(383 days)
The Synexis Sphere Rx is a stand-alone air purifier device intended for medical purposes and is used for the reduction of bacteria and viruses in the air. The device is intended for use in professional healthcare environments. The Sphere Rx is not intended for use near HF surgical equipment or MRI settings.
The Synexis Sphere Rx air purifier demonstrated a ≥ 4 log reduction of bacteria and viruses under the following exposure/ working conditions:
| Organism Type | Organism Name | Test Temp/RH | Avg Net Log Reduction/Time@ High Fan Speed |
|---|---|---|---|
| Gram- bacteria | K. aerogenes | 25±3 deg C, 60 ±5% RH | 4.25 / 240m |
| Gram+ bacteria | S. epidermidis | 25±3 deg C, 60 ±5% RH | 4.19 / 360m |
| Virus | MS2 | 25±3 deg C, 60 ±5% RH | 4.55 / 300m |
| Organism Type | Organism Name | Test Temp/RH | Avg Net Log Reduction/Time@ Low Fan Speed |
| Gram- bacteria | K. aerogenes | 25±3 deg C, 60 ±5% RH | 4.25 / 240m |
| Gram+ bacteria | S. epidermidis | 25±3 deg C, 60 ±5% RH | 4.13 / 480m |
| Virus | MS2 | 25±3 deg C, 60 ±5% RH | 4.11 / 480m |
The Synexis Sphere Rx is a photocatalytic air purifier that utilizes a photocatalytic oxidation purification process involving a light-activated catalyst which reacts with organic pollutants to oxidize them. The Sphere Rx draws ambient air through multiple filters including a carbon filter, a MERV filter and a photocatalytic filter that Synexis refers to as a 'Sail'.
When the ambient air containing oxygen and water molecules contacts the photocatalytic filter exposed to UV light, a chemical reaction is initiated inside the device that generates hydroxyl radicals, super oxides and hydrogen peroxides. Synexis refers to the hydrogen peroxide molecules as dry hydrogen peroxide or DHP to distinguish these molecules from the aqueous form of hydrogen peroxide.
The mechanism of action for the Sphere Rx photocatalytic air purifier to reduce microorganisms, including bacteria and viruses, in the air for small room environments relies on combination of capture and destruction. Ambient air is continuously circulated through MERV and carbon filters and a photocatalytic medium under UV light exposure inside the device to achieve a 4 log reduction.
Here's a breakdown of the acceptance criteria and study information for the Synexis Sphere Rx, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Required Performance) | Reported Device Performance (Synexis Sphere Rx) | Meets Criteria? |
|---|---|---|---|
| Microbial Reduction | ≥ 4 log reduction of specified bacteria and viruses. | High Fan Speed: |
- K. aerogenes (Gram- bacteria): 4.25 log reduction in 240 minutes
- S. epidermidis (Gram+ bacteria): 4.19 log reduction in 360 minutes
- MS2 bacteriophage (Virus): 4.55 log reduction in 300 minutes
Low Fan Speed:
- K. aerogenes (Gram- bacteria): 4.25 log reduction in 240 minutes
- S. epidermidis (Gram+ bacteria): 4.13 log reduction in 480 minutes
- MS2 bacteriophage (Virus): 4.11 log reduction in 480 minutes | Yes |
| Air Composition Safety (Gases) | Emissions do not exceed permissible exposure limits for: H2O2 gas (≤ 5.8 ppb), O3 (≤ 0.05 ppm), SO2 (≤ 2 ppm), CO (≤ 35 ppm), NO2 (≤ 1 ppm), CH2O (≤ 0.016 ppm), Total VOCs (≤ 1.4 ppm). | Reported Results: - H2O2 gas: PASS
- O3: PASS
- SO2: PASS
- CO: PASS
- NO2: PASS
- CH2O: PASS
- Total VOCs: PASS | Yes |
| Electrical Safety | Compliance with UL 507:2017 Electric Fans. | PASS | Yes |
| EMC Compatibility | Compliance with IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. | PASS | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the kill kinetics, air composition, electrical safety, or EMC compatibility tests. It mentions that "Non-clinical device performance testing was conducted on the subject Synexis Sphere Rx device to assess the performance and safety of the device."
The data provenance is from non-clinical device performance testing conducted by Synexis LLC and reported to the FDA. The country of origin for the data is not explicitly stated, but given that Synexis LLC is based in Lenexa, Kansas, USA, and the submission is to the U.S. FDA, it is likely that the testing was conducted in the USA. The data is prospective as it involves the testing of the Synexis Sphere Rx device itself to determine its performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is Not Applicable as the Synexis Sphere Rx is an air purifier, and its performance (microbial reduction, air emissions, electrical safety) is determined by laboratory testing and adherence to engineering standards, not by expert interpretation of medical images or clinical data. "Ground truth" in this context refers to the measured performance against established scientific benchmarks and regulatory standards.
4. Adjudication Method for the Test Set
This information is Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human readers or expert consensus to resolve discrepancies in interpretations, such as in image-based diagnostic studies. The tests conducted for the Synexis Sphere Rx were objective, quantitative measurements in a laboratory setting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is Not Applicable. This device is an air purifier, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is Not Applicable in the context of an "algorithm only" performance, as this is a physical device, not a software algorithm for data analysis. However, the performance testing described in the document is effectively a "standalone performance" of the device itself, without human intervention aside from operating the device during the tests. The results show the intrinsic capability of the Synexis Sphere Rx to reduce airborne microbes and maintain safe emissions under specific conditions.
7. The Type of Ground Truth Used
The "ground truth" used for the performance evaluation of the Synexis Sphere Rx is based on:
- Quantitative Laboratory Measurements: For microbial reduction, the ground truth is the measured log reduction of specific organisms (K. aerogenes, S. epidermidis, MS2 bacteriophage) under controlled environmental conditions (temperature, humidity, fan speed).
- Permissible Exposure Limits (PELs) and Regulatory Standards: For air composition, the ground truth is defined by established safety limits for various gaseous species (e.g., Tox Risk Assessment, UL 867, NIOSH, EC Joint Research Report 19).
- Engineering Standards: For electrical safety and EMC compatibility, the ground truth is defined by compliance with recognized industrial standards such as UL 507:2017 and IEC 60601-1-2:2014.
8. The Sample Size for the Training Set
This information is Not Applicable. The Synexis Sphere Rx is a physical air purifier, not an AI model that requires a "training set" for machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is Not Applicable for the same reason as point 8.
§ 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).