Aortic Perfusion Cannulae may be used in pediatric or adult populations based on the 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

Edwards Aortic Perfusion Cannulae are sterile, non-pyrogenic, single-use cannulae made of flexible and non-flexible polymeric materials. They are intended for perfusion of the ascending aorta during cardiopulmonary bypass procedures.

Edwards' Aortic Perfusion Cannulae are available in a range of sizes with a variety of tip and hole configurations, including straight, angled, stainless steel, and plastic tips. They terminate in a connector or connector acceptance of 3/8" (9.5 mm) or 1/4" (6.3 mm), and are available in non-wire-reinforced and stainless steel wire-reinforced configurations to help prevent kinking and twisting of the cannulae. Edwards Aortic Perfusion Cannulae are also available with Duraflo™ coating.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to address your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Testing	Criteria	Reported Device Performance(Met/Not Met/Not Mentioned)
Sterility	Per ISO 11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices	Met
Ethylene oxide sterilization residuals	ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals	Met
Biocompatibility	Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours.	Met
Conical Fittings	Fittings must be compatible with standard connections.	Met
Assembly Leak	Pressure drop must meet minimum requirement.	Met
Kink	The cannulae shall not kink at a pre-determined diameter.	Met
Cannula Crush	Cannula shall not crush when a pre-determined compression is applied.	Met
Tip Crush	Distal tip of cannula shall withstand a minimum weight without cracking or breaking.	Met
Vent Plug Crush	Must withstand pre-determined compressive force without breaking or crumbling.	Met
Cap Removal Force	Removal force meets a pre-determined axial force.	Met
Corrosion	Metallic components shall show no signs of corrosion.	Met
Assembly Tensile	Confirmation of the bond strength of the catheter assembly must meet pre-determined loads.	Met
Hemolysis	Dynamic hemolysis testing must show that devices are non-hemolytic.	Met
Pressure Drop	Pressure drop testing to confirm flow rate values for product labeling.	Met

Note: The document explicitly states, "The performance testing met the acceptance criteria," indicating that all listed criteria were satisfied.

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

The provided text describes bench and laboratory testing only. It does not mention a "test set" in the context of patient data or clinical trials. Therefore, information about sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable to this submission. The tests were performed on the device itself.

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

This information is not applicable. The ground truth for the "test set" (which consists of the device's physical and functional properties) was established through engineering specifications, industry standards (ISO), and direct measurement or observation during bench testing, not through expert human evaluation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human reviewers during data labeling or clinical trial endpoint assessment. The testing described here is objective bench testing against pre-defined engineering criteria.

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

There was no MRMC comparative effectiveness study performed. This submission is for an Aortic Perfusion Cannula, which is a medical device (hardware), not an AI algorithm or a diagnostic tool utilizing human interpretation. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

This information is not applicable. The device is an Aortic Perfusion Cannula, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the device's performance was based on:

Engineering specifications and standards: Pre-determined diameters for kinking, minimum weight for tip crush, pre-determined compressive force for vent plug crush, pre-determined axial force for cap removal, pre-determined tensile loads for assembly strength.
International Standards (ISO): Specifically ISO 11135-1 (sterilization), ISO 10993-7 (EO residuals), and ISO 10993-1 (biocompatibility).
Objective measurements and observations: Confirmation of compatibility with standard connections, meeting minimum pressure drop requirements, showing no signs of corrosion, and demonstrating non-hemolytic properties.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This information is not applicable for the same reason as above; there is no training set. The "ground truth" for the device's design and manufacturing was established through established engineering practices, material science, and regulatory compliance requirements.

Summary

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510(k) Summary

Submitter:	Edwards Lifesciences LLC
Contact Person:	Karen Jones, Senior Manager, Regulatory Affairs12050 Lone Peak PkwyDraper, UT 84020(801) 565-6231
	MAR 13 2013
Date Prepared:	October 31, 2012
Trade Name:	Edwards Lifesciences® Aortic Perfusion Cannulae
Classification Name:	Catheter, Cannula and Tubing, Vascular, CardiopulmonaryBypass
	21 CFR Part 870.4210, Product Code DWF, Class II
Predicate Device:	K831769 - Aortic Perfusion CannulaeK033463 - Aortic Perfusion Pediatric Cannulae

Device Description:

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Indications for Use:

Aortic perfusion cannulae are Intended for perfusion of the aorta during short-term (≤ 6 hours) cardiopulmonary bypass procedures.

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 Aortic Perfusion Cannulae have the same fundamental scientific technology and principles of operation as the predicate devices. Minor differences in features relate to customer reference rather than the clinical performance of the device. The product range of sizes now includes 6 to 24 French and 6 to 14.8 inches in length. Tips are open or slotted; straight, bent or curved; metal or plastic. Devices have vent caps or vent plugs, connectors or standard acceptance for connecting to the circuit. Several models are offered with a heparin coating. It has been demonstrated that the subject Aortic Perfusion 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. Additionally, the polymeric material formulations in the devices have evolved, but material types remain the same as those originally cleared in predicate submissions. All configurations may be considered for pediatric use based on the physical needs of the pediatric patient.

Non Clinical 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.

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Edwards Lifesciences LLC Traditional 510(k) Premarket Notification Aortic Perfusion Cannula

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 circulatingblood path, duration ≤ 24 hours.
Conical Fittings	Fittings must be compatible with standard connections.
Assembly Leak	Pressure drop must meet minimum requirement.
Kink	The cannulae shall not kink at a pre-determined diameter.
Cannula Crush	Cannula shall not crush when a pre-determined compression isapplied.
Tip Crush	Distal tip of cannula shall withstand a minimum weight withoutcracking or breaking
Vent Plug Crush	Must withstand pre-determined compressive force without breaking orcrumbling
Cap Removal Force	Removal force meets a pre-determined axial force
Corrosion	Metallic components shall show no signs of corrosion.
Assembly Tensile	Confirmation of the bond strength of the catheter assembly must meet
	pre-determined loads.
Hemolysis	Dynamic hemolysis testing must show that devices are non-hemolytic.
Pressure Drop	Pressure drop testing to confirm flow rate values for product labeling

The Aortic Perfusion 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 Aortic Perfusion Cannulae are substantially equivalent to the cited predicate devices. The nonclinical tests demonstrate that the devices are as safe and as effective as the legally marketed devices.

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

Public Health Service

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

March 13, 2013

Edwards Lifesciences LLC C/O Karen Jones 12050 Lone Peak Pkwy. Draper, UT 84020

Re: K123370

Trade/Device Name: Aortic Perfusion Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: Class II Product Code: DWF Dated: January 21, 2013 Received: January 22, 2013

Dear Ms. Jones:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Karen Jones

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,

Matthew Gັ퀘訓llebrenner

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): K123370

Edwards Lifesciences® Aortic Perfusion Cannula Device Name:

Indications for Use:

Aortic perfusion cannulae are Intended for perfusion of the aorta during short-term (≤ 6 hours) cardiopulmonary bypass procedures.

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

Prescription Use X (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亮刷illebrenner

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).