The Edwards eSheath Introducer Set consists of a sheath and 2 introducers. It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES). The 14 French introducer set is used to facilitate introduction of the 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16 French introducer set is used to facilitate introduction of the 29mm SAPIEN 3 THV and Commander Delivery System into the vasculature.

The sheath shaft is comprised of 2 layers of material (HDPE/TecoFlex coextruded outer layer and PTFE liner). The outer and inner layer are folded, creating a seam which allows the distal region of the sheath to temporarily expand in diameter when a device is inserted. A tapered strain relief at the proximal end of the sheath shaft helps provide hemostasis when the sheath is inserted.

A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals (valves) to provide hemostasis: a duckbill seal, a disc seal, and a cross slit seal. The housing also includes flushport tubing and a stopcock to allow for flushing of the sheath.

Two introducers are provided to aid in the introduction of the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The introducers are radiopaque and feature a tapered tip and guidewire lumen.

AI/ML Overview

Here's an analysis of the provided text regarding the Edwards eSheath Introducer Set, focusing on acceptance criteria and the study that proves the device meets them. Please note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive "study" in the academic sense of proving efficacy through clinical trials. Therefore, some of the requested information may not be present as it pertains more to clinical studies of diagnostic AI devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics for the Edwards eSheath Introducer Set. Instead, it lists the types of non-clinical tests performed to demonstrate that "performance characteristics... are equivalent to the predicates, and to verify that design requirements are satisfied." The stated outcome for all tests is "successfully completed."

Acceptance Criteria Category (Implicit)	Specific Test Performed	Reported Device Performance
Physical Integrity / Visual Quality	Visual Surface Inspection	Successfully completed (meets design requirements)
Dimensional Accuracy	Dimensional Inspection	Successfully completed (meets design requirements)
Imaging Visibility	Radiopacity/Visualization	Successfully completed (meets design requirements)
Functional Compatibility	Guidewire Compatibility	Successfully completed (meets design requirements)
Hemostasis Control	Hemostasis	Successfully completed (meets design requirements)
Ease of Use / Durability	Lubricity and Durability of the Sheath	Successfully completed (meets design requirements)
Structural Resilience	Kink Resistance	Successfully completed (meets design requirements)
Expandability / Return Capability	Seam Return After Expansion	Successfully completed (meets design requirements)
Component Strength	Bond Strength	Successfully completed (meets design requirements)
Interoperability	Device Interaction	Successfully completed (meets design requirements)
Surface Properties	Hydrophilic Coating Characterization	Successfully completed (meets design requirements)
Cleanliness	USP Particulate Test	Successfully completed (meets design requirements)
Sterility Assurance	Sterilization Validation	Successfully completed (meets design requirements)
Biocompatibility	Cytotoxicity	Successfully completed (meets design requirements)
	Hemocompatibility	Successfully completed (meets design requirements)
	Systemic Toxicity	Successfully completed (meets design requirements)
	Material Mediated Pyrogenicity	Successfully completed (meets design requirements)
	Irritation/Intracutaneous Reactivity	Successfully completed (meets design requirements)
	Sensitization	Successfully completed (meets design requirements)
	Chemical Acceptability	Successfully completed (meets design requirements)
Blood Compatibility	Thrombogenicity	Successfully completed (meets design requirements)
Product Protection	Packaging Integrity	Successfully completed (meets design requirements)
Product Lifespan	Shelf Life Verification	Successfully completed (meets design requirements)

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

This document describes non-clinical (bench) testing, not a clinical study involving patient data. Therefore, the concept of a "test set" in the context of human data or AI algorithms is not applicable here. The data provenance is internal to Edwards Lifesciences, derived from various laboratory and engineering tests; it is not data from human subjects or from a specific country of origin in that sense. These were likely prospective tests performed on manufactured samples of the device.

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

Not applicable. Ground truth for non-clinical engineering tests (e.g., bond strength, dimensional accuracy, sterilization) is established through standardized methodologies, engineering specifications, and validated measurement equipment, not through expert human interpretation in the way a diagnostic imaging study would use radiologists.

4. Adjudication Method for the Test Set

Not applicable. Since the tests are objective, performance is measured against established specifications or standards. There is no human interpretation or adjudication required in the sense of resolving conflicting expert opinions.

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 device is a physical medical introducer set, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical introducer set, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

Engineering Specifications: Predetermined design requirements and tolerances.
International/National Standards: Adherence to standards like USP for particulates, ISO standards for sterilization, and specific test methods for biocompatibility (e.g., ISO 10993 series).
Predicate Device Performance: The primary goal is to demonstrate equivalence in performance characteristics to the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set. The "training" for such a device would be its design and manufacturing process, which is refined through iterative engineering development and testing.

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

Not applicable. As this is not an AI/ML device, the concept of a "training set" and associated ground truth establishment does not apply. The analogous process for a physical medical device involves:

Defining design inputs and requirements based on intended use, user needs, and regulatory standards.
Developing and manufacturing prototypes.
Conducting iterative non-clinical testing (similar to the "Summary of Non-Clinical Testing" listed) to ensure the device meets those requirements.
Refining the design based on test results.

Summary Takeaway:

The document is a 510(k) summary for a physical medical device (catheter introducer set). Its purpose is to demonstrate substantial equivalence to existing predicate devices through comprehensive non-clinical (bench) testing. The questions regarding AI acceptance criteria, training/test sets, expert ground truth, adjudication, and MRMC studies are not applicable to the nature of this particular device and its regulatory submission pathway. The acceptance criteria are implicitly met by "successfully completing" the listed non-clinical tests, which are designed to show that the device performs equivalently to its predicates and meets all relevant design requirements and safety standards.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three figures in profile, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The seal is black and white.

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

November 24, 2015

Edwards Lifesciences Karen Reynolds Regulatory Affairs Associate III 1 Edwards Way Irvine, California 92614-5686

Re: K152225

Trade/Device Name: Edwards eSheath Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 26, 2015 Received: October 27, 2015

Dear Karen Reynolds:

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 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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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" (21CFR 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.

M.R. Hilleman

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) K152225

Device Name Edwards eSheath Introducer Set

Indications for Use (Describe)

The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.

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)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) Summary

Submitter:	Edwards Lifesciences, LLCOne Edwards WayIrvine, CA 92663
Contact:	Karen Reynolds Phone: 949-250-2500, Fax: 949-756-4408
Prepared:	August 5, 2015
Trade Name:	Edwards eSheath Introducer Set
Common Name:	Catheter, Introducer
Classification:	Catheter Introducer21 CFR 870.1340, Product Code DYB
PredicateDevices:	RetroFlex 3 Introducer Sheath Set (K093877)Solopath Balloon Expandable Transfemoral Introducer (K100819)

Device Description:

Intended Use:

Entry of interventional devices into the vascular system

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Indication:

The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.

Comparison to Predicate:

The Edwards eSheath Introducer Set (models 914ES) is substantially equivalent in function, performance, and design to the RetroFlex 3 Introducer Sheath Set (K093877), Solopath Balloon Expandable Transfemoral Introducer (K100819), and Cook Medical Check-Flo Performer Extra Large Introducer (K142829). The Edwards eSheath and the Solopath Introducer have an expandable shaft. The Edwards eSheath is expanded in the vasculature by the device that is passed through the inner diameter and the Solopath Introducer is expanded in the vasculature via inflation. The eSheath device compatibility testing was completed using the Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system (commercially available per PMA P140031). The RetroFlex 3 Introducer Sheath Set (K093877) has the same proximal end (housing, hemostasis control, and flush tube) and introducer as the Edwards eSheath but does not include the expansion feature.

Summary of Non-Clinical Testing:

Non-clinical testing was completed to demonstrate that the performance characteristics of the Edwards eSheath Introducer Set are equivalent to the predicates, and to verify that design requirements are satisfied. Specifically, the following design verification and validation testing was successfully completed:

. Visual Surface Inspection
Dimensional Inspection .
. Radiopacity/Visualization
Guidewire Compatibility
. Hemostasis
. Lubricity and Durability of the Sheath
Kink Resistance ●
Seam Return After Expansion
Bond Strength ●
. Device Interaction
Hydrophilic Coating Characterization .
. USP Particulate Test
. Sterilization Validation
Biocompatibility Tests: .
- . Cytotoxicity
- Hemocompatibility ■
- I Systemic Toxicity
- I Material Mediated Pyrogenicity
- I Irritation/Intracutaneous Reactivity
- Sensitization I
- 트 Chemical Acceptability
Thrombogenicity
Packaging Integrity
Shelf Life Verification ●

Conclusion:

Based upon device testing and descriptive characteristics, the Edwards eSheath Introducer Set is substantially equivalent to the predicate device and performance testing has demonstrated that safety and efficacy are not adversely impacted.

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).