(81 days)
The CAIRE Spirit 300 will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. 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 vacuuminsulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. The economizer regulator riams the ony gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below 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 head regulator be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold. Dependant on the flow selection setting, the manifold either delivers the gas to the the manifolial Deportually diverts a 2 LPM continuos flow directly to the oxygen outlet. The continuos 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 dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.
This document describes a 510(k) premarket notification for the CAIRE Spirit 300, a portable liquid oxygen unit. However, the provided text does not contain acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined.
The document primarily focuses on establishing substantial equivalence to predicate devices (CAIRE Stroller, Puritan Bennett HELiOS, DeVilbiss LP05PP) based on technological characteristics and non-clinical testing. It states that the Spirit 300 "oxygenates similarly" to the predicate devices.
Therefore, I cannot provide the requested information in the format because the data is not present in the provided text.
Here's why and what information is available:
- Acceptance Criteria and Reported Device Performance: This information is typically found in performance testing reports, which are not included here. The document only generically states "non-clinical testing clearly shows that the Spirit 300 oxygenates similarly" to predicate devices. It notes slight differences, such as the Spirit 300 being "more sensitive" and oxygenating "a little better at the higher flow settings" than the DeVilbiss product.
- Sample Size (test set) and Data Provenance: Not specified. "Non-clinical testing" is mentioned, but no details on the number or type of tests, or the origin of any data, are provided.
- Number of Experts and Qualifications: Not specified. This typically relates to ground truth establishment for diagnostic or interpretive devices, which the Spirit 300 is not.
- Adjudication Method: Not applicable or specified.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for diagnostic devices where human readers interpret results, often with AI assistance. The Spirit 300 is an oxygen delivery device.
- Standalone (algorithm only) performance: Not applicable. This device is not an algorithm, but a physical medical device.
- Type of ground truth used: Not applicable in the context of diagnostic performance. For a device like this, performance would be measured against engineering specifications (e.g., oxygen flow rate, concentration, duration).
- Sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to performance/equivalence:
- Description of the Device: The Spirit 300 is a small, lightweight liquid oxygen portable unit with a vacuum-insulated cryogenic dewar, vaporizer coil, economizer regulator, pressure safety relief valves, manifold, electronic printed circuit board conserving device, and protective case. It has a 0.3-liter liquid oxygen capacity.
- Intended Use: Provides supplemental oxygen for ambulatory home healthcare patients by vaporizing medical grade liquid oxygen and dispensing it via an integral electronic conserving device. It is not a life-sustaining or life-supporting device.
- Technological Characteristics vs. Predicate Devices:
- CAIRE Stroller: Spirit 300 has an integral electronic conserving device (delivers doses with patient inhalation) vs. Stroller's continuous flow. Spirit 300 is smaller/lighter. Dewar design, plumbing, fill connectors, relief valves, and vent valves are similar. Non-clinical testing showed similar oxygenation.
- Puritan-Bennett HELiOS: Spirit 300 has an integral electronic conserving device vs. HELiOS's pneumatic conserving device. Otherwise, similar. Non-clinical testing showed similar (or significantly better) oxygenation.
- DeVilbiss #LP05PP: Similar technical operation of conserving devices. Spirit 300 is 0.34L capacity vs. DeVilbiss 0.49L. Non-clinical testing showed similar oxygenation, with Spirit 300 being more sensitive and oxygenating "a little better at the higher flow settings."
§ 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).