(233 days)
The Aesomist LT nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for health care use. This device must be used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
AC-powered air compressor intended to provide a source of compressed air for medical purposes for health care use. This device must be used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy.
1. Acceptance Criteria and Reported Device Performance
This document describes the FDA clearance for the Medline Aeromist LT Nebulizer Compressor (K031686) as "substantially equivalent" to legally marketed predicate devices. It does not contain specific acceptance criteria or performance metrics for the device itself. The FDA letter states that the device is subject to "general controls provisions of the Act," which include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text, as these specific details are not present. The clearance is based on substantial equivalence, implying the device performs similarly to predicate devices already on the market and meets existing safety and effectiveness standards.
Regarding other information requested:
Since the provided document is an FDA 510(k) clearance letter based on substantial equivalence, and not a study report detailing clinical performance or algorithm evaluation, the following information is not present and cannot be extracted:
- 2. Sample size used for the test set and the data provenance: Not applicable.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
This document is a regulatory approval, not a scientific study report. It indicates that the device has met the regulatory requirements for market entry based on its similarity to existing, approved devices.
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.