(230 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biological compatibility of a catheter, with no mention of AI or ML technologies.
Yes
The device is used to remove emboli and thrombi from vessels and for temporary occlusion of blood vessels, which directly addresses a medical condition or alters the structure or function of the body.
No
The device is intended for the removal of emboli and thrombi, temporary occlusion, fluid infusion, and blood sampling, which are interventional or procedural uses, not diagnostic.
No
The device description clearly details a physical catheter with a balloon and stylet, indicating it is a hardware 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description of the Fogarty thru-lumen embolectomy catheter clearly indicates it is a device used within the body for procedures like removing emboli and thrombi from blood vessels, temporary occlusion, fluid infusion, and blood sampling. These are all in vivo procedures.
- Lack of IVD Characteristics: The description does not mention any reagents, test kits, or analysis of samples outside the body, which are hallmarks of IVDs.
Therefore, the Fogarty thru-lumen embolectomy catheter is an invasive surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
DXE, KRA
Device Description
The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a latex balloon at the distal end. One lumen is used for balloon inflation and is accessed through the gate valve at the proximal end. The thru-lumen is used for infusion of fluids, sampling of blood or guidewire passage through the distal tip. A removable stainless steel stylet(s) is provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the arteries of the peripheral vasculature
Indicated Patient Age Range
adults
Intended User / Care Setting
general surgical procedures.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
August 28, 2024
Edwards Lifesciences, LLC Carmen Chen Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K240078
Trade/Device Name: Fogarty Thru-Lumen Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: July 25, 2024 Received: July 25, 2024
Dear Carmen Chen:
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"
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(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).
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 OS 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 Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2024.08.28 shakoor -S 13:34:33 -04'00'
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices
2
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
Submission Number (if known)
Device Name
Fogarty Thru-Lumen Embolectomy Catheter
Indications for Use (Describe)
The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.
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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| Fogarty Thru-Lumen Embolectomy Catheter | ||
|---|---|---|
| 510(k) | ||
| Submitter | Edwards Lifesciences, LLC | |
| One Edwards Way, Irvine, CA 92614 | ||
| Contact Person | Primary Contact | |
| Carmen G. Chen | ||
| Manager, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Telephone: (949) 250 - 5469 | ||
| Email: Carmen_Chen@edwards.com | Secondary Contact | |
| Karen O'Leary | ||
| Sr. Director, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Telephone: (949) 610-9179 | ||
| Email: Karen_OLeary@edwards.com | ||
| Date Prepared | August 26, 2024 | |
| Trade Name | Fogarty Thru-Lumen Embolectomy Catheter | |
| Regulation | ||
| Number / Name | 21 CFR 870.5150 / Embolectomy Catheter | |
| Product Code | DXE, KRA | |
| Regulation | ||
| Class | Class II | |
| Predicate | ||
| Device | Fogarty Thru-Lumen Embolectomy Catheter cleared under K892410 on July 20, | |
| 1989 | ||
| Device | ||
| Description | The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a | |
| latex balloon at the distal end. One lumen is used for balloon inflation and is | ||
| accessed through the gate valve at the proximal end. The thru-lumen is used for | ||
| infusion of fluids, sampling of blood or guidewire passage through the distal tip. A | ||
| removable stainless steel stylet(s) is provided. | ||
| Indications for | ||
| Use | The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the | |
| removal of fresh, soft emboli and thrombi from vessels in the arteries of the | ||
| peripheral vasculature. Additionally, it may also be used for temporary occlusion of | ||
| blood vessels, infusion of fluids, and blood sampling in general surgical | ||
| procedures. | ||
| 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). | ||
| 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: | ||
| Evaluation and testing within a risk management process", issued on September 4, |
- | |
| Fogarty Thru-Lumen Embolectomy Catheter | | |
| | 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 Thru-Lumen Embolectomy Catheter meets the established performance criteria and is substantially equivalent to the predicate device Fogarty Thru-Lumen Embolectomy Catheters. | |
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