(322 days)
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.
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.
The provided text describes the Novaerus NV1050 medical recirculating air cleaner and its substantial equivalence to a predicate device. It includes information on non-clinical testing to demonstrate performance against acceptance criteria.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| 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. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The sample size for the "Inactivation of Micro-organisms", "Filtration of particles", and "Combined Operation" tests involved a single device (Novaerus NV1050) operating in a sealed 580ft3 (16.4m3) room. For the electrical safety and EMC tests, the sample size is not explicitly stated but implies testing of the device itself.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria of the standards listed below." The tests appear to be laboratory-based performance evaluations rather than clinical studies on patient populations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text describes performance testing of an air cleaning device; it does not involve establishing ground truth from expert interpretation of medical images or data. Therefore, this question is not applicable in this context. The ground truth for these tests would be the measured reduction in microorganisms or particles, or compliance with electrical and EMC standards, based on established scientific methods and instrumentation, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the described testing methodology is for device performance (reduction of microorganisms, filtration, electrical safety, EMC) rather than the interpretation of data where adjudication among readers would be necessary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is relevant for AI-assisted diagnostic devices involving human readers. The Novaerus NV1050 is an air cleaning device, and its performance evaluation does not involve human readers interpreting data. Therefore, an MRMC comparative effectiveness study was not done, and this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is framed for AI algorithms. For this device, the "standalone" performance refers to the device's ability to reduce microorganisms and filter particles on its own, without human intervention in its air purification function. The tests for "Inactivation of Micro-organisms," "Filtration of particles," and "Combined Operation" demonstrate the device's standalone performance in a controlled environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests described involves:
- Quantitative measurement of reduction: For microorganism inactivation, the ground truth is the measured log reduction of MS2 Bacteriophage and Bacillus Globigii Endospores. For particle filtration, it's the measured log reduction of polystyrene microspheres.
- Compliance with standards: For electrical safety and electromagnetic compatibility, the ground truth is whether the device meets the specified requirements of IEC 60601-1 and IEC 60601-1-2.
- Quantitative measurement of emissions: For ozone emissions, the ground truth is the measured concentration of ozone.
These are objective, empirical measurements based on scientific methodologies rather than expert consensus, pathology, or outcomes data typically associated with diagnostic medical devices.
8. The sample size for the training set
The provided text only discusses non-clinical performance testing of the final device and does not mention any "training set" for AI/machine learning. This device is an air cleaner, not an AI-driven diagnostic or therapeutic system that would typically require training data. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
As there is no mention of a training set for an AI/machine learning model, this question is not applicable.
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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
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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
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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)
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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
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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.
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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.
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| Feature | Novaerus NV1050(K200321) | Plasmair T2006(K070722) | Comparison |
|---|---|---|---|
| Deviceillustration | Image: Novaerus NV1050 | Image: Plasmair T2006 | Similar |
| IntendedUse/Indicationsfor Use | The Novaerus NV1050 isintended as a roomrecirculating air cleaner.The system is used forfiltering out andinactivating airborneparticles from the air formedical purposes | The Plasmair Model T2006is intended as a room airpurifier/recirculating aircleaner. The system isused for filtering out andinactivating airborneparticles from the air formedical purposes. ThePlasmair T2006 isdesigned to treat indoor airto supplement existingbuilding air treatmentand/or provide airtreatment where noneexists | Similar |
| Uselocation | Medical Facilities | Medical Facilities | Same |
| Technology | Air from the room ispassed through a plasmafield to inactivate airbornemicro-organisms. A HEPAfilter traps the resultingdebris and an activatedcarbon filter absorbs anyozone generated as abyproduct of the plasmafield | Air from the room ispassed through a plasma-ion field to neutralizeairborne micro-organisms.A HEPA filter traps theresulting debris and a thirdcatalytic converter stageabsorbs any oxidants,odors and volatile organiccompounds. | 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 |
| Deviceweight | 112lb (51 kg) | 220lb (100 kg) | |
| Powersource | 110V AC | 110V AC | Identical |
| Air changerates | 6,400 to 31,925 ft3/h(180 to 904 m3/h) in 5steps | 14,125 to 30,000 ft3/h(400 to 850 m3/h) in 3steps | Similar |
| Reductionof biologicalagents | Bacillus Globigiiendospores and MS2phage reduced by 3 logreduction in 10 minutesand 4 log reduction in 15minutes when operating atfull fan speed in a room of580ft3 (16.4m3) | Predicate claims adecontamination of 35m3room from ISO9 to ISO7 in10 minutes | Similar |
| Filtration ofparticles | NV1050 produces a 4 logreduction in 0.5 to 2.0 µmsized particles in 10minutes in a 580ft3(16.4m3) sealed room | Produces a 4 log reductionof particles at 12 ACH at600 m3/h. | Similar |
| Ozoneemitted | Ozone emissions below 10ppb (1/5th FDA limit formedical devices) | No specific claim made,but must be below FDAlimit of 50 ppb | Same |
| Operationalrange | Temperature: 50°F to95°F (10°C to 35 °C)Relative humidity: 10 to 75%RH | Temperature: 41°F to 95°F(5°C to 35°C) Relativehumidity < 95 % non-condensing | Similar |
| Storagerange | Temperature: 13°F to160°F (-10°C to + 71°C)Relative humidity: 10 to 93%RH | Temperature: 32°F to113°F (0°C to 45°C)Relative humidity: 20 % to90 % | Similar |
| Standardsused | IEC 60601-1:2005/A1:2012IEC 60601-1-2:2014 | IEC 60601-1;IEC 60601-1-2 | Identical |
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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:
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| Test name/Methodology/Standard name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| IEC60601-1:2005/A1;2012 | Device electricalsafety | Pass therequirements of theconsensus standard | Pass |
| IEC60601-1-2:2014 | DeviceElectromagneticCompatibility | Pass therequirements of theconsensus standard | Pass |
| Ozone emissions | Confirm ozoneemissions are belowthe maximumpermitted levels<0.050 ppm | Ozone emitted to be<0.050 ppm | Pass in normal operatingconditions and singlefault conditions includingoperating with blockedand past end of life filters |
| Inactivation ofMicro-organisms | To demonstrate thatthe plasma technologyalone can produce a 4log reduction in viablemicro-organisms | The plasmagenerator aloneproduces a 4 logreduction in aspecified micro-organism | A single plasmagenerator of the typeembodied in the NV1050produced a 4 logreduction in MS2Bacteriophage in 5 hourswhen operating in asealed 580ft3 (16.4m3)room |
| Filtration ofparticles | To demonstrate thatthe filter banks alonecan produce a 4 logreduction in particles | The deviceproduces a 4 logreduction in theconcentration of µmsized polystyrenemicrospheres | The device produced a 4log reduction in theconcentration of 0.5 to2.0 µm sized polystyrenemicrospheres in a sealed580ft3 (16.4m3) room in10 minutes |
| CombinedOperation | To demonstrate theperformance of theNV1050 at maximumspeed to inactivateand filter out specifiedmicro-organisms | To produce a 4 logreduction in thespecified micro-organisms | NV1050 running atmaximum speed in a580ft3 (16.4m3)sealedroom:• Bacillus GlobigiiEndospores: A 4 logreduction produced in15 minutes.Prolonged operationover 24 hours toconfirm that thereduction in themicro-organisms wasmaintained and noviable micro-organisms were |
| recycled back into theambient air. | |||
| • | MS2 Bacteriophage :A 4 log reductionproduced in 15minutes. |
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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.
§ 880.5045 Medical recirculating air cleaner.
(a)
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.(b)
Classification. Class II (performance standards).