(47 days)
The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation.
The core technology components of the Molekule Air Pro RX air purifier have been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure conditions:
| Organism | Name | Average Maximum log reduction
/exposure time (hours) |
|----------|-------------------|---------------------------------------------------------|
| | | Room temperature test |
| Virus | MS2 bacteriophage | 5.21 / 24 hours |
The Molekule Air Pro RX air purifier employs a photo-electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria, viruses and mold in air in medical facilities. The Molekule Air Pro RX air purifier includes a pre-filter and low energy ultraviolet lights (UV-A 320-400 nm), and a catalytic filter.
Here's a summary of the acceptance criteria and study information for the Molekule Air Pro RX, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Organism and Metric) | Reported Device Performance (Molekule Air Pro RX) |
|---|---|
| MS2 bacteriophage log reduction | 5.21 log reduction after 24 hours of exposure at room temperature |
Study Details
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Sample size used for the test set and the data provenance: Not explicitly stated for specific tests, but the performance data presented is for MS2 bacteriophage. The context implies the tests were conducted for the purpose of this 510(k) submission (prospective in that sense) and likely within the US, given the FDA submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the performance test (log reduction of MS2 bacteriophage) is based on laboratory measurements of destruction, not expert interpretation.
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Adjudication method for the test set: Not applicable. This is a performance test involving direct measurement, not assessment by experts requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a device that directly destroys microorganisms; human reader performance is not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes. The performance tests described (e.g., MS2 bacteriophage log reduction) evaluate the device's efficacy in destroying bacteria and viruses independently, without human interaction influencing the destruction process.
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The type of ground truth used: For the performance test, the ground truth is laboratory measurement of microorganism destruction, specifically the calculated log reduction of MS2 bacteriophage.
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The sample size for the training set: Not applicable. This is a hardware device undergoing performance testing, not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for a machine learning algorithm.
Summary of Non-Clinical Tests Provided:
The 510(k) submission included several non-clinical tests to support substantial equivalence:
- Risk Analysis
- Software verification and validation testing
- Electrical safety testing per UL 507:2017
- Electromagnetic compatibility (EMC) testing per IEC 60601-1-2: 2014
- Performance tests for UV light leakage and light intensity
- Fluid modeling to confirm no impact on laminar flow systems
- Testing to demonstrate filtration performance and destruction of bacteria
- Third-party testing to characterize the kill rate kinetics for MS2 bacteriophage deposited on the catalytic filter media when exposed to the UV-A light. This test showed an average of 3.41 LOG reduction after one hour and 5.21 LOG reduction after 24 hours of UV exposure at room temperature.
§ 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).