(531 days)
The SEDARA™ Gas Mixer System is indicated for mixing and delivering Nitrous Oxide (N₂O) and Oxygen (0₂), in a ratio of 1:1, at a fixed concentration of 50% / 50% (V/V), to spontaneously breathing patients of at least 15 kg body weight and four years of age, who have been examined by the attending physician prior to SEDARA™ System use and are under the continuous supervision of a healthcare professional in a clinical facility, such as a hospital, a free-standing ambulatory surgical center, or an outpatient clinic.
USP N₂O and 0₂gases are blended to the 50%/50% concentration (V/V) and delivered upon demand to spontaneously breathing patients through a demand valve internal to the SEDARA™ Gas Mixer. Patient inspiration draws the gas mixture via a breathing circuit with a hand-held strapless face mask. The Oxygen is supplied by the user either from a standard gas cylinder or from an 0₂ wall outlet. The Nitrous Oxide is supplied from a small cylinder equipped with a tamper-resistant valve. The SEDARA™ Gas Mixer can be operated only with the use of a Security Key. The Security Key allows access and activation of the Gas Mixer, secures the N₂O Cylinder in use, and provides safekeeping of incremental N₂O Cylinders in the accompanying Transport Cart storage drawers, to guard against abuse and theft of the gas. The SEDARA™ Gas Mixer is provided with multiple levels of safety to ensure proper dosing. Visual and audible alarms signal the absence of adequate gas flow, the emptying of a gas cylinder, or technical failure of the mixer. The gas exhaled by the patient into the face mask is channeled through the exhalation limb of the breathing circuit to the SEDARA™ Scavenger and removed via the hospital's waste gas disposal system.
The provided text describes the EDARA™ Gas Mixer System, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific studies conducted to demonstrate performance against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a 510(k) summary and FDA clearance letter, which typically focuses on demonstrating equivalence to existing devices rather than detailing novel performance studies with explicit acceptance criteria.
Therefore, I cannot provide the requested table and detailed study information based on the given text.
The text does state the following about the device's performance characteristics in comparison to the predicate device:
- "mixes Nitrous Oxide and Oxygen to a 50%/50% (V/V) mixture with the same accuracy"
- "includes a waste gas scavenger fully equivalent to the predicate scavenger"
This implies that the accuracy of gas mixing and the effectiveness of waste gas scavenging are key performance aspects, and for these, the standard set is "the same accuracy" or "fully equivalent" to the predicate devices. However, the specific quantitative acceptance criteria and the studies proving them are not detailed in this document.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).