The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

Device Description

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight and angled configurations in various lengths.

AI/ML Overview

The provided text refers to a medical device, the "Merit Hydrophilic Guide Wire," and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, study design, and ground truth for an AI/ML model are not applicable.

However, I can extract information related to the device's performance testing and how it met acceptance criteria for substantial equivalence to predicate devices.

Summary of Acceptance Criteria and Device Performance (for the Merit Hydrophilic Guide Wire):

Acceptance Criteria Category	Reported Device Performance
General Equivalence	Substantially equivalent to predicate Merit Hydrophilic Guide Wire [K120644] and Terumo Radiofocus® Glidewire® [K863138].
Tensile Strength	Successfully completed testing; comparable to predicate devices.
Torque Strength	Successfully completed testing; comparable to predicate devices.
Torquability	Successfully completed testing; comparable to predicate devices.
Tip Flexibility	Successfully completed testing; comparable to predicate devices.
Coating Adherence/Integrity	Successfully completed testing (including anatomical model evaluation); comparable to predicate devices.
Catheter Compatibility (Durability)	Successfully completed testing; comparable to predicate devices.
Surface	Successfully completed testing; comparable to predicate devices.
Fracture Test	Successfully completed testing; comparable to predicate devices.
Flex Test	Successfully completed testing; comparable to predicate devices.
Size Designation/Dimensions	Successfully completed testing; comparable to predicate devices.
Radiopacity	Successfully completed testing; comparable to predicate devices.
Biocompatibility	Met requirements of ISO 10993-1: 2009 and FDA Modified ISO 10993 Test Profile FDA Memo G95-1.
Sterilization	Met requirements of ISO 11135-1: 2007 (Ethylene oxide sterilization).
Shelf Life/Aging	Met requirements of ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems).
No New Issues	Difference in wire diameter between modified and cleared devices raised no new issues.

Study Information (Based on Substantial Equivalence Evaluation):

Sample sizes used for the test set and data provenance:
This information is not provided in a way that is applicable to an AI/ML model. The "test set" in this context refers to a series of physical tests performed on the guide wire samples. The document does not specify the number of guide wires tested for each attribute or their provenance. The "data provenance" mentioned in your request (country of origin of data, retrospective/prospective) is relevant for clinical data, not for material property testing of a medical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in this context would typically refer to expert consensus on clinical diagnoses for AI/ML. For a physical device, testing against defined engineering specifications serves as the "ground truth." The document states "protocols based on requirements outlined in guidance's and industry standards," implying established engineering and scientific methods rather than expert clinical consensus on individual test results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies, particularly for AI/ML evaluation. This document describes laboratory testing against established standards.
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:
Not applicable, as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this medical device, the "ground truth" for the performance tests was established by industry standards (e.g., ISO 11070:1998, ISO 11135-1:2007, ASTM F1980-07, ISO 10993-1:2009) and FDA guidance (Coronary and Cerebrovascular Guide Wire Guidance January 1995, FDA Modified ISO 10993 Test Profile FDA Memo G95-1). The device's performance was compared to a "predicate device" (Terumo Radiofocus® Glidewire® K863138) for various attributes.
The sample size for the training set:
Not applicable, as this is not an AI/ML device, and therefore no "training set" in that sense was used. The device underwent physical and chemical testing.
How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.

Summary

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Section 6
510(k) Summary
GeneralProvisions	Submitter Name:Address:	Merit Medical Systems, Inc.Parkmore Business ParkParkmore, Galway, Ireland
	Telephone Number:Fax Number:Contact Person:Registration Number:	(+353) 91 703700 (3061)(+353) 91 680 104Mark Mullaney9616662	JUL 2 9 2013
	Correspondent Name:Address:	Merit Medical Ireland Ltd.Parkmore Business ParkParkmore, Galway, Ireland
	Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	(+353) 91 703700 (3168)(+353) 91 680 104Martha Folan26th June 20139616662
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	Merit Hydrophilic Guide WireHydrophilic Guide WireCatheter Guide Wire
PredicateDevice	Trade Name:Classification Name:	Merit Hydrophilic Guide WireCatheter Guide Wire
	Premarket Notification Predicate Device # 1:Merit Hydrophilic Guide Wire K120644Manufacturer: Merit Medical Systems, Inc
	Premarket Notification Predicate Device # 2:Radiofocus® Glidewire® K863138Manufacturer: Terumo Medical Corp.
	Premarket Notification Predicate Device # 3Merit Hydrophilic Guide Wire K130588Manufacturer: Merit Medical Systems, Inc

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Classification	Class II21 CFR § 870.1330,Product code: DQXDivision of Cardiovascular Devices
Intended Use	The Merit Hydrophilic Guide Wire is intended to be used in the peripheralvascular system to facilitate the placement of devices during diagnosticand interventional procedures.
DeviceDescription	The Merit Hydrophilic Guide Wire consists of a jacketed core wire with ahydrophilic coating applied to the jacket. The wire will be offered instraight and angled configurations in various lengths.
Comparisonto Predicate	Technological characteristics of the subject Merit Hydrophilic Guide Wireare substantially equivalent to those of the predicate, the MeritHydrophilic Guide Wire [K120644]. The difference between the devicesrelates to the guide wire diameter size. The guide wire design remainsunchanged. Predicate device #2 [K863138] Terumo Radiofocus®Glidewire® is the predicate for performance testing parameters.Predicate device #3 [K130588] includes clarification of the Intended usestatement.

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Safety &PerformanceTests	No performance standards have been established under section 514 ofthe Food, Drug and Cosmetic Act for these devices. A battery of testingwas conducted in accordance with protocols based on requirementsoutlined in guidance's and industry standards and these were shown tomeet the acceptance criteria that were determined to demonstratesubstantial equivalence.Where appropriate, the tests were based on the requirements of thefollowing documents:FDA guidance Coronary and Cerebrovascular Guide WireGuidance January 1995. ISO 11070: 1998, Sterile Single-Use Intravascular CatheterIntroducers. ISO 11135-1: 2007 Sterilization of health care products-Ethyleneoxide- 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 SterileBarrier Systems for Medical Devices ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part1: Evaluation and Testing within a risk management process, andthe FDA Modified ISO 10993 Test Profile FDA Memo G95-1. The Merit Hydrophilic Guide Wire was compared to the predicatedevice(s) for various performance attributes that support substantialequivalence of the device. The difference in wire diameter between themodified device and the cleared device [K120644] has raised no newissues. Performance testing was based on Predicate device # 2[K863138] Terumo Radiofocus® Glidewire®.The following is a list of all significant testing that was successfullycompleted:Tensile Strength, Torque Strength, Torquability, Tip Flexibility, CoatingAdherence/Integrity (including Evaluation using Anatomical Model),Catheter Compatibility (Durability), Surface, Fracture Test, Flex test, SizeDesignation/ Dimensions and Radiopacity.As all test results were comparable to the predicate devices and thesubject Merit Hydrophilic guide wire met the predeterminded acceptancecriteria applicable to the safety and efficacy of the device,this hasdemonstrated the subject device is substantially equivalent to predicatedevices.
Summary ofSubstantialEquivalence	Based on the Indications for Use, design, safety and performancetesting, the subject Merit Medical Hydrophilic Guide Wire meets therequirements that are considered essential for its intended use and issubstantively equivalent to the predicate device, the Merit HydrophilicGuide Wire manufactured by Merit Medical Systems Inc.

Safety &PerformanceTests

No performance standards have been established under section 514 ofthe Food, Drug and Cosmetic Act for these devices. A battery of testingwas conducted in accordance with protocols based on requirementsoutlined in guidance's and industry standards and these were shown tomeet the acceptance criteria that were determined to demonstratesubstantial equivalence.Where appropriate, the tests were based on the requirements of thefollowing documents:FDA guidance Coronary and Cerebrovascular Guide WireGuidance January 1995. ISO 11070: 1998, Sterile Single-Use Intravascular CatheterIntroducers. ISO 11135-1: 2007 Sterilization of health care products-Ethyleneoxide- 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 SterileBarrier Systems for Medical Devices ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part1: Evaluation and Testing within a risk management process, andthe FDA Modified ISO 10993 Test Profile FDA Memo G95-1. The Merit Hydrophilic Guide Wire was compared to the predicatedevice(s) for various performance attributes that support substantialequivalence of the device. The difference in wire diameter between themodified device and the cleared device [K120644] has raised no newissues. Performance testing was based on Predicate device # 2[K863138] Terumo Radiofocus® Glidewire®.The following is a list of all significant testing that was successfullycompleted:Tensile Strength, Torque Strength, Torquability, Tip Flexibility, CoatingAdherence/Integrity (including Evaluation using Anatomical Model),Catheter Compatibility (Durability), Surface, Fracture Test, Flex test, SizeDesignation/ Dimensions and Radiopacity.As all test results were comparable to the predicate devices and thesubject Merit Hydrophilic guide wire met the predeterminded acceptancecriteria applicable to the safety and efficacy of the device,this hasdemonstrated the subject device is substantially equivalent to predicatedevices.

Summary ofSubstantialEquivalence

Based on the Indications for Use, design, safety and performancetesting, the subject Merit Medical Hydrophilic Guide Wire meets therequirements that are considered essential for its intended use and issubstantively equivalent to the predicate device, the Merit HydrophilicGuide Wire manufactured by Merit Medical Systems Inc.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 29, 2013

Merit Medical Systems, Inc. Ms. Martha Folan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland

Re: K131710

Trade/Device Name: Merit Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: June 27, 2013 Received: July 1, 2013

Dear Ms. Martha Folan:

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 10 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Folan

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 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" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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K131710

Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire Special Premarket Notification 510(k)

Section 5 Indications for Use Statement

510 (k) Number:

Device Name: Merit Hydrophilic Guide Wire

Indications for Use:

The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system 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)

Bram D. Zuckerman -S 2013.07.29 18:10:49 -04'00'

Page 27

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.