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 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 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.

AI/ML Overview

The provided text describes testing conducted for the InQwire Amplatz Super Stiff Guide Wire (K170700) to demonstrate its substantial equivalence to predicate devices, not specifically for a software algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable.

However, I can extract the information that is present regarding the acceptance criteria and the study performed for this medical device.

1. Table of acceptance criteria and the reported device performance

Test Parameter	Acceptance Criteria	Reported Device Performance
Radiopacity	Based on risk analysis, guidance documents, and industry standards (e.g., FDA guidance Coronary and Cerebrovascular Guide Wire Guidance, ISO 11070:2014)	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Tensile Strength	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Torque Strength	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Tip Flexibility	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Coating Adherence/Integrity	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Catheter and Needle Compatibility	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Lubricity	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Fracture	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Flex	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Particulate Evaluation	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Surface	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Biocompatibility	Based on ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile G95-1	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Corrosion	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Tip Shape	Based on risk analysis, guidance documents, and industry standards	"All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."
Sterilization (Ethylene Oxide)	Based on ISO 11135:2014	Not explicitly detailed, but implied to be met as part of "All test results..."
Packaging (Shelf Life, Integrity)	Based on ASTM F1980-07 and ISO 11607-1:2006	Not explicitly detailed, but implied to be met as part of "All test results..."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each performance test. It states that "A battery of testing was conducted" and implies these were laboratory-based tests comparing the subject device to existing predicate devices.

Sample Size: Not specified.
Data Provenance: The tests are implied to be conducted by the manufacturer, Merit Medical Systems, Inc., which has locations in South Jordan, UT, USA, and Galway, Ireland. The data is from laboratory testing of the physical device, not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a physical medical device, not an AI/software device requiring expert interpretation of results for ground truth. Therefore, this information is not applicable. Ground truth was established through validated engineering and scientific testing methods against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as it refers to expert consensus for interpreting results, which is not relevant for the performance testing of a physical guide wire.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as this is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as this is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the reported tests was established by:

Reference to predicate devices (Merit InQwire® Amplatz Super Stiff Guide Wire [K163575] and Amplatz Super Stiff Guidewire [K843012]).
Adherence to industry standards and guidance documents (e.g., FDA guidance Coronary and Cerebrovascular Guide Wire Guidance, ISO 11070:2014, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006).
Risk analysis.

The "ground truth" for a physical device is its measurable physical and chemical properties and performance characteristics against established benchmarks.

8. The sample size for the training set

This is not applicable as this is not an AI/software device.

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/software device.

Summary

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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

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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 (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

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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)

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GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(+353) 91 703700 (3061)(+353) 91 680 104Mark Mullaney1721504
	Correspondent Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Ireland Ltd.Parkmore Business Park WestGalway, Ireland(+353) 91 703700 (3223)(+353) 91 680 104Michael O'Sullivan5/Apr//20179616662
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	InQwire® AmplatzMerit Medical Guide Wire21 CFR 870.1330 Catheter guide wire
PredicateDevice	Premarket Notification Predicate #1: (Primary Predicate)Trade Name:Classification Name:Premarket Notification:Manufacturer:Premarket Notification Reference DeviceTrade Name:Classification Name:Premarket Notification:Manufacturer:	InQwire®21 CFR 870.1330 Catheter guide wireK163575Merit Medical Systems, Inc.Amplatz Super Stiff Guidewire21 CFR 870.1330 Catheter guide wireK843012Boston Scientific Corporation
Classification	Class II21 CFR 870.1330 Catheter guide wireFDA Product Code: DQXReview Panel: Division of Cardiovascular Devices
Intended Use	Merit Medical guide wires are used to facilitate the placement of devices duringdiagnostic and interventional procedures.
DeviceDescription	Merit InQwire® Amplatz Super Stiff Guide Wires are intended to facilitate theplacement of devices during diagnostic and interventional procedures. The guidewires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, withan inside core wire. The core wire enhances the "Super Stiff" characteristic ofthe 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. 22cmfrom the distal end. These welds are designed to provide integrity and ensurethat 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-inchand 0.038-inch outer diameter with a 1cm, 3cm, 3.5cm ,4cm, 6cm and 7cmstraight 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 thewires diameter and length.The dispenser has a standard flush port luer adapter that accepts any standardluer 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 thewire tip into other devices.
Comparison toPredicate	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 Tipshape variant is also added to the range, spread across the two ODs. None ofthe above changes would be deemed sufficient to affect the technologicalcharacteristics of the device and thus the subject Merit InQwire® Amplatz SuperStiff Guide Wire is substantially equivalent to Predicate Device #1, the MeritInQwire® 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. Thelengths, 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 toPredicate Device #1.
Safety &PerformanceTests	No performance standards have been established under section 514 of theFood, Drug and Cosmetic Act for these devices. Performance testing of thesubject Merit InQwire® Amplatz Super Stiff Guide Wire was conducted based onrisk analysis. A battery of testing was conducted in accordance with protocolsbased on requirements outlined in guidance's and industry standards and thesewere shown to meet the acceptance criteria that were determined todemonstrate substantial equivalence.
	Where appropriate, the tests were based on the requirements of the followingdocuments: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 controlof a sterilization process for medical devices.ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier•Systems for Medical DevicesISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1:•Evaluation and Testing within a risk management process, and the FDAModified 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 andpackaging systems
	The Merit InQwire® Amplatz Super Stiff Guide Wire was compared to thepredicate device for various performance attributes that support substantialequivalence of the device. The difference in assembly between the modifieddevice 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

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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

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Stiff Guidewire [K843012], when it was deemed to be relevant.

	Size Designation	Radiopacity	Tensile	Torque
			Strength	Strength
	Tip Flexibility	Coating	Catheterand	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 MeritInQwire® Amplatz Super Stiff Guide Wire met the predeterminded acceptancecriteria. This has demonstrated that the subject device is substantially equivalentto the predicate devices.
	Based on the Indications for Use, design, safety and performance testing, the
Summary ofSubstantial	subject Merit InQwire® Amplatz Super Stiff Guide Wire is substantially
Equivalence	equivalent to the predicate devices, the cleared Predicate Device #1, the MeritInQwire® 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:

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.