(99 days)
Not Found
No
The device description and performance studies focus on the photochemical reaction and UV-A radiation for microorganism destruction, with no mention of AI or ML technologies.
Yes
The "Intended Use" section explicitly states that the device is "intended for medical purposes" and is "used to destroy microorganisms... in the air". The "Device Description" also refers to it as a "medical ultraviolet air purifier" designed to "destroy bacteria in air in medical facilities." These statements indicate a medical or therapeutic intent for the device.
No
The device is an air purifier intended to destroy microorganisms through a photochemical reaction, not to diagnose a condition or disease.
No
The device description explicitly states it consists of hardware components including a pre-filter, UV-A lamps, a catalytic filter, metal housing, and electronic controls. It is installed in HVAC ducts, indicating a physical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The ViroZap™ Indoor Air Purifier is designed to purify air by destroying microorganisms in the air through a photochemical reaction. It does not interact with or analyze specimens taken from the human body.
- Intended Use: The intended use is to destroy microorganisms entrained on a filter in the air within medical facilities. This is an environmental control function, not a diagnostic function.
- Performance Studies: The performance studies focus on the device's ability to reduce airborne microorganisms in a chamber and on the filter media. These are not studies evaluating the device's ability to diagnose or provide information about a patient's health status based on biological specimens.
Therefore, the ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a medical device, but it falls under a different classification than In Vitro Diagnostics. It is an air purification device intended for use in medical settings.
N/A
Intended Use / Indications for Use
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation.
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions:
| Organism | Name | Average Maximum Log Reduction / Exposure Time
(hours) by Temperature | | |
|---|---|---|---|---|
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus
epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours |
| Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour |
| Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours |
| Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours |
| Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours |
| Bacterial
endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours |
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute):
| Organism | Name | Average Net Log Reduction
in 20 Minutes |
|---|---|---|
| Bacteria | Staphylococcus epidermidis | 5.17 |
| Bacteria | Klebsiella aerogenes | 5.56 |
| Virus | MS2 bacteriophage | 5.00 |
| Virus | Phi-X174 bacteriophage | 5.34 |
| Mold endospore | Aspergillus brasiliensis | 4.50 |
| Bacterial endospore | Bacillus Subtilis | 4.58 |
Product codes
FRA
Device Description
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a medical ultraviolet air purifier, which incorporates patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-fiter, UV-A lamps, and a catalytic filter coated with a photocatalyst. The ViroZap™ has metal housing with electronic controls, and it is installed in the ducts of a building's HVAC system.
It will be available in two sizes: one size with outer dimensions of 28.5 inches by 12.25 inches, and a second size with outer dimensions of 24 inches by 12.25 inches. The ViroZap 110 device has a pre-filter and a chamber equipped with 6 low energy ultraviolet LED lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.
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 Found
Intended User / Care Setting
Medical Facilities
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)
Study to characterize the efficacy of the subject device to reduce respirable bioaerosol levels for six broad-ranged species of microorganisms from room air.
- Brief Description: Six microorganism species were aerosolized in a sealed bioaerosol chamber containing the subject device. Bioaerosol samples were taken at multiple time points throughout each trial, in order to quantify the reduction rate capability of the device.
- Results: Pass. The subject device was effective in reducing a broad range of airborne microorganisms within a short period of time.
In vitro study to characterize the temperature variant kill rate kinetics for six different bioaerosols deposited on the surface of the subject device's photocatalytic coated filter media after exposure to UV-A light.
- Brief Description: Samples of the subject device's photocatalytic coated filter media were tested against six aerosolized microorganisms. The samples were tested at three different temperatures. The kill kinetic testing was assessed at multiple sampling points to create a reduction curve with each species at each temperature. The trials were carried out to quantify at least a 4.0 log reduction.
- Results: Pass. As with the predicate device, the filter media achieved more than a 4.0 log reduction in each species at each temperature.
Test to evaluate the efficacy of filter media following accelerated aging equivalent to one year.
- Brief Description: A microorganism was aerosolized into a sealed environment containing the subject device. Bioaerosol samples were taken at multiple time points throughout each trial to quantify the reduction rate capability of the device.
- Results: Pass. The subject device was effective at reducing the microorganism after undergoing accelerated aging. The results from the aged device were equivalent to trials run on the unaged device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
August 1, 2024
Applied Photonix, LLC % Jeffrey Shapiro King & Spalding LLP 1700 Pennsylvania Avenue, NW Suite 900 Washington DC 20006
Re: K241140
Trade/Device Name: ViroZap™ Indoor Air Purifier, In Duct Model 1008 Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: May 16, 2024 Received: May 16, 2024
Dear Jeffrery Shapiro:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Katharine Segars -S
Katharine Segars, PhD Assistant Director DHT4C: Division of Infection Control 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)
K241140
Device Name
ViroZap™ Indoor Air Purifier, In Duct Model 1008
Indications for Use (Describe)
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation.
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions:
| Organism | Name | Average Maximum Log Reduction / Exposure Time
(hours) by Temperature | | |
|------------------------|-------------------------------|-------------------------------------------------------------------------|------------------|------------------|
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus
epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours |
| Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour |
| Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours |
| Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours |
| Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours |
| Bacterial
endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours |
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute):
| Organism | Name | Average Net Log Reduction
in 20 Minutes |
|---------------------|----------------------------|--------------------------------------------|
| Bacteria | Staphylococcus epidermidis | 5.17 |
| Bacteria | Klebsiella aerogenes | 5.56 |
| Virus | MS2 bacteriophage | 5.00 |
| Virus | Phi-X174 bacteriophage | 5.34 |
| Mold endospore | Aspergillus brasiliensis | 4.50 |
| Bacterial endospore | Bacillus Subtilis | 4.58 |
3
Prescription Use (Part 21 CFR 801 Subpart D)
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4
Image /page/4/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of a row of five red squares above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. The words are in a serif font and are black.
510(k) SUMMARY
ViroZap™ Indoor Air Purifier, In Duct Model 1008
K241140
Submitter:
| Company Name: | Applied Photonix, LLC |
|---|---|
| Company Address: | 3802 Spectrum Blvd. |
| Suite 202-1 | |
| Tampa, FL 33612 | |
| Contact Person: | |
| Phone: | |
| Email: | Dr. D. Yogi Goswami |
| 352-871-3800 | |
| Y.Goswami@holtec.com | |
| Date Prepared: | August 1, 2024 |
| Device: | |
| Proprietary Name: | ViroZapTM Indoor Air Purifier, In Duct Model 1008 |
| Common or Usual Name: | Air purifier ultraviolet or ultraviolet air purifier |
| Classification Name: | Medical Ultraviolet Air Purifier |
| Regulation Number: | 21 C.F.R. § 880.6500 |
| Product Code: | FRA |
| Device Class: | Class 2 |
| Category: | General Hospital |
5
Image /page/5/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of five red squares in a row above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. The words are in a simple, sans-serif font and are black in color.
Predicate Device: The predicate device is shown in the following table:
| Predicate Device | Transformair Indoor Air Purifier |
|---|---|
| Manufacturer | Transformair, Inc. |
| 510(k) Number | K161468 |
| Regulation Number | 21 C.F.R. § 880.6500 |
| Regulation Name | Medical Ultraviolet Air Purifier |
| Regulatory Class | II |
| Product Code | FRA |
| Review Panel | General Hospital |
| Combination Product | No |
Intended Use / Indications for Use:
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation.
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions:
| Organism | Name | Average Maximum Log Reduction / Exposure Time
(hours) by Temperature | | |
|------------------------|-------------------------------|-------------------------------------------------------------------------|------------------|------------------|
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus
epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours |
| Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour |
| Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours |
| Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours |
| Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours |
| Bacterial
endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours |
6
Image /page/6/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of a row of five red squares above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. There is a thin black line above the word "PHOTONIX".
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute):
| Organism | Name | Average Net Log Reduction
in 20 Minutes |
|------------------------|----------------------------|--------------------------------------------|
| Bacteria | Staphylococcus epidermidis | 5.17 |
| Bacteria | Klebsiella aerogenes | 5.56 |
| Virus | MS2 bacteriophage | 5.00 |
| Virus | Phi-X174 bacteriophage | 5.34 |
| Mold endospore | Aspergillus brasiliensis | 4.50 |
| Bacterial
endospore | Bacillus Subtilis | 4.58 |
Device Description:
The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a medical ultraviolet air purifier, which incorporates patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-fiter, UV-A lamps, and a catalytic filter coated with a photocatalyst. The ViroZap™ has metal housing with electronic controls, and it is installed in the ducts of a building's HVAC system.
It will be available in two sizes: one size with outer dimensions of 28.5 inches by 12.25 inches, and a second size with outer dimensions of 24 inches by 12.25 inches. The ViroZap 110 device has a pre-filter and a chamber equipped with 6 low energy ultraviolet LED lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.
Technological Characteristics Comparison:
Compared to the predicate device (K161468), the subject device has the same intended use but differs in the catalytic filter, light source, and the organisms demonstrated to be destroyed by the device (identified in the indications for use statement). The table below provides a comparison of the subject device and predicate device.
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Image /page/7/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of a row of five red squares above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. The text is in a simple, sans-serif font.
Office: (813) 825 - 1790
| Element for
Comparison | Predicate:
Transformair Indoor
Air Purifier; Model
16108
(K161468) | Subject Device:
ViroZapTM; Indoor Air
Purifier, In Duct Model
1008
(K241140) | Comparison |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product type | Medical Ultraviolet Air
Purifier | Medical Ultraviolet Air
Purifier | Identical |
| Regulation
Number | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | Identical |
| Indications
for Use | The Transformair Indoor
Air Purifier, In Duct
Model 16108 is a device
intended for medical
purposes that is used to
destroy microorganisms
entrained on the filter
through a photochemical
reaction in the air by
exposure to UV-A
radiation.
Transformair Indoor Air
Purifier, In Duct Model
16108 has been
demonstrated to destroy
Staphylococcus
epidermidis - a Gram
positive bacterium,
Escherichia coli – a Gram
negative bacterium, MS2,
Phi-X174, Aspergillus
Niger mold spores and
Bacillus globigii
endospores entrained on
the filter of the subject
device under the exposure
conditions described
above. | The ViroZapTM Indoor Air
Purifier, In Duct Model
1008 is a device intended
for medical purposes that
is used to destroy
microorganisms entrained
on the filter through
photochemical reaction in
the air by exposure to UV-
A radiation.
The ViroZapTM Indoor Air
Purifier, In Duct Model
1008 has been
demonstrated to destroy
Staphylococcus
epidermidis - a Gram
positive bacterium,
Klebsiella Aerogenes – a
Gram negative bacterium,
MS2 – a non-enveloped
ssRNA virus, Phi-X174 –
a non-enveloped ssDNA
virus, Bacillus subtilis
endospores, and
Aspergillus brasiliensis
mold spores under the
exposure conditions
described above. | Similar: The proposed
device and the predicate
device have the same
indications for use, except
there are minor differences
in the microorganisms
demonstrated to be
destroyed by the devices.
Both devices are
demonstrated to destroy a
Gram positive bacterium, a
Gram negative bacterium,
a non-enveloped ssRNA
virus, a non-enveloped
ssDNA virus, mold spores,
and endospores. |
| Element for
Comparison | Predicate:
Transformair Indoor
Air Purifier; Model
16108
(K161468) | Subject Device:
ViroZap™; Indoor Air
Purifier, In Duct Model
1008
(K241140) | Comparison |
| Mechanism
of Action | UV light of sufficient
energy (UV-A) activates
photocatalyst that destroys
microorganisms entrained
on the filter through a
photochemical reaction
that is enhanced by a metal
wire mesh. | UV light of sufficient
energy (UV-A LED)
activates photocatalyst that
destroys microorganisms
entrained on the filter
through a photochemical
reaction that is enhanced
by a metal wire mesh. | Identical |
| Use Location | Medical Facilities | Medical Facilities | Identical |
| Installation | In-Duct | In-Duct | Identical |
| Pre-Filter | Standard UL listed air
filter | Standard UL listed air
filter | Identical |
| Photocatalyst | Catalytic filter coated with
TiO2 and held in a metal
wire mesh | Catalytic filter coated with
TiO2 and plasmonic
nanoparticles, and held in
a metal wire mesh | Similar: Both the
proposed and predicate
device use a catalytic filter
coated with TiO2. The
plasmonic nanoparticle
coating was added to the
catalytic filter in the
proposed device to
enhance light capture. |
| Disinfecting | Catalytic filter | Catalytic filter | Similar: Both the
proposed and predicate
device use a catalytic filter
coated with TiO2. The
plasmonic nanoparticle
coating was added to the
catalytic filter in the
proposed device to
enhance light capture. |
| Element for
Comparison | Predicate:
Transformair Indoor
Air Purifier; Model
16108
(K161468) | Subject Device:
ViroZap™; Indoor Air
Purifier, In Duct Model
1008
(K241140) | Comparison |
| Light source | UV-A fluorescent tube
(~320-400 nm) | UV-A LED tube (~320-
400 nm) | Similar: The predicate
device uses a UV-A
fluorescent tube, and the
proposed device uses a
UV-A LED tube with the
same UV-A wavelength
and intensity. |
| Voltage | Up to 120/220 Volt (Plugs
into standard outlet) | Up to 120/220 Volt (Plugs
into standard outlet) | Identical |
| Current | Up to 1.25 amps | Up to 1.25 amps | Identical |
| Power
Consumption | Up to 240 Watts | Up to 240 Watts | Identical |
| Air cleaning
chamber | Particulate pre-filter, UV-
A lamps and a catalytic
filter | Particulate pre-filter, UV-
A lamps and a catalytic
filter | Identical |
| Electronics | UL compliant | UL compliant | Identical |
| Outer
Dimensions | 28.5 inches by 21 inches
by 12.25 inches | 28.5 inches by 21 inches
by 12.25 inches, and 24
inches by 24 inches by
12.25 inches | Identical and Additional
Size:
An additional size will be
offered for the proposed
device to fit inside
additional building ducts. |
8
Image /page/8/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of five red squares arranged horizontally above the company name. The words "APPLIED" and "PHOTONIX" are stacked vertically, with "APPLIED" on top and "PHOTONIX" below.
Office: (813) 825 - 1790
9
Image /page/9/Picture/0 description: The image shows the logo for Applied PhotoniX. The logo consists of five red squares arranged horizontally above the words "APPLIED" and "PHOTONIX", which are stacked vertically. The text is in a simple, sans-serif font.
Office: (813) 825 - 1790
10
Image /page/10/Picture/0 description: The image shows the logo for Applied Photonix. The logo consists of a row of five red squares above the words "APPLIED" and "PHOTONIX", which are stacked on top of each other. The text is in a simple, sans-serif font.
Summary of Non-Clinical Testing:
| Test | Brief Description | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|
| Study to characterize the | |||
| efficacy of the subject | |||
| device to reduce | |||
| respirable bioaerosol | |||
| levels for six broad- | |||
| ranged species of | |||
| microorganisms from | |||
| room air. | Six microorganism species | ||
| were aerosolized in a | |||
| sealed bioaerosol chamber | |||
| containing the subject | |||
| device. |
Bioaerosol samples were
taken at multiple time
points throughout each
trial, in order to quantify
the reduction rate
capability of the device. | Confirmation that the
effectiveness of the
device against ssRNA
virus, ssDNA virus,
Gram negative
bacteria, Gram positive
bacteria, bacteria
endospores, and mold
spores was equivalent
or superior to the
predicate, Transformair
(Κ161468). | Pass
The subject device was
effective in reducing a
broad range of airborne
microorganisms within
a short period of time. |
| In vitro study to
characterize the
temperature variant kill
rate kinetics for six
different bioaerosols
deposited on the surface
of the subject device's
photocatalytic coated
filter media after
exposure to UV-A light. | Samples of the subject
device's photocatalytic
coated filter media were
tested against six
aerosolized
microorganisms.
The samples were tested at
three different
temperatures. The kill
kinetic testing was
assessed at multiple
sampling points to create a
reduction curve with each
species at each
temperature. The trials
were carried out to
quantify at least a 4.0 log
reduction | Confirmation that the
kill kinetics of the
modified catalytic filter
was equivalent or
superior to the
predicate device
catalytic filter. | Pass
As with the predicate
device, the filter media
achieved more than a
4.0 log reduction in
each species at each
temperature. |
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| Test | Brief Description | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|
| Test to evaluate the | |||
| efficacy of filter media | |||
| following accelerated | |||
| aging equivalent to one | |||
| year. | A microorganism was | ||
| aerosolized into a sealed | |||
| environment containing the | |||
| subject device. Bioaerosol | |||
| samples were taken at | |||
| multiple time points | |||
| throughout each trial to | |||
| quantify the reduction rate | |||
| capability of the device. | Confirmation that the | ||
| subject device had | |||
| equivalent performance | |||
| after accelerated aging | |||
| equivalent to one year. | Pass |
The subject device was
effective at reducing
the microorganism
after undergoing
accelerated aging. The
results from the aged
device were equivalent
to trials run on the
unaged device. |
Clinical Testing: N/A
Substantial Equivalence Discussion:
The proposed device and the predicate device have the same indications for use, except there are minor differences in the microorganisms demonstrated to be destroyed by the devices. The minor differences do not constitute a new intended use because both devices are demonstrated to destroy a Gram positive bacterium, a Gram negative bacterium, a non-enveloped ssRNA virus, a nonenveloped ssDNA virus, mold spores, and endospores.
The subject device has a catalytic filter with a coating consisting of TiO2 mixed with plasmonic nanoparticles, whereas the prior cleared version has only a TiO2 coating. Plasmonic nanoparticles are added to improve light capture and thereby performance of the filter. This is demonstrated by testing the subject device using the same lab and test methods that were used for the predecessor. predicate. This change improves device performance and does not raise different questions of safety or effectiveness.
The change from fluorescent to LED UV-A bulbs does not raise different questions of safety or effectiveness since the identical UV-A light (at 365 nm wavelength) is still being delivered.
The subject device is therefore substantially equivalent to the predicate device.
Conclusion:
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as safely and effectively as the legally marketed predicate device (K161468), Class II (21 CFR 880.6500), product code FRA.