The Prelude Pursuit™ Splittable Sheath Introducer is a splittable introducer system indicated for the introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature. The "splittable” function allows the introducer to be withdrawn over a diagnostic/therapeutic catheter (e.g. peripherally inserted central catheter, totally implantable venous access device/port, dialysis, drainage, hemodynamic line, etc.) or pacing/defibrillator lead and from the vessel while maintaining said device in place. The product is available in 16 French sizes, from 5 F through 16 F, and in two different lengths, 13 cm and 25 cm. It is packaged either as a kit with optional accessory components (introducer needle, syringe, guide wire), or as a stand-alone (sheath-dilator) set. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities. The splittable sheath introducer is lubricated with a silicone dispersion and its hub has a threaded locking mechanism for dilator engagement. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip for ease of insertion.

AI/ML Overview

The document provided describes a 510(k) premarket notification for a medical device called the "Prelude Pursuit Splittable Sheath Introducer". It does not describe an AI/ML powered device, therefore, many of the requested categories (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable.

Here's an analysis based on the information provided, focusing on the device's performance given its classification as a medical device (not an AI/ML product):

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (catheter introducer) and not an AI/ML product, the "acceptance criteria" are related to its physical and functional properties, as well as safety standards. The "reported device performance" refers to the successful completion of these tests, demonstrating compliance with the predicate device and established standards.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Dimensional Tests	Introducer sheath tube outer diameter (OD)	Tested and met specifications
	Introducer tip inner diameter (ID)	Tested and met specifications
	Introducer free length	Tested and met specifications
	Dilator tube outer diameter (OD)	Tested and met specifications
	Dilator tip inner diameter (ID)	Tested and met specifications
	Dilator protrusion from introducer when assembled	Tested and met specifications
Functional Tests	Introducer hub break force	Tested and met specifications
	Introducer sheath peel force	Tested and met specifications
	Introducer tube to hub joint strength	Tested and met specifications
	Dilator tube to hub joint strength	Tested and met specifications
	Mating dilator ISO 594-2 compliance	Tested and met specifications (compliant with ISO 594-2:1998)
Simulated Use Test	Introducer sheath / dilator insertion - synthetic tissue	Tested and met specifications
	Sheath - dilator assembly - kink & flexibility	Tested and met specifications
	Mating dilator to introducer engagement	Tested and met specifications
Visual Tests	Introducer soft touch pad attachment	Tested and met specifications
Sterilization	Sterilization validation	Validated (compliant with ISO 11135-1:2007, AAMI TIR28:2009)
Biocompatibility	Cytotoxicity (in vitro)	Tested (compliant with ISO 10993-5:2009)
	Sensitization	Tested (compliant with ISO 10993-10:2010)
	Irritation	Tested (compliant with ISO 10993-10:2010)
	Acute Systemic Toxicity	Tested (compliant with ISO 10993-11:2006)
	Pyrogenicity	Tested (compliant with USP 40, NF 35, <151>)
	Hemolysis	Tested (compliant with ASTM F756-13:2013)
	Thrombogenicity	Tested (compliant with ISO 10993-4:2002/Amd.1:2006, ISO 10993-4:2017)
	Complement Activation	Tested (compliant with ISO 10993-4:2002/Amd.1:2006, ISO 10993-4:2017)
Packaging & Labeling	Packaging integrity	Tested (compliant with ASTM D4169-16, ISO 11607-1, ISO 2233, ASTM F2096, ASTM F1140, ASTM F1980, ASTM F88, ASTM F1929)
	Labeling	Compliant with ISO 15223-1:2016
Risk Management	Application of risk management	Applied (compliant with ISO 14971:2012)

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

This information is not provided in the document. For physical device testing, sample sizes are typically determined by statistical rationale for verification and validation (V&V) testing based on product specifications and standards, but the specific numbers are not disclosed here. The "data provenance" for such a device would refer to the testing being performed in a laboratory setting under controlled conditions, not from patient data.

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

This is not applicable as the device is a physical medical instrument, not an algorithm requiring expert-established ground truth from medical images or data. Ground truth for physical properties is established through validated measurement techniques and adherence to engineering specifications and international standards.

4. Adjudication method for the test set

Not applicable for a physical device. Performance is judged against objective physical and safety 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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device. "Standalone" performance for this device would refer to its physical function as tested against its specifications.

7. The type of ground truth used

For this physical device, the "ground truth" is defined by:

Engineering Specifications: Designed dimensions, material properties, and functional performance targets derived from the device's intended use.
International Standards (e.g., ISO, ASTM, USP): These standards (listed in the document) provide objective, established benchmarks for safety, biocompatibility, sterilization, and functional performance of medical devices. Failure to meet these standards would indicate the device does not meet "ground truth" for safe and effective use.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. There is no "training set" in the context of physical medical device development in this manner.

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

Not applicable, as this is not an AI/ML device.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

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

September 11, 2017

Merit Medical Systems, Inc. Jacquelyn Huyghue Regulatory Affairs Specialist I 65 Great Vallev Parkway Malvern, Pennsylvania 19355

Re: K172117

Trade/Device Name: Prelude Pursuit Splittable Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 11, 2017 Received: July 13, 2017

Dear Jacquelyn Huyghue:

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.

{1}------------------------------------------------

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 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.

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 (DICE) 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 (DICE) 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.

Nicole G. Ibrahim -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K172117

Device Name

Prelude Pursuit™ Splittable Sheath Introducer

Indications for Use (Describe)

The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.

Type of Use (Select one or both, as applicable)

X 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 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:

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."

{3}------------------------------------------------

510(k) Summary - K172117

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number:	Merit Medical Systems, Inc.65 Great Valley ParkwayMalvern, PA 19355(610) 651-5090(801) 545-4285Jacquelyn HuyghueJuly 11, 20172529252
Subject Device	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel:	Prelude Pursuit™ Splittable Sheath IntroducerSheath IntroducerIntroducer, CatheterIIDYB870.1340Cardiovascular
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	St. Jude Medical SJM™ Peel Away IntroducerIntroducer, CatheterK791129St. Jude Medical (formerly Diag Corp.)
ReferenceDevice	This predicate has not been subject to a design-related recallNo reference devices were used in this submission.
DeviceDescription	The Prelude Pursuit™ Splittable Sheath Introducer is a splittableintroducer system indicated for the introduction of various types ofpacing/defibrillator leads and catheters into the venous vasculature.The "splittable” function allows the introducer to be withdrawn over adiagnostic/therapeutic catheter (e.g. peripherally inserted centralcatheter, totally implantable venous access device/port, dialysis,drainage, hemodynamic line, etc.) or pacing/defibrillator lead and fromthe vessel while maintaining said device in place. The product isavailable in 16 French sizes, from 5 F through 16 F, and in two differentlengths, 13 cm and 25 cm. It is packaged either as a kit with optionalaccessory components (introducer needle, syringe, guide wire), or as astand-alone (sheath-dilator) set. The device is provided sterile andintended for single use only. It is for use in hospitals or healthcarefacilities.The splittable sheath introducer is lubricated with a silicone dispersionand its hub has a threaded locking mechanism for dilator engagement.The dilator is designed to conform to the inner diameter of theintroducer and has a tapered tip for ease of insertion.

{4}------------------------------------------------

	Prelude Pursuit™ Splittable Sheath Introducer kit consists of:
	One (1) Splittable Sheath Introducer
	One (1) Dilator
	One (1) .038" x 50 cm or .038" x 80 cm guidewire (depending on the introducer length)
	One (1) 18 G introducer needle
	One (1) 12 cc or 10 cc syringe
	Prelude Pursuit™ Splittable Sheath Introducer stand-alone set consists of:
	One (1) Splittable Sheath Introducer
	One (1) Dilator
	The materials of construction are primarily polymers except for the optional guide wire and introducer needle cannula, which are stainless steel.
Indications for Use	The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.

{5}------------------------------------------------

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

Comparison toPredicateDevice	TechnicalCharacteristics	Predicate Device(K791129)	Subject DevicePrelude Pursuit™Splittable SheathIntroducer
	Device Dimensions (nominal)
	Sheath introducer innerdiameter (French)	5 F through 16 F	5 F through 16 F
	Sheath introducer length(cm)	14 & 23 cm	13 & 25 cm
	Dilator outer diameter(French)	5 F through 16 F	5 F through 16 F
	Dilator length (in)	14 cm: 8.67"and23 cm: 12.01"	13 cm: 7.59"and25 cm: 12.34"
	Dilator tip ID (in)	0.040"	0.039"
	Introducer needle length(cm)	6.6 cm	7 cm
	Introducer needle outerdiameter (gauge)	18 G	18 G
	Guide wire length &diameter (in. x cm)	14 cm: 0.038" x 50cm J-Tipand23 cm: 0.038" x 80cm J-Tip	13 cm: 0.038" x 50cm J-Tipand25 cm: 0.038" x 80cm J-Tip
Syringe volume (cc)	12 cc	12 cc or 10 cc
Device Materials
	The materials ofconstruction areprimarily polymerswith the exceptionof the guide wireand needlecannula, which arestainless steel	The materials ofconstruction areprimarily polymerswith the exceptionof the guide wire andneedle cannula,which are stainlesssteel

Note: All dimensions are nominal.

{6}------------------------------------------------

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

ISO 11070:2014 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 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 10993-4:2002 (Amd.1:2006), Biological Evaluation of Medical Devices - Part 4: Selection of tests for interaction with blood
ISO 10993-4:2017, 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

Performance Data

ISO 10993-10:2010, Biological Evaluation of Medical Devices Part . 10: Tests for irritation and delayed type hypersensitivity
. ISO 10993-11:2006, Biological Evaluation of Medical Devices -Part 11: Tests for systemic toxicity
United States Pharmacopeia 40, National Formulary 35, 2017 . <151> Pyrogen Test
ASTM F756-13:2013, Standard Practice for Hemolytic Properties of ● Materials
ASTM D4169-16:2016. Standard Practice for Performance Testing . of Shipping Containers and Systems
ISO 15223-1: 2016. Medical Devices Symbols to be used with . medical device labels, labeling and information to be supplied - Part 1: General Requirements
ISO 11607-1: 2009 (Amd.1:2014), Packaging for terminally ● sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging Systems
ISO 2233:2000. Packaging -- Complete, filled transport packages . and unit loads -- Conditioning for testing
ISO 594-1:1986. Conical fittings with a 6% (Luer) taper for svringes. ● needles and certain other medical equipment - Part 1: General requirements
ISO 14971:2012, Medical devices Application of risk management ● to medical devices
. ASTM D999-08: 2008 Standard Test Methods for Vibration Testing of Shipping Container

{7}------------------------------------------------

ASTM F2096-11:2011, Standard Test Method for Detecting Gross ● Leaks in Packaging by Internal pressurization (Bubble Test)
ASTM F1140-07:2007 Standard Test Methods for internal . Pressurization Failure Resistance of Unrestrained Packages
ASTM F1980-07:2011 Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices
ASTM F88:2009 Standard Test Method for Seal Strength of Flexible ● Barrier Materials
ASTM F1929:1998 Standard Test Method for Detecting Leaks in . Porous Medical Packaging by Dye Penetration

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

Risk Analysis
Performance

Data cont.

Requirements/Specification Reviews ●
Design Reviews ●
Performance Testing (Verification): ●
- o Dimensional Tests
  - Introducer sheath tube outer diameter (OD) ■
  - . Introducer tip inner diameter (ID)
  - . Introducer free lenath
  - . Dilator tube outer diameter (OD)
  - 트 Dilator tip inner diameter (ID)
  - l Dilator protrusion from introducer when assembled
- o Functional Tests
  - Introducer hub break force
  - Introducer sheath peel force
  - Introducer tube to hub joint strength
  - . Dilator tube to hub joint strength
  - I Mating dilator ISO 594-2 compliance
- o Simulated Use Test
  - 트 Introducer sheath / dilator insertion - synthetic tissue
  - . Sheath - dilator assemblv - kink & flexibility
  - . Mating dilator to introducer engagement
- o Visual Tests
  - Introducer soft touch pad attachment I
Sterilization validation ●
Biocompatibility .

Cytotoxicity o
Sensitization O
Irritation O
Acute Systemic Toxicity O
Pyrogenicity O

Hemolysis

{8}------------------------------------------------

Thrombogenicity o Complement Activation O
Summary of Substantial Equivalence Based on the indications for use, design, safety and performance testing, the subject Prelude Pursuit™ Splittable Sheath Introducer meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the St. Jude Medical SJM™ Peel Away Introducer (K791129).

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).