Inqwire Diagnostic Guide Wire

K163575 · Merit Medical Systems, Inc. · DQX · Mar 3, 2017 · Cardiovascular

Device Facts

• Record ID: K163575
• Device Name: Inqwire Diagnostic Guide Wire
• Applicant: Merit Medical Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 3, 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/interventional procedures. Device consists of blue PTFE-coated flat wire coil with internal core wire; core wire provides stiffness; welded at distal end, proximal end, and 22cm from distal tip to ensure component integrity. Offered in 0.035-inch diameter, 7cm straight tip, lengths 75cm-260cm. Provided in spiral hoop dispenser with flush port luer adapter and J-straightener for tip advancement. Used by clinicians in clinical settings to navigate vasculature or anatomical structures; provides track for subsequent device delivery. Benefits include enhanced stiffness for stable device placement.

Clinical Evidence

Bench testing only. Testing included size, radiopacity, tensile strength, torque strength, tip flexibility, coating adherence/integrity, fracture, flex, particulate evaluation, catheter/needle compatibility, lubricity, surface, biocompatibility, corrosion, and packaging. Testing performed per ISO 11070:2014, ISO 10993-1:2009, and FDA guidance for Coronary and Cerebrovascular Guide Wires.

Technological Characteristics

Guide wire with flat wire coil and core wire; PTFE coating. Dimensions: 0.035" OD, 75-260cm length. Sterilization: Ethylene oxide (ISO 11135-1:2014). Biocompatibility: ISO 10993-1:2009. Packaging: ISO 11607-1:2006. Accelerated aging: ASTM F1980-07. No software or electronic components.

Indications for Use

Indicated for use in facilitating the placement of devices during diagnostic and interventional procedures in patients requiring such interventions.

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 Diagnostic Guide Wire (K133230)
• Amplatz Super Stiff Guidewire (K843012)

Submission Summary (Full Text)

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Image /page/0/Picture/1 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.

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

March 3, 2017

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

Re: K163575

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: February 1, 2017 Received: February 3, 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 devicerelated 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.

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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
Fernando Aguel -S
Aguel

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) K163575

#### 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)

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| Section 5<br>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] (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 West<br>Galway, Ireland<br>Telephone Number: ([phone] (3223)<br>Fax Number: ([phone]<br>Contact Person: Michael O'Sullivan<br>Date of Preparation: 09/Feb//2017<br>Registration Number: 9616662 |
| 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<br>Device | Premarket Notification Predicate#1: (Primary Predicate)<br>Trade Name: InQwire®<br>Classification Name: 21 CFR 870.1330 Catheter guide wire<br>Premarket Notification: K133230<br>Manufacturer: Merit Medical Systems, Inc.<br><br>Premarket Notification Predicate#2: (Reference Predicate)<br>Trade Name: Amplatz Super Stiff Guidewire<br>Classification Name: 21 CFR 870.1330 Catheter guide wire<br>Premarket Notification: K843012<br>Manufacturer: 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<br>during diagnostic and interventional procedures. |
| | procedures. The guide wires consist of a Blue PTFE<br>(Polytetrafluoroethylene) coated flat wire coil, with an inside core wire.<br>The core wire enhances the "Super Stiff" characteristic of the guide wire.<br>The core wire extends the full length of the coil and is welded to the coil<br>at three (3) points; a) the distal end, b) the proximal end and c) a spot<br>weld approx. 22cm from the distal end. These welds are designed to<br>provide integrity and ensure that the guide wire components remain<br>together The outside coil is PTFE coated and this Blue PTFE coating<br>extends from the distal tip of the wire to within 7cm of the proximal tip,<br>which remains uncoated. |
| | The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in<br>0.035-inch outer diameter with a 7cm straight tip configuration and are<br>available in lengths from 75cm to 260cm. The wires will be provided in a<br>spiral hoop dispenser sized appropriately for the wires diameter and<br>length. |
| | The dispenser has a standard flush port luer adapter that accepts any<br>standard luer lock or slip tip syringe to facilitate flushing of the guide wire<br>prior to use. A J-straightener is provided on the dispenser to facilitate the<br>advancement of the wire tip into other devices. |
| Comparison<br>to Predicate | The changes to the device are as follows; a) The core wire OD is greater<br>to provide greater Stiffness; b) The coiling wire is changed from round to<br>flat to enable the 0.035" OD to be maintained; c) There is no safety wire<br>present. Instead the core wire is welded to both the proximal and distal<br>ends; d) An additional spot weld is present, approx. 22cm from the distal<br>tip, that joins the core wire to the coil and; e) The colour of the PTFE<br>coating is changing from green to blue. None of the above changes<br>would be deemed sufficient to affect the technological characteristics of<br>the device and thus the subject Merit InQwire® Amplatz Super Stiff<br>Guide Wire is substantially equivalent to Predicate Device#1, the Merit<br>InQwire® Diagnostic Guide Wire [K133230] and Reference Predicate<br>Device#2, the Amplatz Super Stiff Guidewire [K843012]. |
| | The proposed device OD, of 0.035" is within the range of the Predicate#1<br>(0.035" and 0.038"). The lengths, of 75cm to 260cm, are within the<br>bracketed range of Predicate#1(50cm to 260cm) and the straight tip |

# Section 5

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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.

configuration is also present in the Predicate#1 range (Straight or J Tip).

The indications for use are identical to Predicate Device#1.

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.

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| Special Premarket Notification 510(K) | | | | | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------|--|--|--|
| Safety &<br>Performance<br>Tests | ISO 11135-1:2014 Sterilization of health care products-Ethylene<br>●<br>oxide- Part 1: Requirements for the development, validation and<br>routine control of a sterilization process for medical devices.<br>ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile<br>●<br>Barrier Systems for Medical Devices<br>ISO 10993-1:2009, Biological Evaluation of Medical Devices Part<br>●<br>1: Evaluation and Testing within a risk management process, and<br>the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.<br>ISO 11607-1:2006, Packaging for terminally sterilized medical<br>●<br>devices - Part 1: Requirements for materials, sterile barrier<br>systems and packaging systems<br>The Merit InQwire® Amplatz Super Stiff Guide Wire was compared to the<br>predicate device(s) for various performance attributes that support<br>substantial equivalence of the device. The difference in assembly<br>between the modified device and the cleared device, Merit InQwire®<br>Diagnostic Guide Wire [K133230] has raised no new issues. In some<br>instances, performance characteristic testing was based on the<br>Reference Predicate Device#2, the Amplatz Super Stiff Guidewire<br>[K843012], when it was deemed to be relevant.<br>The following is a list of all testing that was successfully completed: | | | | | | |
| | Size | Radiopacity | Tensile | Torque | | | |
| | Designation<br>Tip Flexibility | Coating<br>Adherence/Integrity<br>Fracture<br>●<br>Flex<br>●<br>Particulate<br>●<br>Evaluation | Strength<br>Catheter and<br>Needle<br>Compatibility | Strength<br>Lubricity | | | |
| | Surface | Biocompatibility | Corrosion | Packaging | | | |
| Summary of<br>Substantial | All test results were comparable to the predicate devices and the subject<br>Merit InQwire® Amplatz Super Stiff Guide Wire met the predeterminded<br>acceptance criteria. This has demonstrated that the subject device is<br>substantially equivalent to the predicate devices.<br>Based on the Indications for Use, design, safety and performance<br>testing, the subject Merit InQwire® Amplatz Super Stiff Guide Wire is<br>substantially equivalent to the predicate devices, the cleared Predicate<br>Device#1, the Merit InQwire® Diagnostic Guide Wire [K133230] and | | | | | | |
| Equivalence | Reference Predicate Device#2, the Amplatz Super Stiff Guidewire<br>[K843012]. | | | | | | |