(322 days)
No reference devices were used in this submission
No
The device description details a system based on physical filtration and plasma generation with simple manual controls and a calendar-based maintenance reminder. There is no mention of adaptive learning, data analysis for optimization, or any other characteristics typically associated with AI/ML.
No.
The device filters and inactivates airborne particles for medical purposes but does not directly treat a patient's disease or condition; it focuses on environmental control.
No
Explanation: The device is described as an "air cleaner" that filters and inactivates airborne particles. Its function is to improve air quality for medical purposes, not to diagnose medical conditions in patients. While it is intended for use in "Medical Facilities," its role is environmental control.
No
The device description clearly outlines a physical cabinet with filters, a plasma generator, and fans, indicating it is a hardware device, not software-only.
Based on the provided information, the Novaerus NV 1050 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as a "room recirculating air cleaner" for "filtering out and inactivating airborne particles from the air for medical purposes." This describes a device that acts on the air in a physical space, not on biological samples taken from the human body.
- Device Description: The description details a system that draws in air, filters it, and uses a plasma generator to inactivate microorganisms within the air. This is consistent with an air purification system.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing diagnostic information about a patient's health status.
- Using reagents or assays to detect specific analytes.
- Performance Studies: The performance studies focus on the device's ability to reduce microorganisms and particles in the air, which aligns with its function as an air cleaner.
- Predicate Device: The predicate device (Plasmair Model T2006) is also an air purification system, further supporting the classification of the NV1050 as an air cleaner rather than an IVD.
In summary, the Novaerus NV 1050 is designed to clean the air in a room, not to perform diagnostic tests on biological samples. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FRF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical Facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria of the standards listed below:
Test name/Methodology/Standard name: IEC60601-1:2005/A1;2012
Purpose: Device electrical safety
Acceptance Criteria: Pass the requirements of the consensus standard
Result: Pass
Test name/Methodology/Standard name: IEC60601-1-2:2014
Purpose: Device Electromagnetic Compatibility
Acceptance Criteria: Pass the requirements of the consensus standard
Result: Pass
Test name/Methodology/Standard name: Ozone emissions
Purpose: Confirm ozone emissions are below the maximum permitted levels
§ 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).
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)
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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 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.