Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe

K193379 · Edwards Lifesciences, LLC · DXE · Jun 12, 2020 · Cardiovascular

Device Facts

• Record ID: K193379
• Device Name: Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXE · Cardiovascular
• Decision Date: Jun 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe are manual surgical instruments used in clinical environments. The Arterial Embolectomy Catheter features a PVC or nylon body (40-80 cm) with a distal latex balloon and proximal hub for syringe-based inflation; a soft, rounded tip facilitates arterial insertion. The Biliary Balloon Probe consists of a single-lumen PVC catheter with a distal latex balloon and a flexible stylet for navigation through sharp angulations. Both devices are single-use, sterile, and manually operated by clinicians. The balloon is inflated via syringe to engage and remove thrombi or stones from the target vessel or duct. These devices provide mechanical assistance for clot or stone extraction, aiding in the restoration of flow or clearance of obstructions.

Clinical Evidence

Bench testing only. Evaluations included product performance testing, balloon inflation testing, packaging validation (ISO 11607-1), sterilization validation (ISO 11135:2014), and ethylene oxide/ethylene chlorohydrin residuals evaluation (ISO 10993-7:2008).

Technological Characteristics

Catheter body: PVC or nylon (3F only). Balloon: Latex. Stylet: Flexible material for stiffness/navigation. Energy source: Manual (syringe-based inflation). Connectivity: None. Sterilization: Ethylene oxide (EO). Form factor: 40, 60, or 80 cm lengths.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from arterial vessels (Arterial Embolectomy Catheter) and removal of stones and ductal debris and exploration (Biliary Balloon Probe).

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

• Pre-amendment devices

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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 González<br>Associate Manager, Regulatory Affairs<br>Edwards Lifesciences<br>(949) 250- 2500 | |
| Date Prepared | June 9, 2020 | |
| Trade Name | Fogarty Arterial Embolectomy<br>Catheter | Fogarty Biliary Balloon Probe |
| Regulation<br>Description | Embolectomy Catheter | Biliary catheter and accessories |
| Regulation Class /<br>Product Code | Class II<br>DXE | Class II<br>GCA |
| Predicate<br>Device(s) | Pre-amendment | Pre-amendment |
| Regulation<br>Number | 21 CFR 870.5150 | 21 CFR 876.5010 |
| Device<br>Description | Fogarty Arterial Embolectomy Catheter<br>The Fogarty Arterial Embolectomy Catheter consists of a catheter<br>body tube made out of polyvinyl chloride (PVC) or nylon (3F only)<br>of 40, 60, or 80 cm lengths.<br><br>The catheter contains a latex balloon at the distal end and a PVC<br>hub at the proximal end for connection to a syringe for balloon<br>inflation. They contain a soft, rounded tip, which promotes easy<br>arterial insertion.<br><br>The model with an “S” has a stylet at the proximal end to support<br>the inflation lumen during shipping and storage.<br><br>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<br>polyvinyl chloride (PVC) catheter body with a latex balloon at the<br>distal end. A hub at the proximal end is used for balloon inflation. | | |
| A flexible stylet is provided with Fogarty Biliary Balloon Probe.<br>The stylet is of a designed stiffness intended to avoid perforation<br>and yet maintain enough shape to facilitate introduction of the<br>probe into areas of sharp angulation. These devices are provided<br>sterile and labeled for single use only. The Fogarty Biliary Balloon<br>Probe is not intended to be used with other devices. | | |
| Indications for<br>Use/Intended Use | The Fogarty Arterial Embolectomy Catheter is indicated for the<br>removal of fresh, soft emboli and thrombi from vessels in the<br>arterial system. To remove fibrous or adherent material, alternative<br>devices such as the Fogarty Adherent Clot and Graft<br>Thrombectomy Catheter are recommended. | |
| | The Fogarty Biliary Balloon Probe is indicated for the removal of<br>stones and ductal debris and exploration. | |
| Comparative<br>Analysis | The subject device is identical to the predicate devices in terms of<br>intended use, indications for use, and technology. The proposed<br>changes involve the creation of new model numbers for the existing<br>legally marketed device with a new packaging configuration, new<br>labels and updates to the IFU as a result of the new model numbers. | |
| | Packaging design verification, sterilization (EO resistance and<br>residuals), product performance and biocompatibility evaluations<br>were conducted to ensure that the change in final packaging did not<br>alter the performance of the subject devices. | |
| | The subject Fogarty Arterial Embolectomy Catheter and Fogarty<br>Biliary Balloon Probe, have been shown to be substantially<br>equivalent to the predicate devices for its intended use in hospitals<br>and other appropriate clinical environments. | |
| Functional/ Safety<br>Testing | The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary<br>Balloon Probe with new packaging configuration are identical to the<br>predicate device in terms of final device and indications for use. To<br>ensure that the Fogarty Arterial Embolectomy Catheter and Fogarty<br>Biliary Balloon Probe with new packaging configuration did not<br>raise any new concerns of safety and effectiveness, and are<br>substantially equivalent to the predicate devices, the following<br>evaluation and testing were performed:<br>Product Performance testing evaluation and Product Test<br>/Balloon Inflation test to demonstrate final device is not<br>affected. | |
| | > Packaging testing in accordance to ISO 11607-1 – Packaging<br>for Terminally Sterilized Medical Devices.<br>> Sterilization testing in accordance to ISO 11135:2014 -<br>Sterilization of health-care products- Ethylene oxide-<br>Requirements for the development, validation and routing<br>control of a sterilization process for medical devices.<br>> EO/ ECH residuals evaluation in accordance to ISO10993-<br>7:2008 - Biological evaluation of medical devices – Part 7:<br>Ethylene oxide sterilization residuals. | |
| | The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary<br>Balloon Probe models have successfully passed performance,<br>packaging, sterility assurance and EO/ECH residuals testing<br>demonstrating that the subject devices are substantially equivalent to<br>the predicate devices. | |
| Conclusion | The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary<br>Balloon Probe are substantially equivalent to the predicate device. | |

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