Search Results

The FemDx FalloView™ is intended for visualization of the cervical canal, uterine cavity, and proximal fallopian tube(s) during diagnostic gynecological procedures.

The FemDx FalloView™ is a disposable, hand-held, battery-operated endoscope that contains a 4.7 mm hysteroscopic cannula, a 1.2 mm falloposcopic catheter, and a visualization system. The catheter is integrated inside the cannula center lumen and can be deployed, retracted, or rotated. The cannula includes a lumen and a proximal female luer lock port for saline irrigation. The visualization system includes a camera module positioned at the tip of the catheter, a controller board, an LCD display integrated into the device's handle, and LED/fiber optic illumination. The FemDx FalloView™ contains embedded software designed to display the real time image on the LCD display, control the illumination light level, and capture a screenshot. The captured image can be transmitted to a computer via Bluetooth and then accessed using the FalloView™ Image Viewer, a separate PC based software application.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against predefined performance targets.

Specifically, it states that "The FemDx FalloView™ passed all applicable testing in accordance with internal requirements and national and international standards. The results demonstrate that the FemDx FalloView™ satisfies the performance, functional, and safety requirements relative to the product specifications, risk analyses, and Instructions for Use, and does not raise different questions of safety and effectiveness than the predicate device." However, it does not quantitatively report on device performance against specific, numerically defined acceptance criteria.

The document lists various non-clinical tests performed, such as "Image quality comparative testing" (including field of view, resolution, depth of field, etc.), "Flow rate and leakage testing," "Dimensional testing," and "Mechanical testing," but it does not provide the specific acceptance criteria for these tests nor the quantitative results that prove the device met them.

Therefore, it is impossible to complete the requested table and answer the specific questions based solely on the provided text. The document confirms that testing was done to demonstrate safety and effectiveness and substantial equivalence, but it does not detail the acceptance criteria or the specific statistical results of studies against those criteria.

Ask a specific question about this device