Search Results

The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the site of the Filtration Element should be between 2.5 and 7.0 mm.

The Emboshield NAVO Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during interventional procedures within carotid arteries or atherectomy in the arterial vasculature of the lower extremity. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element and RX Retrieval Catheter and ancillary items which include loading funnel, flushing syringes, introducer tool and torque devices.

Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them, based on the requested categories.

Important Note: The provided text is a 510(k) summary for a medical device (Embolic Protection System), not an AI/ML device. Therefore, many of the requested categories related to AI model development, such as training sets, expert adjudication of ground truth, and MRMC studies, are not directly applicable or discussed in this document. The focus of this submission is on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and clinical data on safety and efficacy in an expanded indication for use.

Acceptance Criteria and Device Performance for Emboshield NAV6 Embolic Protection System (K191173)

1. Table of Acceptance Criteria and Reported Device Performance

• Deployment and Retrieval Force
• Simulated Use | The assessment concluded these tests should be performed, and the overall conclusion states the device met all acceptance criteria. (Specific pass/fail results for individual non-clinical tests are not detailed in this summary.) |
  | Technological Equivalence | Show substantial equivalence to predicate in:
• Intended Use
• System Components
• Technological Characteristics
• Sterilization
• Materials and Biocompatibility | "The conclusion of the comparison analysis is that the subject Emboshield NAV6 EPS is substantially equivalent to the predicate device." |
  | Safety - Filter Specific | Low occurrence of events directly reflecting filter performance (distal embolization, perforation at filter level, unplanned amputation) | One case of distal embolization, no cases of perforation at the level of the filter, and no unplanned amputations among MAEs. |
  | Overall Safety & Effectiveness | No new safety or effectiveness issues raised. | "The clinical and non-clinical data demonstrate that the subject Emboshield NAV6 EPS met all acceptance criteria and performed similarly to the predicate device and that no new safety or effectiveness issues were raised." |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Clinical Study: n=162 patients.
• Data Provenance: Retrospective clinical data from a "real-world population" of peripheral arterial disease (PAD) patients treated at the Mount Sinai Health Center (USA, implied by FDA submission context, though not explicitly stated as country of origin). The data represents routine clinical practice.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This document does not describe the use of experts to establish a "ground truth" for the clinical test set in the way it would be for an AI/ML diagnostic device. The clinical outcomes (MAE) were observed clinical events, not interpretations by experts for the purpose of a ground truth.
• The MAE definition is a composite of clinical events (death, MI, thrombosis, dissection, distal embolization, perforation, unplanned amputation, TVR). These are typically determined by clinical observation and data collection according to study protocols, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

• Not applicable in the context of this device. The clinical events (MAE) are observed outcomes, not interpretations requiring adjudication.

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. The study evaluates the performance of a medical device (embolic protection system) in a clinical setting, not how human readers' diagnostic accuracy changes with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is not an AI/ML algorithm. The device's performance is measured in its intended use during a clinical procedure.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical study was the occurrence or non-occurrence of predefined clinical events (Major Adverse Events - MAE) in real-world patients. This can be considered a form of "outcomes data."
• For non-clinical testing, the "ground truth" relies on predefined engineering specifications and simulated use outcomes.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device or an algorithm that requires a "training set" in the machine learning sense. The clinical data was used to demonstrate the device's performance in a real-world setting.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" for this type of medical device submission.

Ask a specific question about this device