(172 days)
The Hudson RCI Gas Sampling Oxygen Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
The Hudson RCI nasal cannula with gas sampling port has bifurcated nares that channel oxygen delivery through both nasal prongs while allowing sampling of the patient's exhaled gas from both nasal prongs. Oxygen is delivered to the Cannula during all phases of ventilation through the base of the cannula and is directed through the lower halves of each nasal pronq into the nasal pharynx. During exhalation, oxygen continues to flow into the nasal pharynx through these lower pronq halves. When the gas sampling line is connected to an expiratory gas monitor, a small amount of gas is continuously withdrawn from the nasal pharynx through the upper halves of both nasal prongs. Part of this gas exits one side of the cannula and is routed via a small-bore gas sampling line to the expired gas monitor.
The provided document is a 510(k) summary for the Hudson RCI CO2, Oxygen Nasal Cannula, which is a medical device. This type of document is a premarket submission made to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. Therefore, it focuses on comparing the new device to existing devices rather than presenting extensive new study data to establish performance criteria against a set benchmark in the way you might find for a novel device.
The document does not contain the information requested regarding acceptance criteria and a study proving those criteria are met for the Hudson RCI CO2, Oxygen Nasal Cannula itself.
Specifically, the document lacks the following information for the Hudson RCI device:
- A table of acceptance criteria and the reported device performance: This information is not provided. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics and acceptance thresholds for the new device.
- Sample size used for the test set and the data provenance: Not applicable, as no specific performance test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 is a medical device for gas sampling and oxygen delivery, not an AI software.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide:
- Predicate Device: SALTLER LABS Oxygen Delivery - CO2 Sampling Nasal Cannula (K892406 and K863883).
- Device Description: The Hudson RCI cannula provides bifurcated nares for oxygen delivery through both nasal prongs and simultaneous sampling of exhaled gas from both nasal prongs. Oxygen flows through the lower halves of each prong, and gas is sampled through the upper halves.
- Intended Use: Adjunct to oxygen therapy, delivering low flow oxygen while providing a means to sample expired gas, for monitoring ventilatory rate. No difference in intended use from the predicate device.
- Patient Population: Infant to adult patients requiring low flow oxygen therapy and expired gas monitoring. No difference in patient population from the predicate device.
- Comparison of Technological Characteristics: The main difference from the predicate device is that the Hudson RCI cannula performs both oxygen delivery and CO2 sampling through each nasal prong, whereas the predicate delivers oxygen through one and samples CO2 from the other. However, both operate in a similar manner. The document asserts no difference in technological characteristics that would affect safety or effectiveness compared to the predicate.
- Conclusion: Hudson RCI believes the device is substantially equivalent to the SALTER LABS Oxygen Delivery CO2 Sampling Cannula.
In essence, this document demonstrates substantial equivalence to an existing legally marketed device, which is the primary "acceptance criterion" for a 510(k) submission. It relies on the assumption that if the new device is substantially equivalent to one previously cleared, it is by extension "safe and effective." It does not present new performance data in the structured way implied by your questions, which are more relevant to a novel device or a device with new performance claims.
§ 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).