Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a photocatalytic air purifier with filters and UV light. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
The device is described as an air purifier intended for the reduction of bacteria and viruses in the air, not for direct therapeutic treatment of patients. It operates by cleaning the air, which is a supportive rather than a therapeutic function.

Diagnostic

No

The device is an air purifier intended for medical purposes, specifically for the reduction of bacteria and viruses in the air. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical air purifier with filters, UV light, and a photocatalytic process, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Synexis Sphere Rx is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Synexis Sphere Rx Function: The Synexis Sphere Rx is an air purifier. Its intended use is to reduce bacteria and viruses in the air within professional healthcare environments. It does not analyze or interact with human specimens.
Mechanism of Action: The device works by filtering and using photocatalytic oxidation to purify the air. This is an environmental control function, not a diagnostic process involving biological samples.

Therefore, the Synexis Sphere Rx falls under the category of an air purification device for environmental control in healthcare settings, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

FRA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not specified

Intended User / Care Setting

professional healthcare environments / professional healthcare environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 log 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 EMC	Standard	Result
Electrical Safety	UL 507:2017 Electric Fans	PASS
EMC compatibility	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
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 Bacteria K. aerogenes	4.25 / 240m	PASS
Gram Positive Bacteria S. epidermidis	4.19 / 360m	PASS
Virus MS2 bacteriophage	4.55 / 300m	PASS

Organism Type/Name	Average Net Log Reduction/Time @ Low Fan Speed	Result
Gram Negative Bacteria K. aerogenes	4.25 / 240m	PASS
Gram Positive Bacteria S. epidermidis	4.13 / 480m	PASS
Virus MS2 bacteriophage	4.11 / 480m	PASS

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Average Net Log Reduction

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K211194, K201220

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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 (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

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)

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3

510(k) Summary

Synexis Sphere Rx Air Purifier System K221540

| Owner's Name & Address: | Synexis LLC
11711 W 79th Street
Lenexa, KS 66214 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura LeBoeuf
VP Quality, Regulatory, Clinical Affairs
512-517-5680
lleboeuf@synexis.com |
| Submission Compiled By: | Lisa Peterson
Kaedon Consulting, LLC
lpeterson@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: | Primary
K211194 – Molekule Air Pro
Additional
K201220 – Aerus Medical Guardian |
| Device Description | 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. |
| 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. |

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	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.

5

Table 1. Technological Characteristics Comparison

| | Synexis Sphere Rx | Molekule Air Pro (K211194) | Aerus Medical Guardian (K201220) | Discussion of
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
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
Lay User | Healthcare Professional | Sphere Rx and
Guardian for
professional use
only. |

6

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

7

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

8

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

9

10

11

	Synexis Sphere Rx	Molekule Air Pro	Aerus Guardian	Discussion of Differences
UV Light Exposure
Safety Features	Unit automatically turns off
when door to access UV-A
bulb is opened.	If a validated, serialized, Molekule
filter is missing, the unit will not
operate. The unit authenticates
the filter via NFC, before and
during operation.

The purpose of this system is
to protect the user from any
possibility of exposure to
direct contact with UV-A light
that would occur without a
genuine Molekule Filter
being present. | Unit automatically turns off when
door to access UVGI bulbs is
opened. | Sphere Rx and Guardian
automatically turn off when
door to access bulb is opened. |
| Fan Exposure
Safety Features | Inlet and outlet grate blocks
user from accessing
spinning fan. Safety
feature confirmed by UL
507. | Vanes at outlet and
Honeycomb inlet of fan with
small enough grating to block
user from accessing spinning
fan without tools. Safety
feature confirmed by UL 507. | Inlet and outlet grate blocks
user from accessing spinning
fan. Safety feature confirmed
by UL 507. | None |
| Input Voltage | 120 Volt | 120 Volt | 120 Volt | None |

| Synexis Sphere Rx | Molekule Air Pro air
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
higher fan speeds |
| Power
Consumption | Up to 90 Watts | Up to 152.8 Watts | Up to 117 Watts | Air Pro and Guardian offer
higher fan speeds |
| Electronic Data
Interface | N/A | NFC
WLAN (2.4 GHZ) | N/A | Sphere Rx does not utilize
electronic 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"D
673mm H x 292mm W x
533mm D | The Sphere Rx is a smaller
stand-alone unit that can be wall
mounted or placed on a table
top. |
| Standards | FCC Part 15 B Radio
Frequency Devices
UL 507 Standard for
Electrical
Fans
IEC 60601-1-2
EMC for Medical Devices | FCC Part 15 C Radio
Frequency Devices
UL 507 Standard for Electrical
Fans
IEC 60601-1-2
EMC for Medical Devices | UL 507 Standard for Electrical
Fans
IEC 60601-1-2
EMC for Medical Devices | Sphere Rx and Air Pro comply
with additional FCC standards for
home health use. Although
compliant with FCC standards for
home health, Synexis is not
seeking the home health
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

EMC	Standard	Result
Electrical Safety	UL 507:2017 Electric Fans	PASS
EMC compatibility	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
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 Bacteria
K. aerogenes	4.25 / 240m	PASS
Gram Positive Bacteria
S. epidermidis	4.19 / 360m	PASS
Virus
MS2 bacteriophage	4.55 / 300m	PASS

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

14

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