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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "InQwire Amplatz Super Stiff Guide Wire." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document states that performance testing was conducted based on risk analysis and in accordance with protocols based on guidances and industry standards. It explicitly says: "these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." And "All test results were comparable to the predicate devices and the subject Merit InQwire® Amplatz Super Stiff Guide Wire met the predetermined acceptance criteria."

However, the document does not provide a specific table detailing numerical acceptance criteria and a corresponding column for reported device performance values. It lists the types of tests performed but not the quantitative results or specific thresholds.

Table of Performance Tests Conducted (Acceptance Criteria and Numerical Performance Not Specified):

Performance Attribute	Met Acceptance Criteria (Reported)
Size Designation	Yes (comparable to predicate)
Tip Flexibility	Yes (comparable to predicate)
Surface	Yes (comparable to predicate)
Radiopacity	Yes (comparable to predicate)
Coating Adherence/Integrity	Yes (comparable to predicate)
Fracture Flex	Yes (comparable to predicate)
Particulate Evaluation	Yes (comparable to predicate)
Tensile Strength	Yes (comparable to predicate)
Catheter and Needle Compatibility	Yes (comparable to predicate)
Torque Strength	Yes (comparable to predicate)
Lubricity	Yes (comparable to predicate)
Biocompatibility	Yes (comparable to predicate)
Corrosion	Yes (comparable to predicate)
Packaging	Yes (comparable to predicate)

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any of the performance tests. It also does not mention data provenance such as country of origin of the data or whether the studies were retrospective or prospective. The testing appears to be primarily bench testing (in vitro) rather than human or animal studies, given the type of device and tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the document describes performance testing of a physical medical device (guide wire), not an AI/ML algorithm that requires expert "ground truth" for interpretation of images or other clinical data. The "ground truth" here is the physical performance of the device against engineering and material standards.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-AI reader studies. The performance tests described measure physical properties and do not involve human interpretation.

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. The device is a guide wire, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study involving human readers and AI assistance would have been performed.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance testing is based on engineering standards, in vitro testing protocols, and comparison to legally marketed predicate devices. This includes:

FDA guidance (e.g., Coronary and Cerebrovascular Guide Wire Guidance January 1995)
Industry standards (e.g., ISO 11070:2014, ISO 11135-1:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006)
Bench testing methodologies to evaluate physical and material properties (e.g., tensile strength, flexibility, radiopacity, coating adherence, biocompatibility, corrosion).

8. The sample size for the training set

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This is not applicable for the same reason as #8.

Summary

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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 (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

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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 5510(k) Summary
GeneralProvisions	Submitter Name: Merit Medical Systems, Inc.Address: 1600 West Merit ParkwaySouth Jordan, UT 84095Telephone Number: (+353) 91 703700 (3061)Fax Number: (+353) 91 680 104Contact Person: Mark MullaneyRegistration Number: 1721504Correspondent Name: Merit Medical Ireland Ltd.Address: Parkmore Business Park WestGalway, IrelandTelephone Number: (+353) 91 703700 (3223)Fax Number: (+353) 91 680 104Contact Person: Michael O'SullivanDate of Preparation: 09/Feb//2017Registration Number: 9616662
SubjectDevice	Trade Name: InQwire®Common/Usual Name: Merit Medical Guide WireClassification Name: 21 CFR 870.1330 Catheter guide wire
PredicateDevice	Premarket Notification Predicate#1: (Primary Predicate)Trade Name: InQwire®Classification Name: 21 CFR 870.1330 Catheter guide wirePremarket Notification: K133230Manufacturer: Merit Medical Systems, Inc.Premarket Notification Predicate#2: (Reference Predicate)Trade Name: Amplatz Super Stiff GuidewireClassification Name: 21 CFR 870.1330 Catheter guide wirePremarket Notification: K843012Manufacturer: Boston 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 devicesduring 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 coilat three (3) points; a) the distal end, b) the proximal end and c) a spotweld approx. 22cm from the distal end. These welds are designed toprovide integrity and ensure that the guide wire components remaintogether The outside coil is PTFE coated and this Blue PTFE coatingextends 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 in0.035-inch outer diameter with a 7cm straight tip configuration and areavailable in lengths from 75cm to 260cm. The wires will be provided in aspiral hoop dispenser sized appropriately for the wires diameter andlength.
	The dispenser has a standard flush port luer adapter that accepts anystandard luer lock or slip tip syringe to facilitate flushing of the guide wireprior to use. A J-straightener is provided on the dispenser to facilitate theadvancement of the wire tip into other devices.
Comparisonto Predicate	The changes to the device are as follows; a) The core wire OD is greaterto provide greater Stiffness; b) The coiling wire is changed from round toflat to enable the 0.035" OD to be maintained; c) There is no safety wirepresent. Instead the core wire is welded to both the proximal and distalends; d) An additional spot weld is present, approx. 22cm from the distaltip, that joins the core wire to the coil and; e) The colour of the PTFEcoating is changing from green to blue. None of the above changeswould be deemed sufficient to affect the technological characteristics ofthe device and thus the subject Merit InQwire® Amplatz Super StiffGuide Wire is substantially equivalent to Predicate Device#1, the MeritInQwire® Diagnostic Guide Wire [K133230] and Reference PredicateDevice#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 thebracketed 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 &PerformanceTests	ISO 11135-1:2014 Sterilization of health care products-Ethylene●oxide- Part 1: Requirements for the development, validation androutine control of 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, andthe 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 barriersystems and packaging systemsThe Merit InQwire® Amplatz Super Stiff Guide Wire was compared to thepredicate device(s) for various performance attributes that supportsubstantial equivalence of the device. The difference in assemblybetween the modified device and the cleared device, Merit InQwire®Diagnostic Guide Wire [K133230] has raised no new issues. In someinstances, performance characteristic testing was based on theReference 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
	DesignationTip Flexibility	CoatingAdherence/IntegrityFracture●Flex●Particulate●Evaluation	StrengthCatheter andNeedleCompatibility	StrengthLubricity
	Surface	Biocompatibility	Corrosion	Packaging
Summary ofSubstantial	All test results were comparable to the predicate devices and the subjectMerit InQwire® Amplatz Super Stiff Guide Wire met the predetermindedacceptance criteria. This has demonstrated that the subject device issubstantially equivalent to the predicate devices.Based on the Indications for Use, design, safety and performancetesting, the subject Merit InQwire® Amplatz Super Stiff Guide Wire issubstantially equivalent to the predicate devices, the cleared PredicateDevice#1, the Merit InQwire® Diagnostic Guide Wire [K133230] and
Equivalence	Reference Predicate Device#2, the Amplatz Super Stiff Guidewire[K843012].

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.