Who is the manufacturer of Inqwire Diagnostic Guide Wire?

Merit Medical Systems, Inc. filed the 510(k) submission for Inqwire Diagnostic Guide Wire (K170700).

What is the FDA product code for Inqwire Diagnostic Guide Wire?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Inqwire Diagnostic Guide Wire?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Inqwire Diagnostic Guide Wire?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Inqwire Diagnostic Guide Wire

K170700 · Merit Medical Systems, Inc. · DQX · Apr 6, 2017 · Cardiovascular

Device Facts

Record ID	K170700
Device Name	Inqwire Diagnostic Guide Wire
Applicant	Merit Medical Systems, Inc.
Product Code	DQX · Cardiovascular
Decision Date	Apr 6, 2017
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

InQwire Amplatz Super Stiff Guide Wire facilitates device placement during diagnostic and interventional procedures. Device consists of blue PTFE-coated flat wire coil with internal core wire for stiffness. Core wire welded to coil at distal end, proximal end, and one intermediate point. Available in 0.035-inch and 0.038-inch diameters, lengths 75cm to 260cm, with various straight and J-tip configurations. Provided in spiral hoop dispenser with flush port luer adapter and J-straightener. Used by clinicians in clinical settings to guide catheters or other interventional devices through vasculature or body lumens. Enhances procedural efficiency by providing trackability and support for device delivery.

Clinical Evidence

Bench testing only. No clinical data. Performance testing conducted per risk analysis and industry standards including ISO 11070:2014, ISO 11135:2014, ASTM F1980-07, and ISO 10993-1:2009. Evaluated attributes: size, radiopacity, tensile strength, torque, tip flexibility, coating integrity, lubricity, catheter/needle compatibility, and corrosion resistance. All results met predetermined acceptance criteria.

Technological Characteristics

Materials: Blue PTFE-coated flat wire coil, internal core wire. Dimensions: 0.035"/0.038" OD, 75-260cm length. Configuration: Straight/J-tip. Sterilization: Ethylene oxide (ISO 11135:2014). Packaging: ISO 11607-1:2006. Biocompatibility: ISO 10993-1:2009. Mechanical: Welded core-to-coil assembly.

Indications for Use

Indicated for patients undergoing diagnostic and interventional procedures requiring device placement.

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 (K163575)

Reference Devices

Amplatz Super Stiff Guidewire (K843012)

Related Devices

K163575 — Inqwire Diagnostic Guide Wire · Merit Medical Systems, Inc. · Mar 3, 2017
K133230 — INQWIRE DIAGNOSTIC GUIDE WIRE · Merit Medical Systems, Inc. · Dec 12, 2013
K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) · Merit Medical Ireland, Ltd. · Jan 21, 2026
K061670 — LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE · William Cook Europe Aps · Jan 19, 2007
K140608 — MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE · Merit Medical Systems, Inc. · Sep 12, 2014

Submission Summary (Full Text)

{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. 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 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 Provisions | Submitter Name: Address: Telephone Number: Fax Number: Contact Person: Registration Number: | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 (+353) 91 703700 (3061) (+353) 91 680 104 Mark Mullaney 1721504 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Correspondent Name: Address: Telephone Number: Fax Number: Contact Person: Date of Preparation: Registration Number: | Merit Medical Ireland Ltd. Parkmore Business Park West Galway, Ireland (+353) 91 703700 (3223) (+353) 91 680 104 Michael O'Sullivan 5/Apr//2017 9616662 | | Subject Device | Trade Name: Common/Usual Name: Classification Name: | InQwire® Amplatz Merit Medical Guide Wire 21 CFR 870.1330 Catheter guide wire | | Predicate Device | Premarket Notification Predicate #1: (Primary Predicate) Trade Name: Classification Name: Premarket Notification: Manufacturer: Premarket Notification Reference Device Trade Name: Classification Name: Premarket Notification: Manufacturer: | InQwire® 21 CFR 870.1330 Catheter guide wire K163575 Merit Medical Systems, Inc. Amplatz Super Stiff Guidewire 21 CFR 870.1330 Catheter guide wire K843012 Boston Scientific Corporation | | Classification | Class II 21 CFR 870.1330 Catheter guide wire FDA Product Code: DQX Review Panel: Division of Cardiovascular Devices | | | Intended Use | Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures. | | | Device Description | Merit InQwire® Amplatz Super Stiff Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure 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 and 0.038-inch outer diameter with a 1cm, 3cm, 3.5cm ,4cm, 6cm and 7cm straight and J tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length. The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J- straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices. | | | | Comparison to Predicate | The changes to the device are as follows; a) A new variant of the core wire OD (0.38") has been added to the range, b) 5 new Tip lengths have been added (1cm, 3cm, 3.5cm, 4cm and 6cm), spread across the two ODs and c) A J Tip shape variant is also added to the range, spread across the two ODs. None of the above changes would be deemed sufficient to affect the technological characteristics of the device and thus the subject Merit InQwire® Amplatz Super Stiff Guide Wire is substantially equivalent to Predicate Device #1, the Merit InQwire® Amplatz Super Stiff Guide Wire [K163575 and the Reference Device, the Amplatz Super Stiff Guidewire [K843012].]. | | | | The proposed new wires add in a new OD of 0.038" as well as Tip length (1cm, 3cm, 3.5cm, 4cm and 6cm) and Tip shape (J tip) variants to the range. The lengths, of 75cm to 260cm, are within the bracketed range of the predicate (75cm to 260cm). The Indications for use of the subject wire are identical to Predicate Device #1. | | | Safety & Performance Tests | 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 InQwire® Amplatz Super Stiff 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 11070:2014, Sterile Single-Use Intravascular Catheter Introducers. • ISO 11135:2014 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. ISO 11607-1:2006, Packaging for terminally sterilized medical devices - • Part 1: Requirements for materials, sterile barrier systems and packaging systems | | | | The Merit InQwire® Amplatz Super Stiff Guide Wire was compared to the predicate device for various performance attributes that support substantial equivalence of the device. The difference in assembly between the modified device and the cleared device, Merit InQwire® Amplatz Super Stiff Guide Wire [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 and | Lubricity | | | | | | Adherence/Integrity | Needle | | | | | | | Fracture ● | Compatibility | | | | | | | Flex ● | | | | | | | | Particulate ● | | | | | | | | Evaluation | | | | | | | Surface | Biocompatibility | Corrosion | Tip Shape | | | | | All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predeterminded acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate devices. | | | | | | | | Based on the Indications for Use, design, safety and performance testing, the | | | | | | | Summary of Substantial | subject Merit InQwire® Amplatz Super Stiff Guide Wire is substantially | | | | | | | Equivalence | equivalent to the predicate devices, the cleared Predicate Device #1, the Merit 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: