(42 days)
Not Found
Not Found
No
The summary describes an air purification device and its performance in reducing airborne microorganisms. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies. The performance is based on physical reduction methods, not algorithmic analysis.
No.
The device's intended use is for air purification (reduction of airborne pathogens), not for direct treatment or diagnosis of disease in a patient, which is the characteristic of a therapeutic device.
No
The device is intended for the reduction of airborne microorganisms and does not perform any diagnostic function.
No
The device description and performance studies clearly indicate a physical device (Aerus Medical Guardian, model F170A) that performs air purification, not a software-only medical device.
Based on the provided information, the Aerus Medical Guardian, model F170A is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use of the Aerus Medical Guardian is to reduce microorganisms from the air in a healthcare environment. It does not analyze human specimens like blood, urine, or tissue.
- The device's function is air purification/disinfection. It physically removes or inactivates microorganisms from the air, rather than providing diagnostic information about a patient's health status based on a biological sample.
Therefore, the Aerus Medical Guardian is an air purification device intended for use in a healthcare setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aerus Medical Guardian, model F170A is a device intended for medical purposes that is used for the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores from the air in a temperature-controlled professional healthcare environment of 7071°F, 4045% RH.
The Aerus Medical Guardian, model F170A demonstrated the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores under the following conditions.
| Organism Type | Organism Name | Test Temp/RH | Exposure Time (m) | Avg Log-Reduction |
|---|---|---|---|---|
| Bacteria | Staphylococcus epidermidis | 72°F / 50% | 60 | 5.95 |
| Bacteria | Erwinia herbicola | 72°F / 50% | 60 | 5.12 |
| Virus | MS2 | 72°F / 50% | 60 | 5.58 |
| Virus | Phi-X174 | 72°F / 50% | 60 | 4.19 |
| Fungal Spore | Aspergillus niger | 72°F / 50% | 60 | 4.12 |
| Bacterial Spore | Bacillus globigii | 72°F / 50% | 60 | 4.22 |
Product codes
FRA
Device Description
Not Found
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
professional healthcare environment
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)
The Aerus Medical Guardian, model F170A demonstrated the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores under the following conditions.
| Organism Type | Organism Name | Test Temp/RH | Exposure Time (m) | Avg Log-Reduction |
|---|---|---|---|---|
| Bacteria | Staphylococcus epidermidis | 72°F / 50% | 60 | 5.95 |
| Bacteria | Erwinia herbicola | 72°F / 50% | 60 | 5.12 |
| Virus | MS2 | 72°F / 50% | 60 | 5.58 |
| Virus | Phi-X174 | 72°F / 50% | 60 | 4.19 |
| Fungal Spore | Aspergillus niger | 72°F / 50% | 60 | 4.12 |
| Bacterial Spore | Bacillus globigii | 72°F / 50% | 60 | 4.22 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Log-Reduction:
Staphylococcus epidermidis: 5.95
Erwinia herbicola: 5.12
MS2: 5.58
Phi-X174: 4.19
Aspergillus niger: 4.12
Bacillus globigii: 4.22
Predicate Device(s)
Not Found
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). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of an eagle, while the text on the right is written in blue. The text is arranged in three lines, with "FDA" on the top line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
June 17, 2020
Aerus Medical LLC % Dave Yungvirt Responsible Third Party Official Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K201220
Trade/Device Name: Aerus Medical Guardian, model F170A Regulation Number: 21 CFR 880.6500 Regulation Name: Medical ultraviolet air purifier Regulatory Class: Class II Product Code: FRA Dated: June 13, 2020 Received: June 16, 2020
Dear Dave Yungvirt:
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 -S
For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201220
Device Name
Aerus Medical Guardian, model F170A
Indications for Use (Describe)
The Aerus Medical Guardian, model F170A is a device intended for medical purposes that is used for the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores from the air in a temperature-controlled professional healthcare environment of 7071°F, 4045% RH.
The Aerus Medical Guardian, model F170A demonstrated the reduction of staphylococcus epidermidis and erwinia herbicola bacteria, MS2 and Phi-X174 viruses and aspergillus niger fungal spores and bacillus globigii bacterial spores under the following conditions.
| Organism Type | Organism Name | Test Temp/RH | Exposure Time (m) | Avg Log-Reduction |
|---|---|---|---|---|
| Bacteria | Staphylococcus epidermidis | 72°F / 50% | 60 | 5.95 |
| Bacteria | Erwinia herbicola | 72°F / 50% | 60 | 5.12 |
| Virus | MS2 | 72°F / 50% | 60 | 5.58 |
| Virus | Phi-X174 | 72°F / 50% | 60 | 4.19 |
| Fungal Spore | Aspergillus niger | 72°F / 50% | 60 | 4.12 |
| Bacterial Spore | Bacillus globigii | 72°F / 50% | 60 | 4.22 |
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) |
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 Druq 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."