The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures.
The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.

Device Description

The Prelude® Small O.D. Introducer Guide Wire is composed of a stainless-steel core wire inside a stainless-steel coil. The guide wire is welded at the distal and proximal tips and has a polished weld finish. The stainless-steel construction provides radiopacity and visibility to the user under X-ray. The wires are available in outer diameters 0.018", 0.021" and 0.025", lengths from 45 cm to 80 cm, straight and double-ended J 3mm / straight tip shapes, Standard and Firm body wire stiffness profiles, with a flexible atraumatic tip.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Prelude Small O.D. Introducer Guide Wire." It details the device's characteristics, intended use, and a comparison to a predicate device, along with a list of non-clinical performance and biocompatibility tests conducted.

However, the request asks for specific information regarding acceptance criteria and a study that proves the device meets the acceptance criteria, particularly in the context of an AI-powered device or a study involving human readers and AI assistance.

The provided document does not describe an AI-powered device, a study involving human readers, a test set with expert ground truth, or an MRMC comparative effectiveness study. The tests listed are for a physical medical guide wire, focusing on its mechanical properties, material integrity, and biocompatibility.

Therefore, I cannot fulfill the request for information on acceptance criteria and study proving device meets the criteria for an AI device or a study involving human readers and AI assistance, as the provided text pertains to a traditional, non-AI medical device.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: While the document states "The subject Prelude Small O.D. Introducer Guide Wire met the predetermined acceptance criteria," it does not list the specific numerical or qualitative acceptance criteria for each test (e.g., "Tensile strength must be >X Newtons"). It also does not report the exact performance results (e.g., "Tensile strength was Y Newtons"). It only confirms that the criteria were met.
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical guide wires tested, not a dataset of images or clinical cases. Sample sizes for each mechanical and biocompatibility test are not provided. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of device testing.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as typically defined for AI/imaging studies (e.g., expert radiological reads) is not relevant for the physical testing of a guide wire.
4. Adjudication method for the test set: Not applicable. There's no "adjudication" for mechanical and biocompatibility tests in the way there would be for expert interpretations of medical images.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable. This type of study involves human readers interpreting medical images, usually with and without AI assistance. The device in question is a physical guide wire, not an AI algorithm for imaging.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is not an algorithm.
7. The type of ground truth used: Not applicable. Ground truth in the context of AI/imaging studies (expert consensus, pathology, outcomes data) is not relevant here. The "ground truth" for this device's performance is derived from standardized physical and chemical tests (e.g., measuring tensile strength against a specification).
8. The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI model.
9. How the ground truth for the training set was established: Not applicable, as there's no training set.

In summary, the provided document is for a conventional medical device (a guide wire) and does not contain the information requested regarding AI device performance studies.

Summary

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December 10, 2024

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K241521

Trade/Device Name: Prelude Small O.D. Introducer Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: Mav 29, 2024 Received: May 29, 2024

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"

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(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).

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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely,

Samuel G. Raben -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

Enclosure

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Indications for Use

510(k) Number (if known) K241521

Device Name Prelude Small O.D. Introducer Guide Wire

Indications for Use (Describe)

The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures.

The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary
GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number:Correspondent Name:Address:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(+353) 91 703798(+353) 91 680104James Kenny1721504Merit Medical Ireland Ltd.Parkmore Business ParkParkmore, Galway, Ireland
	Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	(+353) 91 703798(+353) 91 680104James KennyMay 29, 20249616662
SubjectDevice	Premarket Notification:Trade Name:Common/Usual Name:	K241521Prelude® Small O.D. IntroducerGuide Wire
	Class:Product code:Classification Name:Regulation Number:Regulation Medical Specialty Cardiovascular	Guide WireIIDQXWire, Guide, Catheter21 CFR 870.1330
PredicateDevice	Trade Name:Class:Product code:Classification Name:Regulation Number:Regulation Medical Specialty CardiovascularPremarket Notification:Manufacturer:	Predicate® Uncoated GuidewireIIDQXWire, Guide, Catheter21 CFR 870.1330K770977Integer® Holdings Corporation
DeviceDescription	The Prelude® Small O.D. Introducer Guide Wire is composed of astainless-steel core wire inside a stainless-steel coil. The guidewire is welded at the distal and proximal tips and has a polishedweld finish. The stainless-steel construction provides radiopacityand visibility to the user under X-ray. The wires are available inouter diameters 0.018", 0.021" and 0.025", lengths from 45 cm to80 cm, straight and double-ended J 3mm / straight tip shapes,Standard and Firm body wire stiffness profiles, with a flexibleatraumatic tip.
Intended Use/Indications forUse	The Prelude Small O.D. Introducer Guide Wire is intended tofacilitate the placement of introducer sheaths during diagnostic andinterventional procedures.The Prelude Small O.D. Introducer Guide Wire is indicated for usein the peripheral vasculature only.
Comparisonto Predicate	The subject Prelude Small O.D. Introducer Guide Wire has a similardesign and materials of construction. There is no difference inintended use or differences in technological characteristics betweenthe subject device and predicate device:Both the subject device and predicate device are composed ofstainless-steel core wire with a grind profile ending in a flexibledistal tip. Both have a stainless-steel coil attached at the proximalend and distal end to the core wire. The wires have equivalent wirelengths, wire outer diameters, and wire tip configurations. Neitherhas a safety wire or coating.The fundamental technology and operating principles of the subjectdevice and the predicate device are the same. Both are used tofacilitate the placement of devices during peripheral diagnostic andinterventional procedures.
Safety &PerformanceTests	No applicable mandatory performance standards or special controlsexist for the subject device.A battery of testing was conducted, on the Prelude Small O.D.Introducer Guide Wire, in accordance with test protocols based onrequirements outlined in FDA Guidances and industry standardsand these were shown to meet the acceptance criteria that weredetermined to demonstrate substantial equivalence.The following testing was successfully completed to demonstratethat the device meets the performance requirements for itsintended use

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510(k) Summary

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510(k) Summary

Non-Clinical Performance Testing

Dimensional Verification/Size Designation ●
Guide Wire J-Tip Straightening ●
Surface Finish ●
Fracture Test ●
Flexing Test
Guidewire Radiopacity
Guidewire Joints Tensile Strength
Guidewire Torque Strength
Corrosion Resistance
Tip Flexibility
Kink Resistance
Simulated Use Testing

Biocompatibility Testing

Cytotoxicity ●
Sensitization
Irritation ●

Corporation.

Acute Systemic Toxicity .
Pyrogenicity ●
Genotoxicity ●
Hemocompatibility ●
- o Hemolysis
- o Thrombogenicity
- o Complement Activation

The subject Prelude Small O.D. Introducer Guide Wire met the predeterminded acceptance criteria and showed a performance comparable to the predicate device. This demonstrated that the Prelude Small O.D. Introducer Guide Wire subject device is substantially equivalent to the Predicate Uncoated Guidewire predicate device. The subject Prelude Small O.D. Introducer Guide Wire is Summary of substantially equivalent in intended use, function, materials, Substantial method of operation, and performance to the Predicate Uncoated Equivalence Guidewire (K770977) manufactured by Integer Holdings

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.