(134 days)
The Dive Series Hyperbaric Chambers are rugged and portable, intended to be used to treat: Acute Mountain sickness (AMS) as prescribed by or under the direction of a physician.
Hyperbaric Dive chambers are mild hyperbaric chambers for pressures less than 5 PSI. This chamber is designed after the Gamow bag. It is composed of an airtight bag which is zipped shut with a person inside. The bag is inflated with atmospheric air with a small electric pump. The Hyperbaric Dive chambers are inflated with the Gast DDL 30. DDL40, or DDL120. The Shallow Dive, The Dive, and the Grand Dive utilize a single airtight bag with a single zipper. The bags have two relief valves set to 3.9 and 4 PSI to ensure safe operation (The Shallow Dives are set to 2.9 and 3 PSI to achieve the lower pressure). The chambers all utilize two redundant fill valves (for pressurizing the chamber from the Gast pump), one - two access ports for sampling inside air and one external pressure gauge. An optional pressure gauge can be added to the air sampling valve and positioned for viewing from the inside of the chamber. The Shallow Dive and the Dive weigh 15 pounds while the Grand Dive weighs 32 pounds. The compressor weighs 24 pounds. The bags are constructed of urethane coated nylon. The valves and ports are constructed of metal and plastic. The Shallow Dive is 7 feet long and 27 inches wide and attains 1.2 ATA (3 PSI), the Dive is 7 feet long and 27 inches wide and the Grand Dive is 9 feet long and 40 inches wide. These two chambers attain 1.3 ATA (4 PSI). All dimensions are with the devices inflated.
The provided text is a 510(k) summary for Hyperbaric Dive chambers. It establishes substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The document mainly focuses on:
- Device Description: Physical characteristics and operation of the Hyperbaric Dive chambers (Shallow Dive, The Dive, Grand Dive).
- Indications for Use: Treatment of Acute Altitude Sickness (AMS) as prescribed by a physician.
- Predicate Device Comparison: A detailed table comparing the new devices (Shallow Dive, The Dive, Grand Dive) to two predicate devices (Gamow Bag/HT/ Model-2 and BLKS-307 Monoplace Hyperbaric Oxygen Treatment System) across various attributes like intended use, dimensions, operating pressure, materials, and contradictions.
- FDA Clearance Letter: Official communication from the FDA confirming substantial equivalence.
Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided text. The requested information regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details are not present in the given summary.
The document's conclusion clearly states: "There is no significance difference between The Shallow Dive, The Grand Dive and the predicate Gamow Bag K874752A and HTI Model-2 K001409." This indicates that the primary method for demonstrating safety and effectiveness was establishing substantial equivalence to existing, legally marketed devices, rather than conducting new performance studies 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).