The Edwards eSheath Introducer Set is indicated for the introduction of the Edwards SAPIEN XT Transcatheter Heart Valve and associated devices into the vascular system.

Device Description

The Edwards eSheath Introducer Set consists of a sheath, introducer, and loader. It is provided sterile for single use and is compatible with a standard 0.035" guidewire.

The sheath shaft is comprised of a PTFE inner liner and a HDPE/TecoFlex coextruded outer layer with a folded seam that can temporarily expand if a device is passed through that is larger than the sheath's inner diameter, and a TecoFlex outer cover that encapsulates the seam. The exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a platinum/iridium radiopaque marker for visibility, and the sheath shaft mates proximally with a housing that contains an extension tube used for flushing of the sheath and three valves (seals) to provide hemostasis.

The introducer is made from polyethylene with barium sulfate for radiopacity, and features a hydrophilic coating to facilitate entry and trackability of the vessel. The introducer is tapered with an atraumatic distal tip and a lumen to accommodate a 0.035" guidewire.

The loader may be used to aid in the insertion of devices into the sheath and may be removed so that the entire working length of the inserted device can be utilized. The loader housing contains a valve (seal) to provide hemostasis.

AI/ML Overview

This document is a 510(k) summary for the Edwards eSheath Introducer Set. It outlines the device's description, intended use, comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain the specific details required to answer all the questions regarding acceptance criteria and a detailed study report. The document describes several tests performed, but it lacks specific acceptance criteria values and detailed study methodologies, sample sizes, and ground truth information for each test.

Here's an attempt to extract and format the available information, noting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed to demonstrate performance. However, specific quantitative acceptance criteria and detailed reported performance values for each test are not provided in this 510(k) summary. The summary only states that these tests were "successfully completed" or that "performance testing has demonstrated that safety and efficacy are not adversely impacted."

Acceptance Criteria (e.g., specific quantitative limits or qualitative outcomes)	Reported Device Performance (e.g., measured values, pass/fail status)
Visual Surface Inspection: (Not specified)	Successfully completed.
Dimensional Inspection: (Not specified)	Successfully completed.
Radiopacity/Visualization: (Not specified)	Successfully completed.
Guidewire Compatibility: (Not specified)	Successfully completed.
Hemostasis: (Not specified)	Successfully completed.
Kink Resistance: (Not specified)	Successfully completed.
Seam Return After Expansion: (Not specified)	Successfully completed.
Bond Strength: (Not specified)	Successfully completed.
Loader Peel Test: (Not specified)	Successfully completed.
Device Interaction: (Compatibility with Edwards SAPIEN XT Transcatheter Heart Valve and NovaFlex+ delivery system)	Compatibility testing completed using specified devices.
Hydrophilic Coating Integrity: (Not specified)	Successfully completed.
USP Particulate Test: (Not specified)	Successfully completed.
Sterilization Validation: (Not specified)	Successfully completed.
Biocompatibility Tests: (Cytotoxicity, Hemocompatibility, Systemic Toxicity, Material Mediated Pyrogenicity, Irritation/Intracutaneous Reactivity, Sensitization, Chemical Acceptability, Thrombogenicity)	Successfully completed.
Packaging Integrity: (Not specified)	Successfully completed.
Shelf Life Verification: (Not specified)	Successfully completed.

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

Sample Size for Test Set: The document does not specify the sample sizes used for any of the listed non-clinical tests.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (laboratory/bench) tests for a new device, they are inherently prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the document describes non-clinical, bench testing of a medical device, not a study involving human-in-the-loop performance or expert interpretation of diagnostic data to establish ground truth.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoint assessments, which are not detailed here.

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

An MRMC comparative effectiveness study was not performed or described in this document. The listed tests are non-clinical evaluations of the device's physical and functional properties, not a comparison of human reader performance with or without AI assistance.

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

This section is not applicable. The device is a physical medical introducer set, not an algorithm or AI system. The tests described are for the physical device's performance.

7. Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" would be established by:

Engineering Specifications/Design Requirements: For tests like dimensional inspection, bond strength, kink resistance, etc., the ground truth is defined by pre-established engineering tolerances and performance specifications.
Industry Standards (e.g., ISO, ASTM, USP): For tests like USP Particulate Test, Biocompatibility (following ISO 10993 series), Sterilization Validation, these standards define the methods and acceptance criteria that serve as the ground truth.
Functional Demonstrations: For compatibility and hemostasis, the ground truth is successful operation and absence of leaks/issues under simulated use conditions.

The document does not explicitly state these ground truth sources for each test but implies their use through the nature of the tests.

8. Sample Size for the Training Set

This section is not applicable as the document describes non-clinical testing of a physical medical device, not an AI/algorithm that requires a training set.

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

This section is not applicable for the reasons stated above.

Summary

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Public Health Service

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

September 18, 2014

Edwards Lifesciences % Neil Delaney Regulatory Affairs Project Manager One Edwards Way Irvine, California 92614

Re: K141696

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: June 23, 2014 Received: June 24, 2014

Dear Neil Delaney,

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

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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 (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,

M.A. Hilleman

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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Indications for Use

510(k) Number (if known) K141696

Device Name Edwards eSheath Introducer Set

Indications for Use (Describe)

The Edwards eSheath Introducer Set is indicated for the introduction of the Edwards SAPIEN XT Transcatheter Heart Valve and associated devices into the vascular 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)

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510(K) Summary

Submitter:	Edwards Lifesciences, LLCOne Edwards WayIrvine, CA 92663
Contact:	Neil Delaney Phone: 949-250-2500, Fax: 949-756-4408
Prepared:	June 6, 2014
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:

The Edwards eSheath Introducer Set consists of a sheath, introducer, and loader. It is provided sterile for single use and is compatible with a standard 0.035" guidewire.

Intended Use:

Entry of interventional devices into the vascular system

Indication:

Indicated for the introduction of the Edwards SAPIEN XT Transcatheter Heart Valve and associated devices into the vascular system.

Comparison to Predicate:

The Edwards eSheath Introducer Set is substantially equivalent in function, performance, and design to the RetroFlex 3 Introducer Sheath Set (K093877) and Solopath Balloon Expandable Transfernoral Introducer (K100819). The Edwards eSheath and the Solopath Introducer have an expandable shaft.

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K141696, 510(k) Summary page 2 of 2

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 XT Transcatheter Heart Valve and NovaFlex+ delivery system. The RetroFlex 3 Introducer Sheath Set has the same proximal end (housing, hemostasis control, and flush tube) and introducer as the Edwards eSheath but does not include the expansion feature. Additional differences from the predicates are material changes to the sheath shaft and to the sheath radiopaque marker, and the addition of a perforation feature to the loader shaft so that it can be peeled away and removed.

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
o Guidewire Compatibility
Hemostasis
o Kink Resistance
Seam Return After Expansion
o Bond Strength
o Loader Peel Test
Device Interaction ●
Hydrophilic Coating Integrity ●
USP Particulate Test ●
Sterilization Validation ●
- Biocompatibility Tests:
  - Cytotoxicity ■
    - Hemocompatibility
    - 트 Systemic Toxicity
    - 트 Material Mediated Pyrogenicity
    - Irritation/Intracutaneous Reactivity
    - Sensitization ■
    - 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).