The Merit PreludeEASE™ Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic or therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.

Device Description

The PreludeEASE™ Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is coated with a hydrophilic coating and is equipped with a sidearm terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and suture ring. The access needle with inner metal needle and outer plastic cannula is an accessory device which is used to gain access to the vein or artery for placement of guide wires.
The PreludeEASE Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guide wire, metal access needle, access needle with inner metal needle and outer plastic cannula, syringe, scalpel and BowTie™ guide wire insertion device.

AI/ML Overview

The provided text is a 510(k) summary for the Merit Medical Systems, Inc. PreludeEASE Hydrophilic Sheath Introducer. It details the device, its intended use, comparison to predicate devices, and outlines the safety and performance tests conducted.

However, it does not contain the specific acceptance criteria and reported device performance in a table format, nor does it describe a study using a test set with ground truth, experts, or a multi-reader multi-case comparison as requested in the input.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and the successful completion of a series of performance (bench) and biocompatibility tests against established international standards.

Therefore, I cannot fulfill all parts of your request based on the provided text. I can only report on what is present in the document.

Missing Information:

A table of acceptance criteria and reported device performance. The document lists the types of tests performed (e.g., "Sheath Introducer Assembly Leak," "Hydrophilic Coating Lubricity") but does not provide specific pass/fail criteria or the quantitative or qualitative results of these tests.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
If a standalone (algorithm only) performance study was done. (This device is a physical medical device, not an algorithm, so this is not applicable).
The type of ground truth used.
Sample size for the training set.
How the ground truth for the training set was established.

Information from the document that is relevant to your request, but does not fully answer each point:

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

This information is not explicitly provided in the document in a table format with specific criteria and performance metrics. The document only lists the types of tests performed. It states "Performance testing of the subject PreludeEASE Hydrophilic Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standard..." This implies that the acceptance criteria were defined by complying with these standards, but the specific values are not presented.

Types of Performance (Bench) Tests Performed:

Surface
Radiodetectability
Size Designation
Sheath Introducer Assembly Leak
Sheath Introducer Hemostasis Valve 5.8 psi Leak
Sheath Introducer Tubing Pull (Force at Break)
Sheath Introducer Hub to Tubing Pull (Force at Break)
Dilator Hub to Tubing Pull (Force at Break)
Sheath / Dilator Tip Peel Back
Hemostasis Valve Dislodgement
Hemostasis Valve Vacuum
Hemostasis Valve Low Pressure with Dilator Dwell
Sidearm to Sheath Hub Pull (Force at Break)
Sheath Hub to Cap Pull (Force at Break)
Sheath Introducer Stiffness and Flex Modulus
Sheath Introducer Kink Resistance
Suture Ring Pull Test
Dilator Stiffness and Flex Modulus
Hydrophilic Coating Lubricity
Hydrophilic Coating Coverage/Adherence and Length
Two-Part Access Needle Metal Cannula to Hub Pull
Two-Part Access Needle Plastic Cannula to Hub Pull
Two-Part Access Needle Insertion and Withdrawal Test
Particulate Evaluation
Kink Resistance
Torque Strength
Packaging Testing
Scalpel Flex Test

Types of Biocompatibility Tests Performed:

Cytotoxicity
Sensitization
Intracutaneous Injection
Acute Systemic Toxicity
Pyrogenicity
Genotoxicity
Hemolysis
Thrombogenicity
Complement Activation
Chemical Characterization

The document concludes that "the subject PreludeEASE Hydrophilic Sheath Introducer meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate devices..." This implies that all these tests passed their respective acceptance criteria, which were derived from the referenced international standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The general statement is "Performance testing of the subject PreludeEASE Hydrophilic Sheath Introducer was conducted..." without specifying test 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:
This information is not applicable as the device is a physical medical instrument, not an AI or diagnostic algorithm requiring expert "ground truth" for a test set in the traditional sense. Performance is assessed through physical and biological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above.

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 as the device is a physical medical instrument, not an AI or diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is a physical medical instrument, not an AI or diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this medical device's performance is established by compliance with recognized international standards (e.g., ISO 11070:1998 for catheter introducers, ISO 10993 for biocompatibility) and internal risk analysis. The physical and chemical properties are tested directly against defined specifications within these standards.

8. The sample size for the training set:
This information is not applicable as the device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are facing to the right.

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

October 16, 2014

Merit Medical Systems, Inc. Ms. Michaela Rivkowich Principal Regulatory Affairs Specialist 1600 West Merit Pkwv. South Jordan, Utah 84095

Re: K140543

Trade/Device Name: PreludeEase Hydrophilic Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 3, 2014 Received: September 4, 2014

Dear Ms. Rivkowich,

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K140543

Device Name PreludeEASE Hydrophilic Sheath Introducer

Indications for Use (Describe)

The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4196(801) 253-6932Michaela RivkowichOctober 16, 20141721504
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	PreludeEASE™ Hydrophilic Sheath IntroducerSheath IntroducerCatheter Introducer
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Prelude® PSI Sheath IntroducerVessel Dilator for PercutaneousCatheterizationK070159Merit Medical Systems, Inc.
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	GlidesheathCatheter IntroducerK102008Terumo Medical Corporation
Classification	Class II21 CFR § 870.1340FDA Product Code: DYBReview Panel: Cardiovascular
Intended Use	The Merit PreludeEASE™ Hydrophilic Sheath Introducer is intended toprovide access and facilitate the percutaneous introduction of variousdevices into veins and/or arteries, including but not limited to the radialartery, while maintaining hemostasis for a variety of diagnostic ortherapeutic procedures.The access needle with inner metal needle and outer plastic cannula isused to gain access to the vein or artery for placement of guide wires.
DeviceDescription	The PreludeEASE™ Hydrophilic Sheath Introducer consists of a sheathintroducer with compatible vessel dilator that snaps securely into thesheath introducer hub. The sheath is coated with a hydrophilic coatingand is equipped with a sidearm terminating in a 3-way stopcock. Thesheath hub contains an integral hemostasis valve and suture ring. Theaccess needle with inner metal needle and outer plastic cannula is anaccessory device which is used to gain access to the vein or artery forplacement of guide wires.
	The PreludeEASE Hydrophilic Sheath Introducer is marketed with anyof the following components, depending on the product configuration:guide wire, metal access needle, access needle with inner metal needleand outer plastic cannula, syringe, scalpel and BowTie™ guide wireinsertion device.
Comparisonto PredicateDevice	The technological characteristics of the subject PreludeEASEHydrophilic Sheath Introducer are substantially equivalent to those ofthe predicate devices. The subject device has the same basic designas the predicate devices in that it consists of a sheath tubing, hub,sidearm and stopcock and is provided with a vessel dilator. The maindifference is in the device materials. Just as the predicate devices, thePreludeEASE is provided with kit components typically used to obtainvascular access.
Safety &PerformanceTests	No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject PreludeEASE Hydrophilic Sheath Introducer wasconducted based on the risk analysis and based on the requirements ofthe following international standard:ISO 11070:1998, Sterile, single-use intravascular catheterintroducers ISO 11135-1:2007, Sterilization of health care products – Ethyleneoxide - Part 1: Requirements for development, validation androutine control of a sterilization process for medical devices ISO 11607-1:2010, Packaging for terminally sterilized medicaldevices Part 1: Requirements for materials, sterile barrier systemsand packaging systems ASTM D4169-09, Standard Practice for performance Testing ofShipping Containers and Systems ISO 2233:2000, Packaging – Complete, filled transport packagesand unit loads – Conditioning for testing ISO 10993-1:2009, Biological Evaluation of Medical Devices Part1: Evaluation and Testing within a risk management process, andFDA guidance Required Biocompatibility Training and ToxicologyProfiles for Evaluation of Medical Devices, May 1, 1995 ANSI/AAMI/ISO 10993-3:2003, Biological Evaluation of MedicalDevices – Part 3: Tests for Genotoxicity, Carcinogenicity andReproductive Toxicity ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medicaldevices - Part 4: Selection of tests for interactions with blood ISO 10993-5:2009, Biological evaluation of medical devices – Part5: Tests for in vitro cytotoxicity ISO 10993-7:2008, Biological evaluation of medical devices – Part7: Ethylene oxide sterilization residuals ISO 10993-10:2010, Biological evaluation of medical devices –Part 10: Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices –Part 11: Tests for systemic toxicity ASTM F756-08, Standard practice for assessment of hemolyticproperties of materials United States Pharmacopeia 35, National Formulary 30, 2012<151> Pyrogen Test

{4}------------------------------------------------

{5}------------------------------------------------

{6}------------------------------------------------

Performance Testing-Bench

Surface
Radiodetectability ●
Size Designation ●
Sheath Introducer Assembly Leak ●
Sheath Introducer Hemostasis Valve 5.8 psi Leak ●
Sheath Introducer Tubing Pull (Force at Break) ●
Sheath Introducer Hub to Tubing Pull (Force at Break) ●
Dilator Hub to Tubing Pull (Force at Break)
Sheath / Dilator Tip Peel Back
Hemostasis Valve Dislodgement
Hemostasis Valve Vacuum
Hemostasis Valve Low Pressure with Dilator Dwell ●
Sidearm to Sheath Hub Pull (Force at Break)
Sheath Hub to Cap Pull (Force at Break) ●
Sheath Introducer Stiffness and Flex Modulus ●
Sheath Introducer Kink Resistance
Suture Ring Pull Test
Dilator Stiffness and Flex Modulus
Hydrophilic Coating Lubricity
Hydrophilic Coating Coverage/Adherence and Length
Two-Part Access Needle Metal Cannula to Hub Pull ●
Two-Part Access Needle Plastic Cannula to Hub Pull
Two-Part Access Needle Insertion and Withdrawal Test
Particulate Evaluation ●
. Kink Resistance
Torque Strength .
Packaging Testing ●
Scalpel Flex Test ●

Biocompatibility

Cytotoxicity ●
Sensitization ●
Intracutaneous Injection ●
Acute Systemic Toxicity
Pyrogenicity ●
Genotoxicity ●
Hemolysis ●
Thrombogenicity ●
Complement Activation ●
Chemical Characterization ●

Safety & Performance Tests cont.

{7}------------------------------------------------

Summary ofSubstantialEquivalence	Based on the indications for use, design, safety and performancetesting. the subject PreludeEASE Hydrophilic Sheath Introducer meetsthe requirements that are considered essential for its intended use andis substantially equivalent to the predicate devices, the Prelude PSISheath Introducer, K070159 and the Glidesheath, K102008.
------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).