(25 days)
The Puritan-Bennett Helios Portable Liquid Oxygen System is intended to provide supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used as an ambulatory source of oxygen both inside and outside the patient's home. It is not intended as life sustaining or life supporting device. The device has no contraindications.
The Helios portable liquid oxygen system consists of a vacuum insulated cryogenic container and plumbing that includes pressure relief valves, heat exchanger tubes and a pneumatic conserving device. The vacuum insulated container allows oxygen to be stored in its liquid state under pressure where the system pressure is controlled by the relief valve. When the patient opens the flow control valve, the liquid oxygen is withdrawn from the container into a vaporizing coil. Once in the vaporizing coil, ambient heat is absorbed by the liquid oxygen, converting it into a gas and warming it to near room temperature. The gas finally passes through the flow control valve and on to the patient at the prescribed metered rate. The device is intended to be used in conjunction with a larger liquid oxygen reservoir where it is filled by mating it to the fill connection on the top of the larger system. The Helios device is a purely mechanical device and contains no electrical or electronic components.
The provided text describes a 510(k) summary for the Puritan-Bennett Helios Portable Liquid Oxygen System. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, performance metrics, or study designs typically found in regulatory submissions for software-as-a-medical-device (SaMD) or AI-powered devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them because the provided text does not contain this type of information.
Specifically, the document states:
- "The Helios liquid oxygen system successfully passed tests in the following areas; - Mechanical/Climatic - Device Performance"
However, it does not provide:
- A table of specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific mechanical/climatic thresholds) or quantitative reported device performance against these criteria.
- Sample sizes for a test set, data provenance, or details about training sets.
- Information on experts, ground truth establishment, or adjudication methods, as these are relevant to studies involving human interpretation or AI model training.
- Details about MRMC comparative effectiveness or standalone algorithm performance.
The document is a 510(k) summary for a purely mechanical medical device (a portable liquid oxygen system), not an AI/SaMD product. The information requested aligns with the evaluation of AI/SaMD, which is not applicable to this device.
§ 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).