(279 days)
The Aura Storm air purifier is a device intended for medical purposes that is used to capture and destroy bacteria and viruses in the air through the multi-stage filtration system and exposure to ultraviolet radiation.
The Aura Storm air purifier has been demonstrated to destroy the following bacteria: Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli, and virus: A/PR8/34 HIN1 virus entrained on the filter of the subject device under the following exposure conditions:
Average Maximum log reduction / entrainment time (minutes) at Fan Speed 4. Room Temperature test: Log 4 (99.99%) / 60 minutes.
Average Maximum log reduction / entrainment time (minutes) at Fan Speed 1. Room Temperature test: Log 4 (99.99%) / 120 minutes.
The Aura Storm is a multi-stage UV-C air purifier that delivers air purification for rooms up to 2700 square feet (*52ft x 52ft). The Storm inactivates and eliminates bacteria and viruses in the Aura Storm may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. The Aura Storm is a standalone device that is controlled via buttons on the top of the unit.
The Aura Storm is a dual-sided system with each side consisting of four-stage is a prefilter. The second stage is a HEPA H13+ filter. The third stage is a TiO2 cold photo-catalyst filter. Finally, the UV-C sterilization lamp emits a 253.7mm designed to activate the photo-catalyst filter and eliminate bacteria and viruses. The anion generator is used strictly to increase the size of the particulate molecules to increase the ability to capture and eliminate the bacteria and viruses. This designed system delivers a third-party tested 99.99% (4-log) sterilization in 60 minutes at the highest fan speed. The Aura storm was also tested at the lowest fan speed and delivered a 99.99% (4-log) sterilization in 120 minutes. The air flow diagram has been submitted in the 510(k) submission.
There is an internal fan which draws in air from both sides of the unit, filters it through the multi-stage system and outputs the filtered air through the top of the unit features a capacitive touch button control to operate the On/Off, fan speed (4 speeds), Auto mode, UV lamp, Anion generator, Child lock, timer, and filter reset. There is also a particulate matter sensor and color bar to indicate the level of clean air.
The Invictus Aura Storm Air Purifier (K212644) has been tested for its ability to reduce bacteria and inactivate viruses, and for its filtration efficiency.
1. Table of Acceptance Criteria and Reported Device Performance
| Title of the Test | Purpose of the Test | Acceptance Criteria and the Source of References | Reported Device Performance |
|---|---|---|---|
| Bacteria Reduction Test | To understand the log reduction rate for Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli | 4 Log reduction of the tested bacteria, 3rd party testing at an accredited laboratory | - Staphylococcus albicans: 99.99% elimination rate (4-Log reduction) in 60 minutes at highest fan speed. |
| - Staphylococcus aureus: 99.99% elimination rate (4-Log reduction) in 60 minutes at highest fan speed. | |||
| - Escherichia Coli: 99.99% elimination rate (4-Log reduction) in 60 minutes at highest fan speed. | |||
| - Overall (Bacteria): 4-LOG reduction in 60 minutes at highest fan speed; 4-LOG reduction in 120 minutes at lowest fan speed. | |||
| Virus Inactivation Test | To understand the log reduction rate for the A/PR8/34 H1N1 virus | 4 Log activation of the tested virus, 3rd party testing at an accredited laboratory | - A/PR8/34 H1N1: ≥ 99.99% (4-Log reduction) in 60 minutes at highest fan speed. |
| - Overall (Virus): 4-LOG reduction in 60 minutes at highest fan speed; 4-LOG reduction in 120 minutes at lowest fan speed. | |||
| Filtration Efficiency Testing | To understand the filtration efficiency of the HEPA filter | ISO 29463 H13 ISO 35H ≥ 99.975% filtration for particles ≥ 0.3 microns, 3rd party testing at an accredited laboratory | 99.98% filtration efficiency for particles greater than or equal to 0.3 microns. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective.
- Bacteria Reduction Test: For each of the three bacteria (Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli), three separate tests were conducted. Each test involved a control group and a test group, indicating a total of 3 samples per bacteria type, or 9 samples for bacteria reduction.
- Virus Inactivation Test: Three separate tests were conducted for the A/PR8/34 H1N1 virus.
- Filtration Efficiency Testing: The sample size for this test is not specified, but it was conducted by a 3rd party accredited laboratory.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for these tests (bacterial/viral counts, filtration efficiency) is established through laboratory measurements and standardized protocols, not by expert consensus or interpretation of images.
4. Adjudication Method
Not applicable for these types of laboratory tests. The results are quantitative measurements obtained through direct testing, rather than subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The device is an air purifier, and its performance is measured through direct laboratory tests for microbial reduction and filtration efficiency, not through human reader interpretation or clinical assessment that would require an MRMC study.
6. Standalone Performance
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The reported performance metrics (log reduction, elimination rates, filtration efficiency) are direct measurements of the device's capability without human intervention in its operation or performance assessment.
7. Type of Ground Truth Used
The ground truth used is based on controlled laboratory measurements of:
- Bacterial colony-forming units (CFU/m3) for bacteria reduction tests.
- Viral activation/reduction measurements for virus inactivation tests.
- Particle counts for filtration efficiency tests.
These measurements are considered objective and quantitative.
8. Sample Size for the Training Set
Not applicable. The Invictus Aura Storm Air Purifier is a physical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
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).