(105 days)
Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil.
Aromapatch™ nasal inhaler
The provided documents are a Food and Drug Administration (FDA) 510(k) clearance letter and an "Indications for Use Statement" for the Aromapatch™ Nasal Inhaler.
These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The FDA letter (K984345) confirms that the Aromapatch™ Nasal Inhaler has been found substantially equivalent to a legally marketed predicate device. This type of clearance (510(k)) generally focuses on demonstrating substantial equivalence to a device already on the market, rather than requiring detailed efficacy studies with acceptance criteria as might be seen for novel high-risk devices or those undergoing Premarket Approval (PMA).
The "Indications for Use Statement" simply describes the intended use of the device: "Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil."
Therefore, I cannot fulfill your request for the specific information about testing and acceptance criteria. The information requested is not present in these documents.
§ 874.5220 Ear, nose, and throat drug administration device.
(a)
Identification. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.