Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter is indicated for the removal and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended.

Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.

Device Description

Fogarty Arterial Embolectomy Catheter: The Fogarty Arterial Embolectomy Catheter consists of a catheter body tube made out of polyvinyl chloride (PVC) or nylon (3F only) of 40, 60, or 80 cm lengths. The catheter contains a latex balloon at the distal end and a PVC hub at the proximal end for connection to a syringe for balloon inflation. They contain a soft, rounded tip, which promotes easy arterial insertion. The model with an “S” has a stylet at the proximal end to support the inflation lumen during shipping and storage. These devices are provided sterile and labeled for single use only.

Fogarty Biliary Balloon Probe: The Fogarty Biliary Balloon Probe consists of a single-lumen polyvinyl chloride (PVC) catheter body with a latex balloon at the distal end. A hub at the proximal end is used for balloon inflation. A flexible stylet is provided with Fogarty Biliary Balloon Probe. The stylet is of a designed stiffness intended to avoid perforation and yet maintain enough shape to facilitate introduction of the probe into areas of sharp angulation. These devices are provided sterile and labeled for single use only. The Fogarty Biliary Balloon Probe is not intended to be used with other devices.

AI/ML Overview

This is a 510(k) summary for a medical device called the Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's efficacy through extensive clinical trials with acceptance criteria directly tied to patient outcomes or AI performance metrics.

Therefore, the typical questions about acceptance criteria for AI/CADe devices, such as performance metrics (sensitivity, specificity), expert involvement in ground truth, sample sizes for test/training sets, and MRMC studies, are not applicable here.

Instead, the "acceptance criteria" in this context are related to demonstrating that the changes made to existing, legally marketed predicate devices (primarily packaging and associated manufacturing/labeling updates) do not negatively impact the device's safety and effectiveness.

Here's how to interpret the provided document in the context of your questions:

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

The document doesn't present a table of specific numerical acceptance criteria and performance for a diagnostic algorithm. Instead, the acceptance criteria are met by demonstrating that the modified device (new packaging configuration for an existing device) maintains the same performance and safety profile as the predicate device.

Acceptance Criteria Category	Reported Device Performance (Summary from K193379)
Functional/Performance	Product Performance testing evaluation and Product Test / Balloon Inflation test demonstrated that the final device is not affected by the change in packaging configuration. The device's fundamental function (e.g., balloon inflation, catheter body integrity) remains consistent with the predicate.
Packaging Integrity	Packaging testing in accordance to ISO 11607-1 (Packaging for Terminally Sterilized Medical Devices) was successfully completed. This ensures the packaging maintains sterility and protects the device throughout its shelf life and distribution.
Sterilization Efficacy	Sterilization testing in accordance to ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide) was performed to ensure the new packaging configuration can be effectively sterilized while meeting established requirements for development, validation, and routine control of the sterilization process.
Biocompatibility/Safety	EO/ ECH residuals evaluation in accordance to ISO 10993-7:2008 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals) was conducted. This ensures any residues from the ethylene oxide sterilization process are within safe limits, indicating continued biocompatibility. Biocompatibility evaluations were conducted to ensure the change in final packaging did not alter the performance or safety of the subject devices (though specific tests aren't detailed, ISO 10993 series are often used).
Overall Equivalence	"The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe models have successfully passed performance, packaging, sterility assurance and EO/ECH residuals testing demonstrating that the subject devices are substantially equivalent to the predicate devices." The core "performance" is that the device (catheter) physically performs as intended for its stated Indications for Use, which is implicitly demonstrated by the absence of negative impact from packaging changes and by comparing it to the pre-amendment predicate device. The new model numbers, labels, and IFU updates stemming from the packaging change were also part of this evaluation.

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

This is not applicable to this type of 510(k) submission. The "test set" here refers to the actual physical devices and packaging subjected to the engineering and biocompatibility tests. The document does not specify exact sample sizes for each test (e.g., how many catheters were tested for balloon inflation, how many packaging samples for integrity). Data provenance (country of origin, retrospective/prospective) is not relevant to these engineering and material tests.

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

Not applicable. "Ground truth" in the context of device performance in this 510(k) is established by adherence to recognized international standards (e.g., ISO 11607-1, ISO 11135, ISO 10993-7) and internal company specifications for manufacturing and quality control. There isn't an "expert" panel adjudicating test results in the same way they would for a diagnostic AI's clinical performance.

4. Adjudication method for the test set

Not applicable. Test results are evaluated against predetermined pass/fail criteria defined by the relevant standards and internal specifications, rather than through an adjudication process involving multiple human experts.

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. This device is a physical embolectomy catheter and biliary balloon probe, not a diagnostic AI or CADe system. Therefore, MRMC studies are not relevant.

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

Not applicable, as this is not an AI/algorithm-driven device.

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

The "ground truth" for the tests performed (packaging, sterilization, material safety, basic functional performance) is based on:

International standards: ISO 11607-1, ISO 11135, ISO 10993-7 provide the objective criteria for what constitutes acceptable performance and safety.
Predicate device characteristics: The modified device must perform equivalently to the existing, legally marketed predicate device, which inherently established its "ground truth" for safety and effectiveness in its original clearance.
Engineering specifications: The manufacturer's own design and quality specifications for the device's materials, dimensions, and function.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 12, 2020

Edwards Lifesciences, LLC Wendy Gonzalez Associate Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K193379

Trade/Device Name: Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe Regulation Number: 21 CFR 870.5150 and 21 CFR 876.5010 Regulation Name: Embolectomy Catheter and Biliary Catheter and Accessories Regulatory Class: Class II Product Code: DXE, GCA Dated: May 18, 2020 Received: May 20, 2020

Dear Ms. Gonzalez:

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 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

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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 (QS) 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.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention 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) K193379

Device Name

Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe

Indications for Use (Describe)

Fogarty Arterial Embolectomy Catheter:

The Fogarty Arterial Embolectorny Catheter is indicated for the removal and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended.

Fogarty Biliary Balloon Probe:

The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.

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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510(K) SUMMARY

Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Wendy Vera GonzálezAssociate Manager, Regulatory AffairsEdwards Lifesciences(949) 250- 2500
Date Prepared	June 9, 2020
Trade Name	Fogarty Arterial EmbolectomyCatheter	Fogarty Biliary Balloon Probe
RegulationDescription	Embolectomy Catheter	Biliary catheter and accessories
Regulation Class /Product Code	Class IIDXE	Class IIGCA
PredicateDevice(s)	Pre-amendment	Pre-amendment
RegulationNumber	21 CFR 870.5150	21 CFR 876.5010
DeviceDescription	Fogarty Arterial Embolectomy CatheterThe Fogarty Arterial Embolectomy Catheter consists of a catheterbody tube made out of polyvinyl chloride (PVC) or nylon (3F only)of 40, 60, or 80 cm lengths.The catheter contains a latex balloon at the distal end and a PVChub at the proximal end for connection to a syringe for ballooninflation. They contain a soft, rounded tip, which promotes easyarterial insertion.The model with an “S” has a stylet at the proximal end to supportthe inflation lumen during shipping and storage.These devices are provided sterile and labeled for single use only.
Fogarty Biliary Balloon Probe
The Fogarty Biliary Balloon Probe consists of a single-lumenpolyvinyl chloride (PVC) catheter body with a latex balloon at thedistal end. A hub at the proximal end is used for balloon inflation.
A flexible stylet is provided with Fogarty Biliary Balloon Probe.The stylet is of a designed stiffness intended to avoid perforationand yet maintain enough shape to facilitate introduction of theprobe into areas of sharp angulation. These devices are providedsterile and labeled for single use only. The Fogarty Biliary BalloonProbe is not intended to be used with other devices.
Indications forUse/Intended Use	The Fogarty Arterial Embolectomy Catheter is indicated for theremoval of fresh, soft emboli and thrombi from vessels in thearterial system. To remove fibrous or adherent material, alternativedevices such as the Fogarty Adherent Clot and GraftThrombectomy Catheter are recommended.
	The Fogarty Biliary Balloon Probe is indicated for the removal ofstones and ductal debris and exploration.
ComparativeAnalysis	The subject device is identical to the predicate devices in terms ofintended use, indications for use, and technology. The proposedchanges involve the creation of new model numbers for the existinglegally marketed device with a new packaging configuration, newlabels and updates to the IFU as a result of the new model numbers.
	Packaging design verification, sterilization (EO resistance andresiduals), product performance and biocompatibility evaluationswere conducted to ensure that the change in final packaging did notalter the performance of the subject devices.
	The subject Fogarty Arterial Embolectomy Catheter and FogartyBiliary Balloon Probe, have been shown to be substantiallyequivalent to the predicate devices for its intended use in hospitalsand other appropriate clinical environments.
Functional/ SafetyTesting	The Fogarty Arterial Embolectomy Catheter and Fogarty BiliaryBalloon Probe with new packaging configuration are identical to thepredicate device in terms of final device and indications for use. Toensure that the Fogarty Arterial Embolectomy Catheter and FogartyBiliary Balloon Probe with new packaging configuration did notraise any new concerns of safety and effectiveness, and aresubstantially equivalent to the predicate devices, the followingevaluation and testing were performed:Product Performance testing evaluation and Product Test/Balloon Inflation test to demonstrate final device is notaffected.
	> Packaging testing in accordance to ISO 11607-1 – Packagingfor 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 routingcontrol 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 Arterial Embolectomy Catheter and Fogarty BiliaryBalloon Probe models have successfully passed performance,packaging, sterility assurance and EO/ECH residuals testingdemonstrating that the subject devices are substantially equivalent tothe predicate devices.
Conclusion	The Fogarty Arterial Embolectomy Catheter and Fogarty BiliaryBalloon Probe are substantially equivalent to the predicate device.

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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).