Edwards Lifesciences' EMBOL-X Introducer Sheath is a sterile, non-pyrogenic, singleuse 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 device also has additional suture loops on the proximal end of the Introducer housing and a design that allows air to vent from the Introducer during insertion.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the lack of information for a device like an introducer sheath:

Important Note: The provided document describes a medical device (introducer sheath), not an AI or software-based diagnostic tool. Therefore, many of the requested categories like "multi-reader multi-case study," "standalone algorithm performance," "sample size for training set," and "ground truth for training set" are not applicable or not present in this type of submission. Medical devices like this are typically evaluated based on engineering performance, biocompatibility, and manufacturing quality to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Performed	Reported Performance
Biocompatibility	Cytotoxicity	Met acceptance criteria.
	Haemocompatibility	Met acceptance criteria.
	Irritation/Intracutaneous Toxicity	Met acceptance criteria.
	Sensitization	Met acceptance criteria.
	Systemic Toxicity	Met acceptance criteria.
	Pyrogenicity	Met acceptance criteria.
	Genotoxicity	Met acceptance criteria.
	Thrombogenicity	Met acceptance criteria.
Sterility	Sterility Testing	Met acceptance criteria.
Performance Testing / Shelf Life	Tensile	Met acceptance criteria.
	Leak	Met acceptance criteria.
	Vent	Met acceptance criteria.
	Latch Compression	Met acceptance criteria.
	Flange Flex	Met acceptance criteria.
	Insertion, Removal, and Retention Force	Met acceptance criteria.
Functional/Compatibility	Functional/Compatibility testing with associated devices	Met acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample sizes used for each functional and safety test (e.g., how many sheaths were tested for tensile strength or leak). It only states that "All data met acceptance criteria."
Data Provenance: Not specified. This type of submission for a physical medical device typically does not detail data provenance in the same way an AI/software device would. The tests are likely conducted in a controlled lab environment.
Retrospective/Prospective: Not applicable in the context of this device's testing. These are laboratory-based engineering and biological tests, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: For a physical medical device like an introducer sheath, "ground truth" as it relates to expert consensus on diagnostic images or clinical outcomes is not relevant. The "ground truth" comes from objective measurements against engineering specifications and validated biological testing methodologies. The document does not mention the use of external experts for establishing this kind of ground truth. Internal quality control and R&D personnel are typically responsible for these measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies or image interpretation. These are not relevant for the functional and safety testing of a physical medical device.

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 device is a physical medical instrument (introducer sheath), not an AI or software-based diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

Not Applicable: This device is a physical medical instrument, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Technical Specifications / Biocompatibility Standards: The "ground truth" for this device comes from established engineering specifications (e.g., tensile strength, leak rate limits) and widely accepted biocompatibility standards (e.g., ISO 10993 series). The device is tested against these predefined, objective criteria.

8. The sample size for the training set

Not Applicable: This device is a physical medical instrument and does not involve AI or machine learning, which would require a training set.

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

Not Applicable: This device is a physical medical instrument and does not involve AI or machine learning training data.

Summary

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510(k) Summary

Submitter:	Edwards Lifesciences LLC
SubmitterContact:	Luke Meidell, Regulatory Affairs Associate II12050 Lone Peak PkwyDraper, UT 84020Ph - (801) 565-6212Fax - (801) 565-6108	JUL 2 4 2013
Date Prepared:	July 19, 2013
Trade Name:	Edwards EMBOL-X™ Introducer Sheath
Classification Name:	Introducer, Catheter, Cardiovascular Devices Panel;21 CFR §870.1340 Product Code DYB, Class II
Predicate Device:	K002973, EMBOL-X Introducer

Device Description:

The device also has additional suture loops on the proximal end of the Introducer housing and a design that allows air to vent from the Introducer during insertion.

Intended Use:

Intended as a device access port to the vasculature during cardiovascular surgery.

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Indications for Use:

The Indications for Use statement was revised from the predicate device (which allowed introduction of intravascular devices) to only allow introduction of EMBOL-X Intra-Aortic Filters. This revised Indication still falls within the old indication, although it limits the device to use with one intravascular device-the EMBOL-X Intra-Aortic Filter.

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

Comparative Analysis:

The subject device has the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate device. It has been demonstrated that the subject EMBOL-X Introducer Sheath is comparable to the predicate device in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised.

Functional/Safety Testing:

The functional data indicate that the EMBOL-X Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device. The following functional tests were performed:

Biocompatibility .
- Cytotoxicity o
- Haemocompatibility o
- Irritation/Intracutaneous Toxicity o
- Sensitization o
- Systemic Toxicity o
- Pyrogenicity o
- Genotoxicity o
- Thrombogenicity o
. Sterility
Performance Testing / Shelf Life .
- Tensile 0
- Leak 0

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Vent 0
Latch Compression o
Flange Flex O
Insertion, Removal, and Retention Force o
Functional/Compatibility testing with associated devices ਼

All data met acceptance criteria.

Conclusion:

The Edwards EMBOL-X Introducer Sheath testing confirms that the subject EMBOL-X Introducer Sheath is substantially equivalent to the predicate EMBOL-X Introducer.

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Public Health Service

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

July 24, 2013

Edwards Lifesciences LLC C/O Luke Meidell, Regulatory Affairs Associate II 12050 Lone Peak Pkwy Draper, UT 84020

Re: K123714

Trade/Device Name: Edwards EMBOL-X™M Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer. Catheter Regulatory Class: Class II Product Code: DYB Dated: July 12, 2013 Received: July 15, 2013

Dear Mr. Luke 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. Iisting 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 device-related 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,

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

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Page 2 - Mr. Luke Meidell

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

M.A. Zillemann

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 Statement 510(k) Number (if known): K123714 Device Name: EMBOL-X Introducer Sheath Indications for Use: The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters. Prescription Use OR Over-The-Counter Use X (Per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

M. A. Hillman

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).