(173 days)
Preamendment Fogarty Arterial Embolectomy Catheter
Not Found
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI/ML terms or data processing.
Yes
The device is used for the removal of emboli and thrombi from blood vessels in the peripheral arterial vasculature, which directly treats a medical condition.
No
This device is designed for therapeutic removal of emboli and thrombi, not for diagnosing medical conditions.
No
The device description clearly outlines a physical catheter with a balloon and gate valve, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This examination is performed outside of the living body.
- Device Function: The description clearly states that the Fogarty arterial embolectomy catheter is used to physically remove emboli and thrombi from vessels within the peripheral arterial vasculature of adult patients. This is an interventional procedure performed inside the body.
- Lack of Specimen Examination: There is no mention of the device being used to analyze or examine any bodily fluids or tissues in vitro.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fogarty arterial embolectomy catheter with gate valve is indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial vasculature.
Product codes
DXE
Device Description
The Fogarty Arterial Embolectomy Catheter with Gate Valve provides a means of clearing emboli and thrombi from vessels in the arteries of the peripheral vasculature through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 2F and is available in 45 cm length. The catheter contains a latex balloon at the distal end and a gate valve at the proximal end for connection to a syringe for balloon inflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the peripheral arterial vasculature
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was performed in accordance with ISO 10993-1: 2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and FDA guidance document, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”, issued on September 4, 2020. Bench testing was performed in accordance with Edwards’ current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. All testing met the existing predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Preamendment Fogarty Arterial Embolectomy Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
May 22, 2024
Edwards Lifesciences Yagna Angirish Sr. Regulatory Affairs Specialist 1 Edwards Way Irvine, California 92614
Re: K233820
Trade/Device Name: Fogarty Arterial Embolectomy Catheter with Gate Valve 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 Yagna Angirish:
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/cdrb/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).
1
Your device is also subject to, among other requirements, the Quality System (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S Date: 2024.05.22 O'connell - S 12:31:23 -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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Fogarty Arterial Embolectomy Catheter with Gate Valve
Indications for Use (Describe)
The Fogarty arterial embolectomy catheter with gate valve is indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial vasculature.
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 PRAStaff(@fda.hhs.gov
"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."
3
| Fogarty Arterial Embolectomy Catheter with Gate Valve | ||
|---|---|---|
| 510(k) | ||
| Submitter | Edwards Lifesciences, LLC | |
| One Edwards Way, Irvine, CA 92614 | ||
| (949) 250-1119 | ||
| Contact Person | Primary Contact | Secondary Contact |
| Yagna Angirish | ||
| Sr. Specialist, Regulatory Affairs | Aeree Lee | |
| Sr. Manager, Regulatory Affairs | ||
| Edwards Lifesciences LLC | Edwards Lifesciences LLC | |
| One Edwards Way, | ||
| Irvine, CA USA, 92614 | One Edwards Way, | |
| Irvine, CA USA, 92614 | ||
| Tel.: (949) 250-1119 | Tel.: (949) 250-5155 | |
| Email: yagna_angirish@edwards.com | Email: aeree_lee@edwards.com | |
| Date Prepared | May 20, 2024 | |
| Trade Name | Fogarty Arterial Embolectomy Catheter with Gate Valve | |
| Regulation | ||
| Number / Name | 21 CFR 870.5150 / Embolectomy catheter | |
| Product Code | DXE | |
| Regulation | ||
| Class | Class II | |
| Predicate | ||
| Device | Preamendment Fogarty Arterial Embolectomy Catheter | |
| Device | ||
| Description | The Fogarty Arterial Embolectomy Catheter with Gate Valve provides a means of | |
| clearing emboli and thrombi from vessels in the arteries of the peripheral | ||
| vasculature through inflation of the balloon and engagement with the arterial wall | ||
| beyond the vascular obstruction followed by gentle withdrawal of the catheter | ||
| thereby removing the obstruction from its position. | ||
| The device catheter size is 2F and is available in 45 cm length. The catheter | ||
| contains a latex balloon at the distal end and a gate valve at the proximal end for | ||
| connection to a syringe for balloon inflation. | ||
| Indications for | ||
| Use | The Fogarty Arterial Embolectomy Catheter with Gate Valve is indicated for use | |
| in adult patients for the removal of fresh, soft emboli and thrombi from vessels in | ||
| the peripheral arterial vasculature. | ||
| Comparative | ||
| Analysis | The subject device is identical to the predicate device in terms of the intended use, | |
| indications for use, and technological characteristics (including design, material, | ||
| chemical composition, principle of operation), except for a gate valve at the | ||
| proximal end rather than a hub. | ||
| Device Testing | Biocompatibility testing was performed in accordance with ISO 10993-1: 2018 – | |
| Biological evaluation of medical devices – Part 1: Evaluation and testing within a | ||
| risk management process, and FDA guidance document, Use of International | ||
| Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: | ||
| Fogarty Arterial Embolectomy Catheter with Gate Valve | ||
| Evaluation and testing within a risk management process”, issued on September 4, 2020. | ||
| Bench testing was performed in accordance with Edwards’ current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. | ||
| All testing met the existing predetermined acceptance criteria. | ||
| Conclusion | Based on the performance testing and the technological characteristics, the Fogarty Arterial Embolectomy Catheter with Gate Valve meets the established performance criteria and is substantially equivalent to the predicate device Fogarty Arterial Embolectomy Catheters. |
510(K) SUMMARY
4