(53 days)
The Fogarty Fortis Arterial Embolectomy Catheters are indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial system.
The Fogarty Fortis Arterial Embolectomy Catheters provide a means of clearing emboli and thrombi from vessels in the arteries of the peripheral system 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 4F and are available in 40 cm and 80 cm lengths. The device consists of a radiopaque catheter shaft with an integrated elastomeric latex balloon and an atraumatic tip that is inserted surgically into arterial vessels of the peripheral system. A hub at the proximal end is used for balloon inflation.
This document is a 510(k) summary for the Fogarty Fortis Arterial Embolectomy Catheter. It outlines the device description, indications for use, and a comparative analysis to a predicate device. The document states that "All testing met the existing predetermined acceptance criteria." However, it does not provide any specific acceptance criteria or detailed study results for device performance.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria and the study proving the device meets them because it is not present in the provided text.
Based on the available information:
- 1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document only states, "All testing met the existing predetermined acceptance criteria."
- 2. Sample size used for the test set and the data provenance: This information is not provided. The document mentions "Bench testing was performed in accordance with Edwards' current design requirements," but no details on sample size or data provenance are given.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- 4. Adjudication method for the test set: This information is not provided.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a medical device (catheter), not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm, so this concept is not applicable.
- 7. The type of ground truth used: For a physical medical device like an embolectomy catheter, "ground truth" would typically refer to established engineering standards, biocompatibility testing guidelines (e.g., ISO 10993-1), and internal design requirements. The document states:
- "Biocompatibility testing was performed in accordance with ISO 10993-1: 2018..."
- "Bench testing was performed in accordance with Edwards' current design requirements."
- 8. The sample size for the training set: This is a physical medical device, not a machine learning model, so there is no "training set."
- 9. How the ground truth for the training set was established: Not applicable, as there is no training set.
The document focuses on substantiating equivalence to a predicate device through bench testing and biocompatibility assessments, stating that the new device meets "existing predetermined acceptance criteria" without detailing what those criteria are or the specific performance metrics achieved.
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July 2, 2024
Edwards Lifesciences Aeree Lee Sr Manager, Regulatory Affairs 1 Edwards Way Irvine, California 92614
Re: K241330
Trade/Device Name: Fogarty Fortis Arterial Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: May 10, 2024 Received: May 10, 2024
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 (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 (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,
Image /page/1/Picture/7 description: The image shows the name Gregory W. O'connell -S. It also shows that it was digitally signed by Gregory W. O'connell -S on 2024.07.02 at 15:15:44 -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)
Device Name
Fogarty Fortis Arterial Embolectomy Catheter
Indications for Use (Describe)
The Fogarty Fortis Arterial Embolectomy Catheters are indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial system.
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 Fortis Arterial Embolectomy Catheter | ||
|---|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLCOne Edwards WayIrvine, CA 92614 | |
| Contact Person | Primary Contact | Secondary Contact |
| Aeree Lee | Karen O'Leary | |
| Sr. Manager, Regulatory Affairs | Sr. Director, Regulatory Affairs | |
| Edwards Lifesciences LLC | Edwards Lifesciences LLC | |
| One Edwards Way, | One Edwards Way, | |
| Irvine, CA USA, 92614 | Irvine, CA USA, 92614 | |
| Tel.: (949) 250-5155 | Tel.: (949) 250-0715 | |
| Email: aeree_lee@edwards.com | Email: karen_oleary@edwards.com | |
| Date Prepared | July 1, 2024 | |
| Trade Name | Fogarty Fortis Arterial Embolectomy Catheter | |
| RegulationNumber / Name | 21 CFR 870.5150 / Embolectomy catheter | |
| Product Code | DXE | |
| Regulation Class | Class II | |
| Predicate Device | Preamendment Fogarty Arterial Embolectomy Catheter (Preamendment statusgranted on May 20, 2020) | |
| DeviceDescription | The Fogarty Fortis Arterial Embolectomy Catheters provide a means of clearingemboli and thrombi from vessels in the arteries of the peripheral system throughinflation of the balloon and engagement with the arterial wall beyond thevascular obstruction followed by gentle withdrawal of the catheter therebyremoving the obstruction from its position.The device catheter size is 4F and are available in 40 cm and 80 cm lengths. Thedevice consists of a radiopaque catheter shaft with an integrated elastomericlatex balloon and an atraumatic tip that is inserted surgically into arterial vesselsof the peripheral system. A hub at the proximal end is used for balloon inflation. | |
| Indications forUse | The Fogarty Fortis Arterial Embolectomy Catheters are indicated for use in adultpatients for the removal of fresh, soft emboli and thrombi from vessels in theperipheral arterial system. | |
| ComparativeAnalysis | The subject device is identical to the predicate device in terms of the intendeduse, indications for use, and technological characteristics, except for the catheterbody tubing material and the balloon wall dimension to the subject device toallow for withstanding a greater pull-force. The differences do not raise any newconcerns of safety and effectiveness. Verification for the subject devicesdemonstrate substantial equivalence to the predicates. The provided benchtesting demonstrates the subject devices are substantially equivalent to thepredicates. | |
| Device Testing | Biocompatibility testing was performed in accordance with ISO 10993-1: 2018 –Biological evaluation of medical devices – Part 1: Evaluation and testing within |
510(K) SUMMARY
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| Fogarty Fortis Arterial Embolectomy Catheter |
|---|
| 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 designrequirements. In addition, shelf-life, packaging, and sterilization validationshave been performed to existing specifications. |
| All testing met the existing predetermined acceptance criteria. |
| Conclusion |
| Based on the performance testing and the technological characteristics, theFogarty Fortis Arterial Embolectomy Catheters meet the establishedperformance criteria and are substantially equivalent to the predicate FogartyArterial Embolectomy Catheters. |
§ 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).