Edwards Lifesciences' EMBOL-X Introducer Sheath is a 17 Fr, sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen housing and a removable, snap-lock obturator. The housing has a flexible suture flange for attachment to the vessel and orientation markings on the shaft and suture flange to assist in the placement of the EMBOL-X Introducer Sheath. Inside the housing is an internal valve to prevent backbleeding. The housing also has suture loops on the proximal end of the Introducer housing, and vent grooves, vent holes, and a central lumen in the obturator that leads to the vent plug to assist in venting air from the Introducer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the EMBOL-X Introducer Sheath, based on the provided text:

Edwards Lifesciences LLC Special 510(k) Premarket Notification EMBOL-X Introducer Sheath (K140398)

1. Acceptance Criteria and Reported Device Performance

The document states that the functional and accelerated aging bench testing was performed to support a specification change and a shelf life increase. It also emphasizes that all data met acceptance criteria, demonstrating that the device is as safe and effective as the predicate device. However, the exact quantitative acceptance criteria for each test (e.g., maximum allowable leak rate, minimum tensile strength) are not explicitly stated in the provided text. The tables below summarize the tests performed and the general reported outcome.

Acceptance Criterion (Type of Test)	Reported Device Performance
Leak Testing	Met acceptance criteria (no specific values provided)
Leak without device inserted	Met acceptance criteria
Leak with obturator inserted	Met acceptance criteria
Leak with filter inserted	Met acceptance criteria
Tensile Testing	Met acceptance criteria (no specific values provided)
Introducer bond joints	Met acceptance criteria
Obturator vent plug bond joint	Met acceptance criteria
Additional Obturator Testing	Met acceptance criteria (no specific values provided)
Vent time	Met acceptance criteria
Latch compression force	Met acceptance criteria
Insertion force	Met acceptance criteria
Removal and retention force	Met acceptance criteria
Filter Compatibility Testing	Met acceptance criteria (no specific values provided)
Insertion force	Met acceptance criteria
Deployment capability	Met acceptance criteria
Deployment force	Met acceptance criteria
Retraction force	Met acceptance criteria
Removal and retention force	Met acceptance criteria
Additional Introducer Testing	Met acceptance criteria (no specific values provided)
Suture flange flex	Met acceptance criteria
Design Validation	Validation complete through surgeon evaluation and benchtop study

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

The document does not specify the exact sample sizes used for each of the functional/safety tests. It only states that "All data met acceptance criteria." The provenance of the data is not explicitly mentioned (e.g., country of origin). Since these are bench tests and surgeon evaluations, the data would be considered prospective as it's generated specifically for this submission.

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

For "Design Validation," the document mentions "surgeon evaluation."

Number of experts: Not specified (simply "surgeon evaluation" implies at least one, but the exact number is not given).
Qualifications of experts: Explicit qualifications are not provided, other than being "surgeons."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth, particularly for the surgeon evaluation mentioned under design validation. The bench testing would likely rely on direct measurement against predefined specifications, rather than expert adjudication.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. The submission relies on bench testing and a general "surgeon evaluation" for design validation, not a comparative study of human readers with vs. without AI assistance. This device is an introducer sheath, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This question is not applicable. The EMBOL-X Introducer Sheath is a physical medical device, not an algorithm or AI system. Therefore, there is no "standalone" algorithm-only performance to assess.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" would be the predefined engineering specifications and performance targets for each test (e.g., a specific leak rate, tensile strength, or force range). For the "Design Validation," the ground truth was established through surgeon evaluation (user feedback/opinion on device design and functionality) and the results of a benchtop study.

8. Sample Size for the Training Set

This question is not applicable. As the EMBOL-X Introducer Sheath is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" in this context.

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

This question is not applicable for the same reasons as #8.

Summary

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Edwards Lifesciences LLC Special 510(k) Premarket Notification EMBOL-X Introducer Sheath

K140398, 510(k) Summary page 1 of 2

510(k) Summary
Submitter:	Edwards Lifesciences LLC	MAR 1 9 2014
Contact Person:	Luke Meidell, Regulatory Affairs Associate III12050 Lone Peak PkwyDraper, UT 84020(801) 565-6212
Date Prepared:	February 17, 2014
Trade Name:	EMBOL-X Introducer Sheath
Classification Name:	Catheter Introducer21 CFR Part 870.1340, Product Code DYB, Class II
Predicate Device:	K123714, EMBOL-X Introducer Sheath

Device Description:

The housing has a flexible suture flange for attachment to the vessel and orientation markings on the shaft and suture flange to assist in the placement of the EMBOL-X Introducer Sheath. Inside the housing is an internal valve to prevent backbleeding.

The housing also has suture loops on the proximal end of the Introducer housing, and vent grooves, vent holes, and a central lumen in the obturator that leads to the vent plug to assist in venting air from the Introducer.

The EMBOL-X Introducer Sheath is intended for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.

Indications For Use:

The Indications for Use for the EMBOL-X Introducer Sheath is as follows:

The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.

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Comparative Analysis:

The subject device has the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate device. The subject EMBOL-X Introducer Sheath is comparable to the predicate device in fundamental scientific technology, materials, principles of operation, and functional performance evaluations. No new issues of safety or effectiveness have been raised as a result of the specification change or shelf life increase.

Functional/Safety Testing:

The following functional and accelerated aging bench testing was performed to support the specification change and the shelf life increase. All data met acceptance criteria, demonstrating that the device is as safe and effective as the predicate device.

. Leak Testing - Leak without device inserted, leak with obturator inserted, leak with filter inserted.
Tensile Testing Introducer bond joints, obturator vent plug bond joint. .
. Additional Obturator Testing - Vent time, latch compression force, insertion force, removal and retention force.
. Filter Compatibility Testing - Insertion force, deployment capability, deployment force, retraction force, removal and retention force.
Additional Introducer Testing Suture flange flex .
. Design Validation - Design was validated through surgeon evaluation and a bench top study .

Conclusion:

Based on the Indications for Use, comparative analysis, and functional/safety testing results, the EMBOL-X Introducer Sheath is substantially equivalent to the predicate device and demonstrates no new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Public Health Service

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

March 19, 2014

Edwards Lifesciences c/o Luke Meidell Regulatory Affairs Associate III 12050 Lone Peak Pkwy Draper, Utah 84020

K140398 Re:

Trade/Device Name: Embol-X Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 17, 2014 Received: February 18, 2014

Dear Mr. Meidell.

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

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Page 2 - Luke Meidell

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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,

MA.S.L.Lieman

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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K140398, Indications for Use Page 1 of 1

Statement of Indications for Use

Indications for Use

510(k) Number (if known): K140398

Device Name: EMBOL-X Introducer Sheath

The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters

Prescription Use X (Per 21 CFR 801.109)

OR Over-The-Counter Use_

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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

M. L. Lieberman

Page B-2

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).