(29 days)
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. 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 NAV6 Embolic Protection System. It outlines the device description, its intended use, a comparison to predicate devices, and a list of performance tests conducted. However, it does not include information about acceptance criteria, specific study results demonstrating device performance against those criteria, or details regarding ground truth, expert involvement, or multi-reader studies.
The "Performance Data" section lists various tests performed (e.g., Bioburden Testing, Wire Movement, Coating Integrity, Particulate Testing, Biocompatibility). While these tests were "successfully completed," the document does not report specific metrics or thresholds that define "successful completion" for each test. Consequently, it's impossible to create a table of acceptance criteria and reported performance with quantitative data based on the provided text.
Here's an analysis of the requested information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Bioburden Testing: (Implicitly: acceptable bioburden levels) | Successfully completed |
| Wire Movement: (Implicitly: smooth, controlled movement) | Successfully completed |
| Coating Integrity: (Implicitly: durable, intact coating) | Successfully completed |
| Particulate Testing: (Implicitly: acceptable particulate levels) | Successfully completed |
| Coating Adhesion Testing: (Implicitly: adequate adhesion) | Successfully completed |
| Friction Testing: (Implicitly: acceptable friction levels) | Successfully completed |
| Coating Thickness: (Implicitly: within specified range) | Successfully completed |
| Coating Appearance: (Implicitly: acceptable appearance) | Successfully completed |
| Biocompatibility: (Implicitly: non-toxic, non-allergenic, non-hemolytic, etc.) | Successfully completed |
| * Cytotoxicity | Successfully completed |
| * Hemocompatibility (Hemolysis, Complement Activation, Coagulation) | Successfully completed |
| * Acute Systemic Toxicity | Successfully completed |
| * Intracutaneous Toxicity (Irritation) | Successfully completed |
| * Sensitization | Successfully completed |
| * Material-Mediated Pyrogenicity | Successfully completed |
Note: The provided text only states that these tests were "successfully completed." It does not provide any specific quantitative (e.g., "bioburden
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).