Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 163

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 163
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 life-supporting or some implantable devices, or devices that have
a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in
Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification
and clearance process in order to be commercially distributed.

510(k) Clearance marketing pathway

To obtain 510(k) clearance,
a manufacturer must submit to the FDA a premarket notification demonstrating that the proposed device is “substantially equivalent”
to a predicate device already on the market. A predicate device is a legally marketed device that is not subject to premarket approval,
i. e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that
has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process.
The FDA’s 510(k) clearance process usually takes from three to twelve months, but may take longer. The FDA may require additional
information, including clinical data, to make a determination regarding substantial equivalence. In addition, FDA collects user fees for
certain medical device submissions and annual fees and for medical device establishments. For fiscal year 2025, the standard user fee
for a 510(k) premarket notification application is $24,335.

If the FDA agrees that the
device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market
the device. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device
is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request
a risk-based classification determination for the device in accordance with the “ de novo” process, which is a route
to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

After a device receives 510(k)
clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification
in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novoreclassification.
The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k