(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.
§ 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).