(286 days)
The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room.
The HAMILTON-H900 humidifier is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications for patients > 10 kg.
The HAMILTON-BC8022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
The HAMILTON-BC4022 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of adult and pediatric patients > 10 kg.
The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive mechanical ventilation of infants > 10 kg.
The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of infants > 10 kg.
The HAMILTON-H900 respiratory gas humidifier is designed to add heat and moisture to respiratory gases, which are then administered to patients who need invasive or noninvasive ventilation. The breathing gas is passed through a humidifier chamber, where the gas is heated and humidified using an external heat source.
The HAMILTON-H900 humidifier uses breathing circuits that are recognized automatically when connected to the humidifier. The humidifier uses two heating systems as heat sources:
- -A heating plate that has contact with the metal plate of a special humidifier chamber inserted into the base of the humidifier prior to application, thus heating the water contained inside the chamber.
- -The controlled heating within the breathing circuits.
The respiratory gas exiting the humidifier chamber is continuously monitored using temperature sensors that are integrated into the humidifier base. Additionally, a temperature probe inside the breathing tube is used to measure the temperature of the gas delivered to the patient airway.
The design of the breathing tubes offers heating performance over the entire length by providing constant heating of the entire tube wall, from the chamber exit to the patient connection. A float mechanism, together with detection of the water level inside the humidifier chamber and the autofill mechanism, keeps a constant water level.
The HAMILTON-BC8022 and HAMILTON-BC8010 are single-use, dual-limb breathing circuits comprising heated inspiratory and heated expiratory tubes. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
The HAMILTON-BC4022 and HAMILTON-BC4010 are single-limb breathing circuits comprising a heated inspiratory tube. The humidifier chamber uses a float mechanism to keep a constant water level inside the auto-feed chamber.
This document is a 510(k) Summary for medical device clearance, specifically for the Hamilton-H900 respiratory gas humidifier and associated breathing circuits. It details the device's characteristics and compares them to predicate devices to establish substantial equivalence.
Based on the provided text, the document describes performance data regarding electrical safety, electromagnetic compatibility, mechanical testing, software verification and validation, biocompatibility, and a human factors/usability study. However, it does not contain information about studies involving human readers, ground truth established by experts, or specific acceptance criteria and performance data in a comparative table for an AI/human-in-the-loop system.
The document states:
- "Hamilton Medical has demonstrated the HAMILTON-H900 humidifier and the HAMILTON-BC-series breathing circuits to have adequate performance."
- "The following performance and nonclinical data were provided in support of the substantial equivalence determination."
- It then lists various technical tests meeting industry standards (IEC, ISO).
Therefore, I cannot directly answer your request for a table of acceptance criteria and reported device performance (in the context of an AI/human-in-the-loop system as implied by the prompt's follow-up questions) or any details related to expert ground truth, adjudication, MRMC studies, or multi-reader studies, as these concepts are not mentioned in this regulatory submission for a respiratory humidifier and its circuits. This document focuses on the technical performance and safety of hardware and software components against established engineering standards and predicate devices.
To answer your specific questions based only on the provided text:
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A table of acceptance criteria and the reported device performance:
- The document provides several comparison tables for "Characteristic used for comparison" (e.g., flow range, accuracy displayed temperature, humidity performance, etc.) against predicate devices (Tables 1, 2, and 3). These characteristics can be interpreted as performance metrics, and the device's reported values are listed. However, explicit "acceptance criteria" for these values are not stated as pass/fail thresholds within these tables, but rather as performance characteristics matched or compared to predicates.
- For the non-clinical tests (e.g., Electrical Safety, EMC, Mechanical Testing, Software V&V, Biocompatibility, Human Factors), the acceptance criterion is implicitly compliance with the stated industry standards (e.g., IEC 60601-1, ISO 8185, ISO 5367, ISO 5356-1, ISO 10993-1). The reported device performance is that it "complies with" these standards.
Example (from various sections, not a single explicit table):
Acceptance Criterion (Implied) Reported Device Performance Source Section Compliance with IEC 60601-1 (Electrical Safety) The devices comply with the IEC 60601-1 standard for safety. Electrical Safety and Electromagnetic Compatibility Compliance with ISO 8185 (Respiratory Gas Humidifiers) The devices comply with the ISO 8185 standard for respiratory gas humidifiers. Electrical Safety and Electromagnetic Compatibility Airway temperature control (Invasive mode) 33°C - 43°C Table 1 Humidity performance (Invasive mode) >33 mg H2O/L at up to 60 L/min flow and 26°C ambient temp. Table 1 Software Validation (Level of Concern: Major) All specified requirements have been implemented correctly and completely. Software Verification and Validation Testing Biocompatibility (following ISO 10993-1) Testing in accordance with ISO 10993-1 performed, including Cytotoxicity, Sensitization & Irritation, Systemic Toxicity, Genotoxicity, Implantation Testing, Extractables and Leachables. Biocompatibility Compliance with ISO 5367 (Breathing Tubes) The breathing circuits comply with the ISO 5367 standard for breathing tubes. Mechanical Testing Human Factors / Usability Conformance with "Applying Human Factors and Usability Engineering to Medical Devices, 2016" guidance. Human Factors / Usability Study -
Sample sizes used for the test set and the data provenance: Not specified in the document for the performance studies. The testing appears to be primarily lab-based performance and safety verification of the device hardware and software. It does not mention clinical trial data or patient data sets.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is not evaluating an AI system against expert consensus or ground truth derived from expert review. It's about a hardware medical device (humidifier) and its compliance with engineering standards.
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Adjudication method: Not applicable (no expert review process described).
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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. This is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but hardware and embedded software. The software V&V was done, but it's not a standalone AI algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the functional performance (e.g., temperature, humidity), the "ground truth" would be measurements from calibrated instruments and adherence to the specifications derived from the predicate devices and applicable standards. For other tests like electrical safety, EMC, and biocompatibility, the ground truth is compliance with the specified international standards. No expert consensus, pathology, or outcomes data is mentioned as ground truth.
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The sample size for the training set: Not applicable. This document is about a finished medical device (hardware and embedded software), not a machine learning model that undergoes a separate training phase.
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How the ground truth for the training set was established: Not applicable. (See #8).
§ 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).