(87 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of the introducer set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an introducer set used to facilitate the introduction and removal of compatible devices, such as transcatheter heart valves, into the vasculature. Its primary function is to provide access, not to treat a disease or condition itself.
No
The device is an introducer set used to facilitate the introduction and removal of other medical devices, particularly transcatheter heart valves, into the vasculature. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (sheath, dilator, introducer, etc.) and describes their material composition and mechanical properties. There is no mention of software as a component or function of the device.
Based on the provided information, the Edwards eSheath Optima introducer set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the introduction and removal of compatible devices used with transcatheter heart valves. This is a procedural device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical device (sheath, dilators, introducer) designed to be inserted into the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is used to access and manipulate structures within the body during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Strength, 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, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Edwards eSheath Introducer Set (K200258)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a stylized image. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
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.
1
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
2
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
3
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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4
510(k) Summary
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, 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, Introducer
21 CFR 870.1340, Product Code DYB |
| Predicate Device: | Edwards eSheath Introducer Set (K200258) |
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.
Intended Use:
Entry of interventional devices into the vascular system.
5
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.