The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

Device Description

The Edwards eSheath Optima introducer set consists of a sheath, vessel dilator, introducer, and insheath dilator. The Edwards Optima introducer set is available with inner sheath diameter of 14 French (model 14000ES14). The Edwards eSheath Optima introducer set is used to facilitate introduction of the Edwards transcatheter heart valve systems into the vasculature.

The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer iacket expands by stretching radially. temporarily expanding the shaft diameter. 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 to provide hemostasis, and an extension tube with stopcock for flushing.

The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.

The loader (included in the Edwards delivery system) 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

The provided document is an FDA 510(k) clearance letter and summary for the Edwards eSheath Optima introducer set. It demonstrates substantial equivalence to a predicate device based on non-clinical testing. However, it does not contain a detailed study meeting the specific criteria you've outlined, particularly for AI/algorithm performance. The information provided relates to the physical and functional performance of a medical device, not an AI or software component.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: While the document mentions various bench tests were "successfully completed" and "all design requirements were met," it does not provide specific quantitative acceptance criteria or detailed numerical results for each test.
2. Sample sized used for the test set and the data provenance: Not applicable, as this is non-clinical bench testing of a physical device, not an AI or software study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 device does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI/software performance. For a physical device, the "ground truth" would be the engineering specifications and established test methods.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

The document describes the Edwards eSheath Optima introducer set, a physical medical device.

Device Description:
The introducer set comprises a sheath, vessel dilator, introducer, and in-sheath dilator. It's designed to facilitate the introduction and removal of compatible devices used with Edwards transcatheter heart valves. Key features include an expandable inner member and outer jacket, a radiopaque marker, a hydrophilic coating, hemostatic seals, and an optional in-sheath dilator.

Non-Clinical Testing:
A list of bench tests was performed to demonstrate substantial equivalence to the predicate device and that all design requirements were met. These tests cover various physical and functional aspects of the device, including:

Recovered Outer Diameter (OD)
In-Sheath Dilator (ISD) Max Distal OD
Tip OD
ISD Insertion & Retrieval
Tip Inner Diameter (ID)
Sheath Insertion & Retrieval
Sheath Working Length
ISD Working Length
Hemostasis
Kink Radius
Fishmouth
Lubricity and Durability
Bond Tensile Strengths (Sheath Housing to Shaft, Sheath Shaft to Tip, Flush Tube to Housing, Stopcock to Flush Tub, ISD Hub to Shaft)
Transcatheter Heart Valve (THV)/Sheath Interaction
Device Interaction
Guidewire Compatibility
Delivery System Insertion & Retrieval
Crimped THV Retrieval
Radiopacity
Particulate Testing
Sterilization Validation
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity)

The document states that these tests were "successfully completed" and that "all design requirements were met," leading to the conclusion that the device is substantially equivalent to the predicate. However, it does not provide specific acceptance criteria values or the quantitative results from these tests.

Summary

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March 27, 2025

Edwards Lifesciences Andrea Gasca Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K244046

Trade/Device Name: Edwards eSheath Optima introducer set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 20, 2024 Received: December 30, 2024

Dear Andrea Gasca:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Image /page/2/Figure/2 description: The image shows a signature block. The signature is from FINN E. DONALDSON. The signature was digitally signed on March 27, 2025 at 09:17:47 -04'00'.

Finn Donaldson Acting Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K244046

Device Name Edwards eSheath Optima introducer set

Indications for Use (Describe)

The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

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)

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510(k) Summary

Submitter:	Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614(949) 250-2500
Contact:	Andrea Gasca Phone: (949) 250-2500
Prepared:	December 30, 2024
Trade Name:	Edwards eSheath Optima Introducer Set
Common Name:	Catheter, Introducer
Classification:	Catheter, Introducer21 CFR 870.1340, Product Code DYB
Predicate Device:	Edwards eSheath Introducer Set (K200258)

Device Description:

Intended Use:

Entry of interventional devices into the vascular system.

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Indications for Use:

The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

Comparison to Predicate:

The Edwards eSheath Optima introducer set (model 14000ES14) is substantially equivalent to the previously cleared predicate device because the devices have intended use and the same or similar technological characteristics. The Edwards eSheath Optima introducer set has modified shaft dimensions, an elastomeric outer jacket for seamless expansion, a locking mechanism for the introducer, and an optional in-sheath dilator. The provided bench testing demonstrates that after the technological changes from the predicate devices remain substantially equivalent.

Summary of Non-Clinical Testing:

Non-clinical testing was completed to demonstrate that the performance characteristics of the Edwards eSheath Optima introducer set are equivalent to the predicate and all design requirements were met. The following bench testing was successfully completed:

. Recovered Outer Diameter (OD)
In-Sheath Dilator (ISD) Max Distal OD ●
Tip OD ●
ISD Insertion ●
ISD Retrieval ●
Tip Inner Diameter (ID)
Sheath Insertion ●
Sheath Retrieval ●
Sheath Working Length ●
ISD Working Length ●
Hemostasis
Kink Radius ●
Fishmouth ●
Lubricity and Durability ●
Sheath Housing to Shaft Bond Tensile ● Strenath
Sheath Shaft to Tip Tensile Strength ●
Flush Tube to Housing Bond Tensile ● Strength
. Stopcock to Flush Tub Bond Tensile Strength
. ISD Hub to Shaft Tensile Strength
Transcatheter Heart Valve ● (THV)/Sheath Interaction
Device Interaction ●
Guidewire Compatibility ●
Delivery System Insertion ●
Delivery System Retrieval ●
Crimped THV Retrieval ●
Radiopacity ●
Particulate Testing ●
Sterilization Validation ●
Biocompatibility ●
- Cytotoxicity o
- Sensitization o
- Irritation o
- Material Mediated Pyrogenicity O
- Acute Systemic Toxicity O
- Hemocompatibility o
Thrombogenicity .

Conclusion:

Based upon device testing and descriptive characteristics, the Edwards eSheath Optima infroducer set is substantially equivalent to the predicate device has the same intended use as the predicate device.

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).