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.

Device Description

The 7F PreludeEASE™ Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. A rotating suture ring is affixed to the sheath hub. The sheath tubing is coated with a hydrophilic coating. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The 7F PreludeEASE Hydrophilic Sheath Introducer is available in 11cm, 16cm and 23cm lengths and is designed to accept 0.018", 0.021" and 0.035" diameter guide wires. The 7F 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

Here's a breakdown of the acceptance criteria and study information for the PreludeEASE Hydrophilic Sheath Introducer, extracted from the provided text. Please note that the document primarily focuses on demonstrating substantial equivalence through performance testing rather than a comparative effectiveness study with human readers assisted by AI. Therefore, several requested sections (like MRMC study, human reader improvement, standalone algorithm performance, and training set details) are not applicable or cannot be found in this specific document.

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Implied by standard)	Reported Device Performance
Performance Testing - Bench
Size Designation	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Kink Resistance	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Sheath / Dilator Tip Peel Back	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Surface	Met requirements of applicable standards (ISO 11070:1998) and risk analysis (e.g., visual inspection for defects).	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Hydrophilic Coating Lubricity	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Hydrophilic Coating Coverage and Adherence	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Hydrophilic Coating Length	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Sheath Stiffness and Flex Modulus	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Sheath Introducer Hub to Tubing Pull	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Sheath Introducer Tubing Pull	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Dilator Hub to Tubing Pull	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Dilator Stiffness and Flex Modulus	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Sheath Introducer Assembly Leak	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Radiodetectability	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Simulated Use	Met requirements of applicable standards (ISO 11070:1998) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Biocompatibility
Cytotoxicity	Met requirements of applicable standards (ISO 10993-5:2009) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Sensitization	Met requirements of applicable standards (ISO 10993-10:2010) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Intracutaneous Injection	Met requirements of applicable standards (ISO 10993-10:2010) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Acute Systemic Toxicity	Met requirements of applicable standards (ISO 10993-11:2006) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Pyrogenicity	Met requirements of applicable standards (United States Pharmacopeia 35, National Formulary 30, 2012 <151>) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Genotoxicity	Met requirements of applicable standards (ANSI/AAMI/ISO 10993-3:2003) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Hemolysis	Met requirements of applicable standards (ASTM F756-08) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Thrombogenicity	Met requirements of applicable standards (ISO 10993-4:2002) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Complement Activation	Met requirements of applicable standards (ISO 10993-4:2002) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Chemical Characterization	Met requirements of applicable standards (ISO 10993-1:2009) and risk analysis.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Sterilization & Packaging
Sterilization	Met requirements of ISO 11135:2014, and ISO 10993-7:2008.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.
Packaging	Met requirements of ASTM D4169-09, and ISO 2233:2000.	Met predetermined acceptance criteria applicable to the safety and efficacy of the device.

Note: The acceptance criteria are "predetermined" and "applicable to the safety and efficacy of the device" guided by the referenced international and national standards. Specific numerical thresholds are not provided in this summary.

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

The document indicates "Performance testing of the subject 7F PreludeEASE Hydrophilic Sheath Introducer was conducted." However, it does not specify the sample sizes (number of devices tested) for any of the individual performance or biocompatibility tests.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be a prospective performance evaluation of the manufactured device, conducted by the manufacturer, Merit Medical Systems, Inc. This is a premarket notification for a medical device cleared by the FDA, implying the tests were conducted to demonstrate the device meets specified standards for safety and effectiveness.

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

This document describes a series of engineering and biocompatibility tests for a physical device. It does not involve medical images or diagnostic interpretations requiring expert ground truth establishment for a test set in the context of an AI/algorithm. Therefore, this section is not applicable.

4. Adjudication method for the test set

As there is no "test set" in the context of diagnostic interpretation requiring expert consensus, adjudication methods are not applicable to this type of device performance testing.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to the regulatory clearance of a physical medical device (sheath introducer), not an AI algorithm. Therefore, details about human reader improvement with or without AI assistance are not relevant or present.

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

No, a standalone (algorithm-only) performance study was not done. This document is about a physical medical device, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the performance testing described here is the established performance requirements and specifications outlined in the referenced international (ISO) and national (ASTM, USP) standards, along with the device's risk analysis. For example, for "kink resistance," the ground truth would be a defined level of force or deformation the device must withstand without kinking, as specified by ISO 11070:1998. For biocompatibility tests, the ground truth is the absence of a toxic, inflammatory, or immune response as defined by the respective ISO 10993 standards.

8. The sample size for the training set

This document does not describe the development or evaluation of an AI algorithm, so there is no "training set" in this context. The tests are for verifying the physical properties and biological safety of a manufactured medical device.

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

As there is no training set for an AI algorithm, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The symbol is rendered in a dark color, contrasting with the lighter background.

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

June 19, 2015

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

Re: K150257

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: May 21, 2015 Received: May 22, 2015

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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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 and Part 809), 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 vours.

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Device Name PreludeEASE Hydrophilic Sheath Introducer

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 comblete 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."

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5.0 510(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 RivkowichFebruary 2, 20151721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel:	PreludeEASE™ Hydrophilic Sheath IntroducerSheath IntroducerCatheter IntroducerIIDYB870.1340Cardiovascular
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	PreludeEASE™ Hydrophilic Sheath IntroducerSheath IntroducerK140543Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall.
ReferenceDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Glidesheath Slender™Sheath IntroducerK142183Terumo Medical Corporation

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DeviceDescription	The 7F PreludeEASE™ Hydrophilic Sheath Introducer consists of asheath introducer with compatible vessel dilator that snaps securelyinto the sheath introducer hub. The sheath hub contains an integralhemostasis valve. A rotating suture ring is affixed to the sheath hub.The sheath tubing is coated with a hydrophilic coating. A sidearm isaffixed to the sheath hub and has a 3-way stopcock at its proximal end.The 7F PreludeEASE Hydrophilic Sheath Introducer is available in11cm, 16cm and 23cm lengths and is designed to accept 0.018", 0.021"and 0.035" diameter guide wires.The 7F PreludeEASE™ Hydrophilic Sheath Introducer is marketed withany of the following components, depending on the productconfiguration: guide wire, metal access needle, access needle withinner metal needle and outer plastic cannula, syringe, scalpel andBowTie™ guide wire insertion device.
Indications forUse	There is no change in the indications for use statement from thepredicate to the subject device.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 andtherapeutic 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.
Comparison toPredicateDevice	The technological characteristics of the subject 7F PreludeEASEHydrophilic Sheath Introducer are substantially equivalent to those ofthe predicate 4F through 6F PreludeEASE Hydrophilic SheathIntroducer. The subject device has the same basic design as thepredicate device in that it consists of sheath tubing, hub, sidearm andstopcock and is provided with a vessel dilator. The difference betweenthe subject and the predicate devices is in the French size to expandthe product line to include the 7F sheath introducer. The subject deviceutilizes the same materials as the predicate device with the exception ofthe orange colorant which is used to differentiate the 7F size from theother sizes.

DeviceDescription

The 7F PreludeEASE™ Hydrophilic Sheath Introducer consists of asheath introducer with compatible vessel dilator that snaps securelyinto the sheath introducer hub. The sheath hub contains an integralhemostasis valve. A rotating suture ring is affixed to the sheath hub.The sheath tubing is coated with a hydrophilic coating. A sidearm isaffixed to the sheath hub and has a 3-way stopcock at its proximal end.The 7F PreludeEASE Hydrophilic Sheath Introducer is available in11cm, 16cm and 23cm lengths and is designed to accept 0.018", 0.021"and 0.035" diameter guide wires.The 7F PreludeEASE™ Hydrophilic Sheath Introducer is marketed withany of the following components, depending on the productconfiguration: guide wire, metal access needle, access needle withinner metal needle and outer plastic cannula, syringe, scalpel andBowTie™ guide wire insertion device.

Indications forUse

There is no change in the indications for use statement from thepredicate to the subject device.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 andtherapeutic 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.

Comparison toPredicateDevice

The technological characteristics of the subject 7F PreludeEASEHydrophilic Sheath Introducer are substantially equivalent to those ofthe predicate 4F through 6F PreludeEASE Hydrophilic SheathIntroducer. The subject device has the same basic design as thepredicate device in that it consists of sheath tubing, hub, sidearm andstopcock and is provided with a vessel dilator. The difference betweenthe subject and the predicate devices is in the French size to expandthe product line to include the 7F sheath introducer. The subject deviceutilizes the same materials as the predicate device with the exception ofthe orange colorant which is used to differentiate the 7F size from theother sizes.

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No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject 7F PreludeEASE Hydrophilic Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standard:

. ISO 11070:1998, Sterile, single-use intravascular catheter introducers
. ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
. ASTM D4169-09, Standard Practice for performance Testing of Shipping Containers and Systems
. ISO 2233:2000. Packaging - Complete. filled transport packages and unit loads - Conditioning for testing
. ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
. ANSI/AAMI/ISO 10993-3:2003, Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical . devices – Part 4: Selection of tests for interactions with blood
. ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008, Biological evaluation of medical devices Part . 7: 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 hemolytic properties of materials
. United States Pharmacopeia 35, National Formulary 30, 2012 <151> Pyrogen Test

The following tests were performed to demonstrate there were no unacceptable risks associated with the changes made to the device:

Performance Testing - Bench

. Size Designation
Kink Resistance ●
Sheath / Dilator Tip Peel Back ●
. Surface
Hydrophilic Coating Lubricity
.
Performance

Data

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Hydrophilic Coating Coverage and Adherence .
Hydrophilic Coating Length .
Sheath Stiffness and Flex Modulus
Sheath Introducer Hub to Tubing Pull (Force at Break) ●
Sheath Introducer Tubing Pull (Force at Break) ●
Dilator Hub to Tubing Pull (Force at Break) ●
Dilator Stiffness and Flex Modulus ●
. Sheath Introducer Assembly Leak
Radiodetectabillity ●
Simulated Use .

Performance

Data

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

The results of the testing demonstrated that the subject 7F PreludeEASE Hydrophilic Sheath Introducer met the predetermined acceptance criteria applicable to the safety and efficacy of the device.

Based on the indications for use, design, safety and performance testing, the subject 7F PreludeEASE Hydrophilic Sheath Introducer Summary of meets the requirements that are considered essential for its intended Substantial use and is substantially equivalent to the predicate device, the Equivalence PreludeEASE Hydrophilic Sheath Introducer, K140543 manufactured by Merit Medical Systems, Inc..

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).