Search Results

The Endoscopic Spray Applicator is intended to be used for the application of two nonhomogeneous fluids to a treatment site.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Gas Assisted Endoscopic Applicator." This document primarily focuses on the regulatory clearance process and does not contain the detailed technical information required to answer your specific questions about acceptance criteria, study design, or performance metrics.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory pathway for market entry based on comparison to existing devices. However, it does not provide the specific performance data from a clinical or technical study that would outline acceptance criteria and how the device met them.

Therefore, I cannot provide the requested information based on the text provided.

To answer your questions, I would need a document that details:

• The specific performance characteristics tested (e.g., fluid delivery accuracy, flow rate, pressure range, material compatibility).
• The quantitative acceptance criteria for each of those characteristics.
• The results of a study (bench, animal, or clinical) demonstrating that the device's performance met those criteria.
• Information on the study's design, sample sizes, ground truth establishment, and expert involvement.

Ask a specific question about this device