(60 days)
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.
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 juqular vein. The Small Occlusion catheters are intended to be used for temporary occlusion in the peripheral vascular system. The catheter consists of a single-lumen polyvinylchloride (PVC) 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 to maintain the straight catheter shape and to ensure that the lumen remains opened during storage or sterilization of the product. The device is supplied sterile and for single use only. This Traditional 510(k) is submitted to request clearance for changes to the indications for use statement. The proposed changes to the indications for use statement do not alter the intended use of the Fogarty Occlusion Catheter (i.e., temporary vessel occlusion).
This document is a 510(k) premarket notification for the Fogarty Occlusion Catheter. It outlines the device's indications for use, its description, and a comparison to predicate devices. The key takeaway is that the submission is for a change to the indications for use statement, not a change in the device's design, materials, or technology. Therefore, the "study" described focuses on the analysis of these changed indications rather than performance testing of the physical device.
Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness with Revised Indications for Use: The specific vessels identified for each size catheter (Large: aorta, vena cava, internal jugular vein; Small: peripheral vascular system) are expected to have similar safety and effectiveness compared to the general indications of the predicate device. | Conclusion of Analysis: An analysis was performed, and it was determined that "the specific vessels identified for each size catheter would be expected to have similar safety and effectiveness compared to the general indications for the predicate." The changes to the indications for use do not change the intended use or adversely impact safety and effectiveness. |
| Identical Design, Materials, Technology, and Operating Principles (compared to current legally marketed version): The device with the proposed change must maintain identical core characteristics. | Stated Identity: "The device with the proposed change to the indication for use statement has the identical design, materials, technology, and operating principles as the current legally marketed version of the device." |
| Compliance with Applicable Design Practices and Regulations (for current legally marketed version): The predicate device should already meet these standards. | Stated Compliance: "The current legally marketed version of the Fogarty Occlusion Catheter complies with all applicable design practices and regulations and was most recently cleared by FDA via K093911 (SE 21 Jan 2010) for modifications of its packaging." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission is for a change in indications for use based on an analysis and comparison to a predicate device, not empirical performance testing on a "test set" of patients or data.
- Data Provenance: Not applicable in the context of a traditional performance study. The "data" used is the existing regulatory clearance and performance records of the predicate device (Fogarty Occlusion Catheter, K093911) and a comparative analysis of the proposed indications. This is an analysis based on existing knowledge and regulatory precedent, not new prospective or retrospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not explicitly provided. The "ground truth" here is the regulatory assessment of similar safety and effectiveness for the modified indications. This would have been established by the internal regulatory and medical affairs teams at Edwards Lifesciences through their analysis. The FDA then reviews this submission. The number and qualifications of individuals involved in the applicant's internal analysis are not detailed.
4. Adjudication Method for the Test Set
- Not applicable. There was no "test set" in the sense of clinical cases requiring expert adjudication. The assessment was an internal analysis by the manufacturer, followed by a regulatory review by the FDA.
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
- No MRMC comparative effectiveness study was done. This device is a physical medical device (catheter), not an AI/software product that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone performance study was done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" used in this regulatory submission is a comparative analysis and expert judgment (internal to the manufacturer) that the proposed expanded indications for use for temporary vessel occlusion (specifying large vessels for large catheters and peripheral vessels for small catheters) are equally safe and effective as the more general indications of the legally marketed predicate device. This relies on the established safety and efficacy profile of the existing identical device and the predicate. It is not based on pathology, outcomes data, or a new expert consensus on a novel dataset for this specific submission, but rather on the consistency with existing medical understanding and regulatory clearances for the same device.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not a machine learning or AI device.
§ 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).