and 0.038-inch outer diameter with a 1cm, 3cm, 3.5cm ,4cm, 6cm and 7cm<br>straight and J tip configuration and are available in lengths from 75cm to 260cm.<br>The wires will be provided in a spiral hoop dispenser sized appropriately for the<br>wires diameter and length.<br>The dispenser has a standard flush port luer adapter that accepts any standard<br>luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-<br>straightener is provided on the dispenser to facilitate the advancement of the<br>wire tip into other devices. | | | | Comparison to<br>Predicate | The changes to the device are as follows; a) A new variant of the core wire OD<br>(0.38") has been added to the range, b) 5 new Tip lengths have been added<br>(1cm, 3cm, 3.5cm, 4cm and 6cm), spread across the two ODs and c) A J Tip<br>shape variant is also added to the range, spread across the two ODs. None of<br>the above changes would be deemed sufficient to affect the technological<br>characteristics of the device and thus the subject Merit InQwire® Amplatz Super<br>Stiff Guide Wire is substantially equivalent to Predicate Device #1, the Merit<br>InQwire® Amplatz Super Stiff Guide Wire [K163575 and the Reference Device,<br>the Amplatz Super Stiff Guidewire [K843012].]. | | | | The proposed new wires add in a new OD of 0.038" as well as Tip length (1cm,<br>3cm, 3.5cm, 4cm and 6cm) and Tip shape (J tip) variants to the range. The<br>lengths, of 75cm to 260cm, are within the bracketed range of the predicate<br>(75cm to 260cm). The Indications for use of the subject wire are identical to<br>Predicate Device #1. | | | 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. Performance testing of the<br>subject Merit InQwire® Amplatz Super Stiff Guide Wire was conducted based on<br>risk analysis. A battery of testing was conducted in accordance with protocols<br>based on requirements outlined in guidance's and industry standards and these<br>were shown to meet the acceptance criteria that were determined to<br>demonstrate substantial equivalence. | | | | Where appropriate, the tests were based on the requirements of the following<br>documents:<br>FDA guidance Coronary and Cerebrovascular Guide Wire Guidance<br>•<br>January 1995.<br>ISO 11070:2014, Sterile Single-Use Intravascular Catheter Introducers.<br>•<br>ISO 11135:2014 Sterilization of health care products-Ethylene oxide-<br>•<br>Part 1: Requirements for the development, validation and routine control<br>of a sterilization process for medical devices.<br>ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier<br>•<br>Systems for Medical Devices<br>ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1:<br>•<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>•<br>Part 1: Requirements for materials, sterile barrier systems and<br>packaging systems | | | | The Merit InQwire® Amplatz Super Stiff Guide Wire was compared to the<br>predicate device for various performance attributes that support substantial<br>equivalence of the device. The difference in assembly between the modified<br>device and the cleared device, Merit InQwire® Amplatz Super Stiff Guide Wire<br>[K163575] has raised no new issues. In some instances, performance | | ## Section 5 510(k) Summary {4}------------------------------------------------ and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated. characteristic testing was based on the Reference Device, the Amplatz Super {5}------------------------------------------------ Stiff Guidewire [K843012], when it was deemed to be relevant. | | Size Designation | Radiopacity | Tensile | Torque | | | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------|-----------|--|--| | | | | Strength | Strength | | | | | Tip Flexibility | Coating | Catheter<br>and | Lubricity | | | | | | Adherence/Integrity | Needle | | | | | | | Fracture<br>● | Compatibility | | | | | | | Flex<br>● | | | | | | | | Particulate<br>● | | | | | | | | Evaluation | | | | | | | Surface | Biocompatibility | Corrosion | Tip Shape | | | | | All test results were comparable to the predicate devices and the subject Merit<br>InQwire® Amplatz Super Stiff Guide Wire met the predeterminded acceptance<br>criteria. This has demonstrated that the subject device is substantially equivalent<br>to the predicate devices. | | | | | | | | Based on the Indications for Use, design, safety and performance testing, the | | | | | | | Summary of<br>Substantial | subject Merit InQwire® Amplatz Super Stiff Guide Wire is substantially | | | | | | | Equivalence | equivalent to the predicate devices, the cleared Predicate Device #1, the Merit<br>InQwire® Amplatz Super Stiff Guide Wire [K163575] and the Reference Device, | | | | | | | | the Amplatz Super Stiff Guidewire [K843012] | | | | | | The following is a list of all testing that was successfully completed: