18 ms·
The next obvious thing to show is the substantial equivalence table. This is where the manufacturers argue that their new device is so similar from the perspect
by oezi 3y ago
The next obvious thing to show is the substantial equivalence table. This is where the manufacturers argue that their new device is so similar from the perspective of purpose and technology to the previous (predicate) device that they want to skip trials and a more thorough vetting.
This is where the manufacturers routinely bend the truth by listing the favorable attributes ('both devices are based on Windows PCs') but hide aspects which differ (the materials used for sound insulation for instance in the Philips CPAP scandal).
If the equivalence tables could be shown for each ancestry tree it would become very apparent that the attributes are cherry-picked (I believe).
- TheJoeMan 3y agoDo note that the summary pdf page is not the whole submission. 510(k)’s are hundreds of pages. I cannot speak fully for the CPAP foam, but with a predicate you still list every “material” in your device with cut sheets, etc, as well as documented biocompatibility for “airway contact” portions which include the foam. For Philips, it seems the foam degraded into a different, toxic compound which was an oversight.