Edwards Lifesciences cardioplegia delivery sets are comprised of various configurations of clear manifold connections in either straight, Y-shaped, or 4-way connections which are joined by appropriate lengths of clear, flexible tubing. Depending upon configuration, the cardioplegia delivery set may contain a vent port adapter with female luer lock, a tapered tubing adapter, tubing clamps, and/ or male and/ or female luer lock connectors.

The exterior and/ or inner-luminal cannula surfaces of product codes containing a "D" or "DII" are coated with Duraflo TM (heparin) coating.

When used on devices for cardiopulmonary surgery, the Duraflo coating improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.

Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

AI/ML Overview

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Edwards Lifesciences™ Cardioplegia Delivery Sets.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Pressure vs. flow	Not explicitly detailed, but implied to demonstrate comparable performance to the predicate device.	Met acceptance criteria.
Clamp closure	Not explicitly detailed, but implied to demonstrate comparable performance to the predicate device.	Met acceptance criteria.
Kink	Not explicitly detailed, but implied to demonstrate comparable performance to the predicate device.	Met acceptance criteria.
Assembly tensile	Not explicitly detailed, but implied to demonstrate mechanical integrity comparable to the predicate device.	Met acceptance criteria.
Overall Functional/Safety Performance	Device performs in a substantially equivalent manner compared to the predicate device.	All data met acceptance criteria.

2. Sample Size and Data Provenance:

The document does not explicitly state the sample sizes used for each functional test. The study appears to be a retrospective comparison based on the statement "The functional data indicate that the Cardioplegia Delivery sets perform in a substantially equivalent manner when compared to the predicate device" and the comparative analysis section. There is no information regarding the country of origin of the data.

3. Number of Experts and Qualifications:

Not applicable. This device is a medical accessory, and its performance evaluation relies on engineering and functional testing rather than clinical interpretation by experts for ground truth establishment.

4. Adjudication Method:

Not applicable. As noted above, the evaluation is based on engineering and functional testing, not expert adjudication of clinical findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is typically used for diagnostic devices that assist human readers in interpreting medical images or data. The Edwards Lifesciences™ Cardioplegia Delivery Sets are an accessory used in cardiopulmonary bypass, and their effectiveness is evaluated through functional performance, not reader accuracy.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical medical accessory, not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth for the device's functional performance是在engineering standards and established performance characteristics of the predicate device. The goal was to prove substantial equivalence to a legally marketed predicate device, meaning the new device performs within expected parameters for its intended use.

8. Sample Size for the Training Set:

Not applicable. The device is not an AI/ML model, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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510(k) Summarv

JAN 1 2 2012

Submitter:	Edwards Lifesciences LLC
Contact Person:	Karen Jones, Senior Manager, Regulatory Affairs12050 Lone Peak PkwyDraper, UT 84020(801) 565-6231
Date Prepared:	December 12, 2011
Trade Name:	Edwards Lifesciences™ Cardioplegia Delivery Sets
Classification Name:	Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting21 CFR Part 870.4290, Product Code DTL, Class II
Predicate Device:	K892368 Cardioplegia Delivery Sets

Device Description:

The exterior and/ or inner-luminal cannula surfaces of product codes containing a "D" or "DII" are coated with Duraflo TM (heparin) coating.

When used on devices for cardiopulmonary surgery, the Duraflo coating improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.

Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.

PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC.

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Indications for Use:

Cardioplegia Delivery Sets with and without Duraflo coating are intended for use as adapters for connecting cardioplegia administration tubing to cardioplegia delivery catheters.

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 subject devices have the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate devices. It has been demonstrated that the subject Cardioplegia Delivery Sets 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:

The functional data indicate that the Cardioplegia Delivery sets perform in a substantially equivalent manner when compared to the predicate device. The following functional tests were performed.

Pressure vs. flow .
Clamp closure .
. Kink
. Assembly tensile

All data met acceptance criteria.

Conclusion:

Testing conducted to qualify the subject changes shows that devices in this product family have met all predetermined acceptance criteria and have been shown to be safe and effective for their intended use. The subject change does not affect the intended use or alter the fundamental scientific technology of the device.

PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

JAN 1 2 2012

Edwards Lifesciences LLC c/o Ms. Karen Jones Sr. Principal Project Manager, Regulatory Affairs 12050 Lone Peak Parkway Draper, UT 84020

Re: K113667 Edwards Lifesciences™ Cardioplegia Delivery Sets Regulation Number: 21 CFR 870.4290 Regulation Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTL Dated: December 12, 2011 Received: December 13, 2011

Firman to wa

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 (Act do not require approval of a provisions of the Pederal Food, Drug, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Karen Jones

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

M. A. Hillemann

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): K|| 366 7

Cardioplegia Delivery Sets Device Name:

Indications for Use:

Cardioplegia Delivery Sets are intended for use as adapters for connecting cardioplegia administration tubing to cardioplegia delivery catheters.

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)

M.S. Willelenn

rdiovascular Devices

510(k) Number K113667

PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences, LLC.

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.