(257 days)
The Transformair Indoor Air Purifier, In Duct Model 16108 is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.
Transformair Indoor Air Purifier, In Duct Model 16108 has been demonstrated to destroy Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger and Bacillus globigii entrained on the filter of the subject device under the following exposure conditions:
| Organism | Name | Average Maximum log reduction /exposure time (hours) | ||
|---|---|---|---|---|
| Test temperature | ||||
| 45°F | 72°F | 110°F | ||
| Bacteria | Staphylococcus | 4.88 / 24 hours | 4.02 / 0.33 hours | 4.20 / 0.33 hours |
| Bacteria | Escherichia coli | 4.31 / 24 hours | 4.79 / 24 hours | 4.40 / 0.33 hours |
| Virus | MS2 bacteriophage | 4.13 / 24 hours | 4.25 / 24 hours | 5.51 / 24 hours |
| Virus | Phi-X174 | 4.37 / 24 hours | 4.37 / 24 hours | 4.37 / 24 hours |
| Mold endospore | Aspergillus Niger | 3.91 / 72 hours | 3.99 / 72 hours | 4.22 / 72 hours |
| Bacterial endospore | Bacillus globigii | 4.11 / 72 hours | 4.41 / 72 hours | 4.41 / 72 hours |
Transformair® is a patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-filter, black light lamps, and a catalytic filter coated with a photocatalyst. The Transformair device has a metal housing with electronic controls and outer dimensions of 28.5 inches by 21 inches by 12.25 inches that is installed in the duct of a buildings HVAC system. The Transformair device has a pre-filter and a chamber equipped with 6 low energy ultraviolet lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.
The provided document describes a medical device, the Transformair Indoor Air Purifier, and its performance data to establish substantial equivalence with a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate set of pass/fail thresholds before the study. Instead, the study results themselves demonstrate the device's efficacy, and these reported results are presented as sufficient to establish substantial equivalence with the predicate device. The performance is measured in "Average Maximum log reduction" over specific exposure times and temperatures. The FDA's acceptance of these results "proves" the device meets the implicit criteria for efficacy for its intended use.
| Organism | Name | Test Temperature | Exposure Time | Reported Average Maximum Log Reduction |
|---|---|---|---|---|
| Bacteria | Staphylococcus epidermidis | 45°F | 24 hours | 4.88 |
| 72°F | 0.33 hours | 4.02 | ||
| 110°F | 0.33 hours | 4.20 | ||
| Bacteria | Escherichia coli | 45°F | 24 hours | 4.31 |
| 72°F | 24 hours | 4.79 | ||
| 110°F | 0.33 hours | 4.40 | ||
| Virus | MS2 bacteriophage | 45°F | 24 hours | 4.13 |
| 72°F | 24 hours | 4.25 | ||
| 110°F | 24 hours | 5.51 | ||
| Virus | Phi-X174 bacteriophage | 45°F | 24 hours | 4.37 |
| 72°F | 24 hours | 4.37 | ||
| 110°F | 24 hours | 4.37 | ||
| Mold endospore | Aspergillus Niger | 45°F | 72 hours | 3.91 |
| 72°F | 72 hours | 3.99 | ||
| 110°F | 72 hours | 4.22 | ||
| Bacterial endospore | Bacillus globigii | 45°F | 72 hours | 4.11 |
| 72°F | 72 hours | 4.41 | ||
| 110°F | 72 hours | 4.41 |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample sizes for each organism tested. It refers to "aerosolized suspensions of the claimed microorganisms" and "kill kinetics for bacteria (Staphylococcus epidermidis and Escherichia coli), viruses (MS2 and Phi-X174), and mold spores (Aspergillus Niger) and bacterial spores (Bacillus globigii)." The implication is that multiple tests were conducted for each organism at various temperatures and exposure times to derive the "Average Maximum log reduction." However, the exact number of replicates or individual samples is not provided.
- Data Provenance: The document states, "Third party testing was performed to evaluate filter performance using aerosolized suspensions of the claimed microorganisms... This testing was done in compliance with FDA Good Laboratory Practices (GLP) as defined in 40 CFR, Part 160." This indicates the tests were conducted in a controlled laboratory environment by an independent third party, likely within the US given the FDA GLP compliance. The data is prospective as it involves active testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This is not applicable as the study involves direct microbiological testing of the device's ability to destroy microorganisms, not human interpretation of data where expert consensus would establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable. The study involves direct measurement of microorganism reduction, not a judgmental interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic algorithms involving human readers, which is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance study was done. The performance results (log reduction of microorganisms) are based solely on the efficacy of the Transformair Indoor Air Purifier device itself under specified testing conditions. There is no human intervention in the device's direct performance of destroying bacteria.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is established through direct microbiological testing against known concentrations of specific organisms (Staphylococcus epidermidis, Escherichia coli, MS2 bacteriophage, Phi-X174 bacteriophage, Aspergillus Niger, and Bacillus globigii). The "log reduction" represents the quantitative measure of the device's ability to destroy these organisms, serving as the ground truth for its germicidal efficacy.
8. The Sample Size for the Training Set:
This device is not an AI/ML algorithm that requires a training set. Its performance is based on physical and chemical processes (UV-A light activating a photocatalyst), which are evaluated through direct performance testing rather than training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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).