The Prelude® Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Device Description

The Prelude® Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is equipped with a side arm terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and a suture ring. The subject sheath introducer has a radiopaque marker tip. The device is marketed with and without an appropriately sized guide wire.

AI/ML Overview

The document provided is a 510(k) Pre-market Notification Summary for a medical device (Prelude® Sheath Introducer), not a study analyzing the performance of an AI/ML powered device. Therefore, it does not contain information related to AI/ML device performance, acceptance criteria for such a device, sample sizes, ground truth establishment, or expert involvement as requested.

The document indicates that the device is a physical medical device (Vessel Dilator for Percutaneous Catheterization) and the 510(k) submission is for a minor change to an existing predicate device (specifically, "The only change that was made was to the radiopaque marker tip material.").

The "Acceptance Criteria" and "Study" described in the document are related to the physical and biological safety and performance of the medical device itself, not to a diagnostic or analytical algorithm.

Here's an attempt to extract relevant information, acknowledging that it pertains to a physical device and not an AI/ML algorithm:

1. Table of acceptance criteria and the reported device performance:

Type of Test/Criterion	Specific Test	Acceptance Criteria	Reported Device Performance
Design Verification	Tortuous path test	Met pre-determined acceptance criteria for safety and efficacy.	Successfully completed.
	Force at break	Met pre-determined acceptance criteria for safety and efficacy.	Successfully completed.
	Radiopacity	Met pre-determined acceptance criteria for safety and efficacy.	Successfully completed. (Note: This was the very aspect that was changed and tested).
	Tip insertion/peel back	Met pre-determined acceptance criteria for safety and efficacy.	Successfully completed.
	Dilator drag	Met pre-determined acceptance criteria for safety and efficacy.	Successfully completed.
	Stiffness	Met pre-determined acceptance criteria for safety and efficacy.	Successfully completed.
Biocompatibility	Cytotoxicity	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-5 (Tests for in vitro cytotoxicity) and FDA guidance.	Successfully completed.
	Sensitization	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-10 (Tests for irritation and skin sensitization) and FDA guidance.	Successfully completed.
	Irritation	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-10 (Tests for irritation and delayed type hypersensitivity) and FDA guidance.	Successfully completed.
	Acute Systemic Toxicity	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-11 (Tests for systemic toxicity) and FDA guidance.	Successfully completed.
	Pyrogenicity	Met pre-determined acceptance criteria for safety and efficacy based on United States Pharmacopeia 33, National Formulary 28, 2010 <151> Pyrogen Test and FDA guidance.	Successfully completed.
	Genotoxicity	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-3 (Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity) and FDA guidance.	Successfully completed.
	Hemolysis	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-4 (Selection of tests for interaction with blood) and ASTM F756-08:2008 (Standard Practice for Assessment of Hemolytic Properties of Materials) and FDA guidance.	Successfully completed.
	Thrombogenicity	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-4 (Selection of tests for interaction with blood) and FDA guidance.	Successfully completed.
	Complement Activation	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-4 (Selection of tests for interaction with blood) and FDA guidance.	Successfully completed.
	Chemical Characterization	Met pre-determined acceptance criteria for safety and efficacy based on ISO 10993-1 (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).	Successfully completed.
Sterilization	Routine Control of Sterilization Process	Met requirements of ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - routine control of a sterilization process for medical devices).	Successfully completed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify sample sizes for each test. The tests are general performance and biocompatibility tests for a physical medical device. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for these types of engineering and biological tests, which are typically performed in a laboratory setting by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is not applicable to a physical device performance and biocompatibility study. "Ground truth" in the context of expert consensus is relevant for diagnostic accuracy studies, typically involving human interpretation of medical images or data. For this device, "ground truth" refers to established scientific principles, regulatory standards (like ISO and ASTM), and pre-defined pass/fail criteria for physical and biological properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving disagreements among multiple human readers in diagnostic accuracy studies. For physical device testing, results are typically objective measurements against engineering specifications and biological standards.

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:
Not applicable. This document describes the safety and performance testing for a physical medical device (sheath introducer), not an AI/ML-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is based on established international standards (ISO, AAMI, ASTM, USP) and FDA guidance documents for medical device testing. These standards define the methodologies and acceptance criteria for various physical, chemical, and biological properties.

8. The sample size for the training set:
Not applicable. There is no AI/ML algorithm involved, so no "training set."

9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML algorithm involved, so no "training set" or ground truth establishment for it.

Summary

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	Section 5
510(k) Summary

GeneralProvisions	Submitter Name:	Merit Medical Systems, Inc.
	Address:	1600 West Merit ParkwaySouth Jordan, UT 84095
	Telephone Number:	(801) 208-4196
	Fax Number:Contact Person:Date of Preparation:Registration Number:	(801) 253-6932Michaela RivkowichMarch 19, 20131721504
SubjectDevice	Trade Name:	Prelude® Sheath Introducer
	Common/Usual Name:	Vessel Dilator for Percutaneous Catheterization
	Classification Name:	Vessel Dilator for Percutaneous Catheterization
PredicateDevice	Trade Name:	Prelude® Sheath Introducer
	Classification Name:	Vessel Dilator for Percutaneous Catheterization
	Premarket Notification:Manufacturer:	K073035Merit Medical Systems, Inc.
Classification	Class II21 CFR § 870.1310FDA Product Code: DREReview Panel: Cardiovascular
Intended Use	The Prelude® Sheath Introducer is intended to provide access andfacilitate the percutaneous introduction of various devices into veinsand/or arteries while maintaining hemostasis for a variety of diagnosticand therapeutic procedures.
DeviceDescription	The Prelude® Sheath Introducer consists of a sheath introducer withcompatible vessel dilator that snaps securely into the sheath introducerhub. The sheath is equipped with a side arm terminating in a 3-waystopcock. The sheath hub contains an integral hemostasis valve and asuture ring. The subject sheath introducer has a radiopaque marker tip.The device is marketed with and without an appropriately sized guidewire.

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Comparison toPredicateDevice	The subject device has the same technological characteristics (i.e., as the predicate device). The only change that was made was to the radiopaque marker tip material.
Safety &PerformanceTests	No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Prelude® 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 ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - routine control of a sterilization process for medical devices 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 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 interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2002 (Amd. 1:2006), Biological evaluation of medical devices – Part 10: Tests for irritation and delayed type hypersensitivity 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 F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials United States Pharmacopeia 33, National Formulary 28, 2010 <151> Pyrogen Test The following is a list of all significant testing that was successfully completed:

Comparison toPredicateDevice

The subject device has the same technological characteristics (i.e., as the predicate device). The only change that was made was to the radiopaque marker tip material.

Safety &PerformanceTests

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Prelude® 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 ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - routine control of a sterilization process for medical devices 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 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 interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2002 (Amd. 1:2006), Biological evaluation of medical devices – Part 10: Tests for irritation and delayed type hypersensitivity 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 F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials United States Pharmacopeia 33, National Formulary 28, 2010 <151> Pyrogen Test The following is a list of all significant testing that was successfully completed:

A 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

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Design Verification

. Tortuous path test
t Force at break
. Radiopacity
Tip insertion/peel back ●
. Dilator drag
Stiffness �

Biocompatibility

. Cytotoxicity
. Sensitization
Irritation .
- Acute Systemic Toxicity .
- ◆ Pyrogenicity
- Genotoxicity .
- ◆ Hemolysis
- Thrombogenicity .
- Complement Activation �
- Chemical Characterization .

The results of the testing demonstrated that the subject Prelude® Sheath Introducer met the pre-determined acceptance criteria applicable to the safety and efficacy of the device.

Summary of Substantial Equivalence

Based on the indications for use, design, safety and performance testing, the subject Prelude® Sheath Introducer meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Prelude® Sheath Introducer, manufactured by Merit Medical Systems, Inc.

Safety & Performance Tests cont.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized depiction of an eagle. The eagle is composed of three parallel, curved lines that suggest the bird's wings and body, conveying a sense of motion and flight.

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

June 7, 2013

Merit Medical Systems, Inc. C/O Michaela Rivkowich Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095

Re: K130791

Trade/Device Name: Prelude® Sheath Introducer Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: May 9, 2013 Received: May 10, 2013

Dear Ms. Michaela 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Z. Z.

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

Enclosure.

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Section 4

Indications for Use

510(k) Number:

Device Name: Prelude® Sheath Introducer

K130791

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).