Fogarty Venous Thrombectomy Catheters

K233819 · Edwards Lifesciences, LLC · DXE · May 22, 2024 · Cardiovascular

Device Facts

• Record ID: K233819
• Device Name: Fogarty Venous Thrombectomy Catheters
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXE · Cardiovascular
• Decision Date: May 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fogarty Venous Thrombectomy Catheters are indicated for use in the peripheral venous vasculature of adult patients for the removal of emboli and thrombi, and may be used for temporary vessel occlusion.

Device Story

Fogarty Venous Thrombectomy Catheter; long, soft-tipped catheter designed for peripheral venous thrombectomy; facilitates advancement past venous valves; minimizes trauma; spring-wound body provides flexibility; braided cover provides strength; single-handed gate valve operation; minimizes leakage; available in 6F, 8F, and 8/10F sizes; color-coded body for identification; used by clinicians in clinical settings; removes emboli/thrombi; provides temporary vessel occlusion; benefits patient by restoring venous flow.

Clinical Evidence

Bench testing only. Includes design verification, biocompatibility (ISO 10993-1:2018), shelf-life, packaging, and sterilization validation. Results met all specifications and acceptance criteria.

Technological Characteristics

Spring-wound body with braiding; gate valve mechanism; 6F, 8F, 8/10F sizes; color-coded; biocompatibility per ISO 10993-1:2018.

Indications for Use

Indicated for adult patients requiring removal of emboli and thrombi from peripheral venous vasculature or temporary vessel occlusion.

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

• Preamendment Fogarty Venous Thrombectomy Catheters

Submission Summary (Full Text)

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May 22, 2024

Edwards Lifesciences, LLC Unji Lee Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K233819

Trade/Device Name: Fogarty Venous Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 30, 2023 Received: December 1, 2023

Dear Unji 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 (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" (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).

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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 QS 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory W. O'connell - S

Digitally signed by Gregory W. O'connell -S Date: 2024.05.22 10:25:26 -04'00

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

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## Indications for Use

Submission Number (if known)

K233819

Device Name

Fogarty Venous Thrombectomy Catheter

Indications for Use (Describe)

Fogarty Venous Thrombectomy Catheters are indicated for use in the peripheral venous vasculature of adult patients for the removal of emboli and thrombi, and may be used for temporary vessel occlusion.

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 VENOUS THROMBECOTMY CATHETERS

| 510(k) Submitter | Edwards Lifesciences, LLC<br>One Edwards Way<br>Irvine, CA, USA 92614 | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Primary Contact:<br>Unji Lee<br>Specialist, Regulatory Affairs<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Tel: [phone]<br>Email: [e-mail] | Secondary Contact:<br>Aditi Iyengar<br>Sr. Manager, Regulatory Affairs<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Tel: [phone]<br>Email: [e-mail] |
| Date Prepared | November 30, 2023 | |
| Trade Name | Fogarty Venous Thrombectomy Catheter | |
| Regulation<br>Number /<br>Regulation Name | 21 CFR 870.5150 / Embolectomy Catheter | |
| Product Code | DXE | |
| Regulation Class | Class II | |
| Predicate Device | Preamendment Fogarty Venous Thrombectomy Catheters | |
| Device<br>Description | Fogarty venous thrombectomy catheters are specifically designed for the<br>performance of venous thrombectomy in adult patients. Fogarty venous<br>thrombectomy catheters have a long, soft tip which is intended to facilitate<br>advancement past the venous valves while minimizing trauma. The flexibility<br>required for the venous procedure is supplied by the spring-wound body. The<br>spring is covered with a braiding for additional strength. The gate valve is<br>designed for single-handed operation and to minimize the possibility of leakage.<br>The gate valve has an arrow to indicate the "open" and "closed" positions. There<br>are three available catheter sizes (6 French (2.0 mm), 8 French (2.7 mm), and<br>8/10 French (2.7/3.3 mm)). Each may be quickly identified by the color-coded<br>body. The size and filling capacity are printed on each catheter. | |
| Indications<br>for Use | Fogarty Venous Thrombectomy Catheters are indicated for use in the<br>peripheral venous vasculature of adult patients for the removal of emboli and<br>thrombi, and may be used for temporary vessel occlusion. | |
| Comparison to<br>Predicate Device | The subject Fogarty Venous Thrombectomy Catheters are substantially equivalent<br>to the preamendment Fogarty Venous Thrombectomy Catheters.<br><br>The Fogarty Venous Thrombectomy Catheters have the same intended use and<br>technological characteristics as the predicate devices, with the exception of minor<br>modifications that have occurred to the design, materials, and device packaging.<br>These differences do not raise any new concerns of safety and effectiveness. | |
| | Bench testing inclusive of design verification, packaging, sterilization, and<br>biocompatibility testing all demonstrate that the subject devices are substantially<br>equivalent to the predicate devices. | |
| 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<br>4, 2020.<br>Bench testing was performed in accordance with Edwards' design requirements.<br>In addition, shelf-life, packaging, and sterilization validations have been<br>performed. The results of the testing demonstrated that the Fogarty Venous<br>Thrombectomy Catheters met all existing specifications and acceptance criteria. | |
| Conclusion | Based on the performance testing and the technological characteristics, the<br>Fogarty Venous Thrombectomy Catheters meet the established performance<br>criteria and have been shown to be substantially equivalent to the predicate<br>devices. | |

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