The Fogarty Occlusion Catheters are indicated for temporary vessel occlusion. The Large Occlusion catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal juqular vein. The Small Occlusion catheters are intended to be used for temporary occlusion in the peripheral vascular system. The catheter consists of a single-lumen polyvinylchloride (PVC) catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter to maintain the straight catheter shape and to ensure that the lumen remains opened during storage or sterilization of the product. The device is supplied sterile and for single use only. This Traditional 510(k) is submitted to request clearance for changes to the indications for use statement. The proposed changes to the indications for use statement do not alter the intended use of the Fogarty Occlusion Catheter (i.e., temporary vessel occlusion).

AI/ML Overview

This document is a 510(k) premarket notification for the Fogarty Occlusion Catheter. It outlines the device's indications for use, its description, and a comparison to predicate devices. The key takeaway is that the submission is for a change to the indications for use statement, not a change in the device's design, materials, or technology. Therefore, the "study" described focuses on the analysis of these changed indications rather than performance testing of the physical device.

Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness with Revised Indications for Use: The specific vessels identified for each size catheter (Large: aorta, vena cava, internal jugular vein; Small: peripheral vascular system) are expected to have similar safety and effectiveness compared to the general indications of the predicate device.	Conclusion of Analysis: An analysis was performed, and it was determined that "the specific vessels identified for each size catheter would be expected to have similar safety and effectiveness compared to the general indications for the predicate." The changes to the indications for use do not change the intended use or adversely impact safety and effectiveness.
Identical Design, Materials, Technology, and Operating Principles (compared to current legally marketed version): The device with the proposed change must maintain identical core characteristics.	Stated Identity: "The device with the proposed change to the indication for use statement has the identical design, materials, technology, and operating principles as the current legally marketed version of the device."
Compliance with Applicable Design Practices and Regulations (for current legally marketed version): The predicate device should already meet these standards.	Stated Compliance: "The current legally marketed version of the Fogarty Occlusion Catheter complies with all applicable design practices and regulations and was most recently cleared by FDA via K093911 (SE 21 Jan 2010) for modifications of its packaging."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This submission is for a change in indications for use based on an analysis and comparison to a predicate device, not empirical performance testing on a "test set" of patients or data.
Data Provenance: Not applicable in the context of a traditional performance study. The "data" used is the existing regulatory clearance and performance records of the predicate device (Fogarty Occlusion Catheter, K093911) and a comparative analysis of the proposed indications. This is an analysis based on existing knowledge and regulatory precedent, not new prospective or retrospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not explicitly provided. The "ground truth" here is the regulatory assessment of similar safety and effectiveness for the modified indications. This would have been established by the internal regulatory and medical affairs teams at Edwards Lifesciences through their analysis. The FDA then reviews this submission. The number and qualifications of individuals involved in the applicant's internal analysis are not detailed.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the sense of clinical cases requiring expert adjudication. The assessment was an internal analysis by the manufacturer, followed by a regulatory review by the FDA.

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 MRMC comparative effectiveness study was done. This device is a physical medical device (catheter), not an AI/software product that assists human readers.

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

No standalone performance study was done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used in this regulatory submission is a comparative analysis and expert judgment (internal to the manufacturer) that the proposed expanded indications for use for temporary vessel occlusion (specifying large vessels for large catheters and peripheral vessels for small catheters) are equally safe and effective as the more general indications of the legally marketed predicate device. This relies on the established safety and efficacy profile of the existing identical device and the predicate. It is not based on pathology, outcomes data, or a new expert consensus on a novel dataset for this specific submission, but rather on the consistency with existing medical understanding and regulatory clearances for the same device.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three overlapping profiles facing to the right.

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

November 23, 2015

Edwards Lifesciences, LLC. Naren Murugan Regulatory Affairs Associate II One Edwards Way Irvine, California 92614

Re: K152762

Trade/Device Name: Fogarty Occlusion Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 23, 2015 Received: September 24, 2015

Dear Naren Murugan:

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 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.

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

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.

Sincerely yours,

Kenneth J. Cavanaugh -S

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) K152762

Device Name Fogarty Occlusion Catheter

Indications for Use (Describe)

Fogarty Occlusion Catheters are indicated for temporary vessel occlusion.

The Large Occlusion catheters are intended to be used for temporary occlusion in the aorta, vena cava, and internal jugular vein.

The Small Occlusion catheters are intended to be used for temporary occlusion in the peripheral vascular system.

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}------------------------------------------------

TRADITIONAL 510(K) SUMMARY 5.0

Submitted by:	Edwards Lifesciences, LLC.
Contact Person:	Naren MuruganEdwards LifesciencesOne Edwards WayIrvine, CADirect Line: 949-250-2861email: Naren murugan@edwards.com
Date of Summary:	September 23, 2015
Device Trade Name:	Fogarty Occlusion Catheter
Product Code:	MJN
Common or Usual Name:	Vascular Occlusion Balloon Catheter
Classification Name:	Vascular Clamp (21 CFR 870.4450)
Predicate Device(s):	Fogarty Occlusion Catheter, Pre-amendment deviceFogarty Occlusion Catheter, K093911 (SE, 21January 2010)
Device Description:	The Fogarty Occlusion Catheters are indicated for temporaryvessel occlusion. The Large Occlusion catheters are intended tobe used for temporary occlusion in the aorta, vena cava andinternal juqular vein. The Small Occlusion catheters areintended to be used for temporary occlusion in the peripheralvascular system. The catheter consists of a single-lumenpolyvinylchloride (PVC) catheter body with a latex balloon at thedistal end and a gate valve at the proximal end. The catheterlumen is used for inflation of the balloon via a syringe connectedto the gate valve. A removable stainless-steel stylet is providedwith each catheter to maintain the straight catheter shape and toensure that the lumen remains opened during storage orsterilization of the product. The device is supplied sterile and forsingle use only.This Traditional 510(k) is submitted to request clearance forchanges to the indications for use statement. The proposedchanges to the indications for use statement do not alter theintended use of the Fogarty Occlusion Catheter (i.e., temporary
Indication for Use:	Fogarty Occlusion Catheters are indicated for temporary vessel occlusion.
	The Large Occlusion catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal jugular vein.
	The Small Occlusion catheters are intended to be used for temporary occlusion in the peripheral vascular system.
Technological Characteristics:	The technological characteristics of the Fogarty Occlusion Catheter are identical to those of the predicate (the current legally marketed version of the Fogarty Occlusion Catheter) in terms of the following:
	Size and shape; Mode of Operation and Intended Use; Target population; Fundamental scientific technology; Patient-contacting materials; and, Method of delivery.
Performance Testing Summary:	The only change made is a change to the indications for use statement, resulting in a revision to the Instructions for Use. An analysis was performed to evaluate these changes and it was determined that the specific vessels identified for each size catheter would be expected to have similar safety and effectiveness compared to the general indications for the predicate.
	The device with the proposed change to the indication for use statement has the identical design, materials, technology, and operating principles as the current legally marketed version of the device, and as such no performance testing was conducted
	The current legally marketed version of the Fogarty Occlusion Catheter complies with all applicable design practices and regulations and was most recently cleared by FDA via K093911(SE 21 Jan 2010) for modifications of its packaging.
Conclusion:	The technology of the Fogarty Occlusion Catheter is identical to the named predicate and the changes to the indications for use do not change the intended use or the adversely impact safety and effectiveness. Therefore, the Fogarty Occlusion Catheter is substantially equivalent to the predicate.

vessel occlusion).

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

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).