Prelude SNAP™™ Splittable Hydrophilic Sheath Introducer is a splittable hemostatic introducer system that is intended for the introduction of various types of pacing leads and catheters. The Prelude SNAP™™ Splittable Hydrophilic Sheath Introducer system consists of a splittable sheath introducer lubricated with hydrophilic coating, dilator, 18g introducer needle, guide wire, and a syringe. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities. The splittable sheath introducer contains a hemostasis valve to minimize blood loss and air ingress during use. The introducer is available with a side-port and three-way stopcock that provides means for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The splittable sheath introducer is available in two lengths: 13cm and 25cm. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip. The materials of construction are primarily polymers with the exception of the guide wire and needle cannula which are stainless steel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Prelude SNAP™ Splittable Hydrophilic Sheath Introducer." This document is from the FDA and details the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness, and substantial equivalence to a predicate device.

It's important to note that this is a medical device and not an AI/ML-based device. Hence, the acceptance criteria and study described are for a physical medical product, not an AI algorithm. Many of the requested points related to AI/ML (e.g., training set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the information provided.

However, I can extract the relevant information regarding the acceptance criteria and studies for this physical medical device.

Acceptance Criteria and Device Performance for the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer

The document states that the device was "thoroughly tested through verification of product specifications and user requirements" and that "the results of the testing demonstrated that the subject Prelude SNAP™ Splittable Hydrophilic Sheath Introducer met the predetermined acceptance criteria of the device."

The study design is based on bench testing, sterilization validation, and biocompatibility testing, referencing several international and industry standards. The acceptance criteria themselves are explicitly stated for some tests, while others are implied as meeting the requirements of the referenced standards.

Here's a summary:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test / Parameter	Acceptance Criteria	Reported Device Performance
Performance Testing	Introducer Sheath Insertion	Met predetermined criteria	Met predetermined criteria
	Introducer Sheath Outer Diameter (O.D.)	Met predetermined criteria	Met predetermined criteria
	Introducer Sheath Tip Inner Diameter (I.D.)	Met predetermined criteria	Met predetermined criteria
	Introducer Sheath Peel Force	Met predetermined criteria	Met predetermined criteria
	Simulated Use Introducer Insertion (Kink and Flexibility)	Met predetermined criteria	Met predetermined criteria
	Introducer Sheath Coating Length	Met predetermined criteria	Met predetermined criteria
	Introducer Sheath Coating Adherence	Met predetermined criteria	Met predetermined criteria
	Introducer Sheath Coating Lubricity/Durability	Met predetermined criteria	Met predetermined criteria
	Particulate Testing	Met predetermined criteria	Met predetermined criteria
Biocompatibility	Cytotoxicity	Complies with ISO 10993-1, 10993-7	Met requirements of the standards (implied acceptable)
	Biological Evaluation (general)	Complies with ISO 10993-1, 10993-7	Met requirements of the standards (implied acceptable)
	Bacterial Endotoxins Test	Complies with USP 37-NF 32 <85>, AAMI/ANSI ST72:2011	Met requirements of the standards (implied acceptable)
	Pyrogen Test	Complies with USP 37-NF 32 <151>	Met requirements of the standards (implied acceptable)
Sterilization	Sterilization Validation	Complies with ISO 11135-1, AAMI TIR28	Met requirements of the standards (implied acceptable)
Packaging	Performance Testing of Shipping Containers and Systems	Complies with ASTM D4169-09	Met requirements of the standards (implied acceptable)
	Packaging for terminally sterilized medical devices	Complies with ISO 11607-1	Met requirements of the standards (implied acceptable)
Risk Management	Application of risk management to medical devices	Complies with ISO 14971:2012	Met requirements of the standards (implied acceptable)
General	Compliance with ISO 11070:1998E (Sterile single-use intravascular catheter introducers)	Met requirements of mentioned standard	Met requirements of the standard (implied acceptable)

Note: For many tests, the document simply states "met the predetermined acceptance criteria of the device" or implies compliance with the referenced standards, rather than providing specific numerical results or thresholds. This is typical for a 510(k) summary where detailed test reports are submitted separately.

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

The document does not specify the exact sample sizes used for each test. The studies were bench tests and laboratory validations (sterilization, biocompatibility). Data provenance would be internal laboratory testing data from Merit Medical Systems, Inc. This device is a physical product, not data-driven software, so terms like "country of origin of the data" or "retrospective/prospective" studies as they apply to clinical data are not directly applicable.

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

Not applicable. Ground truth for a physical medical device is established through engineering specifications, standard test methods, and compliance with recognized industry standards (e.g., ISO, ASTM, USP). It does not involve human expert consensus in the way an AI algorithm for image interpretation would.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of human interpretations or clinical outcomes.

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-assisted diagnostic tool. No MRMC study was performed or needed.

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

Not applicable. This is not an algorithm. Device performance is inherent to its physical design and manufacturing process, independent of human interaction beyond its intended use.

7. The type of ground truth used

The ground truth is based on engineering specifications, established performance standards (e.g., ISO, ASTM, USP), and risk analysis. For example:

Mechanical properties: Defined by engineering design and tested against specifications (e.g., sheath diameter, peel force).
Sterility: Verified through sterilization validation processes adhering to standards like ISO 11135-1.
Biocompatibility: Established by testing materials in accordance with ISO 10993 series for material safety with biological systems.
Functionality: Tested against "user requirements" and "product specifications" (e.g., insertion, kink resistance).

8. The sample size for the training set

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

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

Not applicable. No training set for an AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines beneath them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

October 30, 2015

Merit Medical Systems, Inc. Alina Stubbs Regulatory Affairs Specialist II 65 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K152381

Trade/Device Name: Prelude SNAPTM Splittable Hydrophilic Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 30, 2015 Received: October 1, 2015

Dear Alina Stubbs:

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 of medical devicerelated 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

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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K152381

Prelude SNAP™ Splittable Hydrophilic Sheath Introducer Premarket Notification 510(k)

Merit Medical Systems, Inc.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

	510(k) Number (if known)
	K152231

K152381

Device Name

Prelude SNAPTM Hydrophilic Splittable Sheath Introducer

Indications for Use (Describe)

For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

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:

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FORM FDA 3881 (1/14)

Page 1 of 1

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K152381 510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Systems, Inc.65 Great Valley ParkwayMalvern, PA 19335(610) 651-5046(801) 545-4285Alina StubbsOctober 27, 20152529252
Subject Device	Trade Name:Common/Usual Name:Classification Name:	Prelude SNAP™ Splittable Hydrophilic SheathIntroducerSheath IntroducerIntroducer, Catheter (21 CFR §870.1340)
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Prelude SNAP™ Splittable Sheath IntroducerIntroducer, Catheter (21 CFR §870.1340)K143255 - Prelude SNAP™ Splittable SheathIntroducerMerit Medical Systems, Inc.
Classification		Class II21 CFR § 870.1340FDA Product Code: DYBReview Panel: Cardiovascular
Intended Use		Prelude SNAP™ Splittable Hydrophilic Sheath Introducer is indicated"For the introduction of various types of pacing leads and catheters tothe heart and coronary venous system".

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	Prelude SNAP™™ Splittable Hydrophilic Sheath Introducer is a splittablehemostatic introducer system that is intended for the introduction ofvarious types of pacing leads and catheters. The Prelude SNAP™™Splittable Hydrophilic Sheath Introducer system consists of a splittablesheath introducer lubricated with hydrophilic coating, dilator, 18gintroducer needle, guide wire, and a syringe. The device is providedsterile and intended for single use only. It is for use in hospitals orhealthcare facilities.
DeviceDescription	The splittable sheath introducer contains a hemostasis valve tominimize blood loss and air ingress during use. The introducer isavailable with a side-port and three-way stopcock that provides meansfor air or blood aspiration, fluid infusion, blood sampling, and pressuremonitoring. The splittable sheath introducer is available in two lengths:13cm and 25cm. The dilator is designed to conform to the innerdiameter of the introducer and has a tapered tip.
	The materials of construction are primarily polymers with the exceptionof the guide wire and needle cannula which are stainless steel.

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Summary of the technological characteristics of the modified device compared to the predicate device:

Technical Characteristics	Predicate Device(K143255)	Subject Device
Device Dimensions (nominal)
Sheath introducer inner diameter (French)	6F through 12.5F	6F through 12.5F
Sheath introducer length (cm)	13 & 25 cm	13 & 25 cm
Sheath Introducer sideport and stopcock	Available with and without sideport and stopcock.	Available with sideport and stopcock only.
Dilator outer diameter (French)	6F through 12.5F	6F through 12.5F
Dilator length (in)	13 cm: 8.34"and25 cm: 13.09"	13 cm: 8.34"and25 cm: 13.09"
Dilator tip ID (in)	0.039"	0.039"
Introducer needle length (cm)	7 cm	7 cm
Introducer needle outer diameter (gage)	18 g	18 g
Guide wire length & diameter (in. x cm)	13 cm: 0.038" x 50 cm J-Tipand25 cm: 0.038" x 80 cm J-Tip	13 cm: 0.038" x 50 cm J-Tipand25 cm: 0.038" x 80 cm J-Tip
Syringe volume (cc)	12 cc or 10 cc	12 cc or 10 cc
Device Materials
Sheath Lubricant	Silicone Dispersion	Hydrophilic Coating
All other materials of the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer are identical to the predicate device.

Note: All dimensions are nominal.

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The Prelude SNAP™ Splittable Hydrophilic Sheath Introducer has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the Prelude SNAP™ Splittable Hydrophilic Sheath Introducer:

Risk Analysis
Requirements/Specification Reviews ●
Design Reviews ●
Performance Testing-Bench ●
- Introducer Sheath Insertion O
- O Introducer Sheath Outer Diameter (O.D.)
- Introducer Sheath Tip Inner Diameter (I.D.) o
- Introducer Sheath Peel Force o
- Simulated Use Introducer Insertion (Kink and O Flexibility)
- Introducer Sheath Coating Length O
- Introducer Sheath Coating Adherence o
- Introducer Sheath Coating Lubricity/Durability O
- Particulate Testing O
Sterilization Validation
Biocompatibility Testing .
- o Cytotoxicity

Safety & Performance Tests

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Safety &PerformanceTests(continued)	No performance standards have been established under section 514 ofthe Food, Drug and Cosmetic Act for this device. When applicable,performance testing of the Prelude SNAP™ Splittable HydrophilicSheath Introducer was conducted based on the risk analysis and basedon the requirements of the following international standards:ISO 11070:1998E Sterile single-use intravascular catheterintroducers ISO 11135-1: 2007, Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development,validation and routine control of a sterilization process formedical devices AAMI TIR28:2009, Product adoption and process equivalencefor ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical DevicesPart-1: Evaluation and Testing within a risk managementprocess, ISO 10993-7: 2008, Biological Evaluation of Medical DevicesPart-7 Ethylene Oxide Sterilization Residuals USP 37-NF 32 <85>, United States Pharmacopeia 37, NationalFormulary 32, 2014 <85> Bacterial Endotoxins Test USP 37-NF 32 <151>, United States Pharmacopeia 37,National Formulary 32, <151> Pyrogen Test. 2014 AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods,routine monitoring, and alternatives to batch testing ASTM D4169-09, Standard Practice for Performance Testing ofShipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials, sterile barriersystems and packaging systems ISO 14971:2012, Medical devices - Application of riskmanagement to medical devices The results of the testing demonstrated that the subject PreludeSNAP™ Splittable Hydrophilic Sheath Introducer met thepredetermined acceptance criteria of the device.
Summary ofSubstantialEquivalence	Based on the indications for use, design, safety and performancetesting, the subject Prelude SNAP™ Splittable Hydrophilic SheathIntroducer meets the requirements that are considered essential for itsintended use and is substantially equivalent to the predicate device, thePrelude SNAP™ Splittable Sheath Introducer - K143255, manufacturedby Merit Medical Systems, Inc.

Safety &PerformanceTests(continued)

No performance standards have been established under section 514 ofthe Food, Drug and Cosmetic Act for this device. When applicable,performance testing of the Prelude SNAP™ Splittable HydrophilicSheath Introducer was conducted based on the risk analysis and basedon the requirements of the following international standards:ISO 11070:1998E Sterile single-use intravascular catheterintroducers ISO 11135-1: 2007, Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development,validation and routine control of a sterilization process formedical devices AAMI TIR28:2009, Product adoption and process equivalencefor ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical DevicesPart-1: Evaluation and Testing within a risk managementprocess, ISO 10993-7: 2008, Biological Evaluation of Medical DevicesPart-7 Ethylene Oxide Sterilization Residuals USP 37-NF 32 <85>, United States Pharmacopeia 37, NationalFormulary 32, 2014 <85> Bacterial Endotoxins Test USP 37-NF 32 <151>, United States Pharmacopeia 37,National Formulary 32, <151> Pyrogen Test. 2014 AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods,routine monitoring, and alternatives to batch testing ASTM D4169-09, Standard Practice for Performance Testing ofShipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials, sterile barriersystems and packaging systems ISO 14971:2012, Medical devices - Application of riskmanagement to medical devices The results of the testing demonstrated that the subject PreludeSNAP™ Splittable Hydrophilic Sheath Introducer met thepredetermined acceptance criteria of the device.

Summary ofSubstantialEquivalence

Based on the indications for use, design, safety and performancetesting, the subject Prelude SNAP™ Splittable Hydrophilic SheathIntroducer meets the requirements that are considered essential for itsintended use and is substantially equivalent to the predicate device, thePrelude SNAP™ Splittable Sheath Introducer - K143255, manufacturedby 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).