(164 days)
The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device (digital oxygen conserving device-DOCD). The Spirit 300 is neither a life sustaining nor life supporting device.
The spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure relief valves, a manifold, an electronic printed circuit board conserving device (digital) and a protective case. The dewar has a capacity and capability to store 0.3L of liquid oxygen. The economizer regulator either draws gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below the 20 PSI, the economizer regulator will draw liquid oxygen, from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar headspace to be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold, dependent on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or diverts a 2L PM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosage just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.
This document is a 510(k) summary for the Caire Inc. Spirit 300 Portable Liquid Oxygen Unit. It describes the device, its indications for use, and confirms that modifications have not altered the fundamental scientific technology of the predicate device.
Based on the provided text, there is no acceptance criteria or study information that describes device performance in the way requested. This document is a regulatory submission summary for substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
Here's why:
- Type of Document: This is a 510(k) summary, primarily focused on demonstrating "substantial equivalence" to a predicate device for regulatory approval. It asserts that modifications haven't altered fundamental technology, but it doesn't present the detailed test results or the specific acceptance criteria for those tests.
- Focus on Equivalence: The core of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technical characteristics and demonstrating that any differences don't raise new questions of safety or effectiveness. It's not typically about proving performance against a novel set of clinical acceptance criteria with detailed study results as one might find for a PMA or CE Mark submission.
The document states: "Caire Inc confirms that the modifications described here within have not altered the fundamental scientific technology of the predicate device (Spirit 300) cleared under 510(K) number K013251." This is the primary "proof" offered in this summary, not a new study.
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).