(30 days)
The Fogarty Occlusion Catheter is indicated for temporary vessel occlusion.
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.
This 510(k) submission (K093911) is for a Special 510(k) for changes to the packaging of the Fogarty Occlusion Catheter, not for a new device requiring extensive clinical or algorithm performance studies. Therefore, many of the requested details regarding acceptance criteria for device performance, sample sizes for testing AI algorithms, expert qualifications, and multi-reader comparative effectiveness studies are not applicable to this submission.
The core of this submission revolves around demonstrating that the modified packaging does not alter the functional equivalence or safety of the previously cleared predicate device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Compliance |
|---|---|---|
| Substantial Equivalence | The modified device (with new packaging) must be demonstrated to be substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance. | Demonstrated equivalence to the predicate device. |
| Functional Testing | The catheter must successfully perform its intended function (temporary vessel occlusion) despite the packaging change. | Successfully underwent functional testing demonstrating equivalence to the predicate device. |
| Safety | The packaging changes must not introduce any new safety concerns or compromise the sterility or integrity of the device. | Implied through "Functional/Safety Testing" and substantial equivalence claims. |
2. Sample Size Used for the Test Set and the Data Provenance
- Not Applicable. This submission is not for an AI/ML device that would have a "test set" in the context of algorithm evaluation. The "testing" referred to is functional/safety testing of the medical device itself, likely involving a representative sample of units with the new packaging. The document does not specify the sample size for this functional testing.
- The data provenance would be internal laboratory testing by Edwards Lifesciences, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is not an AI/ML device requiring expert-established ground truth for a test set. Functional testing of the catheter would be assessed against engineering specifications and performance standards by qualified engineers and technicians at the manufacturer.
4. Adjudication Method for the Test Set
- Not Applicable. No expert adjudication method is mentioned or relevant for this type of submission. Performance is assessed against pre-defined functional and safety specifications.
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
- Not Applicable. This is not an AI/ML device. Therefore, no MRMC study, human-in-the-loop performance, or effect size related to AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
- For the functional/safety testing of the device, the "ground truth" would be established by engineering specifications, performance standards, and established safety criteria for vascular occlusion balloon catheters. This would involve laboratory tests measuring physical properties, balloon inflation/deflation characteristics, material integrity, and sterility maintenance.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, no ground truth establishment for a training set is relevant.
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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.
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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 |________________________________________________________________________________________________________________________________________________________
§ 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).