(99 days)
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation.
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions:
| Organism | Name | Average Maximum Log Reduction / Exposure Time
(hours) by Temperature | | |
|------------------------|-------------------------------|-------------------------------------------------------------------------|------------------|------------------|
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus
epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours |
| Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour |
| Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours |
| Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours |
| Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours |
| Bacterial
endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours |
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute):
| Organism | Name | Average Net Log Reduction
in 20 Minutes |
|---------------------|----------------------------|--------------------------------------------|
| Bacteria | Staphylococcus epidermidis | 5.17 |
| Bacteria | Klebsiella aerogenes | 5.56 |
| Virus | MS2 bacteriophage | 5.00 |
| Virus | Phi-X174 bacteriophage | 5.34 |
| Mold endospore | Aspergillus brasiliensis | 4.50 |
| Bacterial endospore | Bacillus Subtilis | 4.58 |
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a medical ultraviolet air purifier, which incorporates patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-fiter, UV-A lamps, and a catalytic filter coated with a photocatalyst. The ViroZap™ has metal housing with electronic controls, and it is installed in the ducts of a building's HVAC system.
It will be available in two sizes: one size with outer dimensions of 28.5 inches by 12.25 inches, and a second size with outer dimensions of 24 inches by 12.25 inches. The ViroZap 110 device has a pre-filter and a chamber equipped with 6 low energy ultraviolet LED lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.
The device in question is the ViroZap™ Indoor Air Purifier, In Duct Model 1008.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is evaluated against its effectiveness in reducing various microorganisms both when entrained on the filter and in a large chamber setting. The acceptance criterion for both main studies (room air reduction and kill rate kinetics) was that the device's effectiveness should be "equivalent or superior to the predicate, Transformair (K161468)." The documentation confirms that this criterion was met, showing the device was effective in reducing the microorganisms.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Study to characterize the efficacy of the subject device to reduce respirable bioaerosol levels for six broad-ranged species of microorganisms from room air. | Confirmation that the effectiveness of the device against ssRNA virus, ssDNA virus, Gram negative bacteria, Gram positive bacteria, bacteria endospores, and mold spores was equivalent or superior to the predicate, Transformair (K161468). | Pass. The subject device was effective in reducing a broad range of airborne microorganisms within a short period of time. |
Specific log reduction data (Average Net Log Reduction in 20 Minutes) for chamber testing are:
- Staphylococcus epidermidis: 5.17
- Klebsiella aerogenes: 5.56
- MS2 bacteriophage: 5.00
- Phi-X174 bacteriophage: 5.34
- Aspergillus brasiliensis: 4.50
- Bacillus Subtilis: 4.58 |
| In vitro study to characterize the temperature variant kill rate kinetics for six different bioaerosols deposited on the surface of the subject device's photocatalytic coated filter media after exposure to UV-A light. | Confirmation that the kill kinetics of the modified catalytic filter was equivalent or superior to the predicate device catalytic filter. | Pass. As with the predicate device, the filter media achieved more than a 4.0 log reduction in each species at each temperature.
Specific log reduction data (Average Maximum Log Reduction / Exposure Time) entrained on filter are:
45°F
-- Staphylococcus epidermidis: 4.94 / 12 hours
-- Klebsiella aerogenes: 5.40 / 1 hour
-- MS2 bacteriophage: 4.32 / 12 hours
-- Phi-X174 bacteriophage: 4.39 / 12 hours
-- Aspergillus brasiliensis: 4.52 / 168 hours
-- Bacillus Subtilis: 4.83 / 168 hours
72°F
-- Staphylococcus epidermidis: 4.54 / 4 hours
-- Klebsiella aerogenes: 6.55 / 1 hour
-- MS2 bacteriophage: 4.51 / 4 hours
-- Phi-X174 bacteriophage: 5.24 / 4 hours
-- Aspergillus brasiliensis: 5.61 / 168 hours
-- Bacillus Subtilis: 4.21 / 168 hours
110°F
-- Staphylococcus epidermidis: 4.51 / 4 hours
-- Klebsiella aerogenes: 6.54 / 1 hour
-- MS2 bacteriophage: 4.58 / 4 hours
-- Phi-X174 bacteriophage: 5.14 / 4 hours
-- Aspergillus brasiliensis: 5.61 / 168 hours
-- Bacillus Subtilis: 4.34 / 168 hours |
| Test to evaluate the efficacy of filter media following accelerated aging equivalent to one year. | Confirmation that the subject device had equivalent performance after accelerated aging equivalent to one year. | Pass. The subject device was effective at reducing the microorganism after undergoing accelerated aging, with results equivalent to trials run on the unaged device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes (e.g., number of test runs or replicates) for the validation studies. It describes the methodology:
- Room Air Reduction Study: "Six microorganism species were aerosolized in a sealed bioaerosol chamber containing the subject device. Bioaerosol samples were taken at multiple time points throughout each trial..."
- In vitro Kill Rate Kinetics: "Samples of the subject device's photocatalytic coated filter media were tested against six aerosolized microorganisms. The samples were tested at three different temperatures." "The trials were carried out to quantify at least a 4.0 log reduction."
The data provenance is not specified in terms of country of origin. The studies appear to be prospective as they involved testing the physical device and its components under controlled laboratory conditions to demonstrate performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for this medical device is established through quantitative laboratory measurements of microorganism reduction, not through expert consensus or interpretation of medical images. Therefore, the concept of "experts establishing ground truth" in the typical sense of a clinical or imaging study is not directly applicable here. The credibility of the results relies on standard microbiology and biodefense testing protocols, and the expertise of the laboratory personnel conducting these tests.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are laboratory-based performance tests, not studies involving human interpretation or adjudication of results in a clinical context. The results are quantitative measurements of microbial reduction.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human readers (e.g., radiologists interpreting images). The ViroZap™ is an air purification device, and its performance is evaluated by its physical ability to destroy microorganisms, not by assisting human decision-making.
6. Standalone (Algorithm Only) Performance
This concept is not applicable to this device. The ViroZap™ is a physical medical device (an air purifier) that works mechanically and photochemically, not an algorithm or software-only device. Its performance is inherently "standalone" in the sense that its efficacy stems from its own physical operation, without human-in-the-loop performance in its primary function of air purification.
7. Type of Ground Truth Used
The ground truth used is based on quantitative microbiological laboratory assays. This involves measuring the reduction of specific microorganism concentrations (Staphylococcus epidermidis, Klebsiella aerogenes, MS2 bacteriophage, Phi-X174 bacteriophage, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores) after exposure to the device or its components under controlled conditions. The "log reduction" values represent the quantitative proof of the device's efficacy.
8. Sample Size for the Training Set
This information is not applicable. The ViroZap™ is a physical device, not an AI/ML algorithm that requires a "training set" of data. Its design and physical properties (e.g., UV-A lamps, catalytic filter) are engineered to achieve the desired microbial destruction.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for a physical device like the ViroZap™. The device's performance is demonstrated through its functional capabilities, measured in the non-clinical testing.
§ 880.6500 Medical ultraviolet air purifier.
(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).