The RetroFlex 3 Introducer Sheath Set is a hydrophilic delivery system used over a compatible 0.035" guidewire for the percutaneous introduction of intravascular devices. The RetroFlex 3 houses three (3) valves (a duckbill valve, a cross-slit valve, and a disc valve) to achieve hemostasis and is fitted with a three-way stopcock to allow infusion or aspiration of fluid. Each RetroFlex 3 Introducer Sheath Set contains a sheath, an introducer (or dilator), and a loader. The loader enables a device to enter into the sheath by bypassing all of the three valves within the sheath. The loader also contains a disc valve for hemostasis. The loader allows for larger devices to enter into the vascular system. The RetroFlex 3 Introducer Sheath is for one-time use only, sold and packaged sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RetroFlex 3™ Introducer Sheath Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implied/Direct)	Reported Device Performance
Physical Characteristics	Visual examination	To meet design specifications and visual quality standards.	Performed; results implied to meet criteria for substantial equivalence.
	Dimensional verification	To meet specified sheath O.D. and I.D. as per Table 7.2.	Performed; results implied to meet criteria for substantial equivalence.
	Tensile strength	To withstand specified tensile forces without failure.	Performed; results implied to meet criteria for substantial equivalence.
	Guidewire compatibility	To allow smooth passage of a compatible 0.035" guidewire.	Performed; results implied to meet criteria for substantial equivalence.
	Hydrophilic coating test	To demonstrate effective and durable hydrophilic properties.	Performed; results implied to meet criteria for substantial equivalence.
Sterility & Packaging	Packaging Integrity	To maintain sterility and prevent damage during storage and handling.	Performed; results implied to meet criteria for substantial equivalence.
	Sterilization Validation	To ensure device is sterile upon packaging and remains so until use.	Performed; results implied to meet criteria for substantial equivalence.
Biocompatibility	Medium Eluate Method (MEM)	No cytotoxic effects.	Performed; results implied to meet criteria for substantial equivalence.
	Agar Overlay Method (AO)	No cytotoxic effects.	Performed; results implied to meet criteria for substantial equivalence.
	Blood Compatibility Test Method	No adverse blood interactions (e.g., hemolysis, coagulation).	Performed; results implied to meet criteria for substantial equivalence.
	Mouse Systemic Injection	No systemic toxicity.	Performed; results implied to meet criteria for substantial equivalence.
	Rabbit Pyrogen (Chemical-Mediated) Test	No pyrogenic response.	Performed; results implied to meet criteria for substantial equivalence.
	Rabbit Intracutaneous Irritation	No significant skin irritation.	Performed; results implied to meet criteria for substantial equivalence.
	Guinea Pig Maximization Test	No significant sensitization.	Performed; results implied to meet criteria for substantial equivalence.
	Complement Activation Test	No significant complement activation.	Performed; results implied to meet criteria for substantial equivalence.
	Thrombogenicity (porcine model)	No significant thrombosis in an in-vivo model.	Performed; results implied to meet criteria for substantial equivalence.
Material/Chemical	Material Verification	To confirm materials meet specifications.	Performed; results implied to meet criteria for substantial equivalence.
	USP Physico-Chemical Test	To meet United States Pharmacopeia standards for physical and chemical properties.	Performed; results implied to meet criteria for substantial equivalence.
Overall Performance	ISO 10555-1:1997, Sec 4.5	To comply with standard for Sterile Single Use Intravascular Catheters.	"RetroFlex 3 Introducer Sheath was verified and tested according to performance testing standards ISO 10555-1:1997, Sec 4.5."
Substantial Equivalence	Comparison to Predicate Devices	The RetroFlex 3 is "similar to the Edwards Introducer Sheath and the Ancure® Sheath, and are common in mode of operation, intended use, and dimensions. The devices have only slight variations to technological design and materials."	"Based on the data presented... the RetroFlex 3 Introducer Sheath Set is substantially equivalent to the predicate devices."

Important Note: The document consistently states that tests were "performed" and that the device "met the requirements threshold to establish substantial equivalence." However, it does not provide specific numerical results or detailed pass/fail criteria for each test. The acceptance criteria are largely implied by the nature of the tests and the conclusion of substantial equivalence.

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

Sample Size: Not explicitly stated for each test. The document lists the types of tests performed (e.g., visual examination, tensile strength, various biocompatibility tests) but does not specify the number of units or animals tested for each.
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be an in-vitro (laboratory) and animal (in-vivo for thrombogenicity, rabbit, mouse, guinea pig) study, not a clinical study involving human patients. Therefore, the retrospective or prospective nature in the context of human data does not apply.

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

Not applicable. This device notification describes engineering and laboratory performance testing and biocompatibility studies, not studies requiring expert clinical interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was not a study involving human interpretation or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the clearance of a medical device based on engineering and biological performance testing, not a study evaluating human reader performance with or without AI assistance.

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

No, an algorithm-only standalone performance study was not done. This being a physical medical device (an introducer sheath), it does not involve an algorithm or AI.

7. The Type of Ground Truth Used

For engineering tests (visual, dimensional, tensile, guidewire, coating, packaging): Ground truth was established by engineering specifications, direct measurements, and compliance with recognized industry standards (e.g., ISO 10555-1:1997).
For biocompatibility tests: Ground truth was established by standardized biological assay protocols and observations, designed to detect cytotoxicity, systemic toxicity, irritation, sensitization, pyrogenicity, complement activation, and thrombogenicity following established regulatory guidelines.

8. The Sample Size for the Training Set

Not applicable. This document describes the clearance of a physical medical device through performance and biocompatibility testing, not the development or evaluation of an AI algorithm that would require a training set.

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

Not applicable, as there was no AI algorithm or training set involved.

Summary

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K093817

510(k) Summary

JUL· - 1 - 2010

Applicant:

Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 USA Phone: 949.250-3837 Fax: 949.756-4408

Date:

May 21, 2010

Contact Persons:

Jason K. Lyon Principal Project Manager, Regulatory Affairs

Irene Parker Sr. Director of Regulatory Affairs

Proprietary Device Name:

RetroFlex 3™ Introducer Sheath Set

Common Device Name:

Catheter Introducer (21 CFR 870.1340, Product Code DYB), and;

Classification:

Predicate Devices:

Class II

Edwards Lifesciences, LLC - Edwards Introducer Sheath cleared under K031087

Guidant EndoVascular Surgery Group -ANCURE® Sheath cleared under K003889

Manufacturer:

Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 USA

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Substantially Equivalent To:

The RetroFlex 3 Introducer Sheath Set was evaluated for in-vitro performance and biocompatibility tests, which are outlined below. The physical characteristics and mode of use of the RetroFlex 3 Introducer Sheath is similar to the Edwards Introducer Sheath and the Ancure® Sheath, and are common in mode of operation, intended use, and dimensions. The devices have only slight variations to technological design and materials. These differences, however, do not alter the fundamental use of the products, which is to facilitate entry into the arterial vasculature.

Based on the data presented in this 510(k) Premarket Notification, the RetroFlex 3 Introducer Sheath Set is substantially equivalent to the predicate devices.

Description of the Device Subject to Premarket Notification:

The RetroFlex 3 Introducer Sheath is for one-time use only, sold and packaged sterile. The table below identifies the model and sheath diameters. (Table 7.2).

Model No.	Sheath O.D.	Sheath I.D.
9120S23	25F	22F
9120S26	28F	24F

Table 7.2 - RetroFlex 3™ Introducer Sheaths

Indications For Use: 7.3

The RetroFlex 3 Introducer Sheath is intended for entry of interventional devices into the vascular system.

Performance Data: 7.4

The RetroFlex 3 Introducer Sheath was verified and tested according to performance testing standards ISO 10555-1:1997, Sec 4.5, Sterile Single Use Intravascular Catheters. The following tests have been conducted to demonstrate substantial equivalence to the predicate devices with respect to intended use, design, materials, and performance. The following non-clinical tests and biocompatibility tests were performed:

. Visual examination
Dimensional verification

7.2

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Tensile strength .
Guidewire compatibility .
Hydrophilic coating test .
. Packaging Integrity
. Sterilization Validation
Biocompatibility .
- Medium Eluate Method (MEM) o
- Agar Overlay Method (AO) o
- Blood Compatibility Test Method o
- Mouse Systemic Injection O
- Rabbit Pyrogen (Chemical-Mediated) Test o
- Rabbit Intracutaneous Irritation o
- Guinea Pig Maximization Test o
- Complement Activation Test o
- Thrombogenicity (porcine model) o
Chemical .
- Material Verification o
- USP Physico-Chemical Test o

7.5 Conclusion:

Based upon the non-clinical testing noted above and the data presented in the 510(k) Premarket Notification, the RetroFlex 3™ Introducer Sheath Set has met the requirements threshold to establish substantial equivalence to the predicate devices for market clearance.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of interconnected lines, possibly representing human figures or abstract shapes.

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

JUL - 1 2010

Edwards Lifesciences, LLC c/o Mr. Jason K. Lyon Principal Project Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K093877

Trade/Device Name: RetroFlex 3TM Introducer Sheath Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: June 25, 2010 Received: June 28, 2010

Dear Mr. Lyon:

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 (117). general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandijng and adulteration.

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 devine 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. Jason K. Lyon

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 (OS) 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" (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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

e. h. hmer

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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Traditional 510(k) - RetroFlex 3™ Introducer Sheath Set Edwards Lifesciences

Statement of Indications for Use

Indications for Use

510(k) Number (if known): K093877

Device Name: RetroFlex 3™ Introducer Sheath Set

The RetroFlex 3™ Introducer Sheath Set is intended for entry of interventional devices into the vascular system.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Divina R. Valenzuela

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Ko 93 877

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).