← Product Code [FRF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF) · K200321 # Novaerus NV1050 (K200321) _Novaerus Us, Inc. · FRF · Dec 28, 2020 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K200321 ## Device Facts - **Applicant:** Novaerus Us, Inc. - **Product Code:** [FRF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF.md) - **Decision Date:** Dec 28, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5045 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The Novaerus NV1050 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. ## Device Story Free-standing cabinet air cleaner; maneuvers by single person; powered by AC wall outlet. Air drawn through front; passes through pre-filter, Dielectric Barrier Discharge plasma generator stage, HEPA filter, and activated carbon filter; exhausted through top panel. Plasma generator inactivates microorganisms (virus/bacteria) via ions, electrons, reactive oxidizing species, UV radiation, and high electric fields. HEPA filter traps particulates; carbon filter removes ozone byproduct. User controls: On/Off, 5-speed fan, filter blockage test button. Indicator light provides calendar-based filter change reminders. Used in medical facilities to reduce airborne biological contaminants; benefits patient/staff by lowering concentration of airborne microorganisms. ## Clinical Evidence Bench testing only. Performance validated in a 580ft3 (16.4m3) sealed room. Plasma generator alone achieved 4-log reduction of MS2 bacteriophage in 5 hours. Combined system at max fan speed achieved 4-log reduction of Bacillus Globigii endospores and MS2 bacteriophage in 15 minutes. Particle filtration (0.5-2.0 µm) achieved 4-log reduction in 10 minutes. Ozone emissions confirmed <0.050 ppm under normal and single-fault conditions. Electrical safety and EMC testing passed per IEC 60601-1 and IEC 60601-1-2. ## Technological Characteristics Free-standing cabinet; 36.5" x 19.0" x 19.1"; 112lb. Powered by 110V AC. Airflow path: pre-filter (ISO16890:2016), 3-bank Dielectric Barrier Discharge plasma generator, HEPA filter (>99.95% efficiency at 0.18µm), activated carbon filter. Standards: IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2014. Ozone emission <10 ppb. Operational range: 50°F-95°F, 10-75% RH. ## Regulatory Identification A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration. ## Predicate Devices - Plasmair Model T2006 ([K070722](/device/K070722.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 28, 2020 Novaerus US Inc Declan Kiely International Quality Director 35 Melrose Place Stamford, Connecticut 06902 Re: K200321 Trade/Device Name: Novaerus NV1050 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: FRF Dated: December 21, 2020 Received: December 28, 2020 Dear Declan Kiely: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200321 Device Name Novaerus NV1050 Indications for Use (Describe) The Novaerus NV 1050 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510K SUMMARY K200321 # 1. SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED Novaerus US Inc 35 Melrose Place Stamford CT 06902 USA Contact Person: Declan Kiely Phone: +1 203 662 0800 Date Prepared: 06th February 2020 ## 2. DEVICE ### Name of Device Novaerus NV1050 ### Common or Usual Name Air Filtration System, HEPA Air Filtration System ### Classification Name/Product Code/CFR Reference Medical recirculating air cleaner, Product Code: FRF CFR Reference: 21 CFR 880.5045 ### 3. PREDICATE DEVICE Predicate: Plasmair Model T2006 [K070722], Commercial name: Sentinel This predicate has not been subject to a design-related recall No reference devices were used in this submission {4}------------------------------------------------ # 4. DEVICE DESCRIPTION The Novaerus NV1050 (NV1050) is a free-standing cabinet of a size that can be maneuvered into position by a single person. The NV1050 is powered from an AC wall outlet. The NV1050 circulates the room air through its cabinet. The air is drawn in through the front of the cabinet, passes through a pre-filter then a Dielectric Barrier Discharge Plasma generator ("plasma generator") stage, and a further two filters (HEPA, Carbon) The cleaned air is exhausted out of the top panel of the cabinet. The device has simple controls: On/Off and fan speed setting from 1 to 5. There is a button to initiate a filter blockage test to check and inform the user if the filters are getting close to requiring changing. The only routine maintenance is a calendar-based filter change schedule indicated in the User Manual; the indicator light on the front panel acts as a reminder that the filters will soon need attention. The airflow path through the NV1050 is: - A general pre- filter to remove particles from the input air flow. . - A bank of three (3) plasma generators, each Plasma Generator consists of ● two (2) plasma Coils. Micro-Organisms, including virus and bacteria, are inactivated by the plasma generator. This occurs through damage by plasma constituents (ions, electrons, reactive oxidizing species, ultraviolet radiation, high electric fields) - A HEPA (High-efficiency Particulate Air) filter to trap the resulting virus/bacteria particulates. - . An activated carbon filter to trap any ozone in the airstream before it is output to the environment. Examples of the individual performance of these elements are: - The general air pre-filter captures over 85% of particles between 0.4 um ● and 10 um per ISO16890:2016. - A single plasma generator produced a 4.4. log reduction in MS2 . bacteriophage in five (5) hours in a sealed room of 580ft3 (16.4m3). The NV1050 has three (3) such plasma generators. - The HEPA filter captures over 99.95% of particles of 0.18um ● - The carbon filter has an expected life of 3000 hours. ● The combined performance of these elements in the reduction of microorganisms is stated on the labelling as, "Bacillus Globigii endospores and MS2 bacteriophage reduced by 99.99% (4 log reduction) in 15 minutes when operating at full fan speed in a room of 580ft3 (16.4m3)". The testing that produced these results is detailed at section 7. {5}------------------------------------------------ # 5. INTENDED USE / INDICATIONS FOR USE The Novaerus NV1050 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes # 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Both the Novaerus NV1050 and the Plasmair Model T2006 are free-standing cabinets that can be moved to a location to provide localized air-cleansing. The NV1050 and T2006 both use a plasma discharge as the method of neutralizing biological contaminants. Both devices use a HEPA filter as the primary method of then trapping the debris and particles. The generation of a plasma field creates extra ozone in the airflow as a byproduct of the electrical discharge. Both devices have a final stage of filtration to remove any residual ozone in the airflow. The predicate device uses a catalytic converter to absorb the ozone. The NV1050 uses an activated carbon filter for this purpose. They are alternative methods to achieve the same objective of removing any residual ozone. The use of an activated carbon filter in the NV1050 is a design choice that makes the device cheaper to manufacture and assists in reducing the cabinet size. It does mean that the carbon filter will have to be changed in a maintenance schedule, but there is already a HEPA filter in both the NV1050 and the predicate device. A HEPA filter will require periodic changes. The additional Carbon filter to be changed in the NV1050 is just an additional item on the maintenance schedule. A table to compare the technical characteristics is below. {6}------------------------------------------------ | Feature | Novaerus NV1050
(K200321) | Plasmair T2006
(K070722) | Comparison | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device
illustration | Image: Novaerus NV1050 | Image: Plasmair T2006 | Similar | | Intended
Use/
Indications
for Use | The Novaerus NV1050 is
intended as a room
recirculating air cleaner.
The system is used for
filtering out and
inactivating airborne
particles from the air for
medical purposes | The Plasmair Model T2006
is intended as a room air
purifier/recirculating air
cleaner. The system is
used for filtering out and
inactivating airborne
particles from the air for
medical purposes. The
Plasmair T2006 is
designed to treat indoor air
to supplement existing
building air treatment
and/or provide air
treatment where none
exists | Similar | | Use
location | Medical Facilities | Medical Facilities | Same | | Technology | Air from the room is
passed through a plasma
field to inactivate airborne
micro-organisms. A HEPA
filter traps the resulting
debris and an activated
carbon filter absorbs any
ozone generated as a
byproduct of the plasma
field | Air from the room is
passed through a plasma-
ion field to neutralize
airborne micro-organisms.
A HEPA filter traps the
resulting debris and a third
catalytic converter stage
absorbs any oxidants,
odors and volatile organic
compounds. | Similar | | Device size
(inches) | 36.5 (h) x 19.0 (w) x 19.1
(d) | 59 (h) x 27.5 (w) x 17.5 (d) | Similar | | Feature | Novaerus NV1050
(K200321) | Plasmair T2006
(K070722) | Comparison | | Device
weight | 112lb (51 kg) | 220lb (100 kg) | | | Power
source | 110V AC | 110V AC | Identical | | Air change
rates | 6,400 to 31,925 ft3/h
(180 to 904 m3/h) in 5
steps | 14,125 to 30,000 ft3/h
(400 to 850 m3/h) in 3
steps | Similar | | Reduction
of biological
agents | Bacillus Globigii
endospores and MS2
phage reduced by 3 log
reduction in 10 minutes
and 4 log reduction in 15
minutes when operating at
full fan speed in a room of
580ft3 (16.4m3) | Predicate claims a
decontamination of 35m3
room from ISO9 to ISO7 in
10 minutes | Similar | | Filtration of
particles | NV1050 produces a 4 log
reduction in 0.5 to 2.0 µm
sized particles in 10
minutes in a 580ft3
(16.4m3) sealed room | Produces a 4 log reduction
of particles at 12 ACH at
600 m3/h. | Similar | | Ozone
emitted | Ozone emissions below 10
ppb (1/5th FDA limit for
medical devices) | No specific claim made,
but must be below FDA
limit of 50 ppb | Same | | Operational
range | Temperature: 50°F to
95°F (10°C to 35 °C)
Relative humidity: 10 to 75
%RH | Temperature: 41°F to 95°F
(5°C to 35°C) Relative
humidity < 95 % non-
condensing | Similar | | Storage
range | Temperature: 13°F to
160°F (-10°C to + 71°C)
Relative humidity: 10 to 93
%RH | Temperature: 32°F to
113°F (0°C to 45°C)
Relative humidity: 20 % to
90 % | Similar | | Standards
used | IEC 60601-1:
2005/A1:2012
IEC 60601-1-2:2014 | IEC 60601-1;
IEC 60601-1-2 | Identical | {7}------------------------------------------------ # 7. SUMMARY OF NON-CLINICAL DATA The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria of the standards listed below: {8}------------------------------------------------ | Test name/
Methodology/
Standard name | Purpose | Acceptance Criteria | Result | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC60601-
1:2005/A1;2012 | Device electrical
safety | Pass the
requirements of the
consensus standard | Pass | | IEC60601-1-
2:2014 | Device
Electromagnetic
Compatibility | Pass the
requirements of the
consensus standard | Pass | | Ozone emissions | Confirm ozone
emissions are below
the maximum
permitted levels
<0.050 ppm | Ozone emitted to be
<0.050 ppm | Pass in normal operating
conditions and single
fault conditions including
operating with blocked
and past end of life filters | | Inactivation of
Micro-organisms | To demonstrate that
the plasma technology
alone can produce a 4
log reduction in viable
micro-organisms | The plasma
generator alone
produces a 4 log
reduction in a
specified micro-
organism | A single plasma
generator of the type
embodied in the NV1050
produced a 4 log
reduction in MS2
Bacteriophage in 5 hours
when operating in a
sealed 580ft3 (16.4m3)
room | | Filtration of
particles | To demonstrate that
the filter banks alone
can produce a 4 log
reduction in particles | The device
produces a 4 log
reduction in the
concentration of µm
sized polystyrene
microspheres | The device produced a 4
log reduction in the
concentration of 0.5 to
2.0 µm sized polystyrene
microspheres in a sealed
580ft3 (16.4m3) room in
10 minutes | | Combined
Operation | To demonstrate the
performance of the
NV1050 at maximum
speed to inactivate
and filter out specified
micro-organisms | To produce a 4 log
reduction in the
specified micro-
organisms | NV1050 running at
maximum speed in a
580ft3 (16.4m3)sealed
room:
• Bacillus Globigii
Endospores: A 4 log
reduction produced in
15 minutes.
Prolonged operation
over 24 hours to
confirm that the
reduction in the
micro-organisms was
maintained and no
viable micro-
organisms were | | | | | recycled back into the
ambient air. | | | | • | MS2 Bacteriophage :
A 4 log reduction
produced in 15
minutes. | {9}------------------------------------------------ ## Software Verification and Validation Testing Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. ## 8. CONCLUSIONS The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K200321](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K200321) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com