Novaerus Defend 1050 cleared by FDA as 510(k) Class II Medical Device
Novaerus Defend 1050 cleared by FDA as 510(k) Class II Medical Device to inactivate and filter out airborne virus and bacteria for medical purposes
Defend 1050 uses patented NanoStrike® technology to damage and inactivate airborne micro-organisms.
Dublin, Ireland and Stamford, CT - Novaerus, a WellAir company that delivers clean air solutions to help prevent the spread of infectious outbreaks, announced today that the U.S. Food and Drug Administration (FDA) cleared the Novaerus Defend 1050 (NV 1050) as a 510(k) Class II Medical Device to inactivate and filter out micro-organisms, including virus and bacteria, for medical purposes. The Novaerus Defend 1050 is the first system that uses NanoStrike®, a patented plasma generating technology, to receive FDA 510(k) clearance.
The Novaerus Defend 1050 is a free-standing, portable recirculating air cleaning system designed for additional frontline protection in healthcare settings such as operating rooms, intensive care units, in vitro fertilization labs, emergency rooms, waiting and treatment areas, neonatal units, and other critical environments including those performing aerosol-generating medical procedures (AGMP).
The Defend 1050's NanoStrike technology uses a plasma field that rapidly inactivates micro-organisms at the molecular level. Within 15 minutes, the Defend 1050 has demonstrated a 4-log (99.99%) reduction of the MS2 bacteriophage RNA virus, an accepted surrogate for SARS-CoV-2. The Defend 1050 also showed a 4-log (99.99%) reduction in Bacillus Globigii endospores (bacterial spores) within 15 minutes, which was maintained over the prolonged operation (24 hours).
The Defend 1050 is currently used in hospitals and healthcare settings worldwide. Given the rapid spread of COVID-19, WellAir moved quickly to understand how this device could potentially combat the virus while moving it through a thorough FDA medical device clearance process. Additionally, the Defend 1050 meets relevant performance criteria in the FDA Guidance, which provides non-binding recommendations that may reduce the risk of viral exposure for patients and healthcare providers during the current public health emergency.
'Our team of outstanding engineers and scientists have been focused on delivering innovative and powerful airborne infection control devices. The FDA clearance on the Defend 1050 is a critical milestone for our company, validating our work to deliver a safe and effective medical device,' said Dr Kevin Devlin, WellAir CEO. 'The Defend 1050 has demonstrated tremendous efficacy in third party testing against viruses, bacteria, VOCs, and particulate matter, which makes it an ideal solution for hospitals and healthcare settings. As we continue to see an alarming rise in the number of COVID-19 cases, we have moved quickly to make the device readily available.'
Defend 1050 utilizes multiple stages to reduce airborne micro-organisms. The first stage is a general air pre-filter that captures particles between 4 and 10 microns from the input airflow. This filtered air passes through a series of NanoStrike coils (plasma generators) that damage and inactivate micro-organisms on contact, including viruses and bacteria. The resulting inactive particulates are trapped by a HEPA (High-efficiency Particulate Air) filter. In a final cleaning stage, an activated carbon filter traps VOCs in the airstream before the air is released into the environment.
The Defend 1050 system is delivered complete with all components necessary for immediate use. It can be wheeled easily by a single person to the desired point of use and plugs into standard outlets. Five airflow speed settings enable optimization to each healthcare environment. The only routine maintenance required is a calendar-based filter change schedule.