The 5.5 F Worley Advanced LVI Lateral Vein Introducer is intended to access the coronary venous system either alone or in a telescopic assembly with other devices. The 5.5 F Worley Advanced LVI Lateral Vein Introducer serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. They have direct contact to the inner heart. 5.5 F Worley Advanced LVI Lateral Vein Introducers come with various curve configurations to facilitate sub-selective access to angulated lateral vein branches. 5.5 F Worley Advanced LVI Lateral Vein Introducers are designed as single use devices and for short term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these introducers.

The 5.5 F Worley Advanced LVI Lateral Vein Introducers have a Device shaft design with two (2) stiffness segmentations. The shaft is reinforced by a metal braid from the proximal end until approximately 0.130 inches from the distal end. The shaft is coated by a medicalgrade coating that provides enhanced lubricity when advanced through the Coronary Sinus Guide Introducer.

The proximal end of the 5.5 F Worley Advanced LVI Lateral Vein Introducers are equipped with a hemostasis valve that reduces the risk of blood loss and air embolism and a side-port with 3-way stopcock to allow fluid infusion and contrast injection.

There are various versions of the introducer curves that are used according to the anatomy of the present coronary vasculature. The distal soft tip has a radius on the outer diameter and the distal tip further contains a polymeric x-ray marker for enhanced visibility under fluoroscopy.

The materials of construction are primarily polymers.

AI/ML Overview

The document describes a 510(k) premarket notification for the "5.5 F Worley Advanced LVI Lateral Vein Introducer". This is a medical device and not an AI/ML product. Therefore, the requested information about acceptance criteria, study details, ground truth, and training data, which are typically associated with AI/ML device evaluations, are not applicable to this submission.

The document primarily focuses on establishing substantial equivalence to a predicate device (Coronary Sinus Guide and Lateral Vein Introducer Kits - K120158) based on intended use, technological characteristics, and safety and performance testing.

Here's a breakdown of the relevant information provided:

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

The document lists "Performance Testing (Verification)" categories and specific tests performed. However, it does not explicitly state numerical acceptance criteria or the specific quantitative results reported for each test. Instead, it indicates that the device has been "thoroughly tested through verification of product specifications and user requirements" and that it "meets the requirements that are considered essential for its intended use."

Here's a table summarizing the types of tests performed:

Test Type	Specific Tests	Reported Device Performance
Performance Testing (Verification)	"Thoroughly tested through verification of product specifications and user requirements." Device "meets the requirements that are considered essential for its intended use."
Dimensional Tests	- Sheath introducer Curve dimensions- Sheath introducer outer diameter (O.D.)- Sheath introducer inner diameter (I.D.)- Sheath introducer free length, overall length	Implied to meet specifications.
Functional Tests	- Sheath introducer soft tip joint integrity- Sheath introducer valve housing separation- Sheath introducer tube/valve housing pull force- Sheath introducer radiopaque tube segment joint pull force- Sheath introducer tube joint pull force	Implied to meet specifications.
Simulated Use Test	- Sheath introducer tube slitting with slitter- Sheath introducer radiopaque tip bend	Implied to meet specifications.
Visual Tests	- Kit pouch integrity- Kit package integrity- Sheath Introducer visual appearance- Guiding catheter visual appearance- LVI visual appearance- Slitter (Cutter) visual appearance	Implied to meet specifications.
Sterilization Validation	(Mentioned as performed)	Implied to meet specifications.
Biocompatibility Testing	- Cytotoxicity	Implied to meet specifications.
Risk Analysis	(Mentioned as performed during development)	Implied to mitigate risks to acceptable levels.
Requirements/Specification Reviews	(Mentioned as performed during development)	Implied to ensure requirements are met during design.
Design Reviews	(Mentioned as performed during development)	Implied to ensure design meets requirements.

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

This information is not provided in the document, as it pertains to clinical trial data or performance study data for AI/ML models, which is not the subject of this 510(k) for a physical medical device. The "Performance Testing (Verification)" refers to engineering and quality control tests, not patient data in the context of AI/ML.

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 information is not applicable/provided. Ground truth and expert adjudication are concepts typically associated with the evaluation of AI/ML algorithms, not for the substantial equivalence demonstration of a physical medical device like an introducer.

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

This information is not applicable/provided for the reasons stated above.

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:

This information is not applicable/provided as this is not an AI/ML device.

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

This information is not applicable/provided as this is not an AI/ML device.

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

This information is not applicable/provided for the reasons stated above. The "ground truth" for a physical device is its adherence to engineering specifications, material properties, and functional performance criteria.

8. The sample size for the training set:

This information is not applicable/provided as this is not an AI/ML device.

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

This information is not applicable/provided as this is not an AI/ML 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 eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

August 27, 2015

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

Re: K152116

Trade/Device Name: 5.5 F Worley Advanced LVI Lateral Vein Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 29, 2015 Received: July 30, 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 (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 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,

Mitchell Stein

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

Enclosure

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Merit Medical Systems, Inc. 5.5 F Worley Advanced LVI Lateral Vein Introducer Special 510(k)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152116

Device Name

5.5 F Worley Advanced LVI Lateral Vein Introducer

Indications for Use (Describe)

For the introduction of various types of pacing or defibrillator leads and catheters.

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)

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 estimated on 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."

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

Over-The-Counter Use

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

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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 StubbsJuly 29, 20152529252
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	5.5 F Worley Advanced LVI Lateral VeinIntroducerSheath IntroducerIntroducer, Catheter (21 CFR §870.1340)
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Coronary Sinus Guide and Lateral VeinIntroducer KitsIntroducer, Catheter (21 CFR §870.1340)K120158Merit 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	For the introduction of various types of pacing or defibrillator leadsand catheters.

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The 5.5 F Worley Advanced LVI Lateral Vein Introducers have a Device shaft design with two (2) stiffness segmentations. The shaft is Description reinforced by a metal braid from the proximal end until approximately 0.130 inches from the distal end. The shaft is coated by a medicalgrade coating that provides enhanced lubricity when advanced through the Coronary Sinus Guide Introducer.

The proximal end of the 5.5 F Worley Advanced LVI Lateral Vein Introducers are equipped with a hemostasis valve that reduces the risk of blood loss and air embolism and a side-port with 3-way stopcock to allow fluid infusion and contrast injection.

There are various versions of the introducer curves that are used according to the anatomy of the present coronary vasculature. The distal soft tip has a radius on the outer diameter and the distal tip further contains a polymeric x-ray marker for enhanced visibility under fluoroscopy.

The materials of construction are primarily polymers.

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

	TechnicalCharacteristics	Predicate DeviceK120158	Subject Device
Comparison toPredicate	Hemostasis valveprovided	Yes	Yes
	Compatible with.038" guide wire	Yes	Yes
	Lengths:	62 cm	66cm
	French sizes:	7 F I.D.	5.5 F I.D.
	Curves:	0 to 180 degree,single or compoundcurves	0 to 180 degree,single or compoundcurves
	Sheath introducerbreak-awayhemostasis valve	Yes	Yes
	Wire braidreinforcementcompletelyencapsulated	Yes	Yes
	Radiopaque tip	Yes	Yes
	Side port for infusionand contrastinjection	Yes	Yes
	UV & heatstabilizers	Yes	Yes
	Stiffnesssegmentations	3	2
	Device Materials	The materials ofconstruction areprimarily polymers.	The materials ofconstruction areprimarily polymers.

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The 5.5 F Worley Advanced LVI Lateral Vein 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 5.5 F Worley Advanced LVI Lateral Vein Introducer:

Risk Analysis ●
Requirements/Specification Reviews ●
Design Reviews
Performance Testing (Verification) including but not limited to: ●
- o Dimensional Tests
  - Sheath introducer Curve dimensions ■
  - Sheath introducer outer diameter (O.D.) ■
  - . Sheath introducer inner diameter (I.D.)
  - 트 Sheath introducer free length, overall length
- I o Functional Tests
  - Sheath introducer soft tip joint integrity ■
  - Sheath introducer valve housing separation
  - Sheath introducer tube/valve housing pull force
  - . Sheath introducer radiopaque tube segment joint pull force
  - 트 Sheath introducer tube joint pull force
- Simulated Use Test o
  - Sheath introducer tube slitting with slitter l
  - I Sheath introducer radiopaque tip bend
- Visual Tests o
  - Kit pouch integrity 트
  - 트 Kit package integrity
  - . Sheath Introducer visual appearance
  - 트 Guiding catheter visual appearance
  - l TVI visual appearance
  - Slitter (Cutter) visual appearance
. Sterilization Validation
Biocompatibility Testing .
- o Cytotoxicity

Safety & Performance Tests

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InternationalStandards	No performance standards have been established under section 514of the Food, Drug and Cosmetic Act for this device. Performancetesting of the 5.5 F Worley Advanced LVI Lateral Vein Introducerwas conducted based on the risk analysis and based on therequirements of the following international standards:ISO 11070: 1998(E), 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 for medicaldevices AAMI TIR28:2009, Product adoption and process equivalence forethylene 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 ISO 10993-17: 2002, Biological evaluation of medical devices -Part 17: Methods for the establishment of allowable limits forleachable substances 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
Summary ofSubstantialEquivalence	Based on the indications for use, design, safety and performancetesting, the subject 5.5 F Worley Advanced LVI Lateral VeinIntroducer meets the requirements that are considered essential forits intended use and is substantially equivalent to the predicatedevice, the Coronary Sinus Guide and Lateral Vein Introducer Kits -K120158, manufactured by Merit Medical Systems, Inc

InternationalStandards

No performance standards have been established under section 514of the Food, Drug and Cosmetic Act for this device. Performancetesting of the 5.5 F Worley Advanced LVI Lateral Vein Introducerwas conducted based on the risk analysis and based on therequirements of the following international standards:ISO 11070: 1998(E), 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 for medicaldevices AAMI TIR28:2009, Product adoption and process equivalence forethylene 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 ISO 10993-17: 2002, Biological evaluation of medical devices -Part 17: Methods for the establishment of allowable limits forleachable substances 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

Summary ofSubstantialEquivalence

Based on the indications for use, design, safety and performancetesting, the subject 5.5 F Worley Advanced LVI Lateral VeinIntroducer meets the requirements that are considered essential forits intended use and is substantially equivalent to the predicatedevice, the Coronary Sinus Guide and Lateral Vein Introducer Kits -K120158, 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).