(257 days)
The air purifier 3707 UVC is used to reduce airborne particles, such as: dust, smoke, pollen, mold spores, animal hair, dust mites that may cause allergy in rooms of enclosed areas such as treatment rooms, hospital wards, intensive care hospital wards and residential homes.
Air Purifier 3707 UVC device is an adjustable and portable personal system for treating air in a specified area of a room. Air Purifier 3707 UVC device contains an air treatment system, including a housing unit with an air inlet and a treated air outlet, a blower and a filter for removing contaminants from the air flowing along Air Purifier 3707 UVC device contains also an air filtering the flow path. system with an Ultraviolet radiation tube which purified air.
The provided 510(k) summary for the Air Purifier 3707 UVC (K033448) does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in the context of device performance metrics (e.g., efficacy in reducing airborne particles).
Instead, the submission focuses on:
- Substantial Equivalence: The primary assertion is that the Air Purifier 3707 UVC is substantially equivalent to the AiroCide TiO2 (K023830) in terms of intended use, characteristics, and device descriptions.
- Compliance with Standards: The device complies with the Standard for Electrostatic Air Cleaners, UL 867, and the Canadian Standard for Electrostatic Air Cleaners, CSA C22.2 No. 187-M1986. These are safety and performance standards for air cleaners in general, not specific clinical performance criteria.
Therefore, many of the requested elements for describing acceptance criteria and a detailed study proving device performance (especially those related to AI/algorithm performance, ground truth, expert review, and sample sizes for testing/training) are not applicable or not provided in this 510(k) submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (AiroCide TiO2 - K023830) | Deemed "substantially equivalent" for intended use, characteristics, and device descriptions by FDA. |
| Compliance with UL 867 (Standard for Electrostatic Air Cleaners) | Device "complies" with UL 867. |
| Compliance with CSA C22.2 No. 187-M1986 (Canadian Standard for Electrostatic Air Cleaners) | Device "complies" with CSA C22.2 No. 187-M1986. |
| Reduction of airborne particles (dust, smoke, pollen, mold spores, animal hair, dust mites) in enclosed areas for allergy sufferers (Intended Use) | This is the intended function, but specific performance metrics (e.g., percentage reduction, time to clear a specific volume) for these particles are not provided or quantified in the document. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This 510(k) submission does not describe a clinical study with a test set of data points or patients for evaluating the device's efficacy in reducing airborne particles. The primary "test" was demonstrating compliance with general air cleaner standards and substantial equivalence.
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)
- Not applicable / Not provided. There was no "ground truth" to establish in the context of a clinical performance study as described. The determination of compliance with standards would involve testing by recognized certification bodies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No such adjudication method is mentioned as there was no expert review of a test set for clinical performance.
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 / Not provided. This device is an air purifier, not an AI-assisted diagnostic or interpretation system. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a physical air purifier, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For the purposes of this 510(k), the "ground truth" for demonstrating substantial equivalence and compliance would have been defined by the requirements of the predicate device's characteristics and the specified performance standards (UL 867, CSA C22.2 No. 187-M1986). There's no mention of clinical outcomes data for this product in this submission.
8. The sample size for the training set
- Not applicable / Not provided. This product does not involve machine learning or an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this is not relevant.
In summary, the 510(k) submission for the Air Purifier 3707 UVC establishes substantial equivalence through comparison to a predicate device and compliance with general product safety and performance standards, rather than through a clinical performance study with specific acceptance criteria for efficacy in reducing airborne particles.
§ 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).