(265 days)
The Fogarty Occlusion Catheters are indicated for temporary vessel occlusion.
The Large Occlusion Catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal jugular vein.
The Small Occlusion Catheters are intended to be used for temporary occlusion in the peripheral vascular system.
Models: 620403F, 620404F, and 620405F
The Fogarty Small Occlusion Catheters (4F, 5F) consist of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The 3F Fogarty Occlusion Catheter is made of Nylon. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter to maintain the straight catheter shape and to ensure that the lumen remains opened during storage of the product.
Models: 62080814F and 62080822F
The Fogarty 8F Large Occlusion Catheters consist 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. A removable stainless-steel stylet is provided with each catheter.
This document is a 510(k) premarket notification for the Fogarty Occlusion Catheter, indicating substantial equivalence to a predicate device. It's important to note that a 510(k) clearance does not involve clinical studies with human participants where AI performance is measured against human readers or a ground truth established by experts. Instead, it focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
In this specific case, the submission emphasizes that the new device is identical to the predicate device in terms of intended use, indications for use, and technology. The changes proposed are related to new model numbers for existing devices, a new alternative packaging configuration, new labels, and updates to the Instructions For Use (IFU). Therefore, the "acceptance criteria" and "study" described are focused on proving that these packaging and labeling changes do not alter the device's performance or safety from the established predicate.
Given this context, many of the typical questions for AI/CADe devices regarding acceptance criteria, ground truth, expert involvement, and MRMC studies are not applicable.
Here's an interpretation based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Packaging Integrity | Compliance with ISO 11607-1 (for terminally sterilized medical devices) | Packaging testing was performed and successfully passed, demonstrating the integrity of the new alternative packaging. |
| Sterilization Efficacy | Compliance with ISO 11135:2014 (ethylene oxide sterilization) | Sterilization testing was successfully passed, ensuring sterility assurance. |
| Ethylene Oxide (EO)/Esterification (ECH) Residuals | Compliance with ISO 10993-7:2008 (biological evaluation of medical devices) | EO/ECH residuals evaluation was successfully passed. |
| Product Performance | Maintain original functional characteristics despite packaging change | Product performance testing and balloon inflation testing were successfully passed. |
| Biocompatibility | Ensure no new biocompatibility concerns due to packaging materials | Biocompatibility testing evaluations were conducted and ensured no alteration in performance. |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for each test mentioned (e.g., how many packages were tested for integrity, how many catheters were tested for performance).
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. These tests are typically conducted in a laboratory setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" here is compliance with established engineering and manufacturing standards (e.g., ISO standards) and performance specifications of the predicate device. There is no expert review of images or clinical data to establish a diagnostic ground truth.
4. Adjudication method for the test set:
- This question is not applicable. As there is no "ground truth" based on expert consensus for clinical interpretation, there is no need for an adjudication method. The tests are objective measurements against predefined standards.
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 question is not applicable. This submission is for a physical medical device (an occlusion catheter) and does not involve AI or any form of image interpretation where human readers would be "assisted" by AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device does not have an algorithm or standalone performance in the context of AI.
7. The type of ground truth used:
- The "ground truth" in this context refers to compliance with recognized industry standards (e.g., ISO 11607-1, ISO 11135:2014, ISO 10993-7:2008) and engineering performance specifications that are identical to the predicate device.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.
9. How the ground truth for the training set was established:
- This question is not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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).