The EndoClamp Aortic Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The EndoClamp Aortic Catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

Device Description

The EndoClamp aortic catheter is a 10.5 Fr, wire-reinforced, three-lumen catheter with an elastomeric balloon near its tip for occluding the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes. The large central lumen of the catheter serves two functions: delivery of cardioplegic solution to the aortic root and venting of fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation and aortic root pressure monitoring. The shaft is marked to indicate the insertion depth. A Clamp-Lock™ device, provided on the shaft, allows the catheter to be locked in position. A colorcoded 3-way stopcock is attached to each lumen for fluid injection, balloon inflation and aortic root pressure monitoring. A rotating hemostasis valve (RHV) is attached to the large central lumen for guidewire insertion on the 100 cm catheter. The Y-connector with three tubing clamps, which enables alternation between cardioplegic solution delivery and aortic root venting, is attached to the central lumen. A vacuum relief valve is included for aortic root venting. Pressure monitoring lines are attached to the balloon inflation lumen and to the aortic root pressure monitoring lumen. Two colorcoded 35 mL syringes are included for contrast injection and balloon inflation. A guidewire is provided with the 100 cm EndoClamp catheter. The devices are provided sterile and non-pyrogenic, and intended for single use only.

AI/ML Overview

This FDA 510(k) summary describes a medical device, not an AI/ML powered device, so many of the requested categories are not applicable. I will extract the information that is available in the provided text.

The Edwards Lifesciences EndoClamp Aortic Catheter is a medical device intended for use in patients undergoing cardiopulmonary bypass. The summary details the device's functional and safety testing to demonstrate its substantial equivalence to a predicate device, K974175, the HeartPort Endoaortic Clamp Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	ISO 10993-1	For External communicating device, indirect blood path, duration ≤24 hours	Met pre-established acceptance criteria
Mechanical Integrity (Y-connector)	Pull Testing	Bond strength (specific values not provided)	Met pre-established acceptance criteria
Fluid Containment (Y-connector)	Burst/Leak Testing	Device leakage (specific values not provided)	Met pre-established acceptance criteria

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify the sample sizes used for the biocompatibility, pull, or burst/leak tests.
Data Provenance: The tests were conducted internally by Edwards Lifesciences LLC, as part of their "Risk Management and Design Controls systems" for a "material formulation change" to the Y-connector. The testing is described as functional/safety testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a medical device approval based on functional and safety testing against engineering specifications, not a diagnostic or prognostic device requiring expert-established ground truth from clinical data.

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

Not applicable. This is a medical device approval based on functional and safety testing against engineering specifications.

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:

Not applicable. This is a medical device, not an AI/ML powered device.

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

Not applicable. This is a medical device, not an AI/ML powered device.

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

For the functional/safety tests, the "ground truth" was established by pre-determined engineering and regulatory acceptance criteria (e.g., ISO 10993-1 for biocompatibility, and unspecified criteria for bond strength and leakage during pull and burst/leak tests). This is based on objective, measurable performance standards for the device components.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this device's approval, as it is not an AI/ML powered device.

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

Not applicable. There is no "training set" or corresponding ground truth for this device approval.

Summary

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Edwards Lifesciences LLC Special 510(k) Premarket Notification EndoClamp Aortic Catheter

OCT 14 2011 K 112694
P. 1 of 2

510(k) Summarv

Submitter:	Edwards Lifesciences® LLC
Contact Person:	Spencer Walker, Regulatory Affairs Associate II12050 Lone Peak PkwyDraper, UT 84020(801) 565-6100
Date Prepared:	September 13, 2011
Trade Name:	Edwards Lifesciences EndoClamp Aortic Catheter
Classification Name:	Vascular Clamp21 CFR Part 870.4450, Product Code DXC, Class II
Predicate Device:	K974175: HeartPort Endoaortic Clamp Catheter

Device Description:

Intended Use:

Comparative Analysis:

lt has been demonstrated that the EndoClamp Aortic Catheter is comparable to the predicate device in intended use and other labeling, fundamental scientific technology, material types, principles of operation and functional performance evaluations. The 'Y'-connector material formulation change has been fully assessed within the Edwards Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to confirm safety and efficacy.

ﻘﺼ

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K112694
P. 2 of 2

Functional/Safety Testing:

The functional data indicate that the EndoClamp Aortic Catheter performs in a substantially equivalent manner when compared with the predicate device. The following functional tests were performed. All data met pre-established acceptance criteria.

Biocompatibility Per ISO 10993-1 for External communicating device, indirect blood path, . duration ≤24 hours.
'Y'-connector Pull Testing Pull test of the 'Y'-connector and bonded tubing for bond . strength.
'Y'-connector Burst/ Leak Testing Burst/Leak to test the 'Y'-connector and bonded tubing . for device leakage.

Conclusion:

The EndoClamp Aortic Catheter is substantially equivalent to the predicate device. The subject change to material formulation has no negative impact on the safety or effectiveness of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a series of flowing lines, possibly representing health and human services.

Public Health Service

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

OCT 1 4 2011

Edwards Lifesciences, LLC c/o Mr. Spencer Walker Regulatory Affairs Associate II 12050 Lone Peak Parkway Draper, UT 84020

Re: K112694

Trade/Device Name: EndoClamp Aortic Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: September 14, 2011 Received: September 15, 2011

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 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 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,

lue

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

Indications for Use

510(k) Number (if known):

K112694

Device Name:

Edwards Lifesciences EndoClamp Aortic Catheter

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 CDBSH, Office Of Device Evaluation (ODE)
Division of Cardiovascular Devices
510(k) Number K112694

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

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).