(187 days)
To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue
Not Found
This document is a 510(k) clearance letter from the FDA for an "Immersion hydrobath." It signifies that the device is substantially equivalent to a legally marketed predicate device. However, this type of regulatory document does not typically contain the detailed information required to describe acceptance criteria and a study proving device performance as requested.
The letter focuses on regulatory approval, referencing existing regulations and indicating that the device can be marketed. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information).
Therefore, based solely on the provided text, I cannot extract the information required to answer your prompt. This document is a regulatory approval, not a performance study report.
§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.