(140 days)
The BREATHE EASY device is a medical recirculating air cleaner designed to remove airborne particles and allergens, such as: dust, smoke, pollen, mold spores, animal hair and dander, dust mites, and harmful fibers, that may lead to allergic reactions.
The BREATHE EASY is an adjustable, personal system for treating air in a specified area of a room. The BREATHE EASY 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 the flow path.
The BREATHE EASY Model AD device contains also an air filtering system with a heater and humidifier for treating ambient air so as to bring it to a preselected respiratory comfort level. The BREATHE EASY device provides a method for guiding the treated air outflow so as to obtain a flow distribution in close proximity to the head of a user, thereby forming a treated air envelope surrounding his respiratory openings.
The BREATHE EASY device is supported on an adjustable support arm, adjustably mounted onto a household furniture (e.g., bed), wall, or wheeled support structure.
The provided text is a 510(k) Summary for the BREATHE EASY device, a medical recirculating air cleaner. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested table and information based on the given input. The document focuses on regulatory classification and substantial equivalence, not detailed performance data or clinical study results.
Here's what I can infer from the document regarding a "study":
- Performance Standards: The document explicitly states: "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act."
- Compliance: It also mentions: "However, the BREATHE EASY complies with the IEC 601-1." IEC 601-1 (now IEC 60601-1) is a general standard for the safety and essential performance of medical electrical equipment, not a standard specific to air cleaner efficacy in removing allergens.
In summary, the provided document does not contain the information needed to answer your questions about acceptance criteria and detailed study results.
§ 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).