The EndoDirect arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The cannula is intended to deliver oxygenated blood for cardiopulmonary bypass for a duration of less than 6 hours. The EndoDirect arterial cannula also allows the hemostatic introduction and removal of vascular catheters such as the Port Access EndoClamp aortic catheter. The EndoDirect arterial cannula is intended for introduction and use through a thoracic trocar or incision.

The AutoIncisor Introducer is intended for use with Port Access arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

Device Description

Edwards EndoDirect arterial cannula is a flexible plastic tube intended to provide a means of safely delivering oxygenated blood for cardiopulmonary bypass procedures and allows for the hemostatic introduction and removal of vascular catheters.

The EndoDirect arterial cannula has the following features: a beveled tip with an end hole, side perfusion holes, and a stabilizer ring for suture and tourniquet, a wirewound shaft for flexibility and kink resistance, a barbed connection site with 3/8 in. acceptance, a hemostasis valve, and a mark indicating tip orientation. A lubricious coating is applied to the surface of the cannula body to facilitate ease of insertion and retraction of the EndoClamp aortic catheter.

AI/ML Overview

The provided text describes a 510(k) submission for the Edwards Lifesciences EndoDirect Arterial Cannula. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, study design elements (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance), and training set details are not applicable or not provided in a 510(k) summary for a device like an arterial cannula.

Here's an explanation based on the provided document:

1. A table of acceptance criteria and the reported device performance

Not Applicable in this context. For a 510(k) submission of a device like an arterial cannula, the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device, not necessarily meeting a predefined set of performance thresholds in a clinical study with specific sensitivity/specificity metrics.

The document states: "The functional data indicate that the proposed device performs in a substantially equivalent manner when compared with the predicate device."

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Intended Use: Comparable	"comparable to the predicate device in intended use and other labeling"
Fundamental Scientific Technology: Comparable	"comparable... fundamental scientific technology"
Material Type: Comparable	"comparable... material type"
Principles of Operation: Comparable	"comparable... principles of operation"
Functional Performance: Substantially Equivalent	"The functional data indicate that the proposed device performs in a substantially equivalent manner when compared with the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Provided / Not Applicable in this context. The 510(k) summary does not describe a clinical "test set" in the way one would for an AI/diagnostic device. The "functional data" mentioned is likely from bench testing (e.g., flow rates, pressure resistance, kink resistance, material compatibility, etc.) rather than a clinical trial with human subjects. The details of such functional testing (sample size, specific test protocols, etc.) are typically submitted as part of the full 510(k) but are not included in the public summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As there's no clinical test set with a "ground truth" to establish in the context of an AI/diagnostic device, this information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set requiring adjudication is described.

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

No. This is a medical device (arterial cannula), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not conducted.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable in the AI/diagnostic sense. For a physical device, the "truth" is typically defined by engineering specifications, material properties, and performance metrics measured through bench testing. The substantial equivalence argument relies on comparing these aspects to a legally marketed predicate device.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this information is not relevant.

In summary: The provided document is a 510(k) summary for a physical medical device (an arterial cannula). The primary goal of this submission is to demonstrate substantial equivalence to an existing predicate device, not to prove performance against specific acceptance criteria in a clinical study for a diagnostic algorithm. Therefore, many of the detailed questions related to AI/diagnostic device evaluation do not apply. The "study" mentioned is the "Functional/Safety Testing" which concluded that the proposed device performs in a "substantially equivalent manner when compared with the predicate device."

Summary

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K093730

510(k) Notification

510(k) Summarv

JAN 1 4 2010

Submitter:	Edwards Lifesciences Research Medical, Inc.
Contact Person:	Spencer Walker, Associate II, Regulatory Affairs6864 South 300 WestMidvale, UT 84047801-565-6103
Date Prepared:	December 2, 2009
Trade Name:	PORT ACCESS Systems EndoDirect Arterial Cannula
Classification Name:	Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass21 CFR Part 870.4210, Product Code DWF, Class II
Predicate Device:	Edwards Lifesciences DirectFlow Arterial Cannula

Device Description:

Intended Use:

EndoDirect Arterial Cannula

AutoIncisor Introducer: The AutoIncisor introducer is intended for use with Port Access arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

Comparative Analysis:

It has been demonstrated that the proposed arterial cannula is comparable to the predicate device in intended use and other labeling, fundamental scientific technology, material type, principles of operation and functional performance evaluations.

Functional/Safety Testing: The functional data indicate that the proposed device performs in a substantially equivalent manner when compared with the predicate device.

Conclusion:

The EndoDirect arterial cannula is substantially equivalent to the cited predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 1 4 2010

Edwards Lifesciences, LLC c/o Spencer Walker Regulatory Affairs Associate II 6864 South 300 West Midvale, UT 84047

Re: K093730

Edwards Lifesciences EndoDirect Arterial Cannula - ED24 Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DWF Dated: December 2, 2009 Received: December 3, 2009

Dear Mr. Walker:

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.

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Page 2 - Mr. Spencer Walker

Please be advised that FDA's issuance of a substantial equivalence determination does not niean 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 (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,

i R. Lacher

/ 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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Indications for Use Statement

510(k) Number (if known):

PORT ACCESS Systems EndoDirect Arterial Cannula Device Name:

Indications for Use:

The AutoIncisor Introducer is intended for use with Port Access arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Durra D. La James

ion Sign-Off Division of Cardiovascular Devices

510(k) Number_K093733

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).