Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

K233619 · Edwards Lifesciences · DXE · May 20, 2024 · Cardiovascular

Device Facts

• Record ID: K233619
• Device Name: Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
• Applicant: Edwards Lifesciences
• Product Code: DXE · Cardiovascular
• Decision Date: May 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the peripheral arterial vasculature in either native vessels or synthetic grafts. The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo-femoral bypass in the peripheral arterial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic pain at rest, or ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge graft include the inability to properly dialyse the patient.

Device Story

Sterile, single-use flexible catheters for mechanical thrombectomy; used in peripheral arterial vasculature. Fogarty Corkscrew Catheter: PVC outer body; radiopaque stainless steel spring; distal spiral-shaped stainless steel cable covered by latex membrane; handle modulates spiral diameter to entrap fibrous material. Fogarty Graft Thrombectomy Catheter: Handle-controlled distal spiral wires; wires extend for passage through narrowed vessels and retract to facilitate removal of organized thrombus/adherent material from synthetic grafts. Operated by clinicians in clinical settings. Output is physical removal of occlusive material; benefits include restoration of blood flow in obstructed grafts or vessels, addressing conditions like claudication, ischemia, or dialysis access failure.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2018. Shelf-life, packaging, and sterilization validations completed. No clinical data provided.

Technological Characteristics

Materials: Polyvinylchloride (PVC) outer body, stainless steel spring/cable, latex membrane. Principle: Mechanical thrombectomy via distal spiral wire expansion/retraction. Form factor: Flexible catheter with proximal handle control. Sterilization: Validated. Software: None.

Indications for Use

Indicated for adult patients with emboli/thrombi in peripheral arterial vasculature (native vessels or synthetic grafts) or requiring removal of organized thrombus/adherent material from synthetic bypass grafts (AV dialysis access or ileo-femoral bypass).

Regulatory Classification

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.

Predicate Devices

• Fogarty Arterial Embolectomy II Catheters (K901625)
• Intramed® Graft Thrombectomy Instrument Set (K942457)

Submission Summary (Full Text)

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May 20, 2024

Edwards Lifesciences Aeree Lee Sr Manager, Regulatory Affairs 1 Edwards Way Irvine, California 92614

# Re: K233619

Trade/Device Name: Fogarty Corkscrew Catheters (140806, 140808, 1408010); Fogarty Graft Thrombectomy Catheters (160245F, 160246F) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: November 9, 2023 Received: November 13, 2023

Dear Aeree Lee:

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 and Part 809); 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory W. Digitally signed by O'connell -S Date: 2024.05.20

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) K233619

Device Name

Fogarty Corkscrew Catheters (140806, 140808, 1408010)

Indications for Use (Describe)

The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the perial vasculature in either native vessels or synthetic grafts.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Indications for Use

510(k) Number (if known) K233619

#### Device Name

Fogarty Graft Thrombectomy Catheters (160245F and 160246F)

### Indications for Use (Describe)

The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo-femoral bypass in the perial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge the inability to properly dialyse the patient.

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 [e-mail]

"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."

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# K233619 510(K) SUMMARY

| 510(k)<br>Submitter | Edwards Lifesciences, LLC<br>One Edwards Way<br>Irvine, CA, USA 92614 | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Primary Contact | Secondary Contact |
| Contact Person | Aeree Lee<br>Sr. Manager, Regulatory Affairs<br>Edwards Lifesciences LLC<br>One Edwards Way,<br>Irvine, CA 92614<br>Telephone: [phone]<br>Email: [e-mail] | Karen O'Leary<br>Sr. Director, Regulatory Affairs<br>Edwards Lifesciences LLC<br>One Edwards Way,<br>Irvine, CA USA, 92614<br>Tel.: [phone]<br>Email: [e-mail] |
| Date Prepared | May 16, 2024 | |
| Trade Name | Fogarty Corkscrew Catheters (140806, 140808, 1408010)<br>Fogarty Graft Thrombectomy Catheters (160245F and 160246F) | |
| Regulation<br>Number/<br>Regulation<br>Name | 21 CFR 870.5150; Embolectomy catheter | |
| Product Code | DXE | |
| Regulation Class | II | |
| Predicate Device | Fogarty Arterial Embolectomy II Catheters (K901625, cleared on July 06, 1990)<br>Intramed® Graft Thrombectomy Instrument Set (K942457, cleared on February 07, 1995) | |
| Device<br>Description | <b>Fogarty Corkscrew Catheters:</b><br>The Fogarty Corkscrew Catheters are sterile, single use flexible catheters consisting<br>of a polyvinylchloride outer catheter body surrounding a movable, radiopaque<br>stainless steel spring body. A second radiopaque, spiral-shaped, stainless steel cable<br>covered by a latex membrane is attached to the distal end of the catheter. A handle<br>to modulate the spiral cable diameter is attached to the inner spring body at the<br>proximal end of the catheter. The spiral cable design of the Fogarty Corkscrew<br>catheter increases the surface area for entrapping fibrous material.<br><br><b>Fogarty Graft Thrombectomy Catheters:</b><br>The Fogarty Graft Thrombectomy catheters are sterile, single use catheters<br>designed to remove organized thrombus and adherent non-thrombotic material<br>from synthetic bypass grafts, specifically synthetic arterial vasculature fistulas for | |
| | dialysis access and synthetic grafts for iliofemoral bypass. During use, the control<br>button on the device handle is grasped and moved forward and aft to cause the<br>spiral wires at the distal end to extend or retract. The spiral wires are extended<br>during passage of the device through a narrowed region of a vessel. The spiral<br>wires are then retracted to facilitate occlusive material removal. | |
| | <b>Fogarty Corkscrew Catheters:</b> | |
| | The Fogarty Corkscrew Catheter is indicated for use in adult patients with<br>emboli/thrombi in the peripheral arterial vasculature in either native vessels or<br>synthetic grafts. | |
| | <b>Fogarty Graft Thrombectomy Catheters:</b> | |
| Indications for<br>Use | The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for<br>the removal of organized thrombus and adherent non-thrombotic material from<br>synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis<br>access and synthetic grafts for ileo-femoral bypass in the peripheral arterial<br>vasculature. General indications for arterial reconstruction of an obstructed graft<br>include disabling claudication, ischemic pain at rest, or ischemic skin lesions or<br>gangrene. General indications for reconstruction of a synthetic AV fistula internal<br>bridge graft include the inability to properly dialyse the patient. | |
| Comparison to<br>Predicate Device | The Fogarty Corkscrew and Graft Thrombectomy Catheters are substantially<br>equivalent to their predicate devices. The subject devices' indications for use were<br>clarified within the existing intended use and are similar to the predicate devices'<br>indications for use. | |
| | The Fogarty Corkscrew and Graft Thrombectomy Catheters have the same<br>technological characteristics as their predicate devices, with the exception of minor<br>modifications that have occurred to the design, materials, and device packaging. The<br>differences do not raise any new questions of safety and effectiveness. The provided<br>bench testing demonstrates the subject devices are substantially equivalent to the<br>predicates. | |
| Device Testing | Biocompatibility testing was performed in accordance with ISO 10993-1: 2018 –<br>Biological evaluation of medical devices – Part 1: Evaluation and testing within a<br>risk management process, and FDA guidance document, Use of International<br>Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1:<br>Evaluation and testing within a risk management process”, issued on September 4,<br>2020.<br>Bench testing was performed in accordance with Edwards' design requirements. In<br>addition, shelf-life, packaging, and sterilization validations have been performed. | |
| Conclusion | Based on the performance testing and the technological characteristics, the Fogarty<br>Corkscrew and Fogarty Graft Thrombectomy Catheters meet the established<br>performance criteria and are substantially equivalent to the predicate devices. | |

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