The Edwards eSheath Introducer Set consists of a sheath and two dilators packaged together, and one loader packaged with the Commander delivery system. The Edwards eSheath Introducer Set is available in two sizes: model 914ES (14F inner diameter) and model 916ES (16F inner diameter). The 14F eSheath introducer set is used to facilitate introduction of the 20mm, 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16F eSheath 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. The sheath shaft exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a radiopaque marker, and the shaft mates proximally with a housing that contains three valves (seals) to provide hemostasis, an extension tube for flushing, and suture holes on the exterior.

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

The loader features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

AI/ML Overview

This document describes the Edwards eSheath Introducer Set, a medical device used for introducing and removing other devices in the vascular system, specifically with the Edwards SAPIEN 3 Transcatheter Heart Valve. The document is a 510(k) premarket notification summary submitted to the FDA, asserting substantial equivalence to a previously cleared device. Due to the nature of the device (a catheter introducer) and the provided document, the "acceptance criteria" and "study" are related to mechanical and material performance, not an AI/ML-based diagnostic or prognostic study. Therefore, many of the requested fields are not applicable in this context.

Here's the information extracted and interpreted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Characteristic	Reported Device Performance
Functional / Mechanical Performance:
Loader Peel Test	Successfully completed (demonstrated satisfactory performance)
Bond Strength Test	Successfully completed (demonstrated satisfactory performance)
Biocompatibility:
Cytotoxicity	Successfully completed (demonstrated satisfactory performance)
Sensitization	Successfully completed (demonstrated satisfactory performance)
Irritation/Intracutaneous Toxicity	Successfully completed (demonstrated satisfactory performance)
Systemic Toxicity	Successfully completed (demonstrated satisfactory performance)
Hemocompatibility	Successfully completed (demonstrated satisfactory performance)
Material Verification	Successfully completed (demonstrated satisfactory performance)
USP Physico-Chemical Test for Plastic Closures	Successfully completed (demonstrated satisfactory performance)
Other Performance:
Sterilization Validation	Successfully completed (demonstrated satisfactory performance)
Packaging Integrity	Successfully completed (demonstrated satisfactory performance)
Shelf Life Verification	Successfully completed (demonstrated satisfactory performance)
Overall Equivalence	Based on device testing and descriptive characteristics, the device is substantially equivalent to the predicate device and has demonstrated to not adversely impact safety and efficacy.

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

Sample Size: Not specified in terms of number of units tested for each test. The document states "Non-clinical testing was completed" and "design verification and validation testing was successfully completed."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would generally be conducted in a laboratory setting by the manufacturer.

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 catheter introducer, not a diagnostic or AI/ML device requiring expert ground truth for classification. The "ground truth" here is the physical and biological performance adhering to established standards.

4. Adjudication method for the test set

Not applicable for this type of device and testing. Performance standards are objective measurements, not subjective evaluations requiring adjudication.

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 is not an AI/ML device, and no human reader study was conducted or is relevant.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's testing is adherence to established engineering, material science, and biocompatibility standards and specifications. This includes:
- Objective measurements: Force, strength, dimensional accuracy, flow rates, etc., for functional tests like "Loader Peel Test" and "Bond Strength Test."
- Standardized biological assays: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility).
- Validated protocols: For sterilization, packaging integrity, and shelf-life verification.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for the device's design would be through iterative engineering development and testing.

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

Not applicable. For a physical device, the "ground truth" for design and manufacturing is established through engineering specifications, material properties, and adherence to relevant industry and regulatory standards.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, 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 2, 2016

Edwards Lifesciences LLC Yi Gao Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K162184

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: August 3, 2016 Received: August 4, 2016

Dear Yi Gao:

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 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" (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,

Brian D. Pullin -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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Indications for Use

510(k) Number (if known) K162184

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)

Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K162184 510(K) Summary

Submitter:	Edwards Lifesciences, LLCOne Edwards WayIrvine, CA 92663
Contact:	Yi GaoPhone: 949-250-2500Fax: 949-756-4408
Prepared:	August 30, 2016
Trade Name:	Edwards eSheath Introducer Set
Common Name:	Catheter, Introducer
Classification:	Catheter Introducer21 CFR 870.1340, Product Code DYB
Predicate Device:	Edwards eSheath Introducer Set (K152225)

Device Description:

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Intended Use:

Entry of interventional devices into the vascular system

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:

A table comparing the proposed device to the predicate devices is provided below.

	Predicate Device	Subject Device
	Edwards eSheath Introducer Set	Edwards eSheath Introducer Set(with Loader)
Manufacturer	Edwards Lifesciences	Identical
510(k)	K152225	K162184
Device Classification	Class II, DYB(21 CFR 870.1340)Catheter Introducer	Identical
Intended Use	Entry of interventional devices into thevascular system	Identical
Indication for Use	The Edwards eSheath Introducer Set isindicated for the introduction and removalof devices used with the EdwardsSAPIEN 3 Transcatheter Heart Valve.	Identical
Target Population	Patients requiring vascular interventionwith the SAPIEN 3 Transcatheter HeartValve	Identical
Anatomical Sites	Human vasculature	Identical
Model Numbers	914ES, 916ES	Identical
Sizes available (French)	14F, 16F inner diameter	Identical
Package Contents	1- Sheath2- Introducer (dilator)	1 - Sheath2 - Dilators1 - Loader (packaged with theCommander delivery system)
Working Length	36.5 cm	Identical
Guidewire Compatibility	0.035" guidewire	Identical
Radiopaque elements	Sheath, Dilators	Identical
SheathHemostasis Control	3 hemostasis seals	Identical
Expansion Mechanism	Expandable seam	Identical
Hydrophilic coating	Sheath, Dilators	Identical
Sterilization Method /Re-use	Ethylene OxideSingle use only	Identical
Sterility AssuranceLevel	10-6 or better	Identical

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

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requirements are satisfied. Specifically, the following design verification and validation testing was successfully completed:

Loader Peel Test ●
Bond Strength Test
Biocompatibility Tests: ●
- Cytotoxicity ၊
- Sensitization ।
- -Irritation/Intracutaneous Toxicity
- Systemic Toxicity -
- Hemocompatibility -
- Material Verification -
- -USP Physico-Chemical Test for Plastic Closures

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.

. Sterilization Validation
Packaging Integrity
Shelf Life Verification .

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).