The Merit Mighty Wire is intended to be used to facilitate the placement of devices during diagnostic and interventional procedures in the central circulatory system, excluding the coronary arteries and neurovasculature.

Device Description

The wire is composed of a PTFE (polytetrafluoroethylene) coated stainless-steel core wire with a grind profile ending in a flexible distal tip. A PTFE coated stainless steel distal coil is laser-welded to the proximal end of the core wire grind profile and plasma arc-welded to the distal end of the core wire profile. The PTFE coating covers 100% of the guide wire surface. For wire lengths 230, 260, and 300cm, an additional radiopaque Platinum-Tungsten marker coil is welded to the core wire flexible distal tip. The distal tip is radiopaque.

AI/ML Overview

The provided text is a compilation of FDA documents related to the 510(k) clearance of the "Mighty Wire Guide Wire". It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device. The document is for a physical medical device (guide wire) and outlines the regulatory process for its clearance based on substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML enabled device from the provided text. The questions pertaining to sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment are not applicable to the content of this document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 28, 2023

Merit Medical Systems, Inc. % James Kenny Senior Regulatory Affairs Specialist Merit Medical Ireland, Ltd. Parkmore Business Park West Galway, Ireland

Re: K230418

Trade/Device Name: Mighty Wire Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 29, 2023 Received: September 29, 2023

Dear James Kenny:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brian D. Pullin -S

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230418

Device Name Mighty Wire Guide Wire

Indications for Use (Describe)

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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K230418

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(+353) 91 703798(+353) 91 680104James Kenny1721504
	Correspondent Name:Address:	Merit Medical Ireland Ltd.Parkmore Business ParkParkmore, Galway, Ireland
	Telephone Number:	(+353) 91 703798
	Fax Number:Contact Person:	(+353) 91 680104James Kenny
	Date of Preparation:	14 February 2023
	Registration Number:	9616662
SubjectDevice	Trade Name:Common/Usual Name:Class:Product code:Classification Name:Regulation Number:	Mighty Wire Guide WireGuide WireIIDQXWire, Guide, Catheter21 CFR 870.1330
	Regulation Medical Specialty Cardiovascular
PredicateDevice	Trade Name:Class:Product code:Classification Name:Regulation Number:Regulation Medical Specialty CardiovascularPremarket Notification:Manufacturer:	Lunderquist Extra-Stiff Wire GuideIIDQXWire, Guide, Catheter21 CFR 870.1330CardiovascularK220137Cook Medical

510(k) Summary

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	510(k) Summary1
--	---------------------

	The Merit Mighty Wire Guide Wire family all have 0.035" outerdiameter with length configurations available in 90, 145, 180, 230,260, and 300cm. The distal tip configurations are Straight, Curved(7.5mm J Radius), Double Curved (75mm/15mm Radius), andExtended Double Curved (55mm/15mm Radius).
DeviceDescription	The wire is composed of a PTFE (polytetrafluoroethylene) coatedstainless-steel core wire with a grind profile ending in a flexibledistal tip. A PTFE coated stainless steel distal coil is laser-weldedto the proximal end of the core wire grind profile and plasma arc-welded to the distal end of the core wire profile. The PTFE coatingcovers 100% of the guide wire surface. For wire lengths 230, 260,and 300cm, an additional radiopaque Platinum-Tungsten markercoil is welded to the core wire flexible distal tip. The distal tip isradiopaque.
Intended Use	The Merit Mighty Wire is intended to be used to facilitate theplacement of devices during diagnostic and interventionalprocedures in the central circulatory system, excluding thecoronary arteries and neurovasculature.

The Merit Mighty Wire Guide Wire family all have 0.035" outerdiameter with length configurations available in 90, 145, 180, 230,260, and 300cm. The distal tip configurations are Straight, Curved(7.5mm J Radius), Double Curved (75mm/15mm Radius), andExtended Double Curved (55mm/15mm Radius).

DeviceDescription

The wire is composed of a PTFE (polytetrafluoroethylene) coatedstainless-steel core wire with a grind profile ending in a flexibledistal tip. A PTFE coated stainless steel distal coil is laser-weldedto the proximal end of the core wire grind profile and plasma arc-welded to the distal end of the core wire profile. The PTFE coatingcovers 100% of the guide wire surface. For wire lengths 230, 260,and 300cm, an additional radiopaque Platinum-Tungsten markercoil is welded to the core wire flexible distal tip. The distal tip isradiopaque.

Intended Use

The Merit Mighty Wire is intended to be used to facilitate theplacement of devices during diagnostic and interventionalprocedures in the central circulatory system, excluding thecoronary arteries and neurovasculature.

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The technological characteristics of the subject Merit Mighty Wire Guide Wire are substantially equivalent to those of Predicate Device, Lunderquist Extra-Stiff Wire Guide [K220137]. The Merit Mightv Wire Guide Wire was developed based on a full characterization of the Lunderquist Extra-Stiff Wire Guide: The wire is composed of a PTFE (polytetrafluoroethylene) coated stainless-steel core wire with a grind profile ending in a flexible distal tip. A PTFE coated stainless steel distal coil is laser-welded to the proximal end of the core wire grind profile and plasma arcwelded to the distal end of the core wire profile. The PTFE coating covers 100% of the quide wire surface. For wire lengths 230. 260. and 300cm, an additional radiopaque Platinum-Tungsten marker coil is welded to the core wire flexible distal tip. The distal tip is radiopaque. The subject device has the same basic design as the predicate. The Comparison Lunderquist Extra-Stiff Wire Guide is comprised of a PTFE coated to Predicate stainless-steel core wire and a PTFE coated stainless-steel coil. The PTFE coated coil is welded to the core on the very distal tip. Wires with lengths 260 and 300cm include an inner gold radiopaque coil. The fundamental technology and operating principles of the subject and the predicate are the same. While the indications for use wordings are not identical, both are intended to facilitate the placement of devices during diagnostic and interventional procedures. The Mighty Wire is for use in the "central circulatory system, excluding the coronary arteries and neurovasculature". The Lunderquist Extra-Stiff Wire Guide is for use in the "major vessels, the aorta and vena cava, including their access vessels and adjacent vessels". The intended use is the same for both the subject Mighty Wire Guide Wire and predicate Lunderquist Extra-Stiff Wire Guide, with both used for the placement and exchange of devices during diagnostic and interventional procedures. No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. A battery of testing was conducted, on the Merit Mighty Wire Guide Wire, in accordance with protocols based on requirements outlined in Safety & quidance's and industry standards and these were shown to meet Performance the acceptance criteria that were determined to demonstrate Tests substantial equivalence.

Where appropriate, the tests were based on the requirements of the

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following documents:

FDA Guidance "Coronary, Peripheral, and Neurovascular ● Performance Tests Guidewires and Recommended Labelling" - October 2019
FDA Guidance "Intravascular Catheters, Wires, and ● Delivery Systems with Lubricious Coatings - Labeling Considerations" - October 2019
FDA Guidance "Submission and Review of Sterility ● Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" - January 2016
FDA Guidance - "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" -September 2020
ISO 11070:2014/Amd.1:2018, Sterile single-use intravascular introducers, dilators and guidewires
ISO 11135:2014/Amd 1:2018, Sterilization of health-care ● products - Ethylene oxide: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10993-1:2018, Biological evaluation of medical devices ● - Part 1: Evaluation and testing within a risk management process
ISO 11607-1:2019, Packaging for terminally sterilized ● medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11737-1:2018/Amd 1:2021, Sterilization of health care ● products - Microbiological methods - - Part 1: Determination of a population of microorganisms on products
ISO 10993-4:2017. Biological evaluation of medical ● devices-Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009/(R)2014, Biological evaluation of medical ● devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021. Biological evaluation of medical ● devices - Part 10: Tests for skin sensitization
ISO 10993-11:2017, Biological evaluation of ● medical devices - Part 11: Tests for systemic toxicity

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ISO 10993-12:2021, Biological evaluation of medical ● devices - Part 12: Sample preparation and reference materials
ISO 10993-18:2020, Biological evaluation of medical ● devices – Part 18: Chemical characterization of materials
. ISO 10993-19:2020, Biological evaluation of medical devices - Part 19: Physico-chemical, morphological, and topographical characterization of materials
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation
. ASTM F2475-20, Standard Guide for Biocompatibility of Medical Device Packaging Materials
ISO 10993-7:2008/Amd.1:2019(E), Biological evaluation of ● medical devices - Part 7: Ethylene oxide sterilization residuals
ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
ASTM D4169-22, Standard Practice for Performance ● Testing of Shipping Containers and Systems
ANSI ST72:2019, Bacterial endotoxins Test methods, ● routine monitoring, and alternatives to batch testing
. ISO 2233:2000, Packaging - Complete, filled transport packages and unit labels - Conditioning for testing
TIR42:2021, Evaluation of Particulates Associated with ● Vascular Medical Devices
TIR28:2016, Product adoption and process equivalence for ethylene oxide sterilization

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

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Performance Non-Clinical Testing-Bench

Dimensional Verification
. Surface Finish
Particulate Evaluation ●
Coating Lubricity ●
Fracture Test ●
Flexing Test ●
. Guidewire Tip Radiopacity
Guidewire Joints Tensile Strength ●
Guidewire Torque Strength ●
Corrosion Resistance ●
Tip Flexibility ●
Kink Resistance ●
Coating Integrity ●
Ancillary Device Compatibility ●
Guidewire Preparation ●
. Guidewire Maneuverability in Catheter
Tracking and Positioning Ancillary devices ●
Guidewire Integrity
J-Straightener Function ●
Guidewire Body Stiffness ●
Guidewire Distal Tip Flexibility ●
Guidewire Trackability ●
Guidewire Tip Shape Retention ●

Biocompatibility

Cytotoxicity ●
Sensitization
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity ●
Genotoxicity ●
Hemocompatibility ●
- o Hemolysis
- Thrombogenicity o

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o Complement Activation All test results were comparable to the predicate device and the subject Merit Mighty Wire Guide Wire met the predeterminded acceptance criteria.This demonstrated that the subject device is substantially equivalent to the predicate device. Based on the comparisons noted, the subject Merit Mighty Wire Summary of Guide Wire meets the requirements that are considered essential Substantial for its intended use and is substantively equivalent to the Predicate Device, the Lunderquist Extra-Stiff Wire Guide [K220137] Equivalence manufactured by Cook Medical.

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.