(270 days)
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 |
The MA-112 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 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 |
Not Found
This document is a 510(k) premarket notification from the FDA, indicating that the device being reviewed is a Medical Recirculating Air Cleaner. Therefore, the device in question is not an AI/ML powered device. The information requested in your prompt (e.g., acceptance criteria for AI algorithms, sample sizes for AI model training/testing, expert adjudication, MRMC studies) is typically associated with the evaluation of AI/ML-driven medical devices.
Since the document provided is for a physical air cleaner and not an AI/ML device, most of the requested information does not apply. However, I can extract what is provided in the document related to acceptance criteria and performance of this physical medical device.
Here's an analysis based on the provided document:
The acceptance criteria for the MA-40 and MA-112 air cleaners are based on their ability to reduce airborne microorganisms. The study proves that the devices meet these criteria by demonstrating a reduction of specific bioaerosol types by >99.99% within certain timeframes in a test chamber.
1. A table of acceptance criteria and the reported device performance
The acceptance criterion for both devices is to reduce airborne microorganisms by >99.99%. The tables provided show the time taken to achieve this reduction for different bioaerosol types and device fan speeds. The device performance (achieving >99.99% reduction) is reported for each scenario.
| BIOAEROSOL TYPE | SPECIES | DEVICE FAN SPEED | TOTAL TRIAL TIME (MINUTES) to achieve >99.99% reduction (MA-40) | TOTAL TRIAL TIME (MINUTES) to achieve >99.99% reduction (MA-112) | Acceptance Criteria: Reduction by >99.99% |
|---|---|---|---|---|---|
| For MA-40 | |||||
| Virus | MS2 bacteriophage | Speed 3 | 30 | Not applicable (MA-40 specific) | Met |
| Speed 2 | 45 | Not applicable (MA-40 specific) | Met | ||
| Speed 1 | 90 | Not applicable (MA-40 specific) | Met | ||
| Virus | Phi-X 174 bacteriophage | Speed 3 | 30 | Not applicable (MA-40 specific) | Met |
| Bacterial | Staphylococcus Epidermidis | Speed 3 | 30 | Not applicable (MA-40 specific) | Met |
| Bacterial | Escherichia coli | Speed 3 | 30 | Not applicable (MA-40 specific) | Met |
| Bacterial | Bacillus Subtilis Endospore | Speed 3 | 30 | Not applicable (MA-40 specific) | Met |
| Speed 2 | 45 | Not applicable (MA-40 specific) | Met | ||
| Speed 1 | 120 | Not applicable (MA-40 specific) | Met | ||
| Mold | Aspergillus Brasiliensis | Speed 3 | 30 | Not applicable (MA-40 specific) | Met |
| For MA-112 | |||||
| Virus | MS2 bacteriophage | Speed 4 | Not applicable (MA-112 specific) | 20 | Met |
| Speed 3 | Not applicable (MA-112 specific) | "20" (implied through position, no specific time given for lower speed without breaking the row) | Met | ||
| Speed 2 | Not applicable (MA-112 specific) | "20" (implied through position) | Met | ||
| Speed 1 | Not applicable (MA-112 specific) | "20" (implied through position) | Met | ||
| Virus | Phi-X 174 bacteriophage | Speed 4 | Not applicable (MA-112 specific) | 20 | Met |
| Bacterial | Staphylococcus Epidermidis | Speed 4 | Not applicable (MA-112 specific) | 20 | Met |
| Bacterial | Escherichia coli | Speed 4 | Not applicable (MA-112 specific) | 20 | Met |
| Bacterial | Bacillus Subtilis Endospore | Speed 4 | Not applicable (MA-112 specific) | 20 | Met |
| Speed 3 | Not applicable (MA-112 specific) | "20" (implied through position) | Met | ||
| Speed 2 | Not applicable (MA-112 specific) | "20" (implied through position) | Met | ||
| Speed 1 | Not applicable (MA-112 specific) | "20" (implied through position) | Met | ||
| Mold | Aspergillus Brasiliensis | Speed 4 | Not applicable (MA-112 specific) | 20 | Met |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The test "sample" here refers to the conditions under which the device was tested. The performance was demonstrated "in a test chamber of 83ft³ (580 ft³)". It's not a biological sample size in the sense of patient data. The document does not specify the number of individual tests or replicates run for each bioaerosol type and fan speed.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a report of performance in a controlled test chamber.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as this is a physical device being tested for its ability to filter and inactivate microorganisms, not an AI/ML algorithm requiring expert interpretation of medical images or data. The "ground truth" is measured by the reduction of bioaerosols in a controlled environment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an adjudication process for human interpretation or AI output. The performance is based on quantitative measurements in a laboratory setting.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device, and therefore no MRMC study involving human readers and AI assistance would be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML algorithm. The "standalone" performance is the device's ability to purify air without human intervention beyond turning it on and setting the fan speed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is the measured reduction of specific bioaerosol concentrations within the test chamber. This is determined through laboratory methods suitable for quantifying microorganisms, which is an objective measurement rather than a subjective expert assessment.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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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 (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
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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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§ 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).