(270 days)
The Hudson RCI AQUATHERM® III Plus External Adjustable Electronic Heater is designed for use with the Hudson RCI Nebulizer Adaptor and the AQUAPAK® system to provide continuous heated aerosol for respiratory applications.
The AquaTherm devices are adjustable output temperature heaters. The AquaTherm Heater is placed between a nebulizer adaptor and a reservoir of sterile solution. When a gas flow is initiated to the nebulizer, sterile solution is drawn up from the reservoir and through the stainless-steel puncture pin in the center of the AquaTherm Heater. The solution is heated as it flows through the pin. The heated solution is then drawn into the nebulizer adaptor where it is aerosolized into the patient gas stream.
This document, K223100, is a 510(k) premarket notification for a medical device (Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than independently proving the device meets specific performance acceptance criteria through a clinical study or a similar robust evaluation of its diagnostic capabilities.
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, expert reads, MRMC studies, ground truth establishment) is not applicable to this document.
This FDA submission is for a heating device used with nebulizers, classified as a Class II device (Nebulizer, product code CAF). The purpose of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.
Here's why the requested information is not present and what is provided:
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No Diagnostic Acceptance Criteria or Performance Reporting: This is not a diagnostic AI device or a device that relies on interpreting data to provide a diagnosis. Its function is to heat sterile solution for aerosolization. Therefore, there are no metrics like sensitivity, specificity, AUC, or other diagnostic performance indicators to report in a table.
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No Clinical Study on Efficacy/Accuracy: The submission demonstrates substantial equivalence through:
- Comparison of Technological Characteristics: Showing similar design, intended use, operating principles, and materials to the predicate.
- Non-Clinical Testing: This includes:
- Biocompatibility: To ensure materials are safe for patient contact (even if indirect).
- Packaging: To ensure the device remains sterile/intact until use.
- Cleaning: To ensure proper reprocessing if applicable (though the device is non-sterile).
- EMC Testing: To ensure electromagnetic compatibility and safety.
- Compliance with Standards: Adherence to relevant ISO and IEC standards (e.g., for safety, quality, and electrical compatibility).
This type of submission does not typically involve clinical trials or multi-reader studies to establish diagnostic accuracy or performance improvement for human readers.
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No Test Set/Ground Truth Details: Since there's no diagnostic performance being evaluated, there are no test sets, data provenance, expert ground truth establishment, or adjudication methods described. "Ground truth" in this context refers more to established engineering and safety standards rather than medical diagnostic truth.
Summary of Relevant Information (from the document) despite the non-applicability of the full request:
- Type of Device: Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (a nebulizer heater).
- Purpose: To provide continuous heated aerosol for respiratory applications.
- Regulatory Pathway: 510(k) Premarket Notification.
- Predicate Device: Aero-Mist Nebulizer Heater/Pegasus Research Corporation (K880473).
- Demonstration of Safety and Effectiveness: Through non-clinical testing (Biocompatibility, Packaging, Cleaning, EMC Testing) and compliance to industry standards (ISO 10993 series, IEC 60601 series).
- Conclusion: The device is substantially equivalent to the predicate and does not raise new issues of safety or effectiveness.
In essence, the "acceptance criteria" for this device are its ability to meet the specified non-clinical performance and safety standards, and to be functionally and technologically similar to the legally marketed predicate device, rather than diagnostic accuracy metrics.
§ 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).