Synexis Sphere Rx

K221540 · Synexis, LLC · FRA · Jun 14, 2023 · General Hospital

Device Facts

• Record ID: K221540
• Device Name: Synexis Sphere Rx
• Applicant: Synexis, LLC
• Product Code: FRA · General Hospital
• Decision Date: Jun 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2

Indications for Use

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.

Device Story

The Synexis Sphere Rx is a photocatalytic air purifier designed for professional healthcare environments. It draws ambient air through a multi-stage filtration system, including a carbon filter, a MERV 11 filter, and a proprietary photocatalytic 'Sail' filter. Inside the device, ambient air containing oxygen and water molecules contacts the photocatalytic filter under UV-A light (320-400 nm), initiating a photochemical reaction that generates hydroxyl radicals, super oxides, and hydrogen peroxide (DHP). This process, combined with mechanical filtration, reduces airborne bacteria and viruses. The device is wall-mounted or table-top, operated by healthcare professionals via a standard on/off and fan speed switch. It provides a ≥ 4 log reduction of microorganisms. By reducing airborne microbial load, the device aims to support infection control in healthcare settings.

Clinical Evidence

No clinical data. Bench testing only. Testing included kill kinetics (≥ 4 log reduction of K. aerogenes, S. epidermidis, and MS2 bacteriophage), air composition testing for gaseous emissions (H2O2, O3, SO2, CO, NO2, CH2O, VOCs), and electrical/EMC safety (UL 507, IEC 60601-1-2).

Technological Characteristics

Photocatalytic air purifier. Materials: Carbon filter, MERV 11 filter, proprietary photocatalytic 'Sail' filter. Energy: 120V AC, 21W UV-A (320-400 nm) custom bulb. Dimensions: 18.7" x 18.7" x 7.7". Connectivity: None. Sterilization: N/A. Software: Basic firmware for fan/power control. Standards: UL 507, IEC 60601-1-2, FCC Part 15 B.

Indications for Use

Indicated for the reduction of bacteria and viruses in the air within professional healthcare environments. Not for use near HF surgical equipment or MRI settings.

Regulatory Classification

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.

Predicate Devices

• Molekule Air Pro (K211194)
• Aerus Medical Guardian (K201220)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Summary

## Synexis Sphere Rx Air Purifier System K221540

| Owner's Name & Address: | Synexis LLC<br>11711 W 79th Street<br>Lenexa, KS 66214 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura LeBoeuf<br>VP Quality, Regulatory, Clinical Affairs<br>512-517-5680<br>[e-mail] |
| Submission Compiled By: | Lisa Peterson<br>Kaedon Consulting, LLC<br>[e-mail] |
| 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: | Primary<br>K211194 – Molekule Air Pro<br>Additional<br>K201220 – Aerus Medical Guardian |
| Device Description | The Synexis Sphere Rx is a photocatalytic air purifier that utilizes a<br>photocatalytic oxidation purification process involving a light-<br>activated catalyst which reacts with organic pollutants to oxidize<br>them. The Sphere Rx draws ambient air through multiple filters<br>including a carbon filter, a MERV filter and a photocatalytic filter that<br>Synexis refers to as a 'Sail'. |
| | When the ambient air containing oxygen and water molecules<br>contacts the photocatalytic filter exposed to UV light, a chemical<br>reaction is initiated inside the device that generates hydroxyl<br>radicals, super oxides and hydrogen peroxides. Synexis refers to<br>the hydrogen peroxide molecules as dry hydrogen peroxide or DHP<br>to distinguish these molecules from the aqueous form of hydrogen<br>peroxide. |
| | The mechanism of action for the Sphere Rx photocatalytic air purifier<br>to reduce microorganisms, including bacteria and viruses, in the air<br>for small room environments relies on combination of capture and<br>destruction. Ambient air is continuously circulated through MERV<br>and carbon filters and a photocatalytic medium under UV light<br>exposure inside the device to achieve a 4 log reduction. |
| Indications for Use: | The Synexis Sphere Rx is a stand-alone air purifier device intended<br>for medical purposes and is used for the reduction of bacteria and<br>viruses in the air. The device is intended for use in professional<br>healthcare environments. The Sphere Rx is not intended for use<br>near HF surgical equipment or MRI settings. |

{4}------------------------------------------------

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 | <i>K. aerogenes</i> | 25±3°C, 60 ±5% RH | 4.25 / 240m | 4.25 / 240m |
| Gram Positive Bacteria | <i>S. epidermidis</i> | 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.

{5}------------------------------------------------

Table 1. Technological Characteristics Comparison

| | Synexis Sphere Rx | Molekule Air Pro (K211194) | Aerus Medical Guardian (K201220) | Discussion of<br>Differences |
|------------------------------|----------------------------------|-------------------------------------|----------------------------------|------------------------------------------------------------|
| 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 |
| Classification<br>Regulation | 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 Professional<br>Lay User | Healthcare Professional | Sphere Rx and<br>Guardian for<br>professional use<br>only. |

{6}------------------------------------------------

| | Synexis Sphere Rx | Molekule Air Pro | Aerus Medical Guardian | Discussion of<br>Differences |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for<br>Use | The Synexis Sphere Rx is a stand-alone air purifier device<br>intended for medical purposes and is used for the<br>reduction of bacteria and viruses in the air. The device is<br>intended for use in professional healthcare environments.<br>The Sphere Rx is not intended for use near HF surgical<br>equipment or in MRI settings.<br>The Synexis Sphere Rx demonstrated the reduction of K.<br>aerogenes and S. epidermis bacteria, and MS2 virus,<br>under the following exposure/working conditions:<br>Average Net Log Reduction / Time @ High Fan Speed.<br>Room Temperature Test<br>Klebsiella aerogenes<br>4.25 / 240 mins<br>Staphylococcus epidermidis<br>4.19 / 360 mins<br>MS2 bacteriophage<br>4.55 / 300 mins<br>Average Net Log Reduction / Time @ Low Fan Speed.<br>Room Temperature Test<br>Klebsiella aerogenes<br>4.25 / 240 mins<br>Staphylococcus epidermidis<br>4.13 / 480 mins<br>MS2 bacteriophage<br>4.11 / 480 mins | The Molekule Air Pro air purifier is a device intended<br>for medical purposes that is used to capture 95% of<br>particulate matter and destroy bacteria, mold, and<br>viruses by exposure to ultraviolet radiation when<br>operated in Auto Mode Standard or manual mode at<br>fan speed 2 or higher.<br>The Molekule Air Pro air purifier has been<br>demonstrated to entrain and destroy the following<br>bioaerosols under the following exposure/working<br>conditions:<br>Average Net Log Reduction / Time @ Fan Speed 6.<br>Room Temperature Test<br>Escherichia Coli<br>4.20 +/- 0.11 / 90 mins<br>Bacillus Subtilis<br>4.02 +/- 0.23 / 30 mins<br>Aspergillus Brasiliensis<br>4.15 ± 0.06 / 60 mins<br>MS2 Bacteriophage<br>4.38 ± 0.15 / 30 mins<br>Single Pass Mechanical Filtration Efficiency<br>Particulate Matter 0.3 to 1.0 micron size particles<br>95% or greater according to ASHRAE 52.2 | The Aerus Medical Guardian, model F170A is a<br>device intended for medical purposes that is used<br>for the reduction of staphylococcus epidermidis and<br>erwinia herbicola bacteria, MS2 and Phi-X174<br>viruses and aspergillum niger fungal spores and<br>bacillus globigii bacterial spores from the air in a<br>temperature-controlled professional healthcare<br>environment of 70 - 71°F, 40 - 45% RH.<br>The Aerus Guardian demonstrated the reduction of<br>staphylococcus epidermidis and erwinia herbicola<br>bacteria, MS2 and Phi-X174 viruses and aspergillum<br>niger fungal spores and bacillus globigii bacterial<br>spores under the following conditions:<br>Staphylococcus epidermidis<br>5.95 / 60<br>Erwinia herbicola<br>5.12 / 60<br>MS2<br>5.58 / 60<br>Phi-X174<br>4.19 / 60<br>Aspergillus niger<br>4.12 / 60<br>Bacillus globigii<br>4.22 / 60 | The subject and predicate devices<br>are intended to reduce microbes<br>in the air by exposure to<br>ultraviolet radiation. The devices<br>demonstrate a 4-log reduction of<br>bacteria and viruses in the air<br>and any minor differences in the<br>wording of the indications for<br>use statement do not impact the<br>intended use of the subject<br>device as compared to the<br>predicate. |

{7}------------------------------------------------

| | Synexis Sphere Rx | Molekule Air Pro | Aerus Medical Guardian | Discussion of<br>Differences |
|--------------------------|----------------------------------------|------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------|
| Environment<br>of<br>Use | Hospital and other healthcare setting. | Hospital and other healthcare setting. Home<br>healthcare. | Hospital and other healthcare setting. | Sphere Rx<br>and<br>Guardian<br>intended for<br>professional<br>use only. |

{8}------------------------------------------------

| | Synexis Sphere Rx | Molekule Air Pro | Aerus Medical Guardian | Discussion of Differences |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Placement | The Sphere Rx can be mounted on<br>the wall or placed on a table using<br>the stand.<br>The Sphere Rx is not intended for<br>use in surgical suites or rooms with<br>air separation devices.<br>It is designed for rooms under<br>1000ft² | Air Pro will work in any room, but<br>giving it space in a central location,<br>is recommended. Placement near<br>the patient is key.<br>It should not be used in<br>surgical suites or in rooms<br>with air separation devices.<br>It is designed for rooms under<br>1000 ft². | Place the Aerus Medical Guardian<br>in a location that allows air to move<br>freely into, around and out of the<br>unit. Allow minimum of 12" of<br>clearance around intake grill<br>(airflow input).<br>Use in temperature-controlled<br>professional healthcare<br>environment of 70 - 71°F, 40 - 45%<br>RH.<br>It is designed for use in 3,000 ft³ /<br>8-10 ft ceilings | The Sphere Rx can be<br>mounted on the wall or placed<br>on a table using the stand. |
| User Control | Standard switch to control fan<br>speed (low, medium, high) and<br>basic on/off switch. | LCD screen with capacitive<br>touchscreen interface. User<br>Interface includes several<br>dedicated screens for fan speed<br>control, PM sensor readings in<br>addition to other administrative<br>functions. Application controls<br>mimic device touch panel. | Device touch panel to control<br>fan speed, on/off setting and<br>reset control. | Sphere Rx uses standard<br>switch for fan speed control<br>and on/off switch with no<br>capacitive touchscreen<br>interface. The user controls<br>are similar to most other<br>devices that healthcare<br>professionals and lay<br>persons are accustomed to<br>using. |
| | Synexis Sphere Rx | Molekule Air Pro | Aerus Medical Guardian | Discussion of<br>Differences |
| Software | Basic firmware (circuit board) to<br>turn unit on/off and change fan<br>speed. | Basic Firmware and App used to<br>turn the unit on, off, and change<br>fan speed. | Basic firmware (circuit board)<br>to turn unit on/off and change<br>fan speed. | Sphere Rx and Guardian<br>utilize basic firmware (circuit<br>board) to turn the unit on/off<br>and change fan speed. |
| Mechanism of<br>Action | UV light of sufficient energy (UV-<br>A) activates photocatalyst that<br>reduces microorganisms in the air<br>through a photochemical reaction. | UV light of sufficient energy (UV-<br>A) activates photocatalyst that<br>destroys microorganisms<br>entrained on the filter through a<br>photochemical reaction. | ActivePure® Cell which<br>contains two UVGI (Ultra Violet<br>Germicidal Irradiation) bulbs<br>plus a TiO2 based<br>photocatalyst reduces<br>microorganisms in the air<br>through a photochemical<br>reaction. | None. The subject and<br>predicate devices reduce<br>microorganisms in the air<br>through a photochemical<br>reaction using UV light. |
| Installation | Wall mount or free standing | Free standing | Free standing | Sphere Rx equipped with<br>wall mount option |
| Filter(s) | 'Sail' Filter coated with<br>proprietary photocatalyst. Total<br>surface area: 22 in2<br>Carbon Filter<br>MERV11 Filter | Total Filter surface area: 1779<br>in2<br>Filter coated with proprietary<br>photocatalyst and a metal wire<br>mesh<br>MERV16 | HEPA filter<br>Multipoint ionizer<br>Two pieces of polycarbonate<br>honeycomb material with a<br>combined surface area of<br>708 square inches, coated<br>with a TiO2 based catalyst<br>called ActivePure® | Subject and predicate utilize<br>similar filters to entrain<br>microorganisms as well as<br>filters coated with a<br>photocatalyst to reduce<br>microorganisms in the air<br>using a photochemical<br>reaction. |
| Photocatalyst | Proprietary catalyst | Proprietary catalyst | Proprietary catalyst | None. Subject and<br>predicates use titanium<br>dioxide (TiO2) catalyst |
| | Synexis Sphere Rx | Molekule Air Pro | Aerus Guardian | Discussion of<br>Differences |
| Light Source | UV Light Source: Custom UV-A<br>Bulb<br>Wavelength: 320-400 nm<br>Total UV Power: 21 W | UV Light Source: LED<br>Wavelength: 320-400 nm<br>Total of 20 UV LEDs split amongst<br>5 PCBs (4 LEDs per PCB)<br>Total UV Power: 16 W<br>Filter Irradiance (Minimum): 20 W/m2 | Two 10-watt UVGI bulbs operating<br>at a wavelength of 254nm | Sphere Rx and Air Pro use<br>UV-A wavelength and<br>Guardian uses UVGI. |
| Air Source | Centrifugal Fan | Centrifugal Fan | Centrifugal Fan | None |
| Flow Control | 3 speeds (low, medium, high)<br>Provide 10-30 CFM airflow rate | 6 speeds (low-high)<br>Provide 25-260 CFM airflow rate | 4 speeds (low-high)<br>Provide 90 - 300 CFM airflow rate | Air Pro and Guardian<br>offer higher fan speeds |
| Device Air Changes<br>Per Hour (ACH) | Roughly 30 CFM in a 1000 ft2<br>room on high setting | Roughly 260 CFM in a<br>1000 ft2 room on setting 6 | Roughly 300 CFM in a 3000 ft3<br>room on high setting | Air Pro and Guardian offer<br>higher fan speeds |

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

| | Synexis Sphere Rx | Molekule Air Pro | Aerus Guardian | Discussion of Differences |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| UV Light Exposure<br>Safety Features | Unit automatically turns off<br>when door to access UV-A<br>bulb is opened. | If a validated, serialized, Molekule<br>filter is missing, the unit will not<br>operate. The unit authenticates<br>the filter via NFC, before and<br>during operation.<br><br>The purpose of this system is<br>to protect the user from any<br>possibility of exposure to<br>direct contact with UV-A light<br>that would occur without a<br>genuine Molekule Filter<br>being present. | Unit automatically turns off when<br>door to access UVGI bulbs is<br>opened. | Sphere Rx and Guardian<br>automatically turn off when<br>door to access bulb is opened. |
| Fan Exposure<br>Safety Features | Inlet and outlet grate blocks<br>user from accessing<br>spinning fan. Safety<br>feature confirmed by UL<br>507. | Vanes at outlet and<br>Honeycomb inlet of fan with<br>small enough grating to block<br>user from accessing spinning<br>fan without tools. Safety<br>feature confirmed by UL 507. | Inlet and outlet grate blocks<br>user from accessing spinning<br>fan. Safety feature confirmed<br>by UL 507. | None |
| Input Voltage | 120 Volt | 120 Volt | 120 Volt | None |

| Synexis Sphere Rx | Molekule Air Pro air<br>purifier | 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 offer<br>higher fan speeds |
| Power<br>Consumption | Up to 90 Watts | Up to 152.8 Watts | Up to 117 Watts | Air Pro and Guardian offer<br>higher fan speeds |
| Electronic Data<br>Interface | N/A | NFC<br>WLAN (2.4 GHZ) | N/A | Sphere Rx does not utilize<br>electronic data interface |
| Dimensions | Width: 18.7 in (47.5 cm)<br>Height: 18.7 in (47.5 cm)<br>Depth: 7.7 in (17.8 cm) | Height: 23.11 in (587 mm)<br>Diameter: 10.83 in (275 mm) | 26.5"H x 11.5"W x 21.0"D<br>673mm H x 292mm W x<br>533mm D | The Sphere Rx is a smaller<br>stand-alone unit that can be wall<br>mounted or placed on a table<br>top. |
| Standards | FCC Part 15 B Radio<br>Frequency Devices<br>UL 507 Standard for<br>Electrical<br>Fans<br>IEC 60601-1-2<br>EMC for Medical Devices | FCC Part 15 C Radio<br>Frequency Devices<br>UL 507 Standard for Electrical<br>Fans<br>IEC 60601-1-2<br>EMC for Medical Devices | UL 507 Standard for Electrical<br>Fans<br>IEC 60601-1-2<br>EMC for Medical Devices | Sphere Rx and Air Pro comply<br>with additional FCC standards for<br>home health use. Although<br>compliant with FCC standards for<br>home health, Synexis is not<br>seeking the home health<br>indication in this submission. |

{12}------------------------------------------------

{13}------------------------------------------------

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 and<br>EMC | Standard | Result |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Electrical Safety | UL 507:2017 Electric Fans | PASS |
| EMC compatibility | IEC 60601-1-2:2014 Medical electrical<br>equipment - Part 1-2: General requirements<br>for basic safety and essential performance -<br>Collateral Standard: Electromagnetic<br>disturbances - 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<br>@ High Fan Speed | Result |
| Gram Negative Bacteria<br>K. aerogenes | 4.25 / 240m | PASS |
| Gram Positive Bacteria<br>S. epidermidis | 4.19 / 360m | PASS |
| Virus<br>MS2 bacteriophage | 4.55 / 300m | PASS |

| | Table 2. Non-Clinical Results Summary | | |
|--|---------------------------------------|--|--|
|--|---------------------------------------|--|--|

{14}------------------------------------------------

| Organism Type/Name | Average Net Log Reduction/Time<br>@ Low Fan Speed | Result |
|------------------------------------------|---------------------------------------------------|--------|
| Gram Negative Bacteria<br>K. aerogenes | 4.25 / 240m | PASS |
| Gram Positive Bacteria<br>S. epidermidis | 4.13 / 480m | PASS |
| Virus<br>MS2 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.