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 does not describe a study involving an AI/algorithmic device. The document is a 510(k) premarket notification for a Merit Hydrophilic Guide Wire, which is a physical medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics is not applicable in this context.

The document discusses the substantial equivalence of the subject guide wire to predicate devices based on various performance attributes and safety tests.

Here's a breakdown of what is provided, as it relates to the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of specific acceptance criteria values and corresponding device performance data for each test. Instead, it states that:

Acceptance Criteria Category	Reported Device Performance
Overall Performance	"As all test results were comparable to the predicate devices and the subject Merit Hydrophilic guide wire met the predetermined acceptance criteria applicable to the safety and efficacy of the device, this has demonstrated the subject device is substantially equivalent to predicate devices."

Tests Performed (implied acceptance criteria for each):

Tensile Strength
Torque Strength
Torquability
Tip Flexibility
Coating Adherence/Integrity (including Evaluation using Anatomical Model)
Catheter Compatibility (Durability)
Surface
Fracture Test
Flex test
Size Designation/Dimensions
Radiopacity

The acceptance criteria for these tests were based on:

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 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.

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

Not applicable for an AI device. For the physical guide wire, the sample sizes for each specific test (e.g., tensile strength, flex test) are not explicitly stated in this summary. The tests were likely conducted on a sufficient number of samples to statistically demonstrate compliance with the acceptance criteria, as is standard practice for medical device testing. The provenance of the "data" (i.e., the physical test results) would be from in-house laboratory testing conducted by Merit Medical Systems, Inc. in Ireland.

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

Not applicable. Ground truth as typically defined for AI models (e.g., expert consensus on medical images) does not apply to the performance testing of a physical guide wire. The "ground truth" for these tests would be the established engineering and biological standards and guidances mentioned above.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1, 3+1" are used for resolving disagreements among multiple human readers in image interpretation, which is not relevant to this physical 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. This is irrelevant to a physical medical device.

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

No. This is irrelevant to a physical medical device.

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

For the physical device, the "ground truth" refers to the established scientific and engineering principles, material properties, and biological safety standards (e.g., biocompatibility standards like ISO 10993) against which the device's performance was measured. There's no "ground truth" in the AI sense.

8. The sample size for the training set

No. This is irrelevant to a physical medical device.

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

No. This is irrelevant to a physical medical device.

Summary

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

APR 0 5 2013

Section 6 510(k) Summary Submitter Name: Merit Medical Systems, Inc. Address: Parkmore Business Park Parkmore, Galway, Ireland Telephone Number: (+353) 91 703700 (3061) (+353) 91 680 104 Fax Number: Mark Mullaney Contact Person: 9616662 Registration Number: General Merit Medical Ireland Ltd. Correspondent Name: Provisions Address: Parkmore Business Park Parkmore, Galway, Ireland (+353) 91 703700 (3168) Telephone Number: (+353) 91 680 104 Fax Number: Martha Folan Contact Person: · 4th April 2013 Date of Preparation: Registration Number: 9616662 Merit Hydrophilic Guide Wire Trade Name: Subject Hydrophilic Guide Wire Common/Usual Name: Device Classification Name: Catheter Guide Wire Trade Name: Merit Hydrophilic Guide Wire Classification Name: Catheter Guide Wire Premarket Notification Predicate Device # 1 Predicate Merit Hydrophilic Guide Wire K120644 Device Manufacturer: Merit Medical Systems, Inc Premarket Notification Predicate Device # 2: Radiofocus® Glidewire® K863138 Manufacturer: Terumo Medical Corp. Class II 21 CFR § 870.1330, Classification Product code: DQX Division of Cardiovascular Devices The Merit Hydrophilic Guide Wire is intended to be used in the peripheral Intended Use vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

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・

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

DeviceDescription	The Merit Hydrophilic Guide Wire consists of a jacketed core wire with ahydrophilic coating applied to the jacket. The wire will be offered in straight andangled configurations in various lengths.
Comparisonto Predicate	Technological characteristics of the subject Merit Hydrophilic Guide Wire aresubstantially equivalent to those of the predicate, the Merit Hydrophilic GuideWire [K120644]. The difference between the devices relates to the guide wirediameter size. The guide wire design remains unchanged. Predicate device #2[K863138] Terumo Radiofocus® Glidewire® is the predicate for performancetesting parameters.
Safety &PerformanceTests	No performance standards have been established under section 514 of theFood, Drug and Cosmetic Act for these devices. A battery of testing wasconducted in accordance with protocols based on requirements outlined inguidance's and industry standards and these were shown to meet theacceptance criteria that were determined to demonstrate substantialequivalence.Where appropriate, the tests were based on the requirements of the followingdocuments:FDA guidance Coronary and Cerebrovascular Guide Wire GuidanceJanuary 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 controlof a sterilization process for medical devices. ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile BarrierSystems for Medical Devices ISO 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. The Merit Hydrophilic Guide Wire was compared to the predicate device(s) forvarious performance attributes that support substantial equivalence of thedevice. The difference in wire diameter between the modified device and thecleared device [K120644] has raised no new issues. Performance testing wasbased on Predicate device # 2 [K863138] Terumo Radiofocus® Glidewire®.The following is a list of all significant testing that was successfully completed:Tensile Strength, Torque Strength, Torquability, Tip Flexibility, CoatingAdherence/Integrity (including Evaluation using Anatomical Model), CatheterCompatibility (Durability), Surface, Fracture Test, Flex test, Size Designation/Dimensions and Radiopacity.As all test results were comparable to the predicate devices and the subjectMerit Hydrophilic guide wire met the predetermined acceptance criteriaapplicable to the safety and efficacy of the device, this has demonstrated thesubject device is substantially equivalent to predicate devices.
SummaryofSubstantialEquivalence	Based on the Indications for Use, design, safety and performance testing, thesubject Merit Medical Hydrophilic Guide Wire meets the requirements that areconsidered essential for its intended use and is substantively equivalent to thepredicate device, the Merit Hydrophilic Guide Wire manufactured by MeritMedical Systems Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol associated with the United States.

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

April 5, 2013

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

Re: K130588

Trade Name: Merit Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: March 4, 2013 Received: March 7, 2013

Dear Ms. 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 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. Ilsting 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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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

ff 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kenneth: Cavañaug

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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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 | 7 (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)

Kenneth J. Cavanaugh 2013.04.05 14:05:59 -04'00'

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.