AEROCURE-MD

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 21, 2021 Aerobiotix, Inc. % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155 Re: K203189 Trade/Device Name: Aerocure-md Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: January 5, 2021 Received: January 6, 2021 Dear Rafael Aguila: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K203189 Device Name AEROCURE-MD Medical Air Purifier Indications for Use (Describe) The Aerobiotix AEROCURE-MD air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. In addition, the device removes particles from the air via HEPA filtration. Type of Use (*Select one or both, as applicable*) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |---------------|----------------------------------------------|---------------------------------------------| | | <div></div> | <div></div> | 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 of information is estimated to average 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." EF PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ # 510(k) SUMMARY: K203189 #### SUBMITTER INFORMATION: | Company Name: | Aerobiotix, Inc. | | |---------------------------------------------------------|--------------------------|--| | | 444 Alexandersville Road | | | | Miamisburg, OH 45342 | | | | Telephone (888) 978-7087 | | | | FAX (937) 388-8145 | | | Official Contact:David Kirschman, M.D. | | | | | President | | | Date Prepared:January 21st, 2021 | | | | DEVICE INFORMATION: | | | | Trade/Proprietary Name:AEROCURE-MD Medical Air Purifier | | | | Common Name:Ultraviolet Medical Air Purifier | | | | Device Class:Class II | | | | Regulation Number:21 CFR 880.6500 | | | | Product Code:FRA | | | | Classification Name:Medical Ultraviolet Air Purifier | | | | Category:General Hospital | | | # PREDICATE DEVICES: Biological Controls MICROCON 800MUV K972064 #### INTENDED USE: The Aerobiotix AEROCURE-MD air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. In addition, the device removes particles from the air via HEPA filtration. {4}------------------------------------------------ # DEVICE DESCRIPTION: The AEROCURE-MD is a free-standing flow-through air purification device which uses germicidal ultraviolet light with supplemental HEPA filtration to remove airborne contamination. The AEROCURE-MD device has a wheeled metal housing with electrical controls and outer dimensions of 74 x 62 x 178 cm which is placed within a room. The device has a pleated pre-filter, ultraviolet photolytic chamber equipped with germicidal ultraviolet lamps, and a 99.97% HEPA filter. The AEROCURE-MD is for over-the-counter use. # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE: The AEROCURE-MD has the following technical characteristics as the Biological Controls MICROCON MAP-800M (K974682) predicate device: | Element of<br>Comparison | Aerobiotix AEROCURE-MD | Biological Controls<br>MICROCON<br>MAP-800M (K974682) | Comparison | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Device Type | Medical UV Air Purifier | Medical UV Air Purifier | Same | | Product Code | FRA | FRA | Same | | Regulation # | 21 CFR 880.6500 | 21 CFR 880.6500 | Same | | Indications for use | The AEROCURE-MD air purifier is a device<br>intended for medical purposes that is used<br>to destroy bacteria and viruses in the air by<br>exposure to ultraviolet radiation.<br>In addition, the device removes particles<br>from the air via HEPA filtration. | Used for filtering<br>airborne particles<br>from air for medical<br>purposes. | Similar | | First Mechanism of<br>Action | HEPA filtration | HEPA filtration | Same | | Second Mechanism<br>of Action | Ultraviolet germicidal lamps | Ultraviolet germicidal<br>lamps | Same | | Construction | Wheeled portable enclosure | Wheeled portable<br>enclosure | Same | | Voltage | 120V/60 Hz | 120V/ 60 Hz | Same | | Electrical<br>certification | Applicable UL Standards<br>compliant, IEC 60601-1-2 | Applicable UL Standards<br>compliant | Similar, the<br>subject device is<br>compatible with<br>IEC 60601-1-2 | | Clean air outflow | 300-450 CFM ("Cubic Feet per Minute") | 250-725 CFM ("Cubic<br>Feet per Minute") | Similar, the<br>subject device<br>has higher flows<br>in worst case<br>condition | {5}------------------------------------------------ # SUMMARY OF NON-CLINICAL TESTING: Shown below is the performance testing performed with the subject device to demonstrate the device can meet the acceptance criteria of the test methodology and standard. | Name of Test<br>Methodology | Purpose | Acceptance Criteria | Results | |------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------| | Microorganism Reduction<br>Testing | Demonstrate reduction<br>of representative<br>organisms in single-pass<br>testing | Greater than 99.9%<br>reduction in single-pass<br>testing | Demonstrated<br>effectiveness against<br>MS2 virus, B. atropheus,<br>S. epidermidis. | | UL 507: 2017 Ed. 10 | PASS | |-------------------------------|----------------------| | IEC 60601-1-2 Ed. 4.0 | PASS | | Particulate Reduction Testing | SIMILAR TO PREDICATE | # CONCLUSION: The conclusions drawn from the nonclinical tests demonstrate that the Aerocure-MD device is as safe, as effective, and performs as well as or better than legally marketed predicate device.