(70 days)
The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.
Hudson RCI® AquaPak® Prefilled Humidifiers add water vapor (molecular H₂O) to a dry medical gas that is suspended in the gas to be inhaled by the patient.
The Hudson RCI® AquaPak® Prefilled Humidifiers are designed to add humidity to inspired gas, helping to control the drying and irritation of the respiratory mucosa. The humidifiers feature a micro-diffuser that produces smaller bubbles and greater surface agitation, allowing for a quiet operation and therapeutic humidity output.
Prefilled sterile reservoirs for AquaPak® Humidifiers come in four sizes; 190ml, 340ml, 540ml and 650ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides humidifier functionality.
Adaptor types provided with Hudson RC1® AquaPak® Prefilled Humidifiers feature an audible pressure relief valve, which indicates a restriction of gas flow to the user.
The provided text describes the 510(k) Summary for the Hudson RCI® AquaPak® Prefilled Humidifier. The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparative characteristics and non-clinical performance testing. However, it does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study proving the device meets those criteria, particularly for a medical AI/ML device.
Here's an analysis of what can be extracted and what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Technology and Features" for the proposed device and predicate devices, which can be interpreted as performance specifications or criteria. It also mentions "Non-clinical Comparative Performance Testing" but doesn't explicitly state quantitative acceptance criteria for each test or detailed results.
| Device Feature/Test | Acceptance Criteria (Implied/Directly Stated) | Reported Device Performance (Directly Stated) |
|---|---|---|
| Flow rate | 1.5 – 10 LPM (for predicate comparison) | 1.5 – 10 LPM |
| Audible notification of occlusion | 5 – 30 psi (for predicate comparison) | 5 – 30 psi |
| Humidity output | At least 10mg H2O/L (for predicate comparison) | At least 10mg H2O/L |
| Cannula Pop-Off, Bottle Burst, Occlusion Test | Does not burst, relieve valve performs as expected | Determines strength of tubing connector, reservoir does not burst when nares are occluded and the relieve valve performs as expected |
| Spitting Test | Will not spit or flood the tubing | Determines the expected outcome that the humidifier will not spit or flood the tubing at the maximum flow rate of 10 LPM |
| Humidification Output Test | N/A (determined rate of humidification) | Determines the rate of humidification at which the liquid is humidified and emitted in milligrams per liter |
| Packaging Integrity Tests | N/A (determines integrity) | Determines the integrity of the packaged device against known shipping tests |
| Ink Adherence Tests | N/A (determines adherence properties) | Determines ink adherence properties of the printed film used in packaging the device |
Missing Information for Acceptance Criteria: The document describes the type of tests performed and the principle of the tests, but it lacks specific quantitative acceptance criteria (e.g., "Cannula Pop-Off strength must be > X Newtons") and the quantitative results (e.g., "Cannula Pop-Off strength was Y Newtons, which passed"). The "Reported Device Performance" column largely reflects the purpose of the test rather than the actual outcome against specific criteria.
2. Sample Sizes and Data Provenance
This document describes a physical medical device (humidifier), not an AI/ML device. Therefore, concepts like "test set," "training set," "data provenance," and "country of origin" as typically applied to AI/ML models are not directly applicable.
- Test Set/Training Set: Not applicable in the context of this traditional medical device. No data sets are mentioned for model training or testing.
- Data Provenance: Not applicable.
3. Number of Experts and Qualifications for Ground Truth
Not applicable for this type of device and study. The "ground truth" for a humidifier's performance would be derived from physical measurements and engineering specifications, not expert consensus on interpretations.
4. Adjudication Method
Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used in evaluating subjective assessments, often in diagnostic imaging by multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device where human reader performance with and without AI would be compared.
6. Standalone Performance
The non-clinical performance testing summarized in Section K (Packaging Integrity, Ink Adherence, Cannula Pop-Off, Bottle Burst, Occlusion, Spitting, Humidification Output) represents the standalone performance evaluation of the device as an engineering product. However, the details of these studies, including specific protocols, sample sizes for each test, and quantitative results against pre-defined acceptance limits, are not provided in this summary document.
7. Type of Ground Truth Used
For the non-clinical comparative performance testing, the "ground truth" would be objective physical measurements and engineering standards (e.g., pressure readings, humidity measurements in mg H2O/L, observation of spitting/flooding). The document indicates that some tests referenced standards (ISTA 2A, ASTM F2252) while others did not ("N/A").
8. Sample Size for the Training Set
Not applicable, as this is not an AI/ML device.
9. How Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device.
Summary of What the Document Provides regarding "Acceptance Criteria" and "Study":
The document provides a high-level summary of non-clinical bench testing conducted to demonstrate that the Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to predicate devices and will perform as intended.
- Acceptance Criteria (Implied): The implied acceptance criteria for the new device are that its performance (flow rate, occlusion notification, humidity output) is comparable to the predicate devices and meets its own stated specifications, and that it passes specific functional and integrity tests (e.g., no spitting/flooding, package integrity, ink adherence).
- Study: The "study" referenced is a series of "Bench Testing" activities focused on:
- Packaging Integrity (referencing ISTA 2A)
- Ink Adherence (referencing ASTM F2252)
- Cannula Pop-Off, Bottle Burst, Occlusion Test
- Spitting Test
- Humidification Output Test
The document states that these tests were performed to "verify that the performance of the proposed Hudson RCI® AquaPak® Prefilled Humidifier is substantially equivalent to the predicate device, and that the Hudson RCI® AquaPak® Prefilled Humidifier will perform as intended."
Missing Detailed Information:
The K141353 summary is intentionally concise and does not include the full study reports. To fully answer your question with explicit acceptance criteria, detailed results, and sample sizes for each bench test, one would need to refer to the complete study reports submitted to the FDA, which are not part of this summary document. The information provided is sufficient for a 510(k) summary (demonstrating substantial equivalence) but not for a detailed scientific publication of a study.
§ 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).