(233 days)
- 1 Air or Gas Embolism
- 2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- 3 Clostridal Myositis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome, and other Acute 4 Traumatic Ischemias
- 5 Decompression Sickness
- Enhancement of Healing in Selected Problem Wounds
- 7 Exceptional Blood Loss (Anemia)
- 8 Intracranial Abscess
- 9 Necrotizing Soft Tissue Infections
- 10 Osteomyelitis (Refractory)
- 11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis
- 12 Skin Grafts & Flaps (Compromised)
- 13 Thermal Burns
These are the indicated uses by the Undersea & Hyperbaric Medical Society.
The device is designed to be used for the indicated uses only.
Not Found
The provided text is a 510(k) premarket notification approval letter for the "MSI i2010 Dual Place Hyperbaric Chamber." This type of document declares a device substantially equivalent to a legally marketed predicate device, rather than presenting a study demonstrating the device meets specific acceptance criteria in the way an AI/ML device would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not available in this document.
The document primarily focuses on:
- Device Name: MSI i2010 Dual Place Hyperbaric Chamber
- Regulation Number: 868.5470
- Regulation Name: Hyperbaric Chamber
- Regulatory Class: II
- Product Code: CBF
- Indications for Use: A list of 13 specific conditions for which the hyperbaric chamber is indicated, as outlined by the Undersea & Hyperbaric Medical Society (e.g., Air or Gas Embolism, Carbon Monoxide Poisoning, Clostridal Myositis and Myonecrosis, Decompression Sickness, etc.).
- Substantial Equivalence: The core finding is that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This means it did not require a new clinical study to prove its safety and effectiveness, but rather demonstrated similarity in design, intended use, and technological characteristics to an already approved device.
§ 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).