(30 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical device (catheter with balloon) and explicitly states the submission is for packaging changes. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated for "temporary vessel occlusion," which is a direct medical intervention to treat or manage a physiological process.
No
Explanation: The device is indicated for "temporary vessel occlusion," which is a therapeutic intervention, not a diagnostic one. It does not measure, detect, or analyze a medical condition.
No
The device description clearly outlines a physical catheter with a balloon and valve, 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:
- Intended Use: The intended use is "temporary vessel occlusion." This is a physical intervention performed in vivo (within the body) to block a blood vessel.
- Device Description: The description details a catheter with a balloon for physical occlusion. It does not mention any components or processes related to testing samples of bodily fluids or tissues in vitro (outside the body).
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, diagnosing conditions based on laboratory tests, or any other activities typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and performed directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The Fogarty Occlusion Catheter is indicated for temporary vessel occlusion.
Product codes
MJN
Device Description
The catheter.consists of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. The device is supplied sterile and for single use only. This Special 510(k) is submitted for clearance of changes to the packaging of the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Functional/Safety Testing: The Fogarty Occlusion Catheter has successfully undergone functional testing demonstrating equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Fogarty Occlusion Catheter, Pre-amendment Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a logo with the letter 'E' in a decorative, mosaic-like style. The letter is set against a background of small squares, creating a stained-glass effect. Below the letter, the word 'Edwards' is printed in a bold, serif typeface.
510(k) Summary
JAN 2 1 2010
Submitter: Edwards Lifesciences. LLC One Edwards Way Irvine, CA 92614-5686 Patricia A. Milbank Contact Person: Vice President, Clinical and Regulatory Affairs Date Prepared: December 17, 2009 Fogarty Occlusion Catheter Trade name: 21CFR 870.4450 Regulatory Number: Classification Name: Vascular Occlusion Balloon Catheter Catheter, Intravascular Occluding, Temporary Class II Regulatory Class: Product Code: MJN Fogarty Occlusion Catheter, Pre-amendment Device Predicate Device: Device Description: The Fogarty Occlusion Catheter is indicated for temporary vessel occlusion. The catheter.consists of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. The device is supplied sterile and for single use only. This Special 510(k) is submitted for clearance of changes to the packaging of the predicate device. Intended Use: The Fogarty Occlusion Catheter is intended for temporary vessel occlusion. Comparative The Fogarty Occlusion Catheter with its modified Analysis: packaging has been demonstrated to be substantially equivalent to the predicate device. Functional/Safety The Fogarty Occlusion Catheter has successfully Testing: undergone functional testing demonstrating equivalence to the predicate device. Conclusion: The changes to the packaging for the Fogarty Occlusion Catheter are substantially equivalent to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 21 2010
Edwards Lifesciences, LLC c/o Patricia A. Milbank Vice President, Clinical and Regulatory Affairs One Edwards Way Irvine, CA 92614-5686
Re: K093911
Fogarty Occlusion Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: December 17, 2009 Received: December 22, 2009
Dear Ms. Milbank:
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. 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. However, we remind you 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.
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Page 2 - Ms. Patricia Milbank
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFD/A/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Duna R. Palmer
f
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093911
Device Name: Fogarty Occlusion Catheter
Indications for Use:
The Fogarty Occlusion Catheter is indicated for temporary vessel occlusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
surina R. lehner
(Division Sign-Off) Division of Cardiovascular Devices
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"10(k) Number_K09391 |________________________________________________________________________________________________________________________________________________________