(172 days)
To deliver oxygen to patients in low to medium concentrations and provide a means to sample expired gases
The Southmedic OxyArm CO2 is an oxygen delivery device with a headset and oxygen delivery port, which is placed in front of the patient vs. nasal cannula or over their mouth and nose. It also contains a port for taking a sample of expired gases, to measure exhaled end-tidal carbon dioxide. It is connected to a standard oxygen source and the sampling tubing to a standard end-tidal carbon dioxide monitor.
The provided document describes a 510(k) premarket notification for the "OxyArm CO2" device, an oxygen delivery and expired gas sampling mask. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a dedicated study.
Therefore, many of the requested details, such as specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable or not present in the provided text because the device's approval is based on equivalence, not novel performance validation requiring such rigorous testing.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way a novel device might. Instead, it compares attributes of the proposed device to predicate devices to establish substantial equivalence. The "Performance" section within the comparison table implicitly serves as the acceptance criteria, where the proposed device is deemed equivalent if it "Yields comparable CO2 waveforms and values at various flow rates of oxygen" and is "Capable O2 % concentration at various flows."
| Attribute | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (OxyArm CO₂) |
|---|---|---|
| CO2 waveforms and values at various oxygen flow rates | Comparable to predicate device (Medsys / Southmedic Capnoxygen mask K971229) | Yes (Yields comparable CO2 waveforms and values at various flow rates) |
| O2 % concentration capability at various flows | Comparable to predicate devices (Southmedic OxyArm O2 - K001865, Medsys / Southmedic Capnoxygen mask K971229) | Yes (Capable O2 % concentration at various flows) |
| Intended for single patient, multi-use | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient requiring oxygen delivery and expired gas sampling | Any patient requiring oxygen delivery and expired gas sampling |
| Intended Environment of Use | Hospital, Physician Office, sub-acute, Emergency services | Hospital, Physician Office, sub-acute, Emergency services |
| Delivers oxygen to patient nose and mouth | Yes | Yes |
| Can measure expired gases | Yes | Yes |
| Materials (Polyethylene, polypropylene, PVC, no latex) | Comparable to predicate devices | Yes (Polyethylene, polypropylene, PVC; No latex) |
2. Sample size used for the test set and the data provenance
The document does not describe a specific clinical or performance test set with a stated sample size. The approval is based on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of attributes and intended use. There is no mention of specific data provenance (country, retrospective/prospective) for a direct device performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No external experts were used to establish ground truth in the context of a performance study for this 510(k) submission. The FDA reviews the provided information and determines substantial equivalence.
4. Adjudication method for the test set
Not applicable. No formal adjudication method involving multiple experts was performed as there was no independent test set demanding such a process.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an oxygen delivery and gas sampling mask, not an AI-powered diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The OxyArm CO2 is a physical medical device, not an algorithm, so standalone performance in this context is irrelevant.
7. The type of ground truth used
Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this 510(k) submission is the established performance and safety profiles of the legally marketed predicate devices. The new device demonstrates that its attributes and performance are comparable to these existing devices, thus inferring its safety and effectiveness.
8. The sample size for the training set
Not applicable. As this is not an AI/machine learning device, there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).