K Number

Device Name

Inqwire Diagnostic Guide Wire

Manufacturer

Merit Medical Systems, Inc.

Date Cleared

2017-03-03

(74 days)

Product Code

DQX

Regulation Number

870.1330

Intended Use

Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Device Description

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 and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated. The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch outer diameter with a 7cm straight 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133230, K843012

Reference Devices

K843012

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide wire, with no mention of AI or ML.

Therapeutic

Explanation: The device is described as a guide wire used to facilitate the placement of other devices during diagnostic and interventional procedures, not to provide therapy itself.

Diagnostic

Explanation: The "Intended Use" states that the guide wires "facilitate the placement of devices during diagnostic and interventional procedures." This indicates that the device itself is a tool used in these procedures, not a device that performs the diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly details a physical guide wire made of materials like PTFE and metal, and includes components like a coil, core wire, and dispenser. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "facilitate the placement of devices during diagnostic and interventional procedures." This describes a tool used within the body to aid in medical procedures, not a device used to test samples outside the body to diagnose conditions.
Device Description: The description details a physical guide wire with specific materials, coatings, and configurations designed for insertion into the body. This is consistent with a medical device used for navigation and support during procedures.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.

Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Product codes (comma separated list FDA assigned to the subject device)

DQX

Device Description

Merit Medical guide wires are used 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 and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated.

The Merit InQwire Amplatz Super Stiff Guide Wires are offered in 0.035-inch outer diameter with a 7cm straight 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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 11135-1:2014 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(s) 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 Diagnostic Guide Wire [K133230] has raised no new issues. In some instances, performance characteristic testing was based on the Reference Predicate Device#2, the Amplatz Super Stiff Guidewire [K843012], when it was deemed to be relevant.

The following is a list of all testing that was successfully completed:
Size Designation
Tip Flexibility
Radiopacity
Coating Adherence/Integrity
Fracture Flex
Particulate Evaluation
Tensile Strength
Catheter and Needle Compatibility
Torque Strength
Lubricity
Surface
Biocompatibility
Corrosion
Packaging

All test results were comparable to the predicate devices and the subject Merit InQwire Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133230, K843012

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K843012

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
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.(b)
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.

Summary

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.

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
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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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

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| Section 5

510(k) Summary
General
Provisions	Submitter Name: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway
South Jordan, UT 84095
Telephone Number: (+353) 91 703700 (3061)
Fax Number: (+353) 91 680 104
Contact Person: Mark Mullaney
Registration Number: 1721504

Correspondent Name: Merit Medical Ireland Ltd.
Address: Parkmore Business Park West
Galway, Ireland
Telephone Number: (+353) 91 703700 (3223)
Fax Number: (+353) 91 680 104
Contact Person: Michael O'Sullivan
Date of Preparation: 09/Feb//2017
Registration Number: 9616662 |
| Subject
Device | Trade Name: InQwire®
Common/Usual Name: Merit Medical Guide Wire
Classification Name: 21 CFR 870.1330 Catheter guide wire |
| Predicate
Device | Premarket Notification Predicate#1: (Primary Predicate)
Trade Name: InQwire®
Classification Name: 21 CFR 870.1330 Catheter guide wire
Premarket Notification: K133230
Manufacturer: Merit Medical Systems, Inc.

Premarket Notification Predicate#2: (Reference Predicate)
Trade Name: Amplatz Super Stiff Guidewire
Classification Name: 21 CFR 870.1330 Catheter guide wire
Premarket Notification: K843012
Manufacturer: 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. |
| | 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 and this Blue PTFE coating
extends from the distal tip of the wire to within 7cm of the proximal tip,
which remains uncoated. |
| | The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in
0.035-inch outer diameter with a 7cm straight 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) The core wire OD is greater
to provide greater Stiffness; b) The coiling wire is changed from round to
flat to enable the 0.035" OD to be maintained; c) There is no safety wire
present. Instead the core wire is welded to both the proximal and distal
ends; d) An additional spot weld is present, approx. 22cm from the distal
tip, that joins the core wire to the coil and; e) The colour of the PTFE
coating is changing from green to blue. 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® Diagnostic Guide Wire [K133230] and Reference Predicate
Device#2, the Amplatz Super Stiff Guidewire [K843012]. |
| | The proposed device OD, of 0.035" is within the range of the Predicate#1
(0.035" and 0.038"). The lengths, of 75cm to 260cm, are within the
bracketed range of Predicate#1(50cm to 260cm) and the straight tip |

Section 5

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.

Special Premarket Notification 510(K)
Safety &
Performance
Tests	ISO 11135-1:2014 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(s) 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®
Diagnostic Guide Wire [K133230] has raised no new issues. In some
instances, performance characteristic testing was based on the
Reference Predicate Device#2, the Amplatz Super Stiff Guidewire
[K843012], when it was deemed to be relevant.
The following is a list of all testing that was successfully completed:
	Size	Radiopacity	Tensile	Torque
	Designation
Tip Flexibility	Coating
Adherence/Integrity
Fracture
●
Flex
●
Particulate
●
Evaluation	Strength
Catheter and
Needle
Compatibility	Strength
Lubricity
	Surface	Biocompatibility	Corrosion	Packaging
Summary of
Substantial	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 subject Merit InQwire® Amplatz Super Stiff Guide Wire is
substantially equivalent to the predicate devices, the cleared Predicate
Device#1, the Merit InQwire® Diagnostic Guide Wire [K133230] and
Equivalence	Reference Predicate Device#2, the Amplatz Super Stiff Guidewire
[K843012].