(99 days)
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 | Staphylococcusepidermidis | 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 |
| Bacterialendospore | 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 Reductionin 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 |
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.
The device in question is the ViroZap™ Indoor Air Purifier, In Duct Model 1008.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is evaluated against its effectiveness in reducing various microorganisms both when entrained on the filter and in a large chamber setting. The acceptance criterion for both main studies (room air reduction and kill rate kinetics) was that the device's effectiveness should be "equivalent or superior to the predicate, Transformair (K161468)." The documentation confirms that this criterion was met, showing the device was effective in reducing the microorganisms.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Study to characterize the efficacy of the subject device to reduce respirable bioaerosol levels for six broad-ranged species of microorganisms from room air. | 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 (K161468). | Pass. The subject device was effective in reducing a broad range of airborne microorganisms within a short period of time. Specific log reduction data (Average Net Log Reduction in 20 Minutes) for chamber testing are: - Staphylococcus epidermidis: 5.17 - Klebsiella aerogenes: 5.56 - MS2 bacteriophage: 5.00 - Phi-X174 bacteriophage: 5.34 - Aspergillus brasiliensis: 4.50 - Bacillus Subtilis: 4.58 |
| 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. | 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. Specific log reduction data (Average Maximum Log Reduction / Exposure Time) entrained on filter are: 45°F -- Staphylococcus epidermidis: 4.94 / 12 hours -- Klebsiella aerogenes: 5.40 / 1 hour -- MS2 bacteriophage: 4.32 / 12 hours -- Phi-X174 bacteriophage: 4.39 / 12 hours -- Aspergillus brasiliensis: 4.52 / 168 hours -- Bacillus Subtilis: 4.83 / 168 hours 72°F -- Staphylococcus epidermidis: 4.54 / 4 hours -- Klebsiella aerogenes: 6.55 / 1 hour -- MS2 bacteriophage: 4.51 / 4 hours -- Phi-X174 bacteriophage: 5.24 / 4 hours -- Aspergillus brasiliensis: 5.61 / 168 hours -- Bacillus Subtilis: 4.21 / 168 hours 110°F -- Staphylococcus epidermidis: 4.51 / 4 hours -- Klebsiella aerogenes: 6.54 / 1 hour -- MS2 bacteriophage: 4.58 / 4 hours -- Phi-X174 bacteriophage: 5.14 / 4 hours -- Aspergillus brasiliensis: 5.61 / 168 hours -- Bacillus Subtilis: 4.34 / 168 hours |
| Test to evaluate the efficacy of filter media following accelerated aging equivalent to one year. | 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, with results equivalent to trials run on the unaged device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes (e.g., number of test runs or replicates) for the validation studies. It describes the methodology:
- Room Air Reduction Study: "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 vitro Kill Rate Kinetics: "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 trials were carried out to quantify at least a 4.0 log reduction."
The data provenance is not specified in terms of country of origin. The studies appear to be prospective as they involved testing the physical device and its components under controlled laboratory conditions to demonstrate performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for this medical device is established through quantitative laboratory measurements of microorganism reduction, not through expert consensus or interpretation of medical images. Therefore, the concept of "experts establishing ground truth" in the typical sense of a clinical or imaging study is not directly applicable here. The credibility of the results relies on standard microbiology and biodefense testing protocols, and the expertise of the laboratory personnel conducting these tests.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are laboratory-based performance tests, not studies involving human interpretation or adjudication of results in a clinical context. The results are quantitative measurements of microbial reduction.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human readers (e.g., radiologists interpreting images). The ViroZap™ is an air purification device, and its performance is evaluated by its physical ability to destroy microorganisms, not by assisting human decision-making.
6. Standalone (Algorithm Only) Performance
This concept is not applicable to this device. The ViroZap™ is a physical medical device (an air purifier) that works mechanically and photochemically, not an algorithm or software-only device. Its performance is inherently "standalone" in the sense that its efficacy stems from its own physical operation, without human-in-the-loop performance in its primary function of air purification.
7. Type of Ground Truth Used
The ground truth used is based on quantitative microbiological laboratory assays. This involves measuring the reduction of specific microorganism concentrations (Staphylococcus epidermidis, Klebsiella aerogenes, MS2 bacteriophage, Phi-X174 bacteriophage, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores) after exposure to the device or its components under controlled conditions. The "log reduction" values represent the quantitative proof of the device's efficacy.
8. Sample Size for the Training Set
This information is not applicable. The ViroZap™ is a physical device, not an AI/ML algorithm that requires a "training set" of data. Its design and physical properties (e.g., UV-A lamps, catalytic filter) are engineered to achieve the desired microbial destruction.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for a physical device like the ViroZap™. The device's performance is demonstrated through its functional capabilities, measured in the non-clinical testing.
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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).
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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
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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 | Staphylococcusepidermidis | 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 |
| Bacterialendospore | 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 Reductionin 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 |
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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 202-1Tampa, FL 33612 |
| Contact Person:Phone:Email: | Dr. D. Yogi Goswami352-871-3800Y.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 |
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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 | Staphylococcusepidermidis | 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 |
| Bacterialendospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours |
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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 Reductionin 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 |
| Bacterialendospore | 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 forComparison | Predicate:Transformair IndoorAir Purifier; Model16108(K161468) | Subject Device:ViroZapTM; Indoor AirPurifier, In Duct Model1008(K241140) | Comparison |
|---|---|---|---|
| Product type | Medical Ultraviolet AirPurifier | Medical Ultraviolet AirPurifier | Identical |
| RegulationNumber | 21 C.F.R. § 880.6500 | 21 C.F.R. § 880.6500 | Identical |
| Indicationsfor Use | The Transformair IndoorAir Purifier, In DuctModel 16108 is a deviceintended for medicalpurposes that is used todestroy microorganismsentrained on the filterthrough a photochemicalreaction in the air byexposure to UV-Aradiation.Transformair Indoor AirPurifier, In Duct Model16108 has beendemonstrated to destroyStaphylococcusepidermidis - a Grampositive bacterium,Escherichia coli – a Gramnegative bacterium, MS2,Phi-X174, AspergillusNiger mold spores andBacillus globigiiendospores entrained onthe filter of the subjectdevice under the exposureconditions describedabove. | The ViroZapTM Indoor AirPurifier, In Duct Model1008 is a device intendedfor medical purposes thatis used to destroymicroorganisms entrainedon the filter throughphotochemical reaction inthe air by exposure to UV-A radiation.The ViroZapTM Indoor AirPurifier, In Duct Model1008 has beendemonstrated to destroyStaphylococcusepidermidis - a Grampositive bacterium,Klebsiella Aerogenes – aGram negative bacterium,MS2 – a non-envelopedssRNA virus, Phi-X174 –a non-enveloped ssDNAvirus, Bacillus subtilisendospores, andAspergillus brasiliensismold spores under theexposure conditionsdescribed above. | Similar: The proposeddevice and the predicatedevice have the sameindications for use, exceptthere are minor differencesin the microorganismsdemonstrated to bedestroyed by the devices.Both devices aredemonstrated to destroy aGram positive bacterium, aGram negative bacterium,a non-enveloped ssRNAvirus, a non-envelopedssDNA virus, mold spores,and endospores. |
| Element forComparison | Predicate:Transformair IndoorAir Purifier; Model16108(K161468) | Subject Device:ViroZap™; Indoor AirPurifier, In Duct Model1008(K241140) | Comparison |
| Mechanismof Action | UV light of sufficientenergy (UV-A) activatesphotocatalyst that destroysmicroorganisms entrainedon the filter through aphotochemical reactionthat is enhanced by a metalwire mesh. | UV light of sufficientenergy (UV-A LED)activates photocatalyst thatdestroys microorganismsentrained on the filterthrough a photochemicalreaction that is enhancedby a metal wire mesh. | Identical |
| Use Location | Medical Facilities | Medical Facilities | Identical |
| Installation | In-Duct | In-Duct | Identical |
| Pre-Filter | Standard UL listed airfilter | Standard UL listed airfilter | Identical |
| Photocatalyst | Catalytic filter coated withTiO2 and held in a metalwire mesh | Catalytic filter coated withTiO2 and plasmonicnanoparticles, and held ina metal wire mesh | Similar: Both theproposed and predicatedevice use a catalytic filtercoated with TiO2. Theplasmonic nanoparticlecoating was added to thecatalytic filter in theproposed device toenhance light capture. |
| Disinfecting | Catalytic filter | Catalytic filter | Similar: Both theproposed and predicatedevice use a catalytic filtercoated with TiO2. Theplasmonic nanoparticlecoating was added to thecatalytic filter in theproposed device toenhance light capture. |
| Element forComparison | Predicate:Transformair IndoorAir Purifier; Model16108(K161468) | Subject Device:ViroZap™; Indoor AirPurifier, In Duct Model1008(K241140) | Comparison |
| Light source | UV-A fluorescent tube(~320-400 nm) | UV-A LED tube (~320-400 nm) | Similar: The predicatedevice uses a UV-Afluorescent tube, and theproposed device uses aUV-A LED tube with thesame UV-A wavelengthand intensity. |
| Voltage | Up to 120/220 Volt (Plugsinto standard outlet) | Up to 120/220 Volt (Plugsinto standard outlet) | Identical |
| Current | Up to 1.25 amps | Up to 1.25 amps | Identical |
| PowerConsumption | Up to 240 Watts | Up to 240 Watts | Identical |
| Air cleaningchamber | Particulate pre-filter, UV-A lamps and a catalyticfilter | Particulate pre-filter, UV-A lamps and a catalyticfilter | Identical |
| Electronics | UL compliant | UL compliant | Identical |
| OuterDimensions | 28.5 inches by 21 inchesby 12.25 inches | 28.5 inches by 21 inchesby 12.25 inches, and 24inches by 24 inches by12.25 inches | Identical and AdditionalSize:An additional size will beoffered for the proposeddevice to fit insideadditional building ducts. |
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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
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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
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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 theefficacy of the subjectdevice to reducerespirable bioaerosollevels for six broad-ranged species ofmicroorganisms fromroom air. | Six microorganism specieswere aerosolized in asealed bioaerosol chambercontaining the subjectdevice.Bioaerosol samples weretaken at multiple timepoints throughout eachtrial, in order to quantifythe reduction ratecapability of the device. | Confirmation that theeffectiveness of thedevice against ssRNAvirus, ssDNA virus,Gram negativebacteria, Gram positivebacteria, bacteriaendospores, and moldspores was equivalentor superior to thepredicate, Transformair(Κ161468). | PassThe subject device waseffective in reducing abroad range of airbornemicroorganisms withina short period of time. |
| In vitro study tocharacterize thetemperature variant killrate kinetics for sixdifferent bioaerosolsdeposited on the surfaceof the subject device'sphotocatalytic coatedfilter media afterexposure to UV-A light. | Samples of the subjectdevice's photocatalyticcoated filter media weretested against sixaerosolizedmicroorganisms.The samples were tested atthree differenttemperatures. The killkinetic testing wasassessed at multiplesampling points to create areduction curve with eachspecies at eachtemperature. The trialswere carried out toquantify at least a 4.0 logreduction | Confirmation that thekill kinetics of themodified catalytic filterwas equivalent orsuperior to thepredicate devicecatalytic filter. | PassAs with the predicatedevice, the filter mediaachieved more than a4.0 log reduction ineach species at eachtemperature. |
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| Test | Brief Description | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|
| Test to evaluate theefficacy of filter mediafollowing acceleratedaging equivalent to oneyear. | A microorganism wasaerosolized into a sealedenvironment containing thesubject device. Bioaerosolsamples were taken atmultiple time pointsthroughout each trial toquantify the reduction ratecapability of the device. | Confirmation that thesubject device hadequivalent performanceafter accelerated agingequivalent to one year. | PassThe subject device waseffective at reducingthe microorganismafter undergoingaccelerated aging. Theresults from the ageddevice were equivalentto trials run on theunaged 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.
§ 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).