(189 days)
The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the peripheral arterial vasculature in either native vessels or synthetic grafts.
The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo-femoral bypass in the peripheral arterial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic pain at rest, or ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge graft include the inability to properly dialyse the patient.
Fogarty Corkscrew Catheters:
The Fogarty Corkscrew Catheters are sterile, single use flexible catheters consisting of a polyvinylchloride outer catheter body surrounding a movable, radiopaque stainless steel spring body. A second radiopaque, spiral-shaped, stainless steel cable covered by a latex membrane is attached to the distal end of the catheter. A handle to modulate the spiral cable diameter is attached to the inner spring body at the proximal end of the catheter. The spiral cable design of the Fogarty Corkscrew catheter increases the surface area for entrapping fibrous material.
Fogarty Graft Thrombectomy Catheters:
The Fogarty Graft Thrombectomy catheters are sterile, single use catheters designed to remove organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arterial vasculature fistulas for dialysis access and synthetic grafts for iliofemoral bypass. During use, the control button on the device handle is grasped and moved forward and aft to cause the spiral wires at the distal end to extend or retract. The spiral wires are extended during passage of the device through a narrowed region of a vessel. The spiral wires are then retracted to facilitate occlusive material removal.
The provided text is a 510(k) summary for the Fogarty Corkscrew Catheters and Fogarty Graft Thrombectomy Catheters. This document details the regulatory clearance process for medical devices by demonstrating substantial equivalence to existing predicate devices.
Crucially, this document does NOT describe the acceptance criteria and study proving an AI/algorithm-based device meets acceptance criteria.
The Fogarty Corkscrew and Graft Thrombectomy Catheters are physical, mechanical medical devices used for embolectomy and thrombectomy. The "Device Testing" section explicitly states: "Bench testing was performed in accordance with Edwards' design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed."
Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI device based on the provided text, as the text pertains to traditional medical devices and their mechanical/biological performance, not AI performance.
If you have a different document describing an AI medical device, please provide that.
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May 20, 2024
Edwards Lifesciences Aeree Lee Sr Manager, Regulatory Affairs 1 Edwards Way Irvine, California 92614
Re: K233619
Trade/Device Name: Fogarty Corkscrew Catheters (140806, 140808, 1408010); Fogarty Graft Thrombectomy Catheters (160245F, 160246F) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: DXE Dated: November 9, 2023 Received: November 13, 2023
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 (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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory W. Digitally signed by O'connell -S Date: 2024.05.20
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) K233619
Device Name
Fogarty Corkscrew Catheters (140806, 140808, 1408010)
Indications for Use (Describe)
The Fogarty Corkscrew Catheter is indicated for use in adult patients with emboli/thrombi in the perial vasculature in either native vessels or synthetic grafts.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Indications for Use
510(k) Number (if known) K233619
Device Name
Fogarty Graft Thrombectomy Catheters (160245F and 160246F)
Indications for Use (Describe)
The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients for the removal of organized thrombus and adherent non-thrombotic material from synthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysis access and synthetic grafts for ileo-femoral bypass in the perial vasculature. General indications for arterial reconstruction of an obstructed graft include disabling claudication, ischemic skin lesions or gangrene. General indications for reconstruction of a synthetic AV fistula internal bridge the inability to properly dialyse the patient.
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."
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K233619 510(K) SUMMARY
| 510(k)Submitter | Edwards Lifesciences, LLCOne Edwards WayIrvine, CA, USA 92614 | |
|---|---|---|
| Primary Contact | Secondary Contact | |
| Contact Person | Aeree LeeSr. Manager, Regulatory AffairsEdwards Lifesciences LLCOne Edwards Way,Irvine, CA 92614Telephone: (949) 250-5155Email: aeree_lee@edwards.com | Karen O'LearySr. Director, Regulatory AffairsEdwards Lifesciences LLCOne Edwards Way,Irvine, CA USA, 92614Tel.: (949) 250-0715Email: karen_oleary@edwards.com |
| Date Prepared | May 16, 2024 | |
| Trade Name | Fogarty Corkscrew Catheters (140806, 140808, 1408010)Fogarty Graft Thrombectomy Catheters (160245F and 160246F) | |
| RegulationNumber/RegulationName | 21 CFR 870.5150; Embolectomy catheter | |
| Product Code | DXE | |
| Regulation Class | II | |
| Predicate Device | Fogarty Arterial Embolectomy II Catheters (K901625, cleared on July 06, 1990)Intramed® Graft Thrombectomy Instrument Set (K942457, cleared on February 07, 1995) | |
| DeviceDescription | Fogarty Corkscrew Catheters:The Fogarty Corkscrew Catheters are sterile, single use flexible catheters consistingof a polyvinylchloride outer catheter body surrounding a movable, radiopaquestainless steel spring body. A second radiopaque, spiral-shaped, stainless steel cablecovered by a latex membrane is attached to the distal end of the catheter. A handleto modulate the spiral cable diameter is attached to the inner spring body at theproximal end of the catheter. The spiral cable design of the Fogarty Corkscrewcatheter increases the surface area for entrapping fibrous material.Fogarty Graft Thrombectomy Catheters:The Fogarty Graft Thrombectomy catheters are sterile, single use cathetersdesigned to remove organized thrombus and adherent non-thrombotic materialfrom synthetic bypass grafts, specifically synthetic arterial vasculature fistulas for | |
| dialysis access and synthetic grafts for iliofemoral bypass. During use, the controlbutton on the device handle is grasped and moved forward and aft to cause thespiral wires at the distal end to extend or retract. The spiral wires are extendedduring passage of the device through a narrowed region of a vessel. The spiralwires are then retracted to facilitate occlusive material removal. | ||
| Fogarty Corkscrew Catheters: | ||
| The Fogarty Corkscrew Catheter is indicated for use in adult patients withemboli/thrombi in the peripheral arterial vasculature in either native vessels orsynthetic grafts. | ||
| Fogarty Graft Thrombectomy Catheters: | ||
| Indications forUse | The Fogarty Graft Thrombectomy Catheter is indicated for use in adult patients forthe removal of organized thrombus and adherent non-thrombotic material fromsynthetic bypass grafts, specifically synthetic arteriovenous grafts used for dialysisaccess and synthetic grafts for ileo-femoral bypass in the peripheral arterialvasculature. General indications for arterial reconstruction of an obstructed graftinclude disabling claudication, ischemic pain at rest, or ischemic skin lesions organgrene. General indications for reconstruction of a synthetic AV fistula internalbridge graft include the inability to properly dialyse the patient. | |
| Comparison toPredicate Device | The Fogarty Corkscrew and Graft Thrombectomy Catheters are substantiallyequivalent to their predicate devices. The subject devices' indications for use wereclarified within the existing intended use and are similar to the predicate devices'indications for use. | |
| The Fogarty Corkscrew and Graft Thrombectomy Catheters have the sametechnological characteristics as their predicate devices, with the exception of minormodifications that have occurred to the design, materials, and device packaging. Thedifferences do not raise any new questions of safety and effectiveness. The providedbench testing 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 arisk management process, and FDA guidance document, Use of InternationalStandard 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' design requirements. Inaddition, shelf-life, packaging, and sterilization validations have been performed. | |
| Conclusion | Based on the performance testing and the technological characteristics, the FogartyCorkscrew and Fogarty Graft Thrombectomy Catheters meet the establishedperformance criteria and are substantially equivalent to the predicate devices. |
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§ 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).