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 Arterial 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 Arterial 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 Arterial Cannulae are intended to provide a means of perfusing blood into the body of a patient during cardiopulmonary bypass procedures.

Edwards Femoral Access Arterial Cannulae are also available with Duraflo® coating.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Edwards Lifesciences Femoral Access Arterial Cannulae, extracted from the provided 510(k) summary:

This submission is a clarification of the Indications for Use statement, and no physical changes were made to the device. The substantial equivalence is based on the device having the same technological characteristics as its predicate devices. Therefore, the "study" described is primarily bench and laboratory testing to confirm that the existing device continues to meet its specifications. It does not involve AI, human readers, or clinical trials in the way typically associated with AI-driven medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Testing	Acceptance Criteria	Reported Device Performance
Sterility	Per ISO11135-1, Sterilization of health care products - Ethylene oxide - Part 1	Performance met the acceptance criteria (assumed as per "The performance testing met the acceptance criteria.")
Ethylene oxide sterilization residuals	ISO 10993-7, Biological evaluation of medical devices - Part 7:	Performance met the acceptance criteria
Biocompatibility	Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours.	Performance met the acceptance criteria
Conical Fittings	Fittings must be compatible with standard connections.	Performance met the acceptance criteria
Dimensional Inspection	Confirmation of critical dimensions such as ID, OD and length.	Performance met the acceptance criteria
Wire Encapsulation	Cannula body wire reinforcement shall be fully encapsulated.	Performance met the acceptance criteria
Cannula Leak	Pressure drop must meet minimum requirement.	Performance met the acceptance criteria
Kink	The cannulae shall not kink at a pre-determined diameter.	Performance met the acceptance criteria
Cannula Crush	The cannulae must not crush at a pre-determined compression.	Performance met the acceptance criteria
Cannula Collapse	The cannulae must not collapse at a pre-determined vacuum pressure.	Performance met the acceptance criteria
Tensile	Confirmation of the bond strength of the catheter assembly must meet pre determined loads.	Performance met the acceptance criteria
Cap removal force	Confirm cap removal force is within pre-determined limits.	Performance met the acceptance criteria

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

Sample Size for Test Set: Not explicitly stated. The testing appears to be bench and laboratory-based, likely involving a representative number of cannulae for each test type, rather than human "test subjects" or diagnostic cases.
Data Provenance: The data is from "Bench and laboratory testing." This indicates the testing was conducted in a controlled environment, likely by the manufacturer, rather than being derived from patient data (e.g., country of origin is not applicable in this context). The study is prospective in nature as new tests were performed on the device.

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

This section is not applicable as the device is a physical medical device (cannula), not a diagnostic algorithm or image analysis system that requires expert interpretation for ground truth. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., ISO standards, pre-determined physical limits).

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for studies where subjective interpretation or discordance among experts needs to be resolved (e.g., in reading medical images). For physical device testing against objective criteria, there is no need for adjudication in this manner.

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

No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic devices to assess how the AI affects human reader performance. As this submission is for a physical medical device and a clarification of its Indications for Use, such a study is not relevant or applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The device is a physical medical instrument (cannula), not an algorithm. Therefore, "standalone algorithm performance" is not a concept that applies here.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on objective engineering specifications and recognized international standards (e.g., ISO11135-1 for sterility, ISO 10993-7 for residuals, ISO 10993-1 for biocompatibility). These standards and internal specifications define the acceptable limits and characteristics for each test item (e.g., "Cannula body wire reinforcement shall be fully encapsulated," "Pressure drop must meet minimum requirement").

8. The Sample Size for the Training Set

Not applicable. This device is a physical, non-AI medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved in the design or evaluation of this cannula.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set.

Summary

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510(k) Summary		MAR 1 5 2013
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 Arterial Cannulae
Classification Name:	cardiopulmonary bypass vascular catheter, cannula or tubingClass II (21 CFR §870.4210).
Predicate Devices
	• K891576, Cleared October 5, 1989
	• K905912, Cleared January 15, 1991

K905312, Cleared January 15, 1991 .
K033463, Cleared July 28, 2004 .

Device Description:

The Edwards Femoral Access Arterial 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

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

Edwards Femoral Access Arterial Cannulae are intended to provide a means of perfusing blood into the body of a patient during cardiopulmonary bypass procedures.

Edwards Femoral Access Arterial Cannulae are also available with Duraflo® coating.

Intended U´se:

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 Arterial 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.

Functional/Safety Testing:

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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, direct circulating blood path, duration ≤ 24 hours.
Conical Fittings	Fittings must be compatible with standard connections.
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 vacuum pressure.
Tensile	Confirmation of the bond strength of the catheter assembly must meet pre determined loads.
Cap removal force	Confirm cap removal force is within pre-determined limits.

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 Arterial Cannulae are substantially equivalent to the cited predicate devices.

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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 features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Public Health Service

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

March 15, 2013

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

Re: K123298

Trade/Device Name: Femoral Access Arterial 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

Bram D

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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Statement of Indications for Use

510(k) Number (if known): K123298

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)

Matthew G. Hillebrenner

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).