(270 days)
Not Found
Not Found
No
The summary focuses on the device's ability to filter and inactivate airborne particles based on fan speed and test chamber results, with no mention of AI or ML technologies.
Yes
The device is intended to filter out and inactivate airborne particles "for medical purposes," which indicates a therapeutic intent by reducing exposure to harmful microorganisms.
No
The device is described as an "air cleaner" intended for "filtering out and inactivating airborne particles." Its function is to reduce the presence of microorganisms in the air, not to diagnose conditions or diseases.
No
The device description and performance studies clearly indicate a physical air cleaning system (MA-40 and MA-112) that filters and inactivates airborne particles, which is a hardware device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is clearly stated as a "room recirculating air cleaner" for "filtering out and inactivating airborne particles from the air for medical purposes." This describes a device that acts on the air in a room, not on biological samples taken from a patient.
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
- Mechanism of Action: The device works by filtering and inactivating airborne microorganisms in the environment, not by analyzing biological markers in a sample.
- Performance Data: The performance data provided relates to the reduction of airborne microorganisms in a test chamber, which is consistent with an air purification device, not an IVD.
Therefore, the MA-40 and MA-112 are air purification devices intended for medical purposes, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MA-40 and MA-112 are intended for use as room recirculating air cleaner. The systems are used for filtering out and inactivating airborne particles from the air for medical purposes.
The MA-40 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)
| BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME
(MINUTES) |
|---|---|---|---|
| Virus | MS2 bacteriophage | Speed 3 | 30 |
| | | Speed 2 | 45 |
| | | Speed 1 | 90 |
| Virus | Phi-X 174 bacteriophage | Speed 3 | 30 |
| Bacterial | Staphylococcus Epidermidis | Speed 3 | 30 |
| Bacterial | Escherichia coli | Speed 3 | 30 |
| Bacterial | Bacillus Subtilis Endospore | Speed 3 | 30 |
| | | Speed 2 | 45 |
| | | Speed 1 | 120 |
| Mold | Aspergillus Brasiliensis | Speed 3 | 30 |
| BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME
(MINUTES) |
| Virus | MS2 bacteriophage | Speed 4 | 20 |
| | | | Speed 3 |
| | | | Speed 2 |
| | | | Speed 1 |
| Virus | Phi-X 174 bacteriophage | Speed 4 | 20 |
| Bacterial | Staphylococcus Epidermidis | Speed 4 | 20 |
| Bacterial | Escherichia coli | Speed 4 | 20 |
| Bacterial | Bacillus Subtilis Endospore | Speed 4 | 20 |
| | | | Speed 3 |
| | | | Speed 2 |
| | | | Speed 1 |
| Mold | Aspergillus Brasiliensis | Speed 4 | 20 |
The MA-112 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)
Product codes (comma separated list FDA assigned to the subject device)
FRF
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(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). On the left is the Department of Health and 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.
September 18, 2023
Medify Air LLC Pragati Anand VP, Ecommerce & Omnichannel 150 E Palmetto Park Rd, Suite 301 Boca Raton, Florida 33432
Re: K223835
Trade/Device Name: MA-40, MA-112 Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: FRF Dated: July 28, 2023 Received: August 2, 2023
Dear Pragati Anand:
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, Christopher K. Dugard -S
Christopher K. Dugard, 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MA-40, MA-112
Indications for Use (Describe)
The MA-40 and MA-112 are intended for use as room recirculating air cleaner. The systems are used for filtering out and inactivating airborne particles from the air for medical purposes.
The MA-40 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)
| BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME
(MINUTES) |
|-----------------|-----------------------------|------------------|-------------------------------|
| Virus | MS2 bacteriophage | Speed 3 | 30 |
| | | Speed 2 | 45 |
| | | Speed 1 | 90 |
| Virus | Phi-X 174 bacteriophage | Speed 3 | 30 |
| Bacterial | Staphylococcus Epidermidis | Speed 3 | 30 |
| Bacterial | Escherichia coli | Speed 3 | 30 |
| Bacterial | Bacillus Subtilis Endospore | Speed 3 | 30 |
| | | Speed 2 | 45 |
| | | Speed 1 | 120 |
| Mold | Aspergillus Brasiliensis | Speed 3 | 30 |
| BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME
(MINUTES) |
| Virus | MS2 bacteriophage | Speed 4 | 20 |
| | | | Speed 3 |
| | | | Speed 2 |
| | | | Speed 1 |
| Virus | Phi-X 174 bacteriophage | Speed 4 | 20 |
| Bacterial | Staphylococcus Epidermidis | Speed 4 | 20 |
| Bacterial | Escherichia coli | Speed 4 | 20 |
| Bacterial | Bacillus Subtilis Endospore | Speed 4 | 20 |
| | | | Speed 3 |
| | | | Speed 2 |
| | | | Speed 1 |
| Mold | Aspergillus Brasiliensis | Speed 4 | 20 |
The MA-112 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)
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)
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