(491 days)
Filtering out airborne particulates from air for medical purposes. HEPAirX 100 is intended for over-the-counter use.
Not Found
This is a letter from the FDA regarding a 510(k) premarket notification for a medical device called HEPAirX 100, a Medical Recirculating Air Cleaner. The document is a clearance letter, meaning the device has been found substantially equivalent to a predicate device.
Unfortunately, this document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. This type of information would typically be found in the 510(k) summary or the full submission, not in the clearance letter itself.
The letter confirms the device's classification, regulation number (21 CFR 880.5045), and product code (FRF). It also includes the "Indications for Use" statement, which specifies that the HEPAirX 100 is for "Filtering out airborne particulates from air for medical purposes" and is intended for over-the-counter use.
To answer your questions, I would need access to the full 510(k) submission document, specifically the sections related to performance testing and clinical data (if any was required and submitted).
§ 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).