Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician.

Femoral Access Cannula may be used in pediatic populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.

Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Device Description

The Edwards Femoral Access Venous Cannulae with or without Duraflo® coating are wire-reinforced thin-wall polymer cannulae. The wire reinforcement is intended to prevent kinking during use.

The clear proximal section of the cannula is unreinforced for clamping and terminates in either a barbed connector for 1/4" or 3/8" tubing connection.

The cannulae are available in various sizes and lengths. Edwards Femoral Access Venous Cannulae are available in a range of sizes with a variety of tip and hole configurations, including stainless steel and plastic tips. The cannulae tips are tapered for easy insertion.

Some cannulae feature incremental depth markings to aid in proper placement and positioning. As an additional aid to placement, the clear tip of some versions of the cannula contains two radiopaque barium stripes for visualization. Some product codes may also include a suture ring.

Edwards Femoral Access Venous Cannulae are intended to provide a means of draining the blood flow of a patient during cardiopulmonary bypass procedures.

Edwards Femoral Access Venous Cannulae are also available with Durafto® coating.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information based on the provided text, focusing on the lack of AI-specific details as this product is a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Testing	Criteria	Reported Device Performance
Sterility	Per ISO11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices	Met the acceptance criteria.
Ethylene oxide sterilization residuals	ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals	Met the acceptance criteria.
Biocompatibility	Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours.	Met the acceptance criteria.
Dimensional Inspection	Confirmation of critical dimensions such as ID, OD and length.	Met the acceptance criteria.
Wire Encapsulation	Cannula body wire reinforcement shall be fully encapsulated.	Met the acceptance criteria.
Cannula Leak	Pressure drop must meet minimum requirement.	Met the acceptance criteria.
Kink	The cannulae shall not kink at a pre-determined diameter.	Met the acceptance criteria.
Cannula Crush	The cannulae must not crush at a pre-determined compression.	Met the acceptance criteria.
Cannula Collapse	The cannulae must not collapse at a pre-determined vacuum pressure.	Met the acceptance criteria.
Tensile	Confirmation of the bond strength of the catheter assembly must meet pre-determined loads.	Met the acceptance criteria.
Cap removal force	Confirm cap removal force is within pre-determined limits.	Met the acceptance criteria.
Corrosion	Metallic components shall show no signs of corrosion.	Met the acceptance criteria.

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

The provided document describes bench and laboratory testing of a physical medical device (Femoral Access Venous Cannulae). There is no mention of a "test set" in the context of patient data, images, or AI models. The testing described is for the physical and chemical properties of the device itself. Therefore, concepts like country of origin or retrospective/prospective data are not applicable here.

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

This information is not applicable as the document describes functional and safety testing of a physical medical device, not a study involving human experts establishing ground truth for diagnostic or AI-driven tasks. The ground truth for the functional/safety testing is based on established engineering and medical device standards (e.g., ISO standards, pre-determined physical limits).

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as points 2 and 3. There is no "test set" in the context of needing expert adjudication.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. The submission describes a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical medical cannula; there is no algorithm or AI component involved, hence no standalone algorithm performance study would be conducted.

7. The Type of Ground Truth Used

The "ground truth" for the functional and safety testing of the Femoral Access Venous Cannulae primarily relies on:

Established Industry Standards: Such as ISO 11135-1 (sterilization), ISO 10993-7 (ethylene oxide residuals), ISO 10993-1 (biocompatibility), and ISO 14971 (risk management). These standards set the benchmarks and methodologies for testing.
Pre-determined Specifications: The criteria for tests like dimensional inspection, wire encapsulation, cannula leak, kink, crush, collapse, tensile strength, and cap removal force are based on the device's design specifications and engineering requirements.

8. The Sample Size for the Training Set

This is not applicable. There is no AI model or "training set" described in the context of this medical device submission.

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

This is not applicable as there is no training set for an AI model.

Summary

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K123303

510(k) Summary
----------------	--

Submitter:	Edwards Lifesciences LLC
Contact Person:	Dannette Crooms, Manager, Regulatory Affairs12050 Lone Peak PkwyDraper, UT 84020(801) 565-6209
Date Prepared:	October 22, 2012
Trade Name:	Edwards Lifesciences® Femoral Access Venous Cannulae
Classification Name:	cardiopulmonary bypass vascular catheter, cannula or tubingClass II (21 CFR §870.4210).

Predicate Devices

K891576, Cleared October 5, 1989 .
K905312, Cleared January 15, 1991 .
K033464, Cleared June 22, 2004 .

Device Description:

The Edwards Femoral Access Venous Cannulae with or without Duraflo® coating are wire-reinforced thin-wall polymer cannulae. The wire reinforcement is intended to prevent kinking during use.

The clear proximal section of the cannula is unreinforced for clamping and terminates in either a barbed connector for 1/4" or 3/8" tubing connection.

Some cannulae feature incremental depth markings to aid in proper placement and positioning. As an additional aid to placement, the clear tip of some versions of the

MAR 22 2013

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cannula contains two radiopaque barium stripes for visualization. Some product codes may also include a suture ring.

Edwards Femoral Access Venous Cannulae are intended to provide a means of draining the blood flow of a patient during cardiopulmonary bypass procedures.

Edwards Femoral Access Venous Cannulae are also available with Durafto® coating.

Intended Use:

Intended for femoral venous and arterial access during cardiopulmonary bypass (CPB).

Indications for Use:

Femoral Access Cannula may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy.. Please consult labeling to determine pressure drop related to flow rates.

Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Comparative Analysis:

The basis for this submission is a clarification of the Indications for Use statement. No physical changes are being made to these devices. The subject devices have the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. It has been demonstrated that the subject Femoral Access Venous Cannulae are comparable to the predicate devices in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised.

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Functional/Safety Testing:

Bench and laboratory testing was performed and assures that the product meets its specifications per the table below. The performance testing met the acceptance criteria.

Testing	Criteria
Sterility	Per ISO11135-1, Sterilization of health care products - Ethylene oxide - Part 1:
Ethylene oxidesterilization residuals	ISO 10993-7, Biological evaluation of medical devices - Part 7:
Biocompatibility	Per ISO 10993-1 for External communicating device, directcirculating blood path, duration ≤ 24 hours.
Dimensional Inspection	Confirmation of critical dimensions such as ID, OD and length.
Wire Encapsulation	Cannula body wire reinforcement shall be fully encapsulated.
Cannula Leak	Pressure drop must meet minimum requirement.
Kink	The cannulae shall not kink at a pre-determined diameter.
Cannula Crush	The cannulae must not crush at a pre-determined compression.
Cannula Collapse	The cannulae must not collapse at a pre-determined vacuumpressure.
Tensile	Confirmation of the bond strength of the catheter assembly mustmeet pre-determined loads.
Cap removal force	Confirm cap removal force is within pre-determined limits.
Corrosion	Metallic components shall show no signs of corrosion.

The Femoral Access Arterial Cannulae conform to the following standards:

· ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing.
· ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
· ISO11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
· ISO14971, Medical devices Application of risk management to medical devices

Conclusion:

The Femoral Access Venous Cannulae are substantially equivalent to the cited predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three lines extending from its body, representing the department's commitment to health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

Public Health Service

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

March 22, 2013

Edwards Lifesciences LLC C/O Dannette Crooms 12050 Lone Peak Pkwy. Draper, UT 84020

Re: K123303

Trade/Device Name: Femoral Access Venous Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: Class II Product Code: DWF Dated: February 15, 2013 Received: February 19, 2013

Dear Ms. Crooms:

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.

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

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Page 2 - Ms. Dannette Crooms

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" (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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sonna M-Patel-raman -S

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

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Statement of Indications for Use

510(k) Number (if known): K123303

Edwards Lifesciences Femoral Access Cannulae Device Name:

Indications for Use:

Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

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)

Sonna MEPatél Traman -S

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).