The IntraClude Intra-Aortic Occlusion Catheter is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion 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 IntraClude Intra-Aortic Occlusion Device is a 9 Fr (3mm), triple-lumen, 100-cm-long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation during cardiopulmonary bypass (CPB). The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The shaft is provided with an extended strain relief, which tapers from 10.5 Fr to the remaining 9 Fr catheter, and is designed to prevent kinking and to avoid compressing the shaft when the hemostasis valve of an arterial cannula introducer sheath is firmly closed around the catheter body.

The large central lumen of the IntraClude catheter serves three functions: accommodating the guidewire, delivering cardiopledia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring. The hub has two flexible extension tubes with an integrated luer connection to provide access for accessories. The shaft is provided with markers to indicate the insertion depth. A Clamp-Lock™ device, provided on the extended strain relief portion, allows the IntraClude catheter to be locked in position to prevent balloon migration during aortic occlusion. The devices are provided sterile and non-pyrogenic; they are intended for single use only.

AI/ML Overview

The provided 510(k) summary describes the Edwards Lifesciences® IntraClude™ Intra-Aortic Occlusion Catheter and its functional and safety testing to support substantial equivalence. However, it does not describe a study that involves an AI/ML device, nor does it provide details sufficient to answer many of the specific questions about AI/ML device acceptance criteria or studies (e.g., sample sizes for training/test sets, expert ground truth, MRMC studies).

The document is for a traditional medical device (a catheter) and focuses on engineering and biocompatibility testing. Therefore, I will extract information related to the device's functional and safety testing as acceptance criteria and their performance, but many parts of your request are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Criterion	Reported Device Performance
Biocompatibility	Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours.	All data met pre-determined acceptance criteria.
Mechanical Integrity	Tensile testing (bond strength of catheter, lumens, connected accessories).	All data met pre-determined acceptance criteria.
Fluid Dynamics	Flow and Venting Rates (cardioplegia flow, aortic root venting rates).	All data met pre-determined acceptance criteria.
Durability	Catheter Bending (functionality after manipulation).	All data met pre-determined acceptance criteria.
Pressure Resistance	Dynamic Pressure (integrity after exposure to dynamic water flow and manipulation).	All data met pre-determined acceptance criteria.
Balloon Performance	Balloon testing (inflation times, diameter, shape, insertion/retraction force, burst pressures).	All data met pre-determined acceptance criteria.
Clinical Validation	Design Validation	Validated through animal and cadaver studies.
Overall Safety & Efficacy	All necessary verification steps	Met pre-determined acceptance criteria to confirm safety and efficacy.

Regarding the specific questions tailored for AI/ML devices:

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

Not applicable for this device. This device is a physical catheter, not an AI/ML software. The "test set" would refer to the samples used in the functional and safety tests (e.g., number of catheters tested for tensile strength, balloon inflation, etc.). These numbers are not provided in the summary.
The design validation states "animal and cadaver studies," but no sample sizes or provenance are given.

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 for this device. As a physical catheter, there is no "ground truth" in the AI/ML sense established by experts for a test set. Ground truth for a physical device is typically based on engineering specifications, physical measurements, and observational outcomes in animal/cadaver studies.

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

Not applicable for this device. This pertains to expert review of output for AI/ML systems.

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 for this device. An MRMC study is for evaluating diagnostic performance of readers, often with AI assistance. This device is a therapeutic and monitoring catheter, not a diagnostic imaging AI.

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

Not applicable for this device. This pertains to standalone AI algorithm performance.

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

For the functional and safety tests, the "ground truth" would be the pre-defined engineering specifications, performance benchmarks, and industry standards (e.g., ISO 10993 for biocompatibility).
For the design validation ("animal and cadaver studies"), the "ground truth" would be observed physiological responses, successful occlusion, cardioplegia delivery, pressure monitoring accuracy, and anatomical compatibility in these models.

8. The sample size for the training set

Not applicable for this device. There is no "training set" as this is not an AI/ML device.

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

Not applicable for this device. There is no "training set" for this non-AI/ML device.

Summary

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510(k) Summary
Submitter:	Edwards Lifesciences® LLC
Contact Person:	Spencer Walker, Regulatory Affairs Associate II12050 Lone Peak PkwyDraper, UT 84020(801) 565-6100
Date Prepared:	October 27, 2011
Trade Name:	Edwards Lifesciences® IntraClude™ Intra-Aortic Occlusion Catheter
Classification Name:	Vascular Clamp21 CFR Part 870.4450, Product Code DXC, Class II
Predicate Device:	K974175: Heartport Endoaortic Clamp Catheter

Device Description:

Indications For Use:

Comparative Analysis:

It has been demonstrated that the IntraClude catheter is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The IntraClude catheter 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.

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Functional/Safety Testing: -

The following functional tests were performed. All data met pre-determined acceptance criteria.

Biocompatibility Per ISO 10993-1 for External communicating device, direct circulating blood . path, duration ≤ 24 hours.
Tensile testing Confirmation of the bond strength of the catheter, lumens, and connected . accessories.
. Flow and Venting Rates - Inspection of catheter, lumens, and accessories for cardioplegia flow and aortic root venting rates.
. Catheter Bending - Inspection of catheter, lumens, and accessories to confirm functionality after manipulation of the catheter.
Dynamic Pressure Confirmation of device integrity after exposure to dynamic water flow and . manipulation of the catheter, lumens, and accessories.
Balloon testing Testing for inflation times, balloon diameter, shape, insertion/retraction . force, and burst pressures.
Design Validation Design was validated through animal and cadaver studies. .

Conclusion:

The IntraClude Intra-Aortic Occlusion Catheter is substantially equivalent to the cited predicate device. Additionally, the IntraClude catheter met all pre-determined acceptance criteria to confirm safety and efficacy.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of a bird in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the perimeter of the circle.

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

DEC - 7 2011

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

Re: K113182

IntraClude Intra-Aortic Occlusion Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: October 27, 2011 Received: October 28, 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 (Act that do not require approval of the Federal Food, Drug,
You may, therefore, market the device, subject to the approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misting 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 or class III (PMA)
can be found in the Code of Fodarel Procellations 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 not 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 election c 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. Willeheme

C - 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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Edwards Lifesciences LLC Special 510{k) Premarket Notification IntraClude Intra-Aortic Occlusion Catheter

Statement of Indications for Use

Indications for Use

KITSIBL 510(k) Number (if known):

Device Name: Edwards Lifesciences IntraClude Intra-Aortic Occlusion Catheter

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)

te of CDRH, Office Of Device Evaluation (ODE)

on Sign. Division of Cardiovascular Devices

510(k) Number_KII 3182

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).