MA-40, MA-112

K223835 · Medify Air, LLC · FRF · Sep 18, 2023 · General Hospital

Device Facts

• Record ID: K223835
• Device Name: MA-40, MA-112
• Applicant: Medify Air, LLC
• Product Code: FRF · General Hospital
• Decision Date: Sep 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2

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.

Device Story

MA-40 and MA-112 are room recirculating air cleaners designed to filter and inactivate airborne particles. Devices operate by drawing ambient air through internal filtration systems; fan speeds are adjustable to control airflow and processing time. Units are intended for use in clinical or medical environments to reduce airborne bioaerosols, including MS2 bacteriophage, Phi-X 174 bacteriophage, Staphylococcus Epidermidis, Escherichia coli, Bacillus Subtilis Endospore, and Aspergillus Brasiliensis. Operation is performed by staff or patients in a room setting. Output is purified air, which benefits patients and staff by reducing exposure to airborne pathogens. Effectiveness is demonstrated by >99.99% reduction of specified microorganisms in controlled test chambers.

Clinical Evidence

Bench testing only. Performance demonstrated via reduction of airborne microorganisms (viruses, bacteria, mold) by >99.99% in 83ft3 and 580ft3 test chambers. Testing evaluated various fan speeds and trial durations (20-120 minutes) for specific species including MS2 bacteriophage, Phi-X 174, S. Epidermidis, E. coli, B. Subtilis, and A. Brasiliensis.

Technological Characteristics

Room recirculating air cleaner; utilizes internal filtration and inactivation mechanisms. Features multiple fan speed settings (1-4). Operates as a standalone unit. No specific materials or software algorithms described.

Indications for Use

Indicated for use as a room recirculating air cleaner to filter and inactivate airborne particles, including viruses, bacteria, and mold, for medical purposes in general patient populations.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known)

K223835

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<br>(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<br>(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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