(268 days)
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.
The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
This device is not intended for use in areas with a sterile field or controlled air flow.
The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.
The device uses a MERV 13 filter for particle filtration. Down upstream of the pre-filter is a PCO component. The PCO consists of a TiO2 coated mesh and UV lights. When the UV lights (UV-C) provide sufficient energy, the TiO2 coated photo catalyst is activated. This component will deactivate microorganisms and viruses through a chemical reaction.
The RGS / RGS mini model numbers RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
The RGS / RGS mini is a medical ultraviolet air purifier intended to destroy bacteria in the air by exposure to ultraviolet radiation. The device was tested for its ability to eliminate specific bacteria and viruses.
Here's the detailed breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria and Source | Reported Device Performance |
|---|---|---|
| Electrical Safety and Electromagnetic Compatibility | UL 507 Standard for Electrical Fans, IEC 60601-1-2 EMC for medical devices | Compliant / Pass |
| Bacteria Reduction Test (Gram-Negative - E. Coli) | Log 4 reduction of Gram-Negative Bacteria (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of E. Coli |
| Bacteria Reduction Test (Gram-Positive - Staph. Epidermidis) | Log 4 reduction of Gram-Positive Bacteria (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of Staphylococcus Epidermidis |
| Virus Inactivation Test (MS-2 Bacteriophage) | Log 4 reduction of representative virus (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of MS-2 Bacteriophage |
| Filtration Efficiency Testing (Gram-Negative - E. Coli) | Log 4 reduction of Gram-Negative Bacteria (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of E. Coli |
| Filtration Efficiency Testing (Gram-Positive - Staph. Epidermidis) | Log 4 reduction of Gram-Positive Bacteria (21 CRF 880.6500) | Compliant / Pass: Log 4 Reduction of Staphylococcus Epidermidis |
| UV Lamp Shelf Life | 12,000 hrs. of continuous operation | Compliant / Pass: 12,000 hrs. of continuous operation |
| Pre-filter Shelf Life | 3 months of continuous operation | Compliant / Pass: 3 months of continuous operation |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes (number of tests) for each microbial reduction, filtration efficiency, or shelf-life test. However, the tests against bacteria and viruses were conducted by "LMS Technologies" to assess reduction capabilities in the air of a test chamber. The origin of the data is not specified beyond being generated by "LMS Technologies," implying a laboratory setting. These tests are inherently retrospective as they are conducted on a completed device to assess its performance against predefined criteria.
Specifically, for the RGS model:
- Staphylococcus Epidermidis: Log reduction of 4.0 PFU/ft^3
- Bacteriophage MS2: Log reduction of 4.02 PFU/ft^3
- Escherichia Coli: Log reduction of 4.24 PFU/ft^3
For the RGS mini model:
- Staphylococcus Epidermidis: Log reduction of 4.04 PFU/ft^3
- Bacteriophage MS2: Log reduction of 4 PFU/ft^3
- Escherichia Coli: Log reduction of 4.0 PFU/ft^3
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The "ground truth" for the performance tests relies on the results obtained by "LMS Technologies," which are standard microbiological and engineering testing methods. Expert consensus for determining the "ground truth" for microbial reduction or filtration efficiency is typically not applicable in this context; instead, it is based on quantitative laboratory measurements compared against defined log reduction targets.
4. Adjudication method for the test set:
Not applicable. The tests involve objective quantitative measurements (e.g., log reduction, hours of operation). There is no mention of an adjudication process for these test results, as they are typically direct measurements against predetermined performance targets.
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 relevant for diagnostic devices or AI algorithms that involve human interpretation, which is not the case for an air purifier.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is an air purifier and does not involve an algorithm or human-in-the-loop performance in the conventional sense of a medical diagnostic or AI device. The performance tests are for the device's physical and functional capabilities in reducing airborne microbes and filtering particles.
7. The type of ground truth used:
The ground truth for the performance tests is derived from quantitative laboratory measurements of microbial reduction and filtration efficiency, and direct functional testing for electrical safety and shelf life. For example, for bacteria and virus reduction, the "ground truth" is the measured log reduction achieved in a controlled test chamber, compared against the acceptance criterion of a "Log 4 reduction."
8. The sample size for the training set:
Not applicable. This device is a physical air purifier, not an AI/ML-based device that requires a training set.
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).