The Merit Prelude IDeal 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 Prelude IDeal 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 and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The Prelude Ideal Hydrophilic Sheath Introducer is available in 7cm. 11cm, 16cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guide wires. The Prelude Ideal 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 and BowTie guide wire insertion device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Prelude IDeal Hydrophilic Sheath Introducer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML algorithm's performance.

Therefore, many of the requested criteria, such as those related to AI/ML specific studies (sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training data), are not applicable to this document. The document describes traditional medical device performance testing.

Here's an analysis of what can be extracted from the document regarding acceptance criteria and performance, as well as the parts that are not applicable:

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

The document lists numerous performance tests performed, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it makes a general statement about the results.

Acceptance Criteria (General)	Reported Device Performance
The device must meet predetermined acceptance criteria applicable to its performance.	"The results of the testing demonstrated that the subject Prelude IDeal Hydrophilic Sheath Introducer met the predetermined acceptance criteria applicable to the performance of the device." (Page 7) The document lists a comprehensive set of tests performed for this device, suggesting that the results for each of these tests were within the predefined acceptable ranges, although the ranges themselves are not specified in this summary. These tests include: - Bench Performance Tests: Suture Ring Rotation, 90º Tip Bend Test/Conditioning, Tensile Tip to Shaft, Sheath Assembly Leak (300kPa), Tensile Hub to Sidearm (4F only), Tensile - Valve Cap to Hub, Tensile Suture Ring to Strain Relief, Dilatory Drag through Sheath Tip and Valve, Sheath Effective Length, Kink Dual Pivot, Stiffness (Force of Deflection), Sidewall Compression, Tip Insertion Force (with coating activation), Coating Lubricity and Durability, Sheath Bend Radius, Radiopacity of Shaft and Tip, Hydrophilic Coating Uniformity and Coverage Length, Tensile - Hub to Shaft, Sheath Tip Ball Gauge Drag, Sheath Shaft Inner Diameter, Sheath Shaft Outer Diameter, Tensile Shaft, Torque Shaft to Hub, Corrosion Resistance, Particulate Evaluation (Outer Surface), Stiffness with Dilator, Catheter Insertion and Exchange, Sheath Stiffness without Dilator. - Biocompatibility Tests (based on ISO standards): Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemolysis, Thrombogenicity, Complement Activation, Chemical Characterization.
The device must demonstrate substantial equivalence to the predicate device regarding safety and effectiveness.	"Based on the indications for use, design, and performance testing, the subject Prelude IDeal Hydrophilic Sheath Introducer raises no new questions of safety or effectiveness compared to the predicate device and is substantially equivalent to the predicate device, the PreludeEASE Hydrophilic Sheath Introducer, K140543 and K150257, manufactured by Merit Medical Systems, Inc." (Page 7)

Acceptance Criteria (General)

Reported Device Performance

The device must meet predetermined acceptance criteria applicable to its performance.

"The results of the testing demonstrated that the subject Prelude IDeal Hydrophilic Sheath Introducer met the predetermined acceptance criteria applicable to the performance of the device." (Page 7) The document lists a comprehensive set of tests performed for this device, suggesting that the results for each of these tests were within the predefined acceptable ranges, although the ranges themselves are not specified in this summary. These tests include: - Bench Performance Tests: Suture Ring Rotation, 90º Tip Bend Test/Conditioning, Tensile Tip to Shaft, Sheath Assembly Leak (300kPa), Tensile Hub to Sidearm (4F only), Tensile - Valve Cap to Hub, Tensile Suture Ring to Strain Relief, Dilatory Drag through Sheath Tip and Valve, Sheath Effective Length, Kink Dual Pivot, Stiffness (Force of Deflection), Sidewall Compression, Tip Insertion Force (with coating activation), Coating Lubricity and Durability, Sheath Bend Radius, Radiopacity of Shaft and Tip, Hydrophilic Coating Uniformity and Coverage Length, Tensile - Hub to Shaft, Sheath Tip Ball Gauge Drag, Sheath Shaft Inner Diameter, Sheath Shaft Outer Diameter, Tensile Shaft, Torque Shaft to Hub, Corrosion Resistance, Particulate Evaluation (Outer Surface), Stiffness with Dilator, Catheter Insertion and Exchange, Sheath Stiffness without Dilator. - Biocompatibility Tests (based on ISO standards): Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemolysis, Thrombogenicity, Complement Activation, Chemical Characterization.

The device must demonstrate substantial equivalence to the predicate device regarding safety and effectiveness.

"Based on the indications for use, design, and performance testing, the subject Prelude IDeal Hydrophilic Sheath Introducer raises no new questions of safety or effectiveness compared to the predicate device and is substantially equivalent to the predicate device, the PreludeEASE Hydrophilic Sheath Introducer, K140543 and K150257, manufactured by Merit Medical Systems, Inc." (Page 7)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the exact sample sizes (number of devices tested) for each of the performance or biocompatibility tests. It only lists the types of tests performed.
Data Provenance: Not specified, but generally, medical device testing for FDA clearance is conducted by the manufacturer (Merit Medical Systems, Inc. in Utah, USA) or its designated testing facilities. This is a pre-market submission, so the data is prospective in the sense that it's generated specifically for this submission.

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)

Not applicable. This is a traditional medical device, not an AI/ML device that requires human expert review for establishing ground truth from medical images or data. Performance is evaluated through physical and chemical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

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 is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. See point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, "ground truth" is established by:

Engineering specifications and design requirements: The device's performance is measured against these pre-defined standards (e.g., specific tensile strength, leak rate, flexibility limits).
International Standards (e.g., ISO): Many tests are conducted according to well-established international standards (e.g., ISO 11070 for catheter introducers, ISO 10993 series for biocompatibility) which set the benchmarks for acceptable performance.
Predicate Device Performance: Comparative testing against the predicate device to show similar performance characteristics is implicit in demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that involves a "training set."

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

Not applicable. See point 8.

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

February 15, 2018

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

Re: K173750

Trade/Device Name: Prelude IDeal Hydrophilic Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 15, 2018 Received: January 16, 2018

Dear David Thomas:

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. Iisting 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); 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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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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kenneth J. Cavanaugh -S

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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Indications for Use

510(k) Number (if known) K173750

Device Name Prelude IDeal 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)

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510(k) Summary - K173750

Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 General Telephone Number: (801) 316-4956 Provisions Fax Number: (801) 253-6982 Contact Person: David Thomas Date of Preparation: January 15, 2018 Registration Number: 1721504 Prelude IDeal™ Hydrophilic Sheath Introducer Trade Name: Common/Usual Name: Sheath Introducer Classification Name: Catheter Introducer Subject Device Requlatory Class: Product Code: DYB 870.1340 21 CFR §: Review Panel: Cardiovascular PreludeEASE™ Hydrophilic Sheath Introducer Trade Name: Classification Name: Sheath Introducer Predicate Premarket Notification: K140543 (Primary Predicate Device) Device K150257 (Secondary Predicate Device) Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject to a design-related recall. The Prelude IDeal 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 and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. Device Description The Prelude Ideal Hydrophilic Sheath Introducer is available in 7cm. 11cm, 16cm and 23cm lengths, (French sizes 4F, 5F, 6F and 7F) and is designed to accept 0.018", 0.021" and 0.025" diameter guide wires. The Prelude Ideal 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 and BowTie™ guide wire insertion device.

ਹ

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Indications forUse	The Merit Prelude IDeal 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 Prelude IdealHydrophilic Sheath Introducer are substantially equivalent to those ofthe predicate 4F through 7F 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 materials used for thesheath that allow for a thinner wall sheath than the predicate devicesand the colorants used on the strain relief, sheath cap and stopcockhandle.

Indications forUse

The Merit Prelude IDeal 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 Prelude IdealHydrophilic Sheath Introducer are substantially equivalent to those ofthe predicate 4F through 7F 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 materials used for thesheath that allow for a thinner wall sheath than the predicate devicesand the colorants used on the strain relief, sheath cap and stopcockhandle.

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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 Prelude IDeal 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
ISO 10993-1:2009, Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
ISO 10993-3:2014, 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

Performance Tests

●

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 F756-17, Standard practice for assessment of hemolytic properties of materials
. United States Pharmacopeia 40, National Formulary 35, 2017 <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

Suture Ring Rotation
90º Tip Bend Test/Conditioning ●
Tensile Tip to Shaft ●
Sheath Assembly Leak, 300kPa
Tensile Hub to Sidearm (4F only) ●
. Tensile - Valve Cap to Hub

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Tensile Suture Ring to Strain Relief .
Dilatory Drag through Sheath Tip and Valve .
Sheath Effective Length ●
Kink Dual Pivot ●
Stiffness, Force of Deflection
Sidewall Compression ●
Tip Insertion Force (with coating activation) ●
Coating Lubricity and Durability
Sheath Bend Radius ●
Radiopacity of Shaft and Tip
Hydrophilic Coating Uniformity, Coverage Length ●
Tensile - Hub to Shaft
Sheath Tip Ball Gauge Drag
Sheath Shaft Inner Diameter ●
Sheath Shaft Outer Diameter ●
Tensile Shaft ●
Torque Shaft to Hub ●
Corrosion Resistance .

Performance Tests cont.

Particulate Evaluation .

Validation Testing

Outer Surface
Stiffness with Dilator .
Catheter Insertion and Exchange ●
. Sheath Stiffness without Dilator

Biocompatibility

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

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	The results of the testing demonstrated that the subject Prelude IDealHydrophilic Sheath Introducer met the predetermined acceptancecriteria applicable to the performance of the device.
Summary ofSubstantialEquivalence	Based on the indications for use, design, and performance testing, thesubject Prelude IDeal Hydrophilic Sheath Introducer raises no newquestions of safety or effectiveness compared to the predicate deviceand is substantially equivalent to the predicate device, thePreludeEASE Hydrophilic Sheath Introducer, K140543 and K150257,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).