The Edwards Percutaneous Sheath Introducer is indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

The Edwards Perculaneous Sheath Introducer is intended to access the venous system and to facilitate catheter insertion. The Percutaneous Sheath Introducers allow access to the venous system for administration of fluids, blood sampling and for pressure monitoring through the additional lumens.

Device Description

The triple lumen percutaneous sheath introducer is used to access the venous system and to facilitate catheter insertion. The multi-lumen feature of the Introducer also allows access to the venous system for administration of fluids, blood sampling and for pressure monitoring through the additional lumens. The introducer is recommended to facilitate insertion of 7.5 - 8.5 French devices.

The introducer is composed of a valve housing to which a sheath is attached distally and three side arm/extension tubes are connected proximally. The valves located in the housing body provide a seal around a catheter when inserted through the introducer and prevent backflow when no catheter is present. A dilator is provided with the introducer to ease insertion of the device into the vessel.

The devices are provided sterile and non-pyrogenic; they are intended for single use only.

AI/ML Overview

The provided document describes a traditional 510(k) premarket notification for a medical device, the Edwards Percutaneous Sheath Introducer, and does not include information about AI/ML device performance or studies. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted or inferred based on the document's content, formatted to match your request:

Acceptance Criteria and Device Performance Study for Edwards Percutaneous Sheath Introducer (K121185)

This device is a traditional medical device (Percutaneous Sheath Introducer), and the provided documentation focuses on its functional and safety testing for regulatory submission. It does not involve AI or machine learning algorithms, thus many of the requested sections (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Biocompatibility	Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≥ 24 hours.	All data met pre-determined acceptance criteria.
Tensile testing	Force required to remove mechanical locks or bonded assembly parts.	All data met pre-determined acceptance criteria.
Insertion and Retraction Force Tests	Insertion and retraction force of a catheter through the entire introducer sheath.	All data met pre-determined acceptance criteria.
Introducer Valve Leak testing	Inspection of pressure drop of the introducer valve with and without a catheter present.	All data met pre-determined acceptance criteria.
Infusion Pressure	Device's ability to administer fluids through the introducer ports with a catheter in place.	All data met pre-determined acceptance criteria.
Catheter Compatibility	Ensure catheter passes freely through the introducer valve while maintaining catheter functionality.	All data met pre-determined acceptance criteria.

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

Sample Size: Not specified in the provided document. The submission states "All data met pre-determined acceptance criteria" for functional/safety testing, but does not detail the number of units or tests performed.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are laboratory/bench tests for device functionality and safety, likely conducted by Edwards Lifesciences LLC.

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

Not applicable. This device is not an AI/ML diagnostic or predictive tool, so "ground truth" derived from expert consensus on medical images or patient data is not relevant to its regulatory submission. The "ground truth" for these tests would be the physical properties and performance metrics of the device itself.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting medical data, typically for AI/ML diagnostic tools. This submission involves technical performance testing, not human interpretation of medical data.

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

No, an MRMC study was not done. This device is a physical medical instrument (Percutaneous Sheath Introducer), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device. The tests performed are for the physical device's standalone performance in various functional aspects.

7. The type of ground truth used

Ground Truth Type: For the functional/safety tests, the "ground truth" refers to the established engineering specifications, performance standards (e.g., ISO 10993-1), and design requirements for the device. For example, for "Tensile testing," the ground truth would be the minimum force required to remove parts as specified in the design.

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

Not applicable. As there is no AI/ML algorithm or training set, the concept of establishing ground truth for a training set does not apply.

Summary

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Edwards Lifesciences LLC Traditional 510(k) Premarket Notification Percutaneous Sheath Introducer

K121185

page: 1 of 2

2012

510(k) Summarv

Submitter:	Edwards Lifesciences LLC	AUG 2 2
Contact Person:	Spencer Walker, Regulatory Affairs Associate III 12050 Lone Peak Pkwy Draper, UT 84020 (801) 565-6100
Date Prepared:	August 17, 2012
Trade Name:	Edwards Percutaneous Sheath Introducer
Classification Name:	Catheter Introducer 21 CFR Part 870.1340, Product Code DYB, Class II
Predicate Device:	K981909: Baxter Hemostasis Valve Introducer

Device Description:

The devices are provided sterile and non-pyrogenic; they are intended for single use only.

Indications For Use:

The Edwards Percutaneous Sheath Introducer is indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

Intended Use

Comparative Analysis:

The Introducer is substantially equivalent to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance. The introducer has been fully assessed within the Edwards' Risk Management and Design Controls systems.

Functional/Safety Testing:

The following functional tests were performed. All data met pre-determined acceptance criteria.

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K121185
page 2 of 2

Edwards Lifesciences LLC Traditional 510(k) Premarket Notification K121185 Percutaneous Sheath Introducer

Biocompatibility Per ISO 10993-1 for External communicating device, direct circulating blood . path, duration ≥ 24 hours.
Tensile testing Force required to remove mechanical locks or bonded assembly parts. .
. Insertion and Retraction Force Tests - Insertion and retraction force of a catheter through the entire introducer sheath.
Introducer Valve Leak testing Inspection of pressure drop of the introducer valve with and . without a catheter present.
Infusion Pressure –Device's ability to administer fluids through the introducer ports with a catheter . in place.
. Catheter Compatibility - Ensure catheter passes freely through the introducer valve while maintaining catheter functionality.

All data met acceptance criteria.

Conclusion:

The Edwards Percutaneous Sheath Introducer is substantially equivalent to the cited predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

AUG 2 2 2012

Edwards Lifesciences, LLC c/o Mr. Spencer Walker Regulatory Affairs Associate III 12050 Lone Peak Pkwy Draper, UT 84020

Re: K121185

Trade Name: Percutaneous Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: August 2, 2012 Received: August 3, 2012

Dear Mr. Walker:

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.

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Page 2 - Mr. Spencer Walker

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

s Hillich

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosures

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Statement of Indications for Use

Indications for Use

1-12-186 510(k) Number (if known):

Device Name: Edwards Lifesciences Percutaneous Sheath Introducer

The Edwards Percutaneous Sheath Introducer is indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

Prescription Use × (Per 21 CFR 801.109)

OR Over-The-Counter Use_

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

ardiovascular Devices

1121182 510(k) Number

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).