Fogarty Thru-Lumen Embolectomy Catheter by Edwards Lifesciences, LLC

The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.

Device Description

The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a latex balloon at the distal end. One lumen is used for balloon inflation and is accessed through the gate valve at the proximal end. The thru-lumen is used for infusion of fluids, sampling of blood or guidewire passage through the distal tip. A removable stainless steel stylet(s) is provided.

AI/ML Overview

It appears there might be a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for a medical device: the Fogarty Thru-Lumen Embolectomy Catheter.

This document is not about an AI/software-as-medical-device (SaMD) or a device that relies on complex algorithms requiring a study to prove its performance against acceptance criteria like sensitivity, specificity, or AUC based on a test set, ground truth, or expert readers.

Instead, this device is a physical catheter used to remove emboli and thrombi. The "acceptance criteria" and "study" proving its performance in this context relate to engineering and biocompatibility testing, not to AI model performance or interpretation of medical images.

Here's why the questions about AI/software-related study methodologies are not applicable to the provided document:

No mention of AI, algorithms, or software: The document describes a physical medical device. There is no indication that it incorporates AI, software, or image analysis to function.
"Study that proves the device meets the acceptance criteria" refers to bench testing: The document explicitly states under "Device Testing": "Bench testing was performed in accordance with Edwards' current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. All testing met the existing predetermined acceptance criteria." This refers to mechanical, material, and sterilization performance, not diagnostic accuracy or AI performance.
Comparison to a predicate device: The basis for clearance is "substantial equivalence" to a predicate device (Fogarty Thru-Lumen Embolectomy Catheter cleared in K892410). The comparative analysis states, "The subject device is identical to the predicate device in terms of the intended use, indications for use, and technological characteristics (including design, material, chemical composition, principle of operation)." This reinforces that it's a physical device, not an AI system that would typically undergo MRMC studies or performance validation against a ground truth dataset of patient images.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) because the provided FDA document pertains to a physical medical device and does not involve AI or software development with the type of validation methodology you are asking about.

To summarize, the document is about the FDA clearance of a conventional medical device, not an AI-powered one. The "acceptance criteria" and "study" refer to engineering and biological safety tests, not the performance metrics of an AI model.

Summary

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August 28, 2024

Edwards Lifesciences, LLC Carmen Chen Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K240078

Trade/Device Name: Fogarty Thru-Lumen Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: July 25, 2024 Received: July 25, 2024

Dear Carmen Chen:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2024.08.28 shakoor -S 13:34:33 -04'00'

For

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices

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OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240078

Device Name

Fogarty Thru-Lumen Embolectomy Catheter

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)

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Fogarty Thru-Lumen Embolectomy Catheter
510(k)Submitter	Edwards Lifesciences, LLCOne Edwards Way, Irvine, CA 92614
Contact Person	Primary ContactCarmen G. ChenManager, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 250 - 5469Email: Carmen_Chen@edwards.com	Secondary ContactKaren O'LearySr. Director, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 610-9179Email: Karen_OLeary@edwards.com
Date Prepared	August 26, 2024
Trade Name	Fogarty Thru-Lumen Embolectomy Catheter
RegulationNumber / Name	21 CFR 870.5150 / Embolectomy Catheter
Product Code	DXE, KRA
RegulationClass	Class II
PredicateDevice	Fogarty Thru-Lumen Embolectomy Catheter cleared under K892410 on July 20,1989
DeviceDescription	The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with alatex balloon at the distal end. One lumen is used for balloon inflation and isaccessed through the gate valve at the proximal end. The thru-lumen is used forinfusion of fluids, sampling of blood or guidewire passage through the distal tip. Aremovable stainless steel stylet(s) is provided.
Indications forUse	The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring theremoval of fresh, soft emboli and thrombi from vessels in the arteries of theperipheral vasculature. Additionally, it may also be used for temporary occlusion ofblood vessels, infusion of fluids, and blood sampling in general surgicalprocedures.
ComparativeAnalysis	The subject device is identical to the predicate device in terms of the intended use,indications for use, and technological characteristics (including design, material,chemical composition, principle of operation).
Device Testing	Biocompatibility testing was performed in accordance with ISO 10993-1: 2018 -Biological evaluation of medical devices – Part 1: Evaluation and testing within arisk management process, and FDA guidance document, Use of InternationalStandard ISO 10993-1, "Biological evaluation of medical devices – Part 1:Evaluation and testing within a risk management process", issued on September 4,2020.
Fogarty Thru-Lumen Embolectomy Catheter
	Bench testing was performed in accordance with Edwards' current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications.
	All testing met the existing predetermined acceptance criteria.
Conclusion	Based on the performance testing and the technological characteristics, the Fogarty Thru-Lumen Embolectomy Catheter meets the established performance criteria and is substantially equivalent to the predicate device Fogarty Thru-Lumen Embolectomy Catheters.

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Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).