(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 minutesLow 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 14, 2023
Synexis, LLC Laura LeBoeuf VP Quality, Regulatory, Clinical Affairs 11711 W. 79th Street Lenexa, Kansas 66214
Re: K221540
Trade/Device Name: Synexis Sphere Rx Regulation Number: 21 CFR 880.6500 Regulation Name: Medical ultraviolet air purifier Regulatory Class: Class II Product Code: FRA Dated: June 8, 2023 Received: June 12, 2023
Dear Laura LeBoeuf:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III -S
Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221540
Device Name Synexis Sphere Rx
Indications for Use (Describe)
The Synexis Sphere Rx is a stand-alone arr 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 |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Synexis Sphere Rx Air Purifier System K221540
| Owner's Name & Address: | Synexis LLC11711 W 79th StreetLenexa, KS 66214 |
|---|---|
| Contact Person: | Laura LeBoeufVP Quality, Regulatory, Clinical Affairs512-517-5680lleboeuf@synexis.com |
| Submission Compiled By: | Lisa PetersonKaedon Consulting, LLClpeterson@kaedonconsulting.com |
| Date: | June 8, 2023 |
| Trade Name: | Synexis Sphere Rx |
| Common Name: | Air Purifier |
| Product Code: | FRA |
| Classification: | Class II (21 CFR 880.6500) |
| Classification Name | Medical UV Air Purifier |
| Predicate Devices: | PrimaryK211194 – Molekule Air ProAdditionalK201220 – Aerus Medical Guardian |
| Device Description | The Synexis Sphere Rx is a photocatalytic air purifier that utilizes aphotocatalytic oxidation purification process involving a light-activated catalyst which reacts with organic pollutants to oxidizethem. The Sphere Rx draws ambient air through multiple filtersincluding a carbon filter, a MERV filter and a photocatalytic filter thatSynexis refers to as a 'Sail'. |
| When the ambient air containing oxygen and water moleculescontacts the photocatalytic filter exposed to UV light, a chemicalreaction is initiated inside the device that generates hydroxylradicals, super oxides and hydrogen peroxides. Synexis refers tothe hydrogen peroxide molecules as dry hydrogen peroxide or DHPto distinguish these molecules from the aqueous form of hydrogenperoxide. | |
| The mechanism of action for the Sphere Rx photocatalytic air purifierto reduce microorganisms, including bacteria and viruses, in the airfor small room environments relies on combination of capture anddestruction. Ambient air is continuously circulated through MERVand carbon filters and a photocatalytic medium under UV lightexposure inside the device to achieve a 4 log reduction. | |
| Indications for Use: | The Synexis Sphere Rx is a stand-alone air purifier device intendedfor medical purposes and is used for the reduction of bacteria andviruses in the air. The device is intended for use in professionalhealthcare environments. The Sphere Rx is not intended for usenear HF surgical equipment or MRI settings. |
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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 Condition Temp/RH | Average Net Log Reduction/Time @ High Fan Speed | Average Net Log Reduction/Time @ Low Fan Speed |
|---|---|---|---|---|
| Gram Negative Bacteria | K. aerogenes | 25±3°C, 60 ±5% RH | 4.25 / 240m | 4.25 / 240m |
| Gram Positive Bacteria | S. epidermidis | 25±3°C, 60 ±5% RH | 4.19 / 360m | 4.13 / 480m |
| Virus | MS2 bacteriophage | 25±3°C, 60 ±5% RH | 4.55 / 300m | 4.11 / 480m |
Technological Characteristics:
The following table summarizes the similarities and differences between the subject and predicate devices.
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Table 1. Technological Characteristics Comparison
| Synexis Sphere Rx | Molekule Air Pro (K211194) | Aerus Medical Guardian (K201220) | Discussion ofDifferences | |
|---|---|---|---|---|
| 510 (k) Holder | Synexis, LLC | Molekule | Aerus Medical, LLC | N/A |
| Device Type | Medical Ultraviolet Air purifier | Medical Ultraviolet Air purifier | Medical Ultraviolet Air purifier | None |
| Product Code | FRA | FRA | FRA | None |
| ClassificationRegulation | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | None |
| Class | II | II | II | None |
| Patient Population | Not specified | Not specified | Not specified | None |
| Rx/OTC | OTC | OTC | OTC | None |
| User | Healthcare Professional | Healthcare ProfessionalLay User | Healthcare Professional | Sphere Rx andGuardian forprofessional useonly. |
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| Synexis Sphere Rx | Molekule Air Pro | Aerus Medical Guardian | Discussion ofDifferences | |
|---|---|---|---|---|
| IndicationsforUse | The Synexis Sphere Rx is a stand-alone air purifier deviceintended for medical purposes and is used for thereduction of bacteria and viruses in the air. The device isintended for use in professional healthcare environments.The Sphere Rx is not intended for use near HF surgicalequipment or in MRI settings.The Synexis Sphere Rx demonstrated the reduction of K.aerogenes and S. epidermis bacteria, and MS2 virus,under the following exposure/working conditions:Average Net Log Reduction / Time @ High Fan Speed.Room Temperature TestKlebsiella aerogenes4.25 / 240 minsStaphylococcus epidermidis4.19 / 360 minsMS2 bacteriophage4.55 / 300 minsAverage Net Log Reduction / Time @ Low Fan Speed.Room Temperature TestKlebsiella aerogenes4.25 / 240 minsStaphylococcus epidermidis4.13 / 480 minsMS2 bacteriophage4.11 / 480 mins | The Molekule Air Pro air purifier is a device intendedfor medical purposes that is used to capture 95% ofparticulate matter and destroy bacteria, mold, andviruses by exposure to ultraviolet radiation whenoperated in Auto Mode Standard or manual mode atfan speed 2 or higher.The Molekule Air Pro air purifier has beendemonstrated to entrain and destroy the followingbioaerosols under the following exposure/workingconditions:Average Net Log Reduction / Time @ Fan Speed 6.Room Temperature TestEscherichia Coli4.20 +/- 0.11 / 90 minsBacillus Subtilis4.02 +/- 0.23 / 30 minsAspergillus Brasiliensis4.15 ± 0.06 / 60 minsMS2 Bacteriophage4.38 ± 0.15 / 30 minsSingle Pass Mechanical Filtration EfficiencyParticulate Matter 0.3 to 1.0 micron size particles95% or greater according to ASHRAE 52.2 | The Aerus Medical Guardian, model F170A is adevice intended for medical purposes that is usedfor the reduction of staphylococcus epidermidis anderwinia herbicola bacteria, MS2 and Phi-X174viruses and aspergillum niger fungal spores andbacillus globigii bacterial spores from the air in atemperature-controlled professional healthcareenvironment of 70 - 71°F, 40 - 45% RH.The Aerus Guardian demonstrated the reduction ofstaphylococcus epidermidis and erwinia herbicolabacteria, MS2 and Phi-X174 viruses and aspergillumniger fungal spores and bacillus globigii bacterialspores under the following conditions:Staphylococcus epidermidis5.95 / 60Erwinia herbicola5.12 / 60MS25.58 / 60Phi-X1744.19 / 60Aspergillus niger4.12 / 60Bacillus globigii4.22 / 60 | The subject and predicate devicesare intended to reduce microbesin the air by exposure toultraviolet radiation. The devicesdemonstrate a 4-log reduction ofbacteria and viruses in the airand any minor differences in thewording of the indications foruse statement do not impact theintended use of the subjectdevice as compared to thepredicate. |
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| Synexis Sphere Rx | Molekule Air Pro | Aerus Medical Guardian | Discussion ofDifferences | |
|---|---|---|---|---|
| EnvironmentofUse | Hospital and other healthcare setting. | Hospital and other healthcare setting. Homehealthcare. | Hospital and other healthcare setting. | Sphere RxandGuardianintended forprofessionaluse only. |
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| Synexis Sphere Rx | Molekule Air Pro | Aerus Medical Guardian | Discussion of Differences | |
|---|---|---|---|---|
| Placement | The Sphere Rx can be mounted onthe wall or placed on a table usingthe stand.The Sphere Rx is not intended foruse in surgical suites or rooms withair separation devices.It is designed for rooms under1000ft² | Air Pro will work in any room, butgiving it space in a central location,is recommended. Placement nearthe patient is key.It should not be used insurgical suites or in roomswith air separation devices.It is designed for rooms under1000 ft². | Place the Aerus Medical Guardianin a location that allows air to movefreely into, around and out of theunit. Allow minimum of 12" ofclearance around intake grill(airflow input).Use in temperature-controlledprofessional healthcareenvironment of 70 - 71°F, 40 - 45%RH.It is designed for use in 3,000 ft³ /8-10 ft ceilings | The Sphere Rx can bemounted on the wall or placedon a table using the stand. |
| User Control | Standard switch to control fanspeed (low, medium, high) andbasic on/off switch. | LCD screen with capacitivetouchscreen interface. UserInterface includes severaldedicated screens for fan speedcontrol, PM sensor readings inaddition to other administrativefunctions. Application controlsmimic device touch panel. | Device touch panel to controlfan speed, on/off setting andreset control. | Sphere Rx uses standardswitch for fan speed controland on/off switch with nocapacitive touchscreeninterface. The user controlsare similar to most otherdevices that healthcareprofessionals and laypersons are accustomed tousing. |
| Synexis Sphere Rx | Molekule Air Pro | Aerus Medical Guardian | Discussion ofDifferences | |
| Software | Basic firmware (circuit board) toturn unit on/off and change fanspeed. | Basic Firmware and App used toturn the unit on, off, and changefan speed. | Basic firmware (circuit board)to turn unit on/off and changefan speed. | Sphere Rx and Guardianutilize basic firmware (circuitboard) to turn the unit on/offand change fan speed. |
| Mechanism ofAction | UV light of sufficient energy (UV-A) activates photocatalyst thatreduces microorganisms in the airthrough a photochemical reaction. | UV light of sufficient energy (UV-A) activates photocatalyst thatdestroys microorganismsentrained on the filter through aphotochemical reaction. | ActivePure® Cell whichcontains two UVGI (Ultra VioletGermicidal Irradiation) bulbsplus a TiO2 basedphotocatalyst reducesmicroorganisms in the airthrough a photochemicalreaction. | None. The subject andpredicate devices reducemicroorganisms in the airthrough a photochemicalreaction using UV light. |
| Installation | Wall mount or free standing | Free standing | Free standing | Sphere Rx equipped withwall mount option |
| Filter(s) | 'Sail' Filter coated withproprietary photocatalyst. Totalsurface area: 22 in2Carbon FilterMERV11 Filter | Total Filter surface area: 1779in2Filter coated with proprietaryphotocatalyst and a metal wiremeshMERV16 | HEPA filterMultipoint ionizerTwo pieces of polycarbonatehoneycomb material with acombined surface area of708 square inches, coatedwith a TiO2 based catalystcalled ActivePure® | Subject and predicate utilizesimilar filters to entrainmicroorganisms as well asfilters coated with aphotocatalyst to reducemicroorganisms in the airusing a photochemicalreaction. |
| Photocatalyst | Proprietary catalyst | Proprietary catalyst | Proprietary catalyst | None. Subject andpredicates use titaniumdioxide (TiO2) catalyst |
| Synexis Sphere Rx | Molekule Air Pro | Aerus Guardian | Discussion ofDifferences | |
| Light Source | UV Light Source: Custom UV-ABulbWavelength: 320-400 nmTotal UV Power: 21 W | UV Light Source: LEDWavelength: 320-400 nmTotal of 20 UV LEDs split amongst5 PCBs (4 LEDs per PCB)Total UV Power: 16 WFilter Irradiance (Minimum): 20 W/m2 | Two 10-watt UVGI bulbs operatingat a wavelength of 254nm | Sphere Rx and Air Pro useUV-A wavelength andGuardian uses UVGI. |
| Air Source | Centrifugal Fan | Centrifugal Fan | Centrifugal Fan | None |
| Flow Control | 3 speeds (low, medium, high)Provide 10-30 CFM airflow rate | 6 speeds (low-high)Provide 25-260 CFM airflow rate | 4 speeds (low-high)Provide 90 - 300 CFM airflow rate | Air Pro and Guardianoffer higher fan speeds |
| Device Air ChangesPer Hour (ACH) | Roughly 30 CFM in a 1000 ft2room on high setting | Roughly 260 CFM in a1000 ft2 room on setting 6 | Roughly 300 CFM in a 3000 ft3room on high setting | Air Pro and Guardian offerhigher fan speeds |
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| Synexis Sphere Rx | Molekule Air Pro | Aerus Guardian | Discussion of Differences | |
|---|---|---|---|---|
| UV Light ExposureSafety Features | Unit automatically turns offwhen door to access UV-Abulb is opened. | If a validated, serialized, Molekulefilter is missing, the unit will notoperate. The unit authenticatesthe filter via NFC, before andduring operation.The purpose of this system isto protect the user from anypossibility of exposure todirect contact with UV-A lightthat would occur without agenuine Molekule Filterbeing present. | Unit automatically turns off whendoor to access UVGI bulbs isopened. | Sphere Rx and Guardianautomatically turn off whendoor to access bulb is opened. |
| Fan ExposureSafety Features | Inlet and outlet grate blocksuser from accessingspinning fan. Safetyfeature confirmed by UL507. | Vanes at outlet andHoneycomb inlet of fan withsmall enough grating to blockuser from accessing spinningfan without tools. Safetyfeature confirmed by UL 507. | Inlet and outlet grate blocksuser from accessing spinningfan. Safety feature confirmedby UL 507. | None |
| Input Voltage | 120 Volt | 120 Volt | 120 Volt | None |
| Synexis Sphere Rx | Molekule Air Pro airpurifier | Aerus Guardian | Discussion of Differences | |
|---|---|---|---|---|
| Current | Up to 0.75 Amps | Up to 1.27 Amps | Up to 1.0 Amps | Air Pro and Guardian offerhigher fan speeds |
| PowerConsumption | Up to 90 Watts | Up to 152.8 Watts | Up to 117 Watts | Air Pro and Guardian offerhigher fan speeds |
| Electronic DataInterface | N/A | NFCWLAN (2.4 GHZ) | N/A | Sphere Rx does not utilizeelectronic data interface |
| Dimensions | Width: 18.7 in (47.5 cm)Height: 18.7 in (47.5 cm)Depth: 7.7 in (17.8 cm) | Height: 23.11 in (587 mm)Diameter: 10.83 in (275 mm) | 26.5"H x 11.5"W x 21.0"D673mm H x 292mm W x533mm D | The Sphere Rx is a smallerstand-alone unit that can be wallmounted or placed on a tabletop. |
| Standards | FCC Part 15 B RadioFrequency DevicesUL 507 Standard forElectricalFansIEC 60601-1-2EMC for Medical Devices | FCC Part 15 C RadioFrequency DevicesUL 507 Standard for ElectricalFansIEC 60601-1-2EMC for Medical Devices | UL 507 Standard for ElectricalFansIEC 60601-1-2EMC for Medical Devices | Sphere Rx and Air Pro complywith additional FCC standards forhome health use. Althoughcompliant with FCC standards forhome health, Synexis is notseeking the home healthindication in this submission. |
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Non-Clinical Performance Data:
Non-clinical device performance testing was conducted on the subject Synexis Sphere Rx device to assess the performance and safety of the device. Performance testing was conducted in accordance with approved Synexis protocols and included the following:
- Kill kinetics testing to verify subject device achieves 4 loq reduction of defined organisms
- Composition of air testing to verify subject device emissions do not exceed permissible exposure limits for seven (7) gaseous species
- Electrical safety and EMC compatibility in accordance UL -507:2017 Electric Fans and 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, respectively.
Table 2 summarizes the performance and safety test results for the Sphere Rx device.
| Electrical Safety andEMC | Standard | Result |
|---|---|---|
| Electrical Safety | UL 507:2017 Electric Fans | PASS |
| EMC compatibility | IEC 60601-1-2:2014 Medical electricalequipment - Part 1-2: General requirementsfor basic safety and essential performance -Collateral Standard: Electromagneticdisturbances - Requirements and tests | PASS |
| Compound | Exposure Limit | Result |
| H2O2 gas | ≤ 5.8 ppb (Tox Risk Assessment) | PASS |
| O3 | ≤.05ppm (UL 867) | PASS |
| SO2 | ≤ 2ppm (NIOSH) | PASS |
| CO | ≤ 35ppm (NIOSH) | PASS |
| NO2 | ≤ 1ppm (NIOSH) | PASS |
| CH2O | ≤ .016 ppm (NIOSH) | PASS |
| Total VOCs | ≤ 1.4 ppm (EC Joint Research Report 19) | PASS |
| Organism Type/Name | Average Net Log Reduction/Time@ High Fan Speed | Result |
| Gram Negative BacteriaK. aerogenes | 4.25 / 240m | PASS |
| Gram Positive BacteriaS. epidermidis | 4.19 / 360m | PASS |
| VirusMS2 bacteriophage | 4.55 / 300m | PASS |
| Table 2. Non-Clinical Results Summary | |||
|---|---|---|---|
| -- | --------------------------------------- | -- | -- |
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| Organism Type/Name | Average Net Log Reduction/Time@ Low Fan Speed | Result |
|---|---|---|
| Gram Negative BacteriaK. aerogenes | 4.25 / 240m | PASS |
| Gram Positive BacteriaS. epidermidis | 4.13 / 480m | PASS |
| VirusMS2 bacteriophage | 4.11 / 480m | PASS |
Clinical Performance Data:
Not Applicable.
Conclusion:
Synexis concludes that the nonclinical tests demonstrate that the Sphere Rx air purifier is as safe, as effective, and performs as well as the legally marketed predicate 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).