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 tip shapes, standard and stiff wire configurations, and in various wire lengths and wire diameters.

AI/ML Overview

Unfortunately, the provided document {0} - {6} does not contain the information required to answer the prompt.

The document is a 510(k) premarket notification for a medical device (Merit Hydrophilic Guide Wire). While it details the device's characteristics, intended use, and the types of safety and performance tests conducted, it does not include a table of acceptance criteria with reported device performance or information about a study involving AI assistance or human reader performance.

Specifically, the document discusses:

Acceptance Criteria: It mentions that tests were shown to "meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not list these criteria or the numerical results for each.
Study Design/Results: The document lists various performance and biocompatibility tests (e.g., Torqueability, Lubricity, Cytotoxicity), but it does not provide:
- Specific performance metrics against acceptance criteria.
- Sample sizes for these tests (beyond stating "a battery of testing").
- Details about how ground truth was established, or involving expert readers, or multi-reader multi-case studies, as these types of studies are typically associated with AI/imaging device evaluations, not mechanical guidewires.
- Any information regarding human readers, AI assistance, or comparative effectiveness studies of that nature.

This document is from 2020 and pertains to a physical medical device (guidewire) that is unlikely to involve AI or a diagnostic imaging component where such detailed study information (like MRMC or human-in-the-loop performance) would be relevant. The questions in your prompt are highly specific to AI/imaging device evaluations.

Summary

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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Merit Medical Systems, Inc. Michael O'sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Galway H91 W274, Ireland

Re: K201595

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: June 9, 2020 Received: June 12, 2020

Dear Michael O'sullivan:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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-regulatory-assistance/contact-usdivision-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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K201595

Device Name Merit Hydrophilic Guidewire

Indications for Use (Describe)

Intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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K201595 510(k) Summary

GeneralProvisions	Submitter Name:	Merit Medical Systems, Inc.
	Address:	1600 West Merit ParkwaySouth Jordan, UT 84095
	Telephone Number:	(+353) 91 703700 (Ext. 3061)
	Fax Number:	(+353) 91 680104
	Contact Person:	Mark Mullaney
	Registration Number:	1721504
GeneralProvisions	Correspondent Name:	Merit Medical Ireland Ltd.
	Address:	Parkmore Business ParkParkmore, Galway, Ireland
	Telephone Number:	(+353) 91 703700 (Ext. 3223)
	Fax Number:	(+353) 91 680104
	Contact Person:Date of Preparation:Registration Number:	Michael O'Sullivan09 June 20209616662
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	Merit Hydrophilic Guide WireGuide WireWire, Guide, Catheter
PredicateDevice	Trade Name:	Merit Hydrophilic Guide Wire
	Classification Name:	21 CFR 870.1330 Catheter GuideWire
	Premarket Notification:	K170933
	Manufacturer:	Merit Medical Systems, Inc.
Classification	Class II21 CFR § 870.1330Product code: DQXDivision of Cardiovascular Devices

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Intended Use	The Merit Hydrophilic Guide Wire is intended to be used in theperipheral vascular system to facilitate the placement of devicesduring diagnostic and interventional procedures.
DeviceDescription	The Merit Hydrophilic Guide Wire consists of a jacketed core wirewith a hydrophilic coating applied to the jacket. The wire will beoffered in straight and angled tip shapes, standard and stiff wireconfigurations, and in various wire lengths and wire diameters.
	Technological characteristics of the subject Merit Hydrophilic GuideWire are substantially equivalent to those of the predicate MeritHydrophilic Guide Wire [K170933].
	The Nitinol core and polyurethane plastic jacket of the subject MeritHydrophilic Guide Wire remain unchanged from the predicate MeritHydrophilic Guide Wire [K170933].
Comparisonto Predicate	The pre-coating step on the predicate has been replaced by a newbase-coating of polyurethane on the subject device, which is appliedto the polyurethane plastic jacket. While the predicate has twocoating applications of the hydrophilic polymer, the subject devicehas a single application of the same polymer. The coating materialformulation has been modified, and there are also some changes inmaterial quantities for the post-coating step.
	Process parameters such as oven timings and temperatures havebeen modified also.
Safety &PerformanceTests	No performance standards have been established under section514 of the Food, Drug and Cosmetic Act for these devices. A batteryof testing was conducted, on the subject Merit Hydrophilic GuideWire, in accordance with protocols based on requirements outlinedin guidance's and industry standards and these were shown to meetthe acceptance criteria that were determined to demonstratesubstantial equivalence.
	Where appropriate, the tests were based on the requirements of thefollowing documents:

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1. FDA Guidance "Coronary, Peripheral, and Neurovascular Guidewires -Performance Tests and Recommended Labelling- Guidance for Industry and Food and Drug Administration Staff" - October 2019
1. FDA Guidance "Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations" - October 2019
1. ISO 11070:2014, Sterile Single-Use Intravascular Catheter Introducers.
1. ISO 11135:2014 Sterilization of health care products-Ethylene oxide-: Requirements for the development, validation and routine control of a sterilization process for medical devices.
1. ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
1. ISO 10993-1:2018. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Guidance for Industry, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

The subject Merit Hydrophilic Guide Wire was compared to the predicate device for various performance attributes that support substantial equivalence of the device.

The following testing was successfully completed:

Performance Testing

1. Size Designation
1. Surface
1. Torqueability
1. Fracture Test
1. Flex Test
1. Lubricity/Coating Integrity
1. Clinical Acceptability
1. Particulate Testing
1. Needle Compatibility Design Validation
1. Lubricity/Coating Integrity Design Validation
1. Clinical Assessment Design Validation
1. Catheter Compatibility Design Validation

Biocompatibility

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Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire - Hydrophilic Coating Formulation and Process Change Traditional Premarket Notification 510(k)

Cytotoxicity ●
. Sensitization
Irritation ●
. Acute Systemic Toxicity
Pyrogenicity ●
Hemocompatibility Hemolysis ●
Hemocompatibility Thrombogenicity .
Hemocompatibility Complement Activation ●

All test results were comparable to the predicate devices and the subject Merit Hydrophilic Guide Wire met the predeterminded acceptance criteria.This has demonstrated that the subject device is substantially equivalent to the predicate device.

Based on the Indications for Use, design, safety and performance Summary of testing, the subject Merit Medical Hydrophilic Guide Wire meets the Substantial requirements that are considered essential for its intended use and Equivalence is substantially equivalent to the Merit Hydrophilic Guide Wire [K170933] predicate device.

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.