(86 days)
Not Found
No
The summary describes a device that uses UV light and HEPA filtration for air purification. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device's intended use is to destroy bacteria and viruses and remove particles from the air, which is an environmental control function rather than directly treating a disease or condition in a patient.
No
The device is an air purifier that removes contaminants from the air using ultraviolet radiation and HEPA filtration; it does not diagnose medical conditions.
No
The device description clearly outlines a physical, free-standing air purification device with a metal housing, electrical controls, filters, and UV lamps, indicating it is a hardware device, not software-only.
Based on the provided information, the Aerobiotix AEROCURE-MD air purifier is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "destroy bacteria and viruses in the air by exposure to ultraviolet radiation" and "removes particles from the air via HEPA filtration." This describes a device that acts on the air in a room, not on biological samples taken from a patient (like blood, urine, tissue, etc.).
- Device Description: The description details a free-standing air purification device with filters and UV lamps. This aligns with an air treatment device, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, disease, or condition.
- Using reagents or assays.
- Outputting diagnostic results.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Aerobiotix AEROCURE-MD is designed to purify the air in the environment.
N/A
Intended Use / Indications for 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.
Product codes
FRA
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.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing performed includes Microorganism Reduction Testing, UL 507: 2017 Ed. 10, IEC 60601-1-2 Ed. 4.0, and Particulate Reduction Testing.
Key results:
- Microorganism Reduction Testing: Demonstrated effectiveness against MS2 virus, B. atropheus, S. epidermidis, achieving greater than 99.9% reduction in single-pass testing.
- UL 507: 2017 Ed. 10: PASS
- IEC 60601-1-2 Ed. 4.0: PASS
- Particulate Reduction Testing: SIMILAR TO PREDICATE
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Greater than 99.9% reduction in single-pass testing for microorganism reduction.
Predicate Device(s)
MICROCON 800MUV K972064
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 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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
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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
Comparison | Aerobiotix AEROCURE-MD | Biological Controls
MICROCON
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
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. | Used for filtering
airborne particles
from air for medical
purposes. | Similar |
| First Mechanism of
Action | HEPA filtration | HEPA filtration | Same |
| Second Mechanism
of Action | Ultraviolet germicidal lamps | Ultraviolet germicidal
lamps | Same |
| Construction | Wheeled portable enclosure | Wheeled portable
enclosure | Same |
| Voltage | 120V/60 Hz | 120V/ 60 Hz | Same |
| Electrical
certification | Applicable UL Standards
compliant, IEC 60601-1-2 | Applicable UL Standards
compliant | Similar, the
subject device is
compatible with
IEC 60601-1-2 |
| Clean air outflow | 300-450 CFM ("Cubic Feet per Minute") | 250-725 CFM ("Cubic
Feet per Minute") | Similar, the
subject device
has higher flows
in worst case
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
| Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Microorganism Reduction | |||
| Testing | Demonstrate reduction | ||
| of representative | |||
| organisms in single-pass | |||
| testing | Greater than 99.9% | ||
| reduction in single-pass | |||
| testing | Demonstrated | ||
| effectiveness against | |||
| MS2 virus, B. atropheus, | |||
| 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.