(92 days)
Hyperbaric chambers are used for treating the indications as currently listed by the Undersea Hyperbaric & Medical Association for hyperbaric oxygen therapy.
The Model ODS1 - Hood Driver is intended for use with monoplace hyperbaric chambers. It is normally used to permit the patient to breath oxygen while the chamber is pressurized on air. However, it can be used to supply the patient with any physiologically appropriate gas which may or may not be the same as the gas used to pressurize the chamber. The ODSI circuit is designed to supply a steady flow of breathing gas to the breathing apparatus used in the chamber. The breathing apparatus can be either a "Sea-Long" hood or a free-flow mask arrangement.
The provided text is a 510(k) summary for a hyperbaric chamber breathing station (ODS1 Hood Driver). It does not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details that would be found in a study proving a device meets acceptance criteria.
This document describes the device's function, its intended use, and compares it to a similar, already legally marketed device (Lifeforce Hyperbaric Chamber System) to demonstrate substantial equivalence. This is a regulatory submission, not a clinical study report.
Therefore, I cannot provide the requested information from the given text as it is not present.
§ 868.5470 Hyperbaric chamber.
(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).