Novaerus NV1050

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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. 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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<br>(K200321) | Plasmair T2006<br>(K070722) | Comparison | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device<br>illustration | Image: Novaerus NV1050 | Image: Plasmair T2006 | Similar | | Intended<br>Use/<br>Indications<br>for Use | The Novaerus NV1050 is<br>intended as a room<br>recirculating air cleaner.<br>The system is used for<br>filtering out and<br>inactivating airborne<br>particles from the air for<br>medical purposes | The Plasmair Model T2006<br>is intended as a room air<br>purifier/recirculating air<br>cleaner. The system is<br>used for filtering out and<br>inactivating airborne<br>particles from the air for<br>medical purposes. The<br>Plasmair T2006 is<br>designed to treat indoor air<br>to supplement existing<br>building air treatment<br>and/or provide air<br>treatment where none<br>exists | Similar | | Use<br>location | Medical Facilities | Medical Facilities | Same | | Technology | Air from the room is<br>passed through a plasma<br>field to inactivate airborne<br>micro-organisms. A HEPA<br>filter traps the resulting<br>debris and an activated<br>carbon filter absorbs any<br>ozone generated as a<br>byproduct of the plasma<br>field | Air from the room is<br>passed through a plasma-<br>ion field to neutralize<br>airborne micro-organisms.<br>A HEPA filter traps the<br>resulting debris and a third<br>catalytic converter stage<br>absorbs any oxidants,<br>odors and volatile organic<br>compounds. | Similar | | Device size<br>(inches) | 36.5 (h) x 19.0 (w) x 19.1<br>(d) | 59 (h) x 27.5 (w) x 17.5 (d) | Similar | | Feature | Novaerus NV1050<br>(K200321) | Plasmair T2006<br>(K070722) | Comparison | | Device<br>weight | 112lb (51 kg) | 220lb (100 kg) | | | Power<br>source | 110V AC | 110V AC | Identical | | Air change<br>rates | 6,400 to 31,925 ft3/h<br>(180 to 904 m3/h) in 5<br>steps | 14,125 to 30,000 ft3/h<br>(400 to 850 m3/h) in 3<br>steps | Similar | | Reduction<br>of biological<br>agents | <i>Bacillus Globigii</i><br>endospores and <i>MS2</i><br><i>phage</i> reduced by 3 log<br>reduction in 10 minutes<br>and 4 log reduction in 15<br>minutes when operating at<br>full fan speed in a room of<br>580ft3 (16.4m3) | Predicate claims a<br>decontamination of 35m3<br>room from ISO9 to ISO7 in<br>10 minutes | Similar | | Filtration of<br>particles | NV1050 produces a 4 log<br>reduction in 0.5 to 2.0 µm<br>sized particles in 10<br>minutes in a 580ft3<br>(16.4m3) sealed room | Produces a 4 log reduction<br>of particles at 12 ACH at<br>600 m3/h. | Similar | | Ozone<br>emitted | Ozone emissions below 10<br>ppb (1/5th FDA limit for<br>medical devices) | No specific claim made,<br>but must be below FDA<br>limit of 50 ppb | Same | | Operational<br>range | Temperature: 50°F to<br>95°F (10°C to 35 °C)<br>Relative humidity: 10 to 75<br>%RH | Temperature: 41°F to 95°F<br>(5°C to 35°C) Relative<br>humidity < 95 % non-<br>condensing | Similar | | Storage<br>range | Temperature: 13°F to<br>160°F (-10°C to + 71°C)<br>Relative humidity: 10 to 93<br>%RH | Temperature: 32°F to<br>113°F (0°C to 45°C)<br>Relative humidity: 20 % to<br>90 % | Similar | | Standards<br>used | IEC 60601-1:<br>2005/A1:2012<br>IEC 60601-1-2:2014 | IEC 60601-1;<br>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/<br>Methodology/<br>Standard name | Purpose | Acceptance Criteria | Result | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC60601-<br>1:2005/A1;2012 | Device electrical<br>safety | Pass the<br>requirements of the<br>consensus standard | Pass | | IEC60601-1-<br>2:2014 | Device<br>Electromagnetic<br>Compatibility | Pass the<br>requirements of the<br>consensus standard | Pass | | Ozone emissions | Confirm ozone<br>emissions are below<br>the maximum<br>permitted levels<br><0.050 ppm | Ozone emitted to be<br><0.050 ppm | Pass in normal operating<br>conditions and single<br>fault conditions including<br>operating with blocked<br>and past end of life filters | | Inactivation of<br>Micro-organisms | To demonstrate that<br>the plasma technology<br>alone can produce a 4<br>log reduction in viable<br>micro-organisms | The plasma<br>generator alone<br>produces a 4 log<br>reduction in a<br>specified micro-<br>organism | A single plasma<br>generator of the type<br>embodied in the NV1050<br>produced a 4 log<br>reduction in MS2<br>Bacteriophage in 5 hours<br>when operating in a<br>sealed 580ft3 (16.4m3)<br>room | | Filtration of<br>particles | To demonstrate that<br>the filter banks alone<br>can produce a 4 log<br>reduction in particles | The device<br>produces a 4 log<br>reduction in the<br>concentration of µm<br>sized polystyrene<br>microspheres | The device produced a 4<br>log reduction in the<br>concentration of 0.5 to<br>2.0 µm sized polystyrene<br>microspheres in a sealed<br>580ft3 (16.4m3) room in<br>10 minutes | | Combined<br>Operation | To demonstrate the<br>performance of the<br>NV1050 at maximum<br>speed to inactivate<br>and filter out specified<br>micro-organisms | To produce a 4 log<br>reduction in the<br>specified micro-<br>organisms | NV1050 running at<br>maximum speed in a<br>580ft3 (16.4m3)sealed<br>room:<br>• Bacillus Globigii<br>Endospores: A 4 log<br>reduction produced in<br>15 minutes.<br>Prolonged operation<br>over 24 hours to<br>confirm that the<br>reduction in the<br>micro-organisms was<br>maintained and no<br>viable micro-<br>organisms were | | | | | recycled back into the<br>ambient air. | | | | • | <i>MS2 Bacteriophage</i> :<br>A 4 log reduction<br>produced in 15<br>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.