Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 143

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 143
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 patient and are those for which safety and efficacy can be assured
by adherence to the FDA’s general controls for medical devices, which include compliance with the applicable portions of the QSR
facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising,
and promotional materials. Class II devices are subject to the FDA’s general controls, and special controls as deemed necessary
by the FDA to ensure the safety and efficacy of the device. These special controls can include performance standards, post-market surveillance,
patient registries, special labeling requirements, premarket data requirements and FDA guidance documents. While most Class I devices
are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA
a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s
permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices
deemed by the FDA to pose the greatest risks, such as life-sustaining, 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.

Our Deep TMS system is classified as a Class II medical
device. For MDD, smoking addiction, and subsequently granted applications relating to MDD (including a 3-minute Theta Burst protocol,
a labeling expansion to include reduction of comorbid anxiety symptoms among depressed patients and an expansion of the labeling for late-life
MDD), we obtained FDA marketing authorization through the 510(k) clearance process. For OCD, we obtained FDA marketing authorization through
the de novoclassification process. Subsequent changes made to our Deep TMS system will be made through one or more of the various
existing FDA review pathways.

510(k) Marketing Clearance Pathway

To obtain 510(k) clearance,
we must submit to the FDA a premarket notification submission 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