Prelude SNAP™ Splittable 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 Sheath Introducer system consists of a splittable sheath introducer (with or without side-port), 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 or without a side-port with 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 medical device, the "Prelude SNAP™ Splittable Sheath Introducer," and its clearance process with the FDA. It details the device's technical characteristics, intended use, and the safety and performance tests conducted. However, the document does not present a formal "acceptance criteria" table with reported device performance against the criteria that would typically be used in a study to prove the device meets these criteria. Instead, it lists the types of tests performed.

Based on the information provided, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various tests performed, implying that certain performance thresholds would have been met. However, it does not explicitly state specific acceptance criteria (e.g., "force greater than X N") or directly report the numerical results of those tests. The tests are categorized as Dimensional, Functional, Simulated Use, Visual, Sterilization validation, and Biocompatibility.

Acceptance Criteria Category	Specific Test	Implied Acceptance Criterion (not explicitly stated in document)	Reported Device Performance (not explicitly stated as numerical values in document)
Dimensional Tests	Introducer tube outer diameter (OD)	Within specified tolerance	Compliant
	Introducer tip inner diameter (ID)	Within specified tolerance	Compliant
	Introducer free length	Within specified tolerance	Compliant
	Dilator tube outer diameter (OD)	Within specified tolerance	Compliant
	Dilator tip inner diameter (ID)	Within specified tolerance	Compliant
	Dilator protrusion from introducer when assembled	Within specified tolerance	Compliant
Functional Tests	Introducer hub break force	Above minimum threshold	Compliant
	Introducer peel	Within specified range for effective splitting	Compliant
	Introducer side-port pull force	Above minimum threshold	Compliant
	Introducer tube to hub joint strength	Above minimum threshold	Compliant
	Dilator tube to hub joint strength	Above minimum threshold	Compliant
Simulated Use Test	Introducer hemostasis	Minimal or no blood leakage	Compliant
	Device insertion through introducer valve	Smooth and unobstructed	Compliant
	Introducer valve hemostasis (liquid leakage)	Minimal or no liquid leakage	Compliant
	Introducer liquid leakage	Minimal or no liquid leakage	Compliant
	Introducer insertion	Smooth and unobstructed	Compliant
	Dilator to introducer engagement	Secure and proper fit	Compliant
	Dilator luer functionality	Proper function of luer connection	Compliant
	Dilator liquid leakage	Minimal or no liquid leakage	Compliant
Visual Tests	Introducer pad printing	Legible and durable	Compliant
	Introducer soft touch pad attachment	Secure and reliable	Compliant
Sterilization Validation	Sterility	Sterile per ISO 11135-1 & AAMI TIR28	Compliant
Biocompatibility Testing	Cytotoxicity, Sensitization, Irritation, Acute System Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility	Biocompatible per ISO 10993 series & USP 37-NF 32 <85>	Compliant

Study Proving Device Meets Acceptance Criteria:

The document mentions "Performance Testing (Verification)" as the study conducted to ensure the device meets the user requirements and specifications.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide specific sample sizes for the test sets used for any of the listed tests. The data provenance (country of origin, retrospective/prospective) is also not specified. These were likely internal engineering and quality assurance tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable and hence not provided. The testing described is for a physical medical device (catheter introducer), not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" for these tests would be the physical properties and performance characteristics of the device itself, measured by calibrated equipment and verified against engineering specifications.

4. Adjudication Method:

This information is not applicable for the type of testing described (physical device performance testing).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI algorithms where human readers interpret medical images. The Prelude SNAP™ Splittable Sheath Introducer is a physical medical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone (algorithm only) study was not done. This is not an AI/software device. The performance tests ("Verification") described are for the physical device itself.

7. Type of Ground Truth Used:

The ground truth used for the device's performance evaluation is based on engineering specifications, material science properties, and established international standards (e.g., ISO, AAMI, USP) for physical and biological performance of medical devices. This includes:

Dimensional measurements: Verifying measurements against design specifications.
Mechanical strength: Quantifying forces required for actions like hub break, peel, pull, and joint strength, compared to safety and functional requirements.
Fluid dynamics: Assessing hemostasis and leakage under simulated use conditions.
Sterility and Biocompatibility: Conforming to established biological safety standards.

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for a physical medical device.

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 a stylized representation of a human figure in profile, with three overlapping heads suggesting community and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

April 9, 2015

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

Re: K143255

Trade/Device Name: Prelude Snap Splittable Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 3, 2015 Received: April 6, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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,

Fernande Aguel Fernando Aguel -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143255

Device Name

Prelude SNAPTM 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)

2 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)

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Attachment 1

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K143255 510(k) Summary

GeneralProvisions	Correspondent Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Systems, Inc.65 Great Valley ParkwayMalvern, PA 19355(610) 651-5046(801) 545-4285Alina StubbsApril 3, 20152529252
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	Prelude SNAPTM Splittable SheathIntroducerSheath IntroducerIntroducer, Catheter (21 CFR §870.1340)
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	ClassicSheathTM Splittable HemostaticIntroducer SystemIntroducer, Catheter (21 CFR §870.1340)K934901 – Tear-Away Sheath IntroducerSet With Integral Hemostasis ValveMerit Medical Systems, Inc.65 Great Valley ParkwayMalvern, PA 19355(formerly operating asThomas Medical Products, Inc.)
Classification	Class II21 CFR §870.1340FDA Product Code: DYBReview Panel: Cardiovascular
Intended Use	Prelude SNAPTM Splittable Sheath Introducer is indicated "For theintroduction of various types of pacing leads and catheters to theheart and coronary venous system".

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The splittable sheath introducer contains a hemostasis valve to Device minimize blood loss and air ingress during use. The introducer is Description available with or without a side-port with 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.

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	TechnicalCharacteristics	Predicate Device(K934901)	Subject Device
	Device Dimensions (nominal)
	Sheath introducer innerdiameter (French)	6F through 12.5F	6F through 12.5F
	Sheath introducer length(cm)	13 & 25 cm	13 & 25 cm
	Dilator outer diameter(French)	6F through 12.5F	6F through 12.5F
	Dilator length (in)	13 cm: 8.95"and25 cm: 13.67"	13 cm: 8.34"and25 cm: 13.09"
	Dilator tip ID (in)	0.038"	0.039"
Comparison toPredicate	Introducer needle length(cm)	7 cm	7 cm
	Introducer needle outerdiameter (gage)	18 g	18 g
	Guide wire length &diameter (in. x cm)	13 cm: 0.038" x45 cm J-Tipand25 cm: 0.038" x80 cm J-Tip	13 cm: 0.038" x50 cm J-Tipand25 cm: 0.038" x80 cm J-Tip
	Syringe volume (cc)	12 cc	12 cc or 10 cc
	Device Materials	The materials ofconstruction areprimarilypolymers with theexception of theguide wire andneedle cannula,which arestainless steel.	The materials ofconstruction areprimarily polymerswith the exceptionof the guide wireand needlecannula, whichare stainlesssteel.

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

Note: All dimensions are nominal.

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The Prelude SNAP™ Splittable 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 Sheath Introducer:

Risk Analysis
Requirements/Specification Reviews
. Design Reviews
Performance Testing (Verification) including but not limited to:
- o Dimensional Tests
  - Introducer tube outer diameter (OD) l
  - I Introducer tip inner diameter (ID)
  - 트 Introducer free length
  - Dilator tube outer diameter (OD) ■
  - l Dilator tip inner diameter (ID)
  - Dilator protrusion from introducer when l assembled
- o Functional Tests
  - Introducer hub break force .
  - . Introducer peel
  - Introducer side-port pull force l
  - Introducer tube to hub joint strength
  - l Dilator tube to hub joint strength
- o Simulated Use Test
  - Introducer hemostasis ■
  - I Device insertion through introducer valve
  - I Introducer valve hemostasis (liquid leakage)
  - l Introducer liquid leakage
  - l Introducer insertion
  - l Dilator to introducer engagement
  - Dilator luer functionality
  - . Dilator liquid leakage
- Visual Tests o
  - Introducer pad printing ■
  - l Introducer soft touch pad attachment
. Sterilization validation

Biocompatibility Testing
- o Cytotoxicity
- Sensitization O
- Irritation O
- Acute System Toxicity O
- Pyrogenicity O
- Genotoxicity O
- Hemocompatibility O

Safety & Performance Tests

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	No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for this device. Performance testing of the Prelude SNAP™ Splittable Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standards:
InternationalStandards	ISO 11070: 1998(E), Sterile, single-use intravascular catheter introducers ISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment – Part 2: Lock fittings ISO 11135-1: 2007, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AAMI TIR28:2009, Product adoption and process equivalence for ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing within a risk management process, ISO 10993-3: 2003, Biological Evaluation of Medical Devices Part-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ISO 10993-4: 2002, Biological Evaluation of Medical Devices Part-4: Selection of Tests for Interactions with Blood, as amended 2006 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 ISO 10993-17: 2002, Biological evaluation of medical devices – Part 17: Methods for the establishment of allowable limits for leachable substances USP 37-NF 32 <85>: 2014, United States Pharmacopeia 37, National Formulary 32, 2014 <85> Bacterial Endotoxins Test ASTM D4169-09, Standard Practice for Performance Testing of Shipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 14971:2012, Medical devices - Application of risk

No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for this device. Performance testing of the Prelude SNAP™ Splittable Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standards:

InternationalStandards

ISO 11070: 1998(E), Sterile, single-use intravascular catheter introducers ISO 594-2:1998, Conical Fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment – Part 2: Lock fittings ISO 11135-1: 2007, Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AAMI TIR28:2009, Product adoption and process equivalence for ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing within a risk management process, ISO 10993-3: 2003, Biological Evaluation of Medical Devices Part-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ISO 10993-4: 2002, Biological Evaluation of Medical Devices Part-4: Selection of Tests for Interactions with Blood, as amended 2006 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 ISO 10993-17: 2002, Biological evaluation of medical devices – Part 17: Methods for the establishment of allowable limits for leachable substances USP 37-NF 32 <85>: 2014, United States Pharmacopeia 37, National Formulary 32, 2014 <85> Bacterial Endotoxins Test ASTM D4169-09, Standard Practice for Performance Testing of Shipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 14971:2012, Medical devices - Application of risk

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Merit Medical Systems, Inc. considers the Prelude SNAP™ Splittable Sheath Introducer substantially equivalent to the currently marketed Summary of predicate device (ClassicSheath™ Splittable Hemostatic Introducer Substantial System - K934901). This assessment is based upon analysis of Equivalence similar technological characteristics, bench testing, and indications for use.

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).