(286 days)
The Hudson RCI® AquaPak® Sterile Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases. It may be used with pediatric (ages 2 years and above) and adult patients.
Hudson RCI® AquaPak® Sterile Prefilled Nebulizers provide sterile water or sterile saline for inhalation therapy. Nebulizers generate aerosol, a fine mist of liquid water (or sodium chloride solution) that is suspended in the gas to be inhaled by the patient during aerosol therapy.
The Hudson RCI® AquaPak® Sterile Prefilled Nebulizers consist of two components, a sterile adaptor and a prefilled sterile reservoir. The adaptor may be type 028 or type 033. The standard model with a yellow collar (type 028) and the quiet model with a blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen stream. Prefilled sterile reservoirs for the Hudson RCI® AquaPak® Sterile Prefilled Nebulizers come in three sizes; 440ml, 760ml and 1070ml, and may be sterile water or sterile sodium chloride solution. The sterile reservoirs are cleared under K141214, and are presented here for reference only. Each reservoir, when combined with an adaptor component, provides nebulizer functionality when connected to a gas source.
The primary purpose of this Traditional 510(k) submission is to change the nebulizer adaptor cleared in K141214 from non-sterile, and update the packaging materials and shelf life to maintain sterility.
The document describes a 510(k) summary for the Hudson RCI® AquaPak® Sterile Prefilled Nebulizers. This is a medical device submission, and the content provided outlines the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the provided text in the context of your request for acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document provides a table outlining the tests performed and a general statement about performance. Specific quantitative acceptance criteria are not explicitly listed in a separate column, but the "Principle of Test" column often hints at what was being measured. The reported device performance for these tests is generally stated as "The device passed all of the acceptance criteria for the tests" or "The packaging passed all of the acceptance criteria for the tests."
| Test Performed | Implied Acceptance Criteria (from Principle of Test) | Reported Device Performance |
|---|---|---|
| Packaging Configuration / Shelf life Testing | Establish integrity of the package materials and sterile barrier after shelf life testing, visual inspections and nebulization function test. (ASTM F1980-07, ASTM F2096) | "The packaging passed all of the acceptance criteria for the tests." |
| Sterility Testing | Validates the correct dose of gamma radiation to ensure a sterile product at the point of use when manufactured, stored, and handled according to the instructions for use. (ISO 11137-1:2006, ISO 11137-2:2013) | "The packaging passed all of the acceptance criteria for the tests." |
| Lift Pressure | Measures the amount of negative pressure required to pull liquid up for nebulization. | "The device passed all of the acceptance criteria for the tests." |
| Oxygen Entrainment | Measures the percentage of oxygen/air mixture when adjusted to preset oxygen percentage. | "The device passed all of the acceptance criteria for the tests." |
| Nebulization Rate | Determines the basic rate at which the liquid is aerosolized and emitted in mL/min. | "The device passed all of the acceptance criteria for the tests." |
| Particle Size Distribution | Determines the particle size (MMAD) and geometric standard deviation (GSD) of the aerosolized liquid. | "The device passed all of the acceptance criteria for the tests." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states "Bench testing has been performed". However, it does not specify the sample size used for any of the tests (e.g., how many devices were tested for lift pressure, nebulization rate, etc.). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. Given it's bench testing, it's typically prospective in nature, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable to the provided document. The document describes a technical device (nebulizer) performance assessment, not an AI or diagnostic device that requires expert-established ground truth for image or data interpretation. The ground truth for these tests would be objective measurements against established engineering and industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. Adjudication methods are relevant for subjective interpretations, typically in diagnostic studies with multiple human readers.
5. 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
This section is not applicable. The document describes the performance of a medical device (a nebulizer), not an AI algorithm designed to assist human readers or interpreters.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the type of testing described (packaging integrity, sterility, lift pressure, oxygen entrainment, nebulization rate, particle size distribution) would be objective measurements against predefined engineering specifications and regulatory standards. For example, sterility would be verified by microbiological testing against a defined sterility assurance level (SAL), and particle size distribution would be measured using validated instruments against a specified range. It's not expert consensus, pathology, or outcomes data in this context.
8. The sample size for the training set
This section is not applicable. The document describes the testing of a physical medical device. There is no mention of a "training set" as this term is typically used in the context of machine learning or AI development.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).