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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 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).

AI/ML Overview

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.

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K Number

K132022

Device Name

LEMAITRE 8F OCCLUSION CATHETER

Manufacturer

LEMAITRE VASCULAR, INC.

Date Cleared

2013-11-06

(128 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K093911

Intended Use

The LeMaitre 8F Occlusion Catheter is indicated for temporary vessel occlusion.

Device Description

The 8F Occlusion Catheters is offered in two balloon sizes; 28 mm or 45mm. It is a single lumen catheter with a latex balloon specifically designed and sized for use in the outlined general procedures. The single lumen (inflation lumen indicated by the white stopcock) is used for balloon inflation. The stop-cock is to maintain balloon inflation level throughout the procedure. The device has radiopaque marker bands at the proximal and distal ends of the balloon to enhance visibility of the balloon location when used under fluoroscopy.

AI/ML Overview

The provided text describes a medical device, the LeMaitre 8F Occlusion Catheter, and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. However, it does not contain information about a study that establishes acceptance criteria and then proves the device meets those criteria, especially in the context of an AI/algorithm-driven device.

The document outlines functional and safety testing, but these tests are for the physical catheter's performance (e.g., inflation volume, burst volume) rather than for an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a physical medical device clearance, not an AI/algorithm-based one:

A table of acceptance criteria and the reported device performance: The document only lists types of tests, not specific acceptance criteria (e.g., a minimum inflation pressure value) or detailed performance results that would be typically found for an AI system (e.g., sensitivity, specificity, AUC).
Sample size used for the test set and the data provenance: No test set information for an algorithm is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no algorithm test set.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document focuses on:

Device Description: Physical characteristics of the LeMaitre 8F Occlusion Catheter.
Intended Use: Temporary vessel occlusion.
Predicate Device: Fogarty Occlusion Catheter (K093911).
Substantial Equivalence: Claiming similar intended use and fundamental scientific technology as the predicate.
Functional/Safety Testing: Mentioning tests like "Volume Required to Inflate Balloon to IFU Indicated Diameter," "Inflation Pressure," "Radial Force," "Contact Area," "Inflation Time," "Deflation Time," and "Burst Volume." These are physical device performance tests.
Sterilization and Biocompatibility: Confirming compliance with relevant standards.

To summarize, the provided text does not contain the type of AI/algorithm performance study details you are asking for.

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