Transformair Indoor Air Purifier

K161468 · Transformair, LLC · FRA · Feb 8, 2017 · General Hospital

Device Facts

• Record ID: K161468
• Device Name: Transformair Indoor Air Purifier
• Applicant: Transformair, LLC
• Product Code: FRA · General Hospital
• Decision Date: Feb 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Transformair Indoor Air Purifier, In Duct Model 16108 is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation. Transformair Indoor Air Purifier, In Duct Model 16108 has been demonstrated to destroy Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger and Bacillus globigii entrained on the filter of the subject device under the following exposure conditions: [Table of log reduction data]. The Transformair Indoor Air Purifier is for Over-The-Counter use.

Device Story

In-duct air purification device; installed in building HVAC systems. Uses photo-electrocatalytic (PEC) technology to destroy airborne microorganisms. Input: ambient air containing bacteria, viruses, and mold spores. Process: air passes through a non-woven polyester pre-filter, then a catalytic filter coated with titanium dioxide (TiO2) and metal wire mesh; 6 UV-A lamps (320-400 nm) illuminate the catalytic surface, triggering a photochemical reaction that generates hydroxyl free radicals. Output: purified air with reduced microbial load. Operated by facility maintenance/HVAC personnel; intended for medical facility environments. Benefits patients/staff by reducing airborne pathogen concentrations.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including GLP-compliant lethality kinetics testing against Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger, and Bacillus globigii across temperature ranges (45°F-110°F), and UL electrical/fire safety testing.

Technological Characteristics

In-duct medical UV air purifier. Materials: non-woven polyester pre-filter, TiO2-coated polyester catalytic filter, metal wire mesh, metal housing. Energy: 120/220V AC, 6 UV-A lamps (320-400 nm). Dimensions: 28.5" x 21" x 12.25". Standards: ANSI/UL 1995-2011, CAN-CSA C22.2 No. 236-11, UL 2043.

Indications for Use

Indicated for destruction of airborne bacteria, viruses, and mold spores in medical facilities. Intended for use in HVAC ducts to reduce microbiological contaminants.

Regulatory Classification

Identification

A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.

Predicate Devices

• ABRACAIR Air Cleaners QTZ300-60 and TI 100-30P (K052732)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a symbolic representation of the department's mission related to health and human well-being.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 21, 2019

Transformair, LLC % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re: K161468

Trade/Device Name: Transformair Indoor Air Purifier Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: January 31, 2017 Received: February 1, 2017

Dear Dave Yungvirt:

This letter corrects our substantially equivalent letter of February 8, 2017

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. 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

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

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K161468

Device Name Transformair Indoor Air Purifier

#### Indications for Use (Describe)

The Transformair Indoor Air Purifier, In Duct Model 16108 is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.

Transformair Indoor Air Purifier, In Duct Model 16108 has been demonstrated to destroy Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger and Bacillus globigii entrained on the filter of the subject device under the following exposure conditions:

| Organism | Name | Average Maximum log reduction /exposure time (hours) | | |
|---------------------|-------------------|------------------------------------------------------|-------------------|-------------------|
| | | Test temperature | | |
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus | 4.88 / 24 hours | 4.02 / 0.33 hours | 4.20 / 0.33 hours |
| Bacteria | Escherichia coli | 4.31 / 24 hours | 4.79 / 24 hours | 4.40 / 0.33 hours |
| Virus | MS2 bacteriophage | 4.13 / 24 hours | 4.25 / 24 hours | 5.51 / 24 hours |
| Virus | Phi-X174 | 4.37 / 24 hours | 4.37 / 24 hours | 4.37 / 24 hours |
| Mold endospore | Aspergillus Niger | 3.91 / 72 hours | 3.99 / 72 hours | 4.22 / 72 hours |
| Bacterial endospore | Bacillus globigii | 4.11 / 72 hours | 4.41 / 72 hours | 4.41 / 72 hours |

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

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

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

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

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

Image /page/3/Picture/0 description: The image shows the word "transformair" in a stylized font, with a series of blue dots and a yellow arc above it. Below the word, the address "3802 Spectrum Blvd. Suite 143, Tampa, FL 33612" is printed in a smaller, simpler font. The address provides a specific location in Tampa, Florida.

# 510(k) SUMMARY

# Transformair Air Purifier

# Submitter:

| Company Name: | Transformair, Inc. |
|------------------|-----------------------------------------------------|
| Company Address: | 3802 Spectrum Blvd.<br>Suite 143<br>Tampa, FL 33612 |

Telephone Number: 352-871-3803 Contact Person: Jaya Rao Date Prepared: 1/19/2017

- Device:

| Proprietary Name: | Transformair Indoor Air Purifier |
|-----------------------|------------------------------------------------------|
| Common or Usual Name: | Air purifier ultraviolet or ultraviolet air purifier |
| Classification Name: | Medical Ultraviolet Air Purifier |
| Regulation Number: | 21 CFR 880.6500 |
| Product Code: | FRA |
| Device Class: | Class 2 |
| Category: | General Hospital |

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

Image /page/4/Picture/1 description: The image shows the logo for "transformair" in a muted green color. Above the logo is a curved line of blue dots and a yellow line. Below the logo is the address "3802 Spectrum Blvd. Suite 143, Tampa, FL 33612".

#### Predicate Device:

The predicate device is shown in the following table:

#### Table 1: Predicate Device

| Predicate Device | ABRACAIR Air Cleaners QTZ300-60 and TI 100-30P |
|---------------------|------------------------------------------------|
| Manufacturer | Abracair, Inc. |
| 510(k) Number | K052732 |
| Regulation Number: | 21 CFR 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 Transformair Indoor Air Purifier, In Duct Model 16108 is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.

Transformair Indoor Air Purifier, In Duct Model 16108 has been demonstrated to destroy Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger and Bacillus globigii entrained on the filter of the subject device under the following exposure conditions:

Table 2. Transformair Lethality Testing Results

| Organism | Name | Average Maximum log reduction /exposure time (hours) | | |
|---------------------|----------------------------|------------------------------------------------------|------------------|------------------|
| | | Test temperature | | |
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus epidermidis | 4.88/ 24 hours | 4.02 /0.33 hours | 4.20 /0.33 hours |
| Bacteria | Escherichia coli | 4.31/ 24 hours | 4.79 /24 hours | 4.40 /0.33 hours |
| Virus | MS2 bacteriophage | 4.13/ 24 hours | 4.25/ 24 hours | 5.51/ 24 hours |
| Virus | Phi-X174 bacteriophage | 4.37/ 24 hours | 4.37/ 24 hours | 4.37/ 24 hours |
| Mold endospore | Aspergillus Niger | 3.91/ 72 hours | 3.99/ 72 hours | 4.22/ 72 hours |
| Bacterial endospore | Bacillus globigii | 4.11/ 72 hours | 4.41/ 72 hours | 4.41/ 72 hours |

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

Image /page/5/Picture/1 description: The image shows the logo for "transformair" in a muted gray color. Above the logo is a curved line of blue dots and a yellow line. Below the logo is the address "3802 Spectrum Blvd. Suite 143, Tampa, FL 33612".

The Transformair Indoor Air Purifier is for Over-The-Counter use.

# Device Description:

Transformair® is a patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-filter, black light lamps, and a catalytic filter coated with a photocatalyst. The Transformair device has a metal housing with electronic controls and outer dimensions of 28.5 inches by 21 inches by 12.25 inches that is installed in the duct of a buildings HVAC system. The Transformair device has a pre-filter and a chamber equipped with 6 low energy ultraviolet lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.

# Technological Characteristics and Principles of Operation:

The Transformair Air Purifier is a medical ultraviolet air purifier unit that traps microorganisms on a filter where they are destroyed by UV photo-catalyzed generation of free radicals in the validated time periods. The air cleaning chamber consists of a metal housing that contains a non-woven polyester prefilter, glass UV-A lamps (~320-400 nm), a catalytic filter. The metal housing has electronics that plug into a standard outlet (120/220 Volt) to power the UV-A lamps.

The Transformair Air Purifier destroys microbiological contaminants in the air through a photochemical reaction that produces hydroxyl free radicals when UV-A light rays are shone on the catalytic surface.

# Substantial Equivalence:

The Transformair Air Purifier is substantially equivalent to the ABRACAIR Air Cleaner (K052732) since the devices have the same general intended use and similar indications, technological characteristics, and principles of operation. A reference table is provided below comparing the Transformair Air Purifier to the predicate.

| Element of<br>Comparison | Transformair | ABRACAIR (K052732) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Transformair, Inc. | Abracair, Inc. |
| Device type | Medical Ultraviolet Air Purifier | Medical Ultraviolet Air Purifier |
| Element of<br>Comparison | Transformair | ABRACAIR (K052732) |
| Regulation Number | 21 CFR 880.6500 | 21 CFR 880.6500 |
| Intended Use /<br>Indications for Use | The Transformair Indoor Air Purifier, In<br>Duct Model 16108 is a device intended<br>for medical purposes that is used to<br>destroy bacteria in the air by exposure to<br>ultraviolet radiation.<br><br>Transformair Indoor Air Purifier, In Duct<br>Model 16108 has been demonstrated to<br>destroy Staphylococcus epidermidis,<br>Escherichia coli, MS2, Phi-X174,<br>Aspergillus Niger and Bacillus globigii<br>entrained on the filter of the subject<br>device under the exposure conditions<br>described in Table 2.<br><br>The Transformair Indoor Air Purifier is<br>for Over-The-Counter use. | The Abracair Air Cleaner is intended for<br>the reduction of aerosolized mold and<br>bacteria within hospitals, nursing homes,<br>medical facilities. The device may be<br>used in occupied spaces within hospital<br>environments such as baby and/or<br>neonatal nurseries, hospital rooms,<br>operating rooms, mortuaries, embalming<br>rooms. |
| Mechanism of<br>action | UV light of sufficient energy (UV-A)<br>activates photocatalyst that destroys<br>microorganisms entrained on the filter<br>through a photochemical reaction that<br>is enhanced by a metal wire mesh. | UV light of sufficient energy (UV-C)<br>activates photocatalyst that destroys<br>microorganisms through a<br>photochemical reaction; UV-C light<br>directly destroys microorganism. |
| Model(s) | Model 16108 | QTZ300-60 and QTZ100-24 |
| Installation | In-Duct | Free standing |
| Filter(s) | Pre-filter made with polyester and<br>catalytic filter made with polyester and<br>coated with titanium dioxide (TiO2) | Filter made with quartz fibers coated with<br>titanium dioxide (TiO2) |
| Photocatalyst | Catalytic filter coated with TiO2 and<br>metal wire mesh | Filter coated with TiO2 |
| Light source | UV-A lamps (~320-400 nm) | UV-C Xenon Flash lamps (~100-285nm) |
| Element of<br>Comparison | Transformair | ABRACAIR (K052732) |
| Voltage | Up to 120 Volt / 220 Volt (plugs into<br>standard outlet) (See Footnote1) | 240 Volt AC / 480 Volt AC |
| Current | Up to 1.25 amps (See Footnote1) | 30 Amps at 240 Volts |
| Power Consumption | Up to 240 Watts (See Footnote1) and<br>Footnote2) | Up to 7020 Watts |
| Air cleaning<br>chamber | Particulate pre-filter, UV-A lamps and a<br>catalytic filter coated with TiO2 and<br>metal wire mesh | UV-C lamps and a catalytic filter coated<br>with TiO2 |
| Electronics | UL compliant | UL compliant |
| Dimensions | 28.5 inches by 21 inches by 12.25 inches | Not available |

#### TABLE 3: SUBSTANTIAL EQUIVALENCE COMPARISON CHART

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

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

3802 Spectrum Blvd. Suite 143, Tampa, FL 33612

ً This does not raise any new issues of safety and efficacy since the Transformair Air Purifier complies with the applicable UL standards for an air duct mounted device.

ً Transformair Air Purifier is different from the primary predicate device since it uses upto 240 W of UV-A light (320-400 nm) with a TiO-coated catalytic filter and a metal wire mesh to enhance activation of the TiO2 photocatalyst instead of upto 7020 W of UV-C light (~100-285nm) used by the primary predicate. This does not raise any new issues of efficacy since the ability of the Transformair device to reduce the concentration of airborne microorganisms is substantiated by the performance testing.

The Transformair Air Purifier and the predicate ABRACAIR Air Cleaners use the action of UV light on a catalytic filter coated with a Titanium Oxide (TiO2) photocatalyst to destroy microbiological contaminants in the air. Both devices use conventional UV-light lamps and filter materials but, unlike the predicate, the Transformair Air Purifier uses UV-A lamps instead of UV-C lamps and has a metal wire mesh on the catalytic filter. Both devices are designed to operate in a medical facility.

The Transformair air purifier has the same intended use of reducing airborne bacteria and mold spores as the predicate device ABRACAIR Air Cleaner (K052732). In addition, the Transformair air purifier is intended to reduce viruses (MS2 and Phi-X174).

The differences in the indications for use and technological characteristics are supported by the performance testing and UL electrical safety testing and do not raise new questions of safety or efficacy.

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

Image /page/8/Picture/1 description: The image shows the logo for Transformair, a company located at 3802 Spectrum Blvd. Suite 143, Tampa, FL 33612. The logo features the company name in a stylized font, with a series of blue dots and a yellow wave above the name. The address is printed in a smaller font below the logo.

# Non-Clinical Performance Testing Summary:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug and Cosmetic Act. However, the Transformair Air Purifier has been tested to demonstrate that the device does not generate Ozone. It has also been certified compliant with the following UL standards:

- । ANSI/UL 1995-2011 & CAN-CSA C22.2 No. 236-11, Heating and Cooling Equipment and
- -UL 2043, Heat and Visible Smoke Release For Discrete Products and Their Accessories Installed in Air-Handling Spaces.

Reference the Table below for specific UL tests conducted.

| Test Conducted | UL Reference Standard | Test Results |
|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|--------------|
| Input Test (Circuits – Other than Electric<br>Heaters) (+) | UL 1995, 4th Ed., Section 40 | PASS |
| Starting Test | UL 1995, 4th ed. Section 69 | PASS |
| Leakage Current Test | UL 1995, 4th ed. Section 68 | PASS |
| Temperature Operation Test (Without Any<br>Supplementary Heating Means)(+) | UL 1995, 4th Ed., Section 41 | PASS |
| Dielectric Voltage-Withstand Test | UL 1995, 4th Ed., Section 54 | PASS |
| Fire Test for Heat and Visible Smoke Release<br>For Discrete Products and Their Accessories<br>Installed in Air-Handling Spaces | UL 1995, 4th Ed., Section 18 and UL<br>2043, 3rd Ed. | PASS |

#### Table 4: Underwriters Laboratories Testing Summary

Third party testing was also performed to evaluate filter performance using aerosolized suspensions of the claimed microorganisms. This testing demonstrated retention of the test organisms on the filter. This testing was done in compliance with FDA Good Laboratory Practices (GLP) as defined in 40 CFR, Part 160.

Lastly, third party testing was performed to establish the kill kinetics for bacteria (Staphylococcus epidermidis and Escherichia coli), viruses (MS2 and Phi-X174), and mold spores (Aspergillus Niger) and bacterial spores (Bacillus globigii) over the range of temperatures expected to occur in an HVAC duct. This testing was done in compliance with FDA Good Laboratory Practices (GLP) as defined in 40 CFR, Part 160. Reference Table below for the lethality testing results.

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

Image /page/9/Picture/1 description: The image shows the logo for Transformair, a company located at 3802 Spectrum Blvd. Suite 143, Tampa, FL 33612. The logo features the company name in a stylized font, with a series of blue dots and a yellow line above the name. The address is printed in a smaller font below the logo.

# Table 5: Transformair Device Lethality Testing Results

| Category | Aerosolized<br>Biological | Test Temperature<br>(°F) | Exposure time<br>(hours) | Average Maximum log<br>reduction |
|--------------------|-------------------------------|--------------------------|--------------------------|----------------------------------|
| Bacteria | Staphylococcus<br>epidermidis | 45°F | 24 hours | 4.88 |
| | | 72°F | 0.33 hour | 4.02 |
| | | 110°F | 0.33 hour | 4.20 |
| Bacteria | Escherichia<br>coli | 45°F | 24 hours | 4.31 |
| | | 72°F | 24 hours | 4.79 |
| | | 110°F | 0.33 hour | 4.40 |
| Virus | MS2<br>bacteriophage | 45°F | 24 hours | 4.13 |
| | | 72°F | 24 hours | 4.25 |
| | | 110°F | 24 hours | 5.51 |
| Virus | Phi-X174<br>bacteriophage | 45°F | 24 hours | 4.37 |
| | | 72°F | 24 hours | 4.37 |
| | | 110°F | 24 hours | 4.37 |
| Mold<br>spore | Aspergillus<br>Niger spores | 45°F | 72 hours | 3.91 |
| | | 72°F | 72 hours | 3.99 |
| | | 110°F | 72 hours | 4.22 |
| Bacterial<br>spore | Bacillus<br>globigii spores | 45°F | 72 hours | 4.11 |
| | | 72°F | 72 hours | 4.41 |
| | 110°F | 72 hours | 4.41 | |
| | | | | |

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

Image /page/10/Picture/0 description: The image shows the logo for "transformair" in a stylized font. Below the logo is the address "3802 Spectrum Blvd, Suite 143, Tampa, FL 33612". The logo has a series of blue dots and a yellow swoosh above the word "transformair".

# Clinical Testing Summary:

Clinical testing has not been performed for the Transformair Air Purifier. Non-clinical bench testing is sufficient to demonstrate substantial equivalence to the predicate ABRACAIR Air Cleaner.

#### Conclusion:

The subject device is substantially equivalent to the predicate device.