(239 days)
AirKEE P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.
AirKEE P900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions:
| Test Item | Avg. max Log Reduction/Entrainment Time (min) (in a 20m3 chamber) |
|---|---|
| Bacteria Staphylococcus aureus | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Bacteria Escherichia coli | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Mold | |
| Aspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Virus | |
| Influenza A virus, H1N1 | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed | |
| Virus | |
| Influenza A virus, H3N3 | Log 4 (99.99%)/60 minutes @ high fan speed |
| Log 4 (99.99%)/120 minutes @ low fan speed |
AirKEE P900 is a mobile multi-function medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE P900 is controlled via a touchscreen control panel on the machine.
AirKEE P900's main components consist of:
Multi-stage air treatment
- a filtration system with primary filter, HEPA filter, activated carbon filter, and nano- O material filter
- UV lamps that generate UV-C irradiation to inactivate and eliminate microorganisms o
- a motor/impeller to move air through the filtration system o
System control
- o a touch panel interface to indicate the working status of the device and consumables
AirKEE P900's multi-stage air treatment: Air enters through the bottommost chamber and fans direct the air in an upwards manner. Firstly, air passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Air then passes through activated carbon filter. Lastly, HEPA H13 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top in an upwards manner.
The control panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.
The AirKEE P900 is a medical ultraviolet air purifier that was tested to demonstrate its effectiveness in capturing and destroying bacteria, mold, and viruses in the air.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microorganism Performance | 4 Log reduction (99.99%) | 4 Log reduction (99.99%) in 60 minutes at high fan speed; and 4 Log reduction (99.99%) in 120 minutes at low fan speed for Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Serratia marcescens, Aspergillus Niger, Influenza A virus, H1N1, and Influenza A virus, H3N3. |
| Fractional Efficiency | Per Standard (IEST-RP-CC001.6 - HEPA and ULPA Filters) | Filter fractional efficiency percentage of 99.99% at 0.1-0.2µm. |
| Electrical Safety and EMC | Per Standard (UL 507, IEC 60601-1-2) | Pass |
| Ozone | Per Standard (UL 867) | Operates at less than 0.05 ppm at its highest fan speed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size for each microorganism performance test (e.g., how many runs were performed for each microorganism). However, it does specify that the tests were conducted "in a 20m³ chamber" and "entrained on the filter of the subject device."
The data provenance is not explicitly mentioned as a country of origin. The submitter is "HealKee Medical Pte Ltd" from Singapore, suggesting the testing might have been conducted in Singapore or a location associated with the company's operations. The data appears to be prospective, as it describes tests conducted specifically for the AirKEE P900 device to demonstrate its performance against predefined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The performance evaluation for microorganism reduction and other non-clinical tests likely relied on established laboratory protocols and standards, rather than expert consensus on individual "cases" in the typical sense of diagnostic imaging. For a medical UV air purifier, the "ground truth" would be the measurable reduction of microorganisms.
4. Adjudication Method for the Test Set:
This information is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations (e.g., radiologists reviewing images) to establish a consensus ground truth. For a device like an air purifier, performance is measured quantitatively through laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not done. This type of study assesses the performance of human readers, with and without AI assistance, which is not relevant for an air purifier.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
For the microorganism performance, the study can be considered a standalone performance study of the device (AirKEE P900) operating independently. The device's ability to destroy microorganisms is measured directly in a controlled environment without human intervention during the process itself (though humans operate and set up the device and tests).
7. Type of Ground Truth Used:
The ground truth used for the microorganism performance is quantitative laboratory measurement (direct bacterial/viral/mold count reduction). This involves culturing and counting microorganisms before and after exposure to the device in a controlled chamber, and computing the log reduction.
For fractional efficiency, electrical safety, EMC, and ozone, the ground truth is established by conformance to recognized standards (IEST-RP-CC001.6, UL 507, IEC 60601-1-2, UL 867).
8. Sample Size for the Training Set:
This information is not applicable. The AirKEE P900 is an electromechanical device with filtration and UV-C technology, not an AI/ML-driven diagnostic or analytical tool that requires a "training set" of data in the typical sense for algorithm development. Its performance is based on its physical design and operation, which are then tested for efficacy.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" for this type of device. The device's design principles and expected performance are based on established scientific principles of filtration, UV-C radiation, and photocatalysis. The validation occurred through the non-clinical tests described.
§ 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).