The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

Device Description

The Baxter Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are used to access the venous system and to facilitate catheter insertion. The introducers are composed of a housing body to which a sheath is attached distally and a side port/extension tube is connected proximally. The sheath is composed of Oligon™ a polyurethane-based antimicrobial material. (Silver is the antimicrobial agent.) A valve is located in the housing body to provide a seal around a catheter when inserted through the Introducer and to prevent backflow when no catheter is present. A dilator is provided with the Introducer to ease insertion of the device into the vessel. The device will be packaged in a tray sealed with a tyvek lid and sterilized using 100% ethylene oxide.

AI/ML Overview

The provided text describes a 510(k) submission for the "Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material." This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through clinical trials. Therefore, the questions related to AI-specific terms like "AI assistance," "standalone algorithm performance," and "training set" are not applicable.

Here's an analysis based on the provided text for the aspects that are relevant:

Acceptance Criteria and Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format with specific performance metrics. Instead, it relies on demonstrating comparable performance and characteristics to predicate devices. The "acceptance criteria" are implicitly met by showing that the device performs similarly to existing, legally marketed devices.

Acceptance Criteria (Inferred from Text)	Reported Device Performance (Summary)
Functional Integrity & Performance: The device must function as intended for venous access and catheter insertion.	Functional testing was performed and determined the device to be "safe and effective and are acceptable in design and construction for their intended use."
Technological Comparability: The device's construction and physical specifications should be comparable to predicate devices.	The device is "technologically comparable to the predicate devices in construction and physical specifications."
Biocompatibility: The materials must be safe for biological contact.	Biocompatibility testing was performed according to ISO 10993-1-1994 and FDA guidance. The device was found to be "biocompatible and nontoxic and acceptable for its intended use."
Substantial Equivalence: Overall safety and effectiveness compared to predicate devices.	"The battery of non-clinical tests discussed above demonstrates that the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material exhibit comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible and chemically acceptable. Based upon those characteristics, the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses."

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

Test Set Sample Size: Not explicitly stated. The document refers to "functional testing" and "biocompatibility testing" but does not quantify the number of units or samples tested for each.
Data Provenance: The document does not specify the country of origin for the data. The testing appears to be internal (Edwards Lifesciences LLC). The studies are retrospective in the sense that they are laboratory/bench tests and material evaluations, not prospective clinical trials on human subjects.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for this type of medical device submission is established through standard engineering principles, materials science, and regulatory compliance (e.g., ISO standards). There's no mention of expert radiologists or similar medical professionals establishing ground truth for a test set in the traditional sense of diagnostic AI. The evaluation is based on objective measurements and established industry standards for device performance and safety.

4. Adjudication Method for the Test Set:

Not applicable. As there isn't a diagnostic "test set" requiring human interpretation or consensus, there's no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed on the subject device because the intended use and indications are the same as the predicate devices. Furthermore, the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material exhibited comparable design characteristics to the predicate devices in the in vitro testing, thus clinical testing was not performed."
Effect Size with/without AI assistance: Not applicable, as this device does not involve AI.

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 (sheath introducer) and does not involve any algorithms or AI for standalone performance.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance and safety is based on:
- Engineering specifications and design requirements: For functional testing (e.g., integrity, performance for venous access).
- International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1: For biocompatibility testing.
- Comparison to predicate devices: The "ground truth" for regulatory approval largely rests on demonstrating substantial equivalence, meaning the new device is as safe and effective as existing legally marketed devices.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable. As there is no training set.

Summary

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Koi 4052
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510(k) Summary, Safety and Effectiveness

Submitter:	Edwards Lifesciences LLCOne Edwards WayIrvine, California 92614 USA
Contact:	Jason SmithPhone: 949-250-2662Fax: 949-250-3579
Device Trade Name:	Edwards Lifesciences Percutaneous SheathIntroducers with Oligon™ material
Common Name:	Percutaneous Sheath Introducer
Classification:	Class II (Reference 21 CFR 870.1340)
Predicate or LegallyMarketed Device:	Baxter Hemostasis Valve IntroducersBaxter Healthcare Intro-Flex® Sheath Introducerswith AMC ThromboshieldBaxter Healthcare Vantex™ Central VenousCatheters with Oligon™ material
Date prepared:	December 6, 2001

Device Description:

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K014052
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Indications for Use:

Technology Comparison:

The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are technologically comparable to the predicate devices in construction and physical specifications. Furthermore, design, manufacturing, and sterilization procedures are representative of current industry practices.

Test Summary, In-vitro:

Functional testing was performed on the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material to evaluate the integrity and performance of the device. Based upon the results of this testing, Edwards Lifesciences has determined that the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are safe and effective and are acceptable in design and construction for their intended use.

Test Summary, In-vivo:

Clinical testing was not performed on the subject device because the intended use and indications are the same as the predicate devices. Furthermore, the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material exhibited comparable design characteristics to the predicate devices in the in vitro testing, thus clinical testing was not performed.

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Koi 4052
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Test Summary, Biocompatibility:

Biocompatibility testing was performed on the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material were found to be biocompatible and nontoxic and acceptable for its intended use.

Rationale for Substantial Equivalence Determination:

The battery of non-clinical tests discussed above demonstrates that the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material exhibit comparable mechanical and functional characteristics to the predicate devices in addition to being biocompatible and chemically acceptable. Based upon those characteristics, the Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material are substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.

Jason Smith 12/16/01
Jason Smith Date

Pason Smith Senior Regulatory Affairs Specialist Edwards Lifesciences LLC

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Image /page/3/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 its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2002

Mr. Jason Smith Senior Regulatory Affairs Specialist Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614-5686

Re: K014052

Percutaneous Sheath Introducer Regulation Number: 870.1370 Regulation Name: Catheter tip occluder. Regulatory Class: Class II Product Code: DYB Dated: December 6, 2001 Received: December 10, 2001

Dear Mr. Smith:

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 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.

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Page 2 - Mr. Jason Smith

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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). 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,

Bram Zuckerman, M.D.

ram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 10

510(k) Number (if known): KO) 4052

Device Name: Edwards Lifesciences Percutaneous Sheath Introducers with Oligon™ material

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use_

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K014052

(Optional Format 1-2-96)

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).