The subject device is comprised of an introducer and introducer sheath. The introducer has a tapered soft/flexible tip and is inserted into the introducer sheath, then inserted into the vessel over a guidewire as an assembly. At the proximal end of the sheath the body tubing is connected to a head assembly. The head assembly consists of a housing that contains three hemostasis valves to minimize blood loss. A side port extension with a three-way stopcock allows for the introduction of anticoagulant, as needed. Once the Introducer/Sheath Assembly has been placed within the vessel, the introducer is removed and the sheath is left in place. The sheath provides and maintains a pathway for the introduction of interventional devices.

AI/ML Overview

The provided document is a 510(k) summary for the Edwards Introducer Sheath, detailing its comparison to predicate devices and results of non-clinical testing. It explicitly states that "All testing demonstrated that the subject device met its acceptance criteria." However, it does not provide a table of specific acceptance criteria values or the reported device performance values for each criterion. It also does not include information about clinical studies in the context of device performance metrics against acceptance criteria.

Therefore, much of the requested information cannot be extracted from this document alone.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Bond Tensile Strength	Met acceptance criteria
Free Passage of a Guidewire	Met acceptance criteria
Kink Resistance (Introducer)	Met acceptance criteria
Kink Resistance (Sheath)	Met acceptance criteria
Flow Rate	Met acceptance criteria

Note: The document states, "All testing demonstrated that the subject device met its acceptance criteria." However, it does not provide the specific numerical values for the acceptance criteria (e.g., minimum tensile strength in Newtons) nor the measured performance values of the device for each test. It only confirms that the device passed these tests.

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

Sample Size: Not specified for the non-clinical tests.
Data Provenance: The tests conducted were "In vitro performance testing." No country of origin is mentioned for the testing data itself, but the submitter is based in Irvine, CA, USA. The document refers to the system being "CE marked and commercially available in the European Union" for clinical usage, but this is not tied to the "test set" for performance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the described tests are non-clinical, in vitro performance tests (e.g., bond tensile strength, kink resistance), not clinical studies involving "ground truth" established by experts.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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

This information is not applicable. The device is an Introducer Sheath, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI-assisted human reader improvement are not relevant.

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

This information is not applicable as the device is a physical medical device, not an algorithm.

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

This information is not applicable. The "ground truth" for the non-clinical performance tests is based on engineering specifications and physical measurements, rather than clinical 'ground truth' types.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning model.

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

This information is not applicable for the same reason as point 8.

Summary

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510(k) Summary

A. Submitter Information

Daun Putnam, Regulatory Specialist Edwards Lifesciences One Edwards Way Irvine, CA 92614-5686 Phone Number: (949) 250-2217 Fax Number: (949) 250-3579 Email address: daun putnam(@edwards.com

B. Device Information

1. Trade Name:
  Edwards Introducer Sheath
1. Common or Usual Name:
  Catheter Introducer
1. Device Classification and Classification Name:
  Class II (DYB, 21 CFR 870.1340 Catheter introducer)
Predicate Device Identification: 4. Cook® Extra Large Check-Flo® Introducer (K902469) Guidant Ancure® Sheath (K003889)
1. Device Description:

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to minimize blood loss. A side port extension with a three-way stopcock allows for the introduction of anticoagulant, as needed. Once the Introducer/Sheath Assembly has been placed within the vessel, the introducer is removed and the sheath is left in place. The sheath provides and maintains a pathway for the introduction of interventional devices.

1. Intended Use:
  The subject device is designed to facilitate the entry of interventional devices into the human vascular system.
1. Technological Comparison of Subject Device to Predicate Device:
  The physical characteristics, the intended use and the mode of use of the subject device are similar to the predicate devices.
1. Summary of Non-Clinical Tests and Conclusions:
  In vitro performance testing and biocompatibility evaluations were conducted on the subject device as part of an endovascular graft delivery system. Tests specific to the subject device include bond tensile strength. free passage of a guidewire, kink resistance of both the introducer and the sheath, and the flow rate. All testing demonstrated that the subject device met its acceptance criteria.
1. Summary of Clinical Tests and Conclusions:
  The subject device is used as part of a system for the deployment of endovascular grafts. The systems are CE marked and commercially available in the European Union. To date, subject devices have been used successfully with few complaints reported.

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K031087

April 2003 Page 32

10 3

C. Submitter's Signature and Date of Summary Preparation

Darun S. Peterson

Daun Putnam
Regulatory Specialist

x//
Date

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

APR 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edward Lifesciences, LLC Mr. Daun Putman Regulatory Specialist One Edward Way Irvine, CA 92614-5686

Re: K031087

Trade/Device Name: Edward Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DYB Dated: April 4, 2003 Received: April 10, 2003

Dear Mr. Putman:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Daun Putman

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Deiter

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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K031087

510(k) Notification Edwards Lifesciences

Indications for Use

510(k) Notification for the Edwards Introducer Sheath Reference:

The Edwards Introducer Sheath is designed to facilitate the entry of interventional devices into the human vascular system.

Prescription Use Only

Da Cei Tel

510(k) Number K031087

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).