The Catheter Introducer Sheath is indicated for use in patients requiring access of the venous system or to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). It is intended to be used for ≤ 72 hours.

Device Description

Edwards Lifesciences' Catheter Introducer Sheath is an 11 Fr. sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen shaft and a hemostasis valve with a side-arm extension tube with a female luer and clamp.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Catheter Introducer Sheath and does not contain information about studies proving the device meets specific acceptance criteria in the manner of a clinical trial or AI/ML performance evaluation. The document focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each test performed, nor does it provide specific numerical results of device performance. Instead, it concludes: "The functional data indicate that the Catheter Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device." and "All data met acceptance criteria." This implies that for each test listed below, there were pre-defined acceptance criteria, and the device successfully met them.

Test Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility & Sterility	Cytotoxicity	Met Biocompatibility Standards	Met Acceptance Criteria
	Sensitization	Met Biocompatibility Standards	Met Acceptance Criteria
	Irritation/Intracutaneous toxicity	Met Biocompatibility Standards	Met Acceptance Criteria
	Systemic toxicity	Met Biocompatibility Standards	Met Acceptance Criteria
	Genotoxicity	Met Biocompatibility Standards	Met Acceptance Criteria
	Haemocompatibility	Met Biocompatibility Standards	Met Acceptance Criteria
	Muscular toxicity	Met Biocompatibility Standards	Met Acceptance Criteria
	Subacute/Subchronic toxicity	Met Biocompatibility Standards	Met Acceptance Criteria
	In Vivo thrombogenicity	Met Biocompatibility Standards	Met Acceptance Criteria
Performance / Shelf Life	Leak Testing (Valve Leak after 72-hour insertion of 7 Fr device, Assembly leak, Valve leak after 6-hour insertion of 9 Fr device, Valve leak after 6-hour insertion of 7 Fr device, Valve leak with no insertion conditioning, Valve leak after multiple insertions, Forward valve leak)	Met Leakage Standards	Met Acceptance Criteria
Tensile Testing	Introducer joint tensile	Met Tensile Strength Standards	Met Acceptance Criteria
	Sideport luer tensile	Met Tensile Strength Standards	Met Acceptance Criteria
	Sideport tubing to body	Met Tensile Strength Standards	Met Acceptance Criteria
Compatibility & Additional Testing	9 Fr balloon catheter insertion force	Met Catheter Insertion Force Standards	Met Acceptance Criteria
	9 Fr balloon catheter retraction force	Met Catheter Retraction Force Standards	Met Acceptance Criteria
	Dilator insertion force	Met Dilator Insertion Force Standards	Met Acceptance Criteria
	Contamination guard connection	Met Connection Integrity Standards	Met Acceptance Criteria
	Introducer sheath and dilator transition	Met Transition Smoothness Standards	Met Acceptance Criteria
	Valve retention force	Met Valve Retention Standards	Met Acceptance Criteria
	Sideport infusion with empty introducer	Met Infusion Performance Standards	Met Acceptance Criteria
	Sideport infusion post clamping	Met Infusion Performance Standards	Met Acceptance Criteria
	Sideport infusion with 10 Fr device	Met Infusion Performance Standards	Met Acceptance Criteria
	Fluoroscopic visibility	Met Visibility Standards	Met Acceptance Criteria
	Kink testing	Met Kink Resistance Standards	Met Acceptance Criteria
Packaging Testing	All Packaging Tests	Met Packaging Integrity Standards	Met Acceptance Criteria

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

The document does not specify the sample sizes used for any of the functional or safety tests. It also does not mention any test sets in the context of clinical data, or the provenance (country of origin, retrospective/prospective) of any data beyond the physical device testing. The "tests" described are laboratory-based, not patient-based clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable to the provided document. The "ground truth" here is established by engineering and material standards, and the results of laboratory tests are presumably interpreted by qualified engineers and scientists involved in the testing and regulatory submission, not by medical experts establishing diagnostic ground truth.

4. Adjudication Method

Not applicable. The tests performed are laboratory-based and would involve measurements against established standards, not interpretation by multiple human readers requiring adjudication.

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

Not applicable. This is a 510(k) submission for a physical medical device (catheter introducer sheath), not an AI/ML-driven diagnostic or assistive technology. Therefore, no MRMC study, human reader improvement effect size, or human-in-the-loop performance is relevant or discussed.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This submission is for a physical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on established engineering standards for medical device performance, material science specifications, biocompatibility guidelines (e.g., ISO standards), and internal performance specifications derived from the predicate device characteristics. For example, "Valve leak" would have a maximum allowable leakage rate, which is the ground truth for that test.

8. Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable, as there is no training set mentioned.

Summary

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

510(k) Summary

.. )

Submitter:	Edwards Lifesciences LLC
Contact Person:	Luke Meidell, Regulatory Affairs Associate II12050 Lone Peak PkwyDraper, UT 84020Ph - (801) 565-6212Fax - (801) 565-6108
Date Prepared:	March 06, 2014
Trade Name:	Edwards Catheter Introducer Sheath
Classification Name:	Introducer, Catheter, Cardiovascular Devices Panel;21 CFR §870.1340 Product Code DYB, Class II
Predicate Device:	K981909, Baxter Hemostasis Valve Introducer

Device Description:

Intended Use:

Intended to be used to access the venous system and to facilitate catheter insertion and allow access for the administration of fluids and blood sampling.

Indications for Use:

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 Catheter introducer Sheath is comparable to the predicate

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device in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised as a result of the packaging configuration change or the revision of the Indications for Use statement.

Functional/Safety Testing:

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

Biocompatibility and Sterility

Cytotoxicity, Sensitization, Irritation/Intracutaneous toxicity, Systemic toxicity, Genotoxicity, Haemocompatibility, Muscular toxicity, Subacute/Subchronic toxicity, In Vivo thrombogenicity,

Performance / Shelf Life

Leak Testing .
Valve Leak after 72-hour insertion of 7 Fr device, Assembly leak, Valve leak after 6-hour insertion of 9 Fr device, Valve leak after 6-hour insertion of 7 Fr device, Valve leak with no insertion conditioning, Valve leak after multiple insertions, Forward valve leak.

Tensile Testing .

Introducer joint tensile, Sideport luer tensile, Sideport tubing to body.

Compatibility and Additional Testing .

9 Fr ballon catheter insertion force, 9 Fr balloon catheter retraction force, Dilator insertion force, Contamination guard connection, Introducer sheath and dilator transition, Valve retention force, Sideport infusion with empty introducer, Sideport infusion post clamping, Sideport infusion with 10 Fr device, Fluoroscopic visibility, Kink testing.

Packaging Testing

All data met acceptance criteria.

Conclusion:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

March 6, 2014

Edwards Lifesciences, LLC. % Luke Meidell Regulatory Affairs Associate III 12050 Lone Peak Pkwy Draper, UT 84020 US

Re: K131627

Trade/Device Name: Catheter Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: February 12, 2014 Received: February 14, 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.

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Page 2 - Mr. Luke Meidell

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 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" (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 vours.

for

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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K131627, page 1 of 1

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

Indications for Use Statement

510(k) Number (if known): K131627

Device Name: Catheter Introducer Sheath

Indications for Use:

. . . . . . . . . .

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)

MZFDA

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).