(324 days)
To promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure, with non critical patients for the treatment of:
- Air or Gas Embolism;
- Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Poisoning Complicated by Cyanide Poisoning;
- Clostridal Myonecrosis;
- Crush Injury, Compartment Syndrome, Acute Traumatic Ischemias;
- Decompression Sickness;
- Enhancement of Healing in Selected Problem Wounds;
- Exceptional Blood Loss;
- Necrotizing Soft Tissue Infections;
- Osteomyelitis (Refractory);
- Radiation Tissue Damage;
- Skin Grafts & Flaps (Compromised);
- Thermal Burns; and
- Adjunctive Hyperbaric Oxygen in Intracranial Abscess.
The HTU3 is a modified version of the HTU2. To comply with the ASME/PVHO-1 safety standard for pressure vessels for human occupancy, Hyox increased the operating pressure of the Company's hyperbaric therapy unit from two times atmospheric pressure to three times atmospheric pressure, the operating pressure of the Sechrist devices. To facilitate this change, certain minor modifications to the HTU2 were necessary to configure the HTU3. including: (1) an increase in the compression time, as well as an increase in the slow, fast, and emergency decompression times (although the compression and the decompression rates remain unchanged); (2) an increase in the thickness of steel used to manufacture the hyperbaric chamber: (3) an increase in thickness of the device's acrylic windows; and (4) a change from a compressor that functions using a diaphragm unit to a compressor that works using a free piston mechanism. Finally, also to comply with the ASME/PVHO-1 safety standard for pressure vessels for human occupancy, Hyox has made two additional modifications. Hyox has modified the shape of the chamber's acrylic windows and the grade of steel from which the hyperbaric chamber is manufactured.
The provided text is a 510(k) summary for the Hyox Systems, Ltd.'s HTU3 Hyperbaric Chamber. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies typically associated with AI/ML device evaluations.
Therefore, I cannot extract the information required by your request from the provided text. The document focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, rather than presenting a detailed performance study against specific acceptance criteria.
§ 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).