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

Device Description

Models: 620403F, 620404F, and 620405F
The Fogarty Small Occlusion Catheters (4F, 5F) consist of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The 3F Fogarty Occlusion Catheter is made of Nylon. 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 of the product.
Models: 62080814F and 62080822F
The Fogarty 8F Large Occlusion Catheters consist of a single-lumen polyvinylchloride 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Fogarty Occlusion Catheter, indicating substantial equivalence to a predicate device. It's important to note that a 510(k) clearance does not involve clinical studies with human participants where AI performance is measured against human readers or a ground truth established by experts. Instead, it focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

In this specific case, the submission emphasizes that the new device is identical to the predicate device in terms of intended use, indications for use, and technology. The changes proposed are related to new model numbers for existing devices, a new alternative packaging configuration, new labels, and updates to the Instructions For Use (IFU). Therefore, the "acceptance criteria" and "study" described are focused on proving that these packaging and labeling changes do not alter the device's performance or safety from the established predicate.

Given this context, many of the typical questions for AI/CADe devices regarding acceptance criteria, ground truth, expert involvement, and MRMC studies are not applicable.

Here's an interpretation based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Summary)
Packaging Integrity	Compliance with ISO 11607-1 (for terminally sterilized medical devices)	Packaging testing was performed and successfully passed, demonstrating the integrity of the new alternative packaging.
Sterilization Efficacy	Compliance with ISO 11135:2014 (ethylene oxide sterilization)	Sterilization testing was successfully passed, ensuring sterility assurance.
Ethylene Oxide (EO)/Esterification (ECH) Residuals	Compliance with ISO 10993-7:2008 (biological evaluation of medical devices)	EO/ECH residuals evaluation was successfully passed.
Product Performance	Maintain original functional characteristics despite packaging change	Product performance testing and balloon inflation testing were successfully passed.
Biocompatibility	Ensure no new biocompatibility concerns due to packaging materials	Biocompatibility testing evaluations were conducted and ensured no alteration in performance.

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

The document does not specify sample sizes for each test mentioned (e.g., how many packages were tested for integrity, how many catheters were tested for performance).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. These tests are typically conducted in a laboratory setting by the manufacturer.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" here is compliance with established engineering and manufacturing standards (e.g., ISO standards) and performance specifications of the predicate device. There is no expert review of images or clinical data to establish a diagnostic ground truth.

4. Adjudication method for the test set:

This question is not applicable. As there is no "ground truth" based on expert consensus for clinical interpretation, there is no need for an adjudication method. The tests are objective measurements against predefined standards.

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:

This question is not applicable. This submission is for a physical medical device (an occlusion catheter) and does not involve AI or any form of image interpretation where human readers would be "assisted" by AI.

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

This question is not applicable. This device does not have an algorithm or standalone performance in the context of AI.

7. The type of ground truth used:

The "ground truth" in this context refers to compliance with recognized industry standards (e.g., ISO 11607-1, ISO 11135:2014, ISO 10993-7:2008) and engineering performance specifications that are identical to the predicate device.

8. The sample size for the training set:

This question is not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.

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

This question is not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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February 14, 2022

Edwards Lifesciences, LLC Anisha Butala Regulatory Affairs Specialist One Edwards Way Irvine, California 92614

Re: K211610

Trade/Device Name: Fogarty Occlusion Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: January 13, 2022 Received: January 14, 2022

Dear Anisha Butala:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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,

for Carmen Gacchina Johnson, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices 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

510(k) Number (if known) K211610

Device Name Fogarty Occlusion Catheters

Indications for Use (Describe)

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 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)

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K211610

SECTION 5. 510(K) SUMMARY

Fogarty Occlusion Catheters
510(k) Submitter	Edwards Lifesciences, LLCOne Edwards Way Irvine, CA, USA 92617
Contact Person	Primary ContactAnisha ButalaSpecialist, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 250-1004Fax: (949) 809-2954Email:Anisha_Butala@edwards.com	Secondary ContactKaren O'LearyDirector, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 250-0715Fax: (949) 809-2954Email: Karen_OLeary@edwards.com
Date Prepared	February 14, 2022
Trade Name	Fogarty Occlusion Catheters
Common Name	Vascular Occlusion Balloon Catheter
ClassificationName	MJN - Catheter, Intravascular Occluding, Temporary
RegulationClass/ProductCode	21 CFR 870.4450/MJN
Predicate Device(s)	Fogarty Occlusion Catheter, K152762, (SE November 23, 2015)
Device Description	Models: 620403F, 620404F, and 620405FThe Fogarty Small Occlusion Catheters (4F, 5F) consist of a single-lumenpolyvinylchloride catheter body with a latex balloon at the distal end and a gatevalve at the proximal end. The 3F Fogarty Occlusion Catheter is made of Nylon.The catheter lumen is used for inflation of the balloon via a syringe connected tothe gate valve. A removable stainless-steel stylet is provided with each catheterto maintain the straight catheter shape and to ensure that the lumen remainsopened during storage of the product.Models: 62080814F and 62080822FThe Fogarty 8F Large Occlusion Catheters consist of a single-lumenpolyvinylchloride catheter body with a latex balloon at the distal end and a gatevalve at the proximal end. The catheter lumen is used for inflation of the balloonvia a syringe connected to the gate valve. A removable stainless-steel stylet isprovided with each catheter.
Indications forUse/Intended Use	Fogarty Occlusion Catheters are intended for temporary vessel occlusion.Models: 620403F, 620404F, and 620405FThe Small Occlusion catheters are intended to be used for temporary occlusionin the peripheral vascular system.Models: 62080814F and 62080822F
	The Large Occlusion catheters are intended to be used for temporary occlusionin the aorta, vena cava and internal jugular vein.
ComparativeAnalysis	The subject device is identical to the predicate device, K152762 in terms ofintended use, indications for use, and technology. The proposed changes involvethe creation of new model numbers for the existing legally marketed devices witha new alternative packaging configuration, new labels, and updates to the IFU asa result of the new model numbers.Packaging design verification, sterilization (EO resistance and residuals), productperformance, and biocompatibility testing evaluations were conducted to ensurethat the change in the new alternative final packaging did not alter theperformance of the subject devices. The subject Fogarty Occlusion Cathetershave been shown to be substantially equivalent to the predicate devices for itsintended use in hospitals and other appropriate clinical environments.
Functional/ SafetyTesting	The Fogarty Occlusion Catheters with new alternative packaging configurationare identical to the predicate device in terms of the final device and indicationsfor use. To ensure that the Fogarty Occlusion Catheters with new alternativepackaging configuration did not raise any new concerns of safety andeffectiveness, and are substantially equivalent to the predicate devices, thefollowing evaluation and testing were performed:Product Performance testing evaluation and Product Test/ Balloon Inflation testing. Packaging testing in accordance to ISO 11607-1 – Packaging for Terminally Sterilized Medical Devices. Sterilization testing in accordance to ISO 11135:2014 - Sterilization of health-care products- Ethylene oxide- Requirements for the development, validation and routing control of a sterilization process for medical devices. EO/ ECH residuals evaluation in accordance to ISO10993-7:2008 – Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals. The Fogarty Occlusion Catheters models have successfully passed performance,packaging, sterility assurance and EO/ECH residuals testing demonstrating thatthe subject devices are substantially equivalent to the predicate devices.
Conclusion	The Fogarty Occlusion Catheters are substantially equivalent to the predicatedevices, K152762.

Table 5-1: Summary Table

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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).