(77 days)
Gebauer's Ethyl Chloride (Fine and Medium Nozzles): Gebauer's Ethyl Chloride is a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections and the temporary relief of minor sports injuries. It is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.
Ethyl Chloride (Fine or Medium Nozzle) is a prescription device consisting of a single organic chemical (Ethyl Chloride) and a precise delivery system. The chemical is selfaerosolized to deliver a pinpoint stream spray.
The provided text describes a 510(k) premarket notification for Gebauer's Ethyl Chloride, a vapocoolant device. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, rather than to establish new performance criteria through a study.
Therefore, the document does not contain the information requested regarding:
- Acceptance criteria and reported device performance in a table.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on demonstrating technological equivalence to existing legally marketed predicate devices.
Here's an analysis of what the document does state concerning the comparison:
Comparison of Technological Characteristics (from {1}):
- Mechanism of Action: Both the new devices (Gebauer's Ethyl Chloride Fine/Medium Nozzle) and predicate devices aerosolize Ethyl Chloride. The cooling action is caused by the evaporation of Ethyl Chloride from the patient's skin.
- Active Ingredient Quality: Both new and predicate devices contain Ethyl Chloride that meets the test specifications delineated in the USP Ethyl Chloride raw material monograph.
- Differences: The only difference noted is the "USP designation for the finished aerosolized product."
- Raw Material: The source and grade of the raw material are identical for the predicate and new devices.
Conclusion of Substantial Equivalence (from {2} and {3}):
- The FDA reviewed the 510(k) submission and determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This determination allows the device to be marketed.
In essence, for this type of submission, the "proof" the device meets acceptance criteria is the demonstration that its technological characteristics and intended use are sufficiently similar to a predicate device that has already been cleared for market. There is no new clinical or performance study conducted by the manufacturer and detailed in this document to establish novel performance metrics or acceptance criteria.
N/A