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

AI/ML Overview

The provided text describes the regulatory submission for the Merit Hydrophilic Guide Wire, asserting its substantial equivalence to a predicate device. However, it does not contain a specific study report with detailed acceptance criteria and reported device performance in the format requested. Instead, it outlines the types of tests performed and the standards referenced to demonstrate safety and efficacy.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is not:

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

The document does not provide a table specifying distinct acceptance criteria values alongside corresponding reported device performance values for each test. It states that "a battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device."

The types of tests successfully completed are listed as:

Coating Adherence/Integrity
Catheter Compatibility
Surface
Fracture Test
Flex Test
Size Designation
Biocompatibility
Chemical Characterization

For each of these, the document implies that predefined acceptance criteria were met, but the specific criteria and results are not detailed.

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

This information is not present in the provided text. The document mentions tests were performed but does not specify sample sizes or data provenance.

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 as the document describes performance testing of a physical medical device (guide wire) against engineering standards and biocompatibility requirements, not a diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable for the same reasons as point 3.

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 information is not applicable. The device is a medical guide wire, not an AI-assisted diagnostic tool.

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

This information is not applicable for the same reasons as point 5.

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

For the performance tests listed, the "ground truth" would be defined by compliance with established industry standards and guidances, such as ISO 11070 for catheter introducers, ASTM F756 for hemolytic properties, and ISO 10993 for biological evaluation. These standards inherently define the acceptable performance parameters. The document also states that the device was compared to a predicate device (K092303) for various performance attributes, implying that the predicate's established safety and efficacy serve as a benchmark.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" in the context of this physical device's testing. Machine learning or AI models, which typically use training sets, are not part of this device's evaluation as described.

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

This information is not applicable for the same reasons as point 8.

In summary:

The document focuses on demonstrating that the modified Merit Hydrophilic Guide Wire is substantially equivalent to its predicate based on a battery of tests against recognized industry standards and guidances. It states that these tests met acceptance criteria, thereby demonstrating the safety and efficacy of the device. However, it does not provide the granular details of these criteria or the test results in a tabular format, nor does it involve elements common to AI device evaluations (like ground truth established by experts, reader studies, or training sets).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a bold, sans-serif font. The word "MEDICAL" is outlined in white, while the rest of the logo is in black. There is a registered trademark symbol to the right of the word "MEDICAL".

Merit Medical Ireland Ltd., KV20644

Parkmore Business Park West, Galway, Ireland.

SEP 1 9 2012

int Tel: +353 (0) 91 703 700 Int Fax: +353 {0} 91 771 888

Web: www.merit.com

Section 5

510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number:	Merit Medical Systems, Inc.1600 West Merit Parkway,South Jordan, UT 84095(801) 208-4349(801) 253-6967Stephanie Erskine1721504
	Correspondent Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Ireland Ltd.Parkmore Business Park,Galway, Ireland(353) 91 703 761(353) 91 771 888Mark MullaneyMarch 1, 20129616662
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	Merit Hydrophilic Guide WireHydrophilic Guide WireCatheter Guide Wire
PredicateDevices	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Merit Hydrophilic Guide WireCatheter Guide WireK092303Merit Medical Systems, Inc.
Classification	Class II21 CFR § 870.1330, 74 DQXDivision of Cardiovascular Devices
Intended Use	The Merit Hydrophilic Guide Wire is intended to facilitate the placementof devices during diagnostic and 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 withstraight and angled tip configurations in various lengths.

Directors: F. Lampropoulos (American), R. Perry (American), K. Stanger (American), M. Butter (Irish) Registered in Dublin, Ireland No. 210890. Registered Office: 25/28 North Wall Quay, Dublin 2.

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Comparison to Predicate ·

Technological characteristics of the subject Merit Hydrophilic Guide Wire are substantially equivalent to those of the predicate, the Merit Hydrophilic Guide Wire {K092303]. The differences between the devices relate to the hydrophilic coating process. The guide wire design remains unchanged.

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No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device.

Where appropriate, the tests were based on the requirements of the following documents:

. FDA Guidance Coronary and Cerebrovascular Guide Wire Guidance January 1995.
. ISO 11070:1998, 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 F756-08 Standard Practice for Assessment of Hemolytic . Properties of Materials
. 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 10993-5:2009 Biological Evaluation of Medical Devices -Part 5: Tests for In-Vitro Cytotoxicity
. ISO 10993-7:2008 - Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
ISO 10993-18:2005 Biological Evaluation of Medical Devices -. Part 18: Chemical Characterization of Materials

The Merit Hydrophilic Guide Wire was compared to the predicate device for various performance attributes that demonstrate the safety or efficacy of the device. Differences in materials between the modified device and the cleared device [K092303] raised no issues of safety and effectiveness. The hydrophilic coating process was modified. The coating solution is made with the identical raw materials, equipment, and processes used for the preparation of the predicate coating solution.

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

. Coating Adherence/Integrity
Catheter Compatibility .
Surface .
Fracture Test .
. Flex Test
Size Designation .
Biocompatibility .
Chemical Characterization .

Safety & ● Performance Tests

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Summary of Substantial Equivalence

Based on the indications for use, design, safety, and performance testing, the subject Merit Hydrophilic Guide Wire meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit Hydrophilic Guide Wire manufactured by Merit Medical Systems, Inc. Differences between the two devices do not raise any significant issues of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

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

SEP 19 2012

Merit Medical Systems, Inc. Mr. Mark Mullaney Regulatory Affairs Manager Parkmore Business Park West, Galway, Ireland

Re: K120644

Trade/Device Name: Merit Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 10, 2012 Received: September 12, 2012

Dear Mr. Mullaney:

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.

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Page 2 - Mr. Mark Mullaney

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 or ury 1 vith 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CMA. Hellehn

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. Merit Hydrophilic Guide Wire Premarket Notification 510(k)

Section 4

Indications for Use Statement

K120644

510(k) Number (if known):

Device Name: Merit Hydrophilic Guide Wire

Indications for Use:

The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.

Prescription Use _ × (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)

. S. Allelu

diovascular Devices

510(k) Number K120644

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.