InQwire® Diagnostic Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The quide wires have a continuous PTFE (Polytetrafluoroethylene) coated coil, inside core wire and a safety wire. The core wire is fixed at the proximal end only and extends to a specified distance from the distal end. The distal segment of the core wire has a profiled taper. The core wire enhances the stiffness of the guide wire. The safety wire extends the full length of the guide wire and is welded at both the distal and proximal end. The safety wire is designed to provide integrity and ensures that the guide wire components remain together.

The InQwire® Diagnostic Guide Wires are offered in 0.035 inch or 0.038 inch outer diameter with different tip configurations (straight or J-tip), single ended or double ended (either end of the wire can be placed into the patient), standard or firm shaft, and are available in lengths from 50cm to 260cm. The wire is placed inside a loop flush dispenser, also referred to as a hoop. The dispenser has a female Luer connection which facilitates solution flushing through the hoop to hydrate the guide wire. The guidewires are secured in the hoop dispenser by a locking J-tip straightener.

This modification details a supplier process change relating to removal of perfluorooctanoic acid (PFOA), used in the manufacture of the PTFE (Polytetrafluoroethylene) coating. More specifically PFOA is a processing aid used for the polymerization process of PTFE, which is flashed off during the oven curing process and therefore not part of the finished InQuire® Diagnostic Guidewire. Due to environmental concerns relating to PFOA, the U.S. Environmental Protection Agency has instructed that all processors of PTFE no longer make, buy or use PFOA(2010/2015 PFOA Stewardship Program). PFOA material is used in the manufacture both the intermediate layer and top layer of the PTFE(Polytetrafluoroethylene) coating.

AI/ML Overview

This document describes the 510(k) summary for the Merit InQwire® (IQ) Diagnostic Guide Wire, specifically addressing a change in the PTFE coating manufacturing process.

Here's an analysis of the provided text:

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

Test	Acceptance Criteria	Reported Device Performance
Surface	Not explicitly stated, but implied to be comparable to the predicate device.	All test results were comparable to the predicate devices.
Coating Adherence/Integrity	Not explicitly stated, but implied to be comparable to the predicate device.	All test results were comparable to the predicate devices.
* Fracture Test	Not explicitly stated, but implied to be comparable to the predicate device.	All test results were comparable to the predicate devices.
* Flexing Test	Not explicitly stated, but implied to be comparable to the predicate device.	All test results were comparable to the predicate devices.
* Coil Lubricity Test	Not explicitly stated, but implied to be comparable to the predicate device.	All test results were comparable to the predicate devices.
Catheter Compatibility	Not explicitly stated, but implied to be comparable to the predicate device.	All test results were comparable to the predicate devices.
Biocompatibility	Not explicitly stated, but implied to be comparable to the predicate device, likely adhering to ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile G95-1.	All test results were comparable to the predicate devices. The device met the predetermined acceptance criteria applicable to the safety and effectiveness of the device.

The document states that "Performance testing of the subject Merit InQwire® Diagnostic 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."

2. Sample size 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 sample size used for the tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) submission for a device modification (supplier process change), the tests would primarily be laboratory-based verification and validation.

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 information is not applicable to the provided document. The study described is a series of engineering and biological performance tests, not a clinical study involving expert interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.

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

This information is not applicable. Adjudication methods are typically used in clinical trials where multiple readers assess cases. This document describes laboratory-based performance testing of a medical device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to the 510(k) submission for a guide wire, which is a physical medical device, not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

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

No, a standalone (algorithm-only) performance study was not done. This document is about a physical medical device.

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

The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The "ground truth" for this device's performance is established by the specifications and measurable outcomes of the engineering and biological tests conducted against established industry standards and FDA guidance. The "truth" is whether the device meets the predetermined physical and chemical parameters.

8. The sample size for the training set

This information is not applicable. This is not a study involving machine learning or AI, so there is no training set in that context.

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

This information is not applicable, as there is no training set for an AI/machine learning model in this context.

Summary

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Merit Medical Systems, Inc.
Merit InQwire® (IQ) Diagnostic Guide Wire
Special Premarket Notification 510(k)

III AERITAEDICA

Section 6 510(k) Summary

DEC 1 2 2013

Section 6
510(k) Summary
GeneralProvisions	Submitter Name:	Merit Medical Systems, Inc.
	Address:	1600 West Merit ParkwaySouth Jordan
	Telephone Number:	(+353) 91 703700 (3061)
	Fax Number:Contact Person:Registration Number:	(+353) 91 680 104Mark Mullaney1721504
	Correspondent Name:	Merit Medical Ireland Ltd.
	Address:	Parkmore Business Park WestGalway, Ireland
	Telephone Number:	(+353) 91 703700 (3052)
	Fax Number:Contact Person:Date of Preparation:Registration Number:	(+353) 91 680 104Siobhan King10/16/20139616662
SubjectDevice	Trade Name:	InQwire®
	Common/Usual Name:	Merit Medical Guide Wire
	Classification Name:	21 CFR 870.1330 Catheter guide wire
PredicateDevice	Trade Name:	InQwire®
	Classification Name:	21 CFR 870.1330 Catheter guide wire
	Premarket Notification:	K002289
	Manufacturer:	Merit Medical Systems, Inc.
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.

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Merit Medical Systems, Inc. Merit InQwire (IQ) Diagnostic Guide Wire Special Premarket Notification 510(k)

Section 6 510(k) Summary

This modification details a supplier process change relating to removal of perfluorooctanoic acid (PFOA), used in the manufacture of the PTFE (Polytetrafluoroethylene) coating. More specifically PFOA is a processing aid used for the polymerization process of PTFE, which is flashed off during the oven curing process and therefore not part of the finished InQuire® Diagnostic Guidewire. Due to environmental concerns relating to PFOA, the U.S. Environmental Protection Agency has instructed that all processors of PTFE no longer make, buy or use PFOA(2010/2015 PFOA Stewardship Program). PFOA material is used in the manufacture both the intermediate র্ব laver and laver laver top of the PTFE(Polytetrafluoroethylene) coating.

Comparison to Predicate

Device

Description

Technological characteristics of the subject Merit InQwire® Diagnostic Guide Wire are substantially equivalent to those of the predicate, the Ment InQwire® Diagnostic Guide Wire [K002289]. The difference between the devices relates to the guide wire coating. The guide wire design and indications remain unchanged.

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Merit Medical Systems, Inc. Merit InQwire® (IQ) Diagnostic Guide Wire Special Premarket Notification 510(k)

Section 6 510(k) Summary

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® Diagnostic 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 quidance Coronary and Cerebrovascular Guide Wire . Guidance January 1995.
ISO 11070:1998, Sterile Single-Use Intravascular Catheter ● Introducers.
ISO 11135-1:2007 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 . Barner 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.

Safety & Performance Tests

The Merit InQwire® Diagnostic Guide Wire was compared to the predicate device for vanous performance attributes that support substantial equivalence of the device. The difference in coating between the modified device and the cleared device [K002289] has raised no new issues.

The following is a list of all significant testing that was successfully completed:

. Surface
Coating Adherence/Integrity .
- o Fracture Test
- Flexing Test O
- o Coil Lubricity Test
· Catheter Compatibility
Biocompatibility �

All test results were comparable to the predicate devices and the subject Merit InQwire® Diagnostic Guide Wire met the predeterminded acceptance criteria applicable to the safety and effectiveness of the device. This has demonstrated the subject device is substantially equivalent to predicate device.

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Merit Medical Systems, Inc.
Merit InQwire® (IQ) Diagnostic Guide Wire Special Premarket Notification 510{k}

Section 6 510(k) Summary

Based on the Indications for Use, design, safety and performance testing, the subject Merit Medical InQwire® Diagnostic Guide Wire meets Summary of the requirements that are considered essential for its intended use and is Substantial substantively equivalent to the predicate device, the cleared Merit Equivalence InQwire® Diagnostic Guide Wire manufactured by Merit Medical Systems Inc. :

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Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.

Public Health Service

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

December 12, 2013

Merit Medical Systems, Inc. Ms. Siobhan King Parkmore Business Park West Galway, Ireland

Re: K133230 Trade/Device Name: InQwire Diagnostic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 7, 2013 Received: November 12, 2013

Dear Ms. King:

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. Drue, 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. Ilisting 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 of medical device-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.

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Page 2- Ms. Siobhan King

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Bram D. Zeolorman -S

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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Merit Medical Systems, Inc.
Ment InQwire Diagnostic Guide Wire Special Premarket Notification 510(k)

Section 5 Indications for Use Statement

510(k) Number (if known):

Device Name: Merit InQwire® Diagnostic Guide Wire

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/6/Picture/13 description: The image shows the name "Bram-D. Zuckerman -S" at the top. Below the name is the date and time "2013.12.12 16:23:45 -05'00'". The FDA logo is in the center of the image, behind the date and time.

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.