IntraClude Intra-Aortic Occlusion Device by Edwards Lifesciences LLC

The IntraClude™ Intra-Aortic Occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion device 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 (model code ICF100) is a 10.5 Fr (3.5mm), 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 device serves three functions: accommodating the guidewire, delivering cardioplegia 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 device 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 text describes a 510(k) premarket notification for the "IntraClude Intra-Aortic Occlusion Device". This document is a regulatory submission for a medical device and does not describe an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML device performance (like acceptance criteria for AI algorithms, sample sizes for AI training/test sets, ground truth establishment by experts for AI, MRMC studies, or standalone algorithm performance) are not applicable to this document.

The document discusses validation for a physical medical device, not a software algorithm.

However, I can extract information regarding the functional/safety testing and general acceptance of the device described in the document.

Detailed Breakdown based on the provided document:

A table of acceptance criteria and the reported device performance

Acceptance Criterion	Reported Device Performance
Biocompatibility (per ISO 10993-1:2009/ Cor 1 for external communicating device, direct circulating blood path, duration ≤ 24 hours)	Tests included Cytotoxicity, Hemolysis, Systemic Toxicity, Irritation, and Sensitization. All data met pre-determined acceptance criteria.
Tensile and Compression/friction testing (Confirmation of the strength of the catheter, lumens, and clamp lock)	All data met pre-determined acceptance criteria.
Flow Rate (Inspection of catheter, lumens, and accessories for cardioplegia flow rate and pressure drop)	All data met pre-determined acceptance criteria.
Catheter Bending/Kink Testing (Inspection of catheter, lumens, and accessories to confirm functionality after manipulation of the catheter)	All data met pre-determined acceptance criteria.
Leakage Testing (Confirmation of device integrity after exposure to pressurized air and manipulation of the catheter, lumens, and accessories)	All data met pre-determined acceptance criteria.
Design Validation by clinicians using a simulated use model (to verify that modifications meet user requirements and intended use)	All data met pre-determined acceptance criteria.

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated for each test. The document generally states "All data met pre-determined acceptance criteria." without quantifying the sample sizes for the functional/safety tests.
- Data provenance: Not specified. This document is a 510(k) submission to the FDA (USA), implying the testing was conducted to meet US regulatory standards, but the physical location or specific type of data (retrospective/prospective) for the tests are not detailed.
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)
- For "Design Validation", it states it was "performed by clinicians". The number and specific qualifications (e.g., years of experience, specialty) of these clinicians are not provided. This validation is for user requirements and intended use, not establishing "ground truth" in the AI/ML sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/ML device requiring ground truth adjudication by multiple readers. The "Design Validation" involved "clinicians" but the adjudication method among them is not described.
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 not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device. The functional/safety tests evaluate the physical device's performance standalone in a controlled environment or in simulated use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the physical device, "ground truth" is defined by pre-determined engineering and biological acceptance criteria for tests like biocompatibility, tensile strength, flow rate, bending, and leakage.
- For "Design Validation", it's based on "user requirements and intended use" as verified by clinicians in a simulated environment.
The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device, so there is no "training set" or corresponding ground truth establishment process in that context.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The image is simple and straightforward, with a focus on the text.

DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Public Health Service

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

January 26, 2017

Edwards Lifesciences LLC Lisa Hessabi Associate Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K163693

Trade/Device Name: IntraClude Intra-Aortic Occlusion Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: December 22, 2016 Received: December 28, 2016

Dear Lisa Hessabi:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerelv.

M.A. Hillebrand
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K163693

Device Name

IntraClude™ Intra-Aortic Occlusion Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Submitter:	Edwards Lifesciences LLC
Contact Person:	Lisa G. Hessabi, Associate Manager, Regulatory AffairsOne Edwards WayIrvine, CA 92614(949) 250-5000
Date Prepared:	January 25, 2017
Trade Name:	IntraClude™ Intra-Aortic Occlusion Device
ClassificationName:	Vascular Clamp21 CFR Part 870.4450, Product Code DXC, Class II
Predicate Device:	K132175 IntraClude™ Intra-Aortic Occlusion Device
Device Description:	The IntraClude Intra-Aortic Occlusion Device (model code ICF100) isa 10.5 Fr (3.5mm), triple-lumen, 100-cm-long catheter with anelastomeric balloon near its distal tip designed to occlude theascending aorta in order to partition the aortic root from arterialcirculation during cardiopulmonary bypass (CPB). The balloonexpands to occlude a range of aorta sizes from 20 to 40 mm. Theshaft is provided with an extended strain relief, which tapers from10.5 Fr to the remaining 9 Fr catheter, and is designed to preventkinking and to avoid compressing the shaft when the hemostasisvalve of an arterial cannula introducer sheath is firmly closed aroundthe catheter body.The large central lumen of the IntraClude device serves threefunctions: accommodating the guidewire, delivering cardioplegiasolution to the aortic root, and venting fluid and air from the aorticroot. The two remaining lumens serve as conduits for ballooninflation/deflation and aortic root pressure monitoring. The hub hastwo flexible extension tubes with an integrated luer connection toprovide 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 device 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.
Indications For Use:	The IntraClude™ Intra-Aortic Occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion device 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.
Comparative Analysis:	Testing demonstrates that the IntraClude device is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The subject device differs from the predicate because of modifications to the strain relief, the addition of a 22 mm sleeve at the hub-to-strain-relief transition, and the change in pad printing inks. The IntraClude device was fully assessed within the Edwards' Risk Management and Design Controls systems.
Functional/Safety Testing:	The following functional tests were performed:Biocompatibility – Per ISO 10993-1:2009/ Cor 1: for External communicating device, direct circulating blood path, duration ≤ 24 hours: tests included Cytotoxicity, Hemolysis, Systemic Toxicity, Irritation, and Sensitization. Tensile and Compression/friction testing - Confirmation of the strength of the catheter, lumens, and clamp lock. Flow Rate - Inspection of catheter, lumens, and accessories for cardioplegia flow rate and pressure drop.
	Catheter Bending/Kink Testing – Inspection of catheter, lumens, and accessories to confirm functionality after manipulation of the catheter. Leakage Testing – Confirmation of device integrity after exposure to pressurized air and manipulation of the catheter, lumens, and accessories. All data met pre-determined acceptance criteria. Design Validation was performed by clinicians using a simulated use model to verify that the modifications to the IntraClude device meet the user requirements and intended use.
Conclusion:	The IntraClude Intra-Aortic Occlusion Device is substantially equivalent to the cited predicate device.

{4}------------------------------------------------

{5}------------------------------------------------

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).