Search Results
Found 1 results
510(k) Data Aggregation
(30 days)
The Emboshield NAV6 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. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
The provided text describes a 510(k) summary for the Emboshield NAV® Embolic Protection System. It outlines the device description, its intended use, and states that a modification was made to the adhesive used for a radiopaque marker on the delivery catheter. The document then lists performance tests conducted to demonstrate substantial equivalence to predicate devices.
However, the provided text does not contain the detailed acceptance criteria for specific performance metrics, nor does it present a study that directly proves the device meets those criteria in the typical format of a clinical trial or algorithm performance study.
The "Performance Data" section merely lists the types of tests conducted (biocompatibility and tensile testing for marker band integrity). It does not provide:
- Quantitative acceptance criteria (e.g., "tensile strength must exceed X N with a P-value < 0.05").
- Reported device performance values for these criteria.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details. These are all elements typically associated with studies demonstrating the effectiveness or accuracy of medical devices, especially those involving image analysis or clinical outcomes.
The submission is for a modification to an existing device (K110909), specifically a change in adhesive for a radiopaque marker. The review focuses on demonstrating that this change does not negatively impact the substantial equivalence to the predicate device, rather than providing a comprehensive de novo validation of the device's clinical performance.
Therefore, I cannot populate the requested table or answer the specific questions regarding sample size, expert ground truth, MRMC, or standalone studies based on the provided document. The document confirms that "Performance testing was successfully completed" and lists the types of tests, but not their results or methodology in detail sufficient to answer your query.
Summary based on available information:
| Aspect | Description |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Not provided in the document. The document states that "Performance testing was successfully completed" and lists categories of tests (Biocompatibility: Cytotoxicity, Hemocompatibility, Coagulation, Acute Systemic Toxicity, Intracutaneous Toxicity, Sensitization, Material-Mediated Pyrogenicity; Tensile Testing: Marker Band Integrity Baseline, and 2 and 3 years Accelerated Aging). However, specific quantitative acceptance criteria or the numerical results of these tests are not detailed. The submission is focused on demonstrating that the modification (adhesive change) does not alter the substantial equivalence, implying that the device continues to meet the criteria established for the predicate device, but these criteria themselves are not listed. |
| 2. Sample size and data provenance | Not applicable/Not provided. The tests listed (biocompatibility, tensile testing) are material/device property tests, not clinical or image |
Ask a specific question about this device
Page 1 of 1