(231 days)
The Humidifier Heater Base PMH7000PLUS/PMH7000 is intended to add moisture and to warm the breathing gases for administration to the patient.
The Humidifier Heater Base, PMH7000PLUS/PMH7000 is intended for use on adult at hospital and home.
The Humidifier Heater Base, PMH7000PLUS/PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.
This heater base features a dual temperature servo control system which regulates the temperature of the gas delivered to the patient and the gas at outlet of humidifying chamber. It continuously monitors temperatures by a dual temperature probe. The heater base warms and humidifies the gas through the humidifier chamber and in addition a heater wire in the patient breathing circuit further controls same gas temperature. The operator is allowed to set the temperature of two locations: temperature of the chamber outlet gas and the gas immediately before delivered to the patient.
The Humidifier Heater Base PMH7000PLUS/PMH7000 is equipped with alarms which activate audible and visual indicators to alert the operator of adverse conditions. Alarms are provided for high and low airway temperature, high and low chamber outlet temperature probe disconnect or fault condition, heater wire fault connection, and the light identifies the area of alarm.
The Humidifier Heater Base PMH7000PLUS/PMH7000 includes several safety features such as prevention of excessive heating which can be harmful to the patient or can cause damage to the heater base itself. To ensure patient safety, the heater base will shut down under any alarm conditions if it continues for 10 minutes.
The Humidifier Heater Base are available in two models, PMH7000PLUS and PMH7000. PMH7000PLUS/PMH7000 has both inspiratory and expiratory heater wires for use in the inspiratory and expiratory limbs of breathing circuit. The use of the expiratory heater wire with PMH7000PLUS/PMH7000 is to control humidity in the expiratory limb and to reduce moisture returned to the ventilator.
The provided text is a 510(k) summary for a medical device (Humidifier Heater Base PMH7000PLUS/PMH7000). It describes the device, its modifications, and its substantial equivalence to a predicate device. However, this document does not contain explicit acceptance criteria tables, detailed study designs with sample sizes, information on ground truth establishment with expert qualifications, adjudication methods, or MRMC comparative effectiveness studies typically found for AI/ML device submissions.
The documentation focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and design modifications. The modifications mainly concern changes to the front and side panel design and the heater wire connector interface to improve maneuverability and connectivity. The core technological characteristics, intended use, operating principle, and performance (temperature and humidity output) are stated to be equivalent to the predicate device.
Therefore, many of the requested data points (especially those related to AI/ML device evaluation) are not present in this type of submission.
Here's an attempt to extract the available information:
- Acceptance Criteria and Reported Device Performance: Explicit acceptance criteria in a table format with specific performance metrics are not detailed in this 510(k) summary. The document states that "Non-clinical testing of Humidifier Heater Base PMH7000PLUS/ PMH7000 has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance capacity and accuracy." It also states, "PMH7000PLUS/ PMH7000 meets the requirements of the IEC 60601-1 and IEC 60601-1-2 electro medical and EMC standards" and "complies with performance and safety requirements of the ISO 8185 particular standard for Humidification Systems." This implies the acceptance criteria were compliance with these specific standards for safety and performance, but the numerical target values are not provided. The reported device performance is that it meets these requirements.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Mechanical Safety | IEC 60601-1, ANSI/AAMI ES60601-1 | Meets all requirements |
| Electrical Safety | IEC 60601-1, ANSI/AAMI ES60601-1 | Meets all requirements |
| Thermal Safety | IEC 60601-1, ANSI/AAMI ES60601-1 | Meets all requirements |
| Environmental Conditions | Covered in non-clinical testing | Meets all requirements |
| EMC | IEC 60601-1-2 | Meets all requirements |
| Functional Verification | Covered in non-clinical testing | Meets all requirements |
| Performance Capacity | ISO 8185 (for humidification systems), same as predicate device | Meets all requirements |
| Accuracy | Covered in non-clinical testing | Meets all requirements |
- Sample Size for Test Set and Data Provenance: Not applicable. This device is not an AI/ML device tested with a "test set" of patient data. The evaluation was based on non-clinical engineering and performance testing.
- Number of Experts and Qualifications for Ground Truth: Not applicable. No experts were used to establish ground truth in the context of diagnostic performance for patient data, as this is not an AI/ML diagnostic device.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not conducted as this is not an AI/ML device that assists human readers.
- Standalone Performance: A standalone performance evaluation was done in the sense of the device's electrical, mechanical, and thermal safety and its ability to meet performance standards (e.g., temperature and humidity output) independently. The testing was "non-clinical."
- Type of Ground Truth Used: The "ground truth" here refers to compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 8185, ANSI/AAMI ES60601-1) and the functional specifications of the device itself (e.g., set temperature, humidity output).
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
- How Ground Truth for the Training Set was Established: Not applicable.
§ 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).