(240 days)
Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.
There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected.
In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient.
The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.
This is a 510(k) premarket notification for the "Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve" and "Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve". The document asserts substantial equivalence to the predicate device "Salter Labs Bubble Humidifier (K161719)".
However, the provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it summarizes non-clinical testing performed to demonstrate safety based on industry standards and establish substantial equivalence to a predicate device.
The document lists various tests performed and standards utilized, but it does not provide:
- A table of acceptance criteria with reported device performance values against those criteria.
- Sample sizes used for test sets.
- Information about ground truth establishment, experts, or adjudication methods.
- Details about MRMC studies or effect sizes for AI assistance.
- Information on standalone algorithm performance or training set details.
The document provides a "Summary of Non-Clinical Testing" and then lists specific types of tests, such as "Humidification Output," "Flow Rate," "Alarm," and "Pull Test." While it states that the results of these tests indicate substantial equivalence, it does not detail the acceptance criteria for each test or the specific reported performance values that met those criteria.
Therefore, I cannot populate the requested table or provide the detailed information about study design, ground truth, and sample sizes that would typically be found in a study demonstrating device performance against acceptance criteria.
The information that is available regarding acceptance criteria and performance is very high-level and can be inferred from the "Comparison of Technological Characteristics" table and the "SUMMARY OF NON-CLINICAL TESTING" section:
Inferred Information from the Document:
1. A table of acceptance criteria and the reported device performance:
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Humidification Output | 10mg/l (from comparison to predicate) | The document implies the proposed device meets 10mg/l as it states "Same" in the Assessment of Equivalence column for this feature. |
| Flow Rate (Model 3230) | N/A (Predicate specifies 6-15 LPM. Proposed 3230 is 2-12 LPM) | 2-12 LPM (Stated as a characteristic; not explicitly stated to meet an acceptance criterion for substantial equivalence in a specific performance manner, but rather as a product characteristic that is similar enough.) |
| Flow Rate (Model 3260) | N/A (Predicate specifies 6-15 LPM. Proposed 3260 is 2-15 LPM) | 2-15 LPM (Stated as a characteristic; not explicitly stated to meet an acceptance criterion for substantial equivalence in a specific performance manner, but rather as a product characteristic that is similar enough.) |
| Alarm (Model 3230) | N/A (Predicate specifies 6 PSI. Proposed 3230 is 4 PSI) | 4 PSI (Stated as a characteristic; not explicitly stated to meet an acceptance criterion for substantial equivalence in a specific performance manner, but rather as a product characteristic that is similar enough.) |
| Alarm (Model 3260) | N/A (Predicate specifies 6 PSI. Proposed 3260 is 6 PSI) | 6 PSI (Stated as a characteristic; not explicitly stated to meet an acceptance criterion for substantial equivalence in a specific performance manner, but rather as a product characteristic that is similar enough, matching the predicate for this model.) |
| Pull Test Specification | Minimum 5lbs at 7in/min (Stated for proposed device; predicate does not state value) | The document implies the device meets this specification, as "Pull Test" is listed under non-clinical testing performed to demonstrate safety. |
| Biocompatibility | Compliance with ISO 18562-1, ISO 18562-2, ISO 18562-3, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18 (for the proposed device). | The document states "Testing has been conducted per a biological evaluation and the applicable endpoints are summarized below" and lists the tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic toxicity, Material Mediated Pyrogenicity, Particulate Matter, Volatile Organic Compounds). It concludes that the devices do not raise new issues of safety or effectiveness compared to the predicate, implying compliance with these standards and successful completion of the tests. |
| Packaging | Not specified explicitly, but implies compliance with relevant standards. | "Packaging" is listed as a performed test; results are implied to be satisfactory for substantial equivalence. |
| Environmental Conditioning (high and low humidity) | Not specified explicitly, but implies compliance with relevant standards. | "Environmental Conditioning (high and low humidity)" is listed as a performed test; results are implied to be satisfactory for substantial equivalence. |
| Aging | Not specified explicitly, but implies compliance with relevant standards. | "Aging" is listed as a performed test; results are implied to be satisfactory for substantial equivalence. |
| Useful life testing | Not specified explicitly, but implies compliance with relevant standards. | "Useful life testing" is listed as a performed test; results are implied to be satisfactory for substantial equivalence. |
| ISO 80601-2-74 (Basic Safety & Essential Performance of Respiratory Humidifying Equipment) | Compliance with the standard. | The document lists this standard as one to which testing was performed, implying successful compliance for "Humidification Output," "Flow Rate," and "Alarm." |
The document does not provide information for the following points as they are typically associated with clinical studies or more detailed performance reports, which are not present here:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests, not diagnostic accuracy requiring expert ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests. For these tests, the "ground truth" would be established by the defined test methods and measurement standards (e.g., a specific method to measure humidification output).
- The sample size for the training set: Not applicable, as this is not a machine learning device.
- How the ground truth for the training set was established: Not applicable, as this is not a machine learning device.
Conclusion from the document:
The document concludes that "Based on the testing performed, including humidification output and additional gas pathway biocompatibility testing according to ISO 18562, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Hudson RCI Bubble Humidifiers are assessed to be substantially equivalent to the predicate devices." This statement implies that all the non-clinical tests were successfully completed and the devices met the performance expectations for substantial equivalence.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).