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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:

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.

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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

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.

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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

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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