(128 days)
The Smiths Medical Thera-Heat™ Heated Humidifier device is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases. The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.
Inspiratory heated limb: An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and noninvasive breathing systems.
Inspiratory and Expiratory heated limbs: An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.
The Thera-Heat™ Heated Humidifier system is a respiratory gas humidifier according to 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to add moisture and if applicable, heat to breathing gases prior to administration to a patient. Indirect heating is used by the Thera-Heat™ to provide an evaporated water content to dry breathing gases.
Respiratory gas humidifiers are used by clinicians to raise the water content of gases delivered to patients. Gases available for medical use do not always have sufficient moisture and may damage or irritate the respiratory tract or desiccate tracheobronchial secretions of patients whose airways have been bypassed. The Thera-Heat™ Heated Humidifier system warms and adds water vapor to the inspired gas by heating water within the humidification chamber as the dry gas passes over the warmed water.
The humidification chamber is an auto-fill style that contains an integral float valve at the water filling port. The float valve regulates the water level inside the chamber to maintain a constant water level. The water supply (liquid reservoir) is a pre-filled sterile water reservoir that connects to a filling port on the humidification chamber. When the liquid reservoir is empty, the caregiver will exchange it with a new one. After the gas is warmed and humidified it is channeled to the breathing tube for delivery to the patient.
The system can be operated using a conventional breathing tube (non-heated) in both limbs, or a heated breathing tube in the inspiratory limb only, or a heated breathing tube in both limbs. The heating of the humidification chamber and the power supplied to the heated breathing tube is provided by the controller unit. The purpose of the heated breathing tube is to regulate the gas temperature from the humidification chamber to the patient, reducing condensation and pooling of water, and the means of controlling the relative humidity by maintaining a temperature gradient between the humidification chamber and the delivered airway temperature. The caregiver sets the controller unit to the desired patient airway temperature, and then sets a humidity index value, which is limited in range by the controller based on the desired patient airway temperature. The control unit will maintain the selected temperature for the patient airway and the humidification chamber output temperature based on the humidity index value.
Accessories for the Thera-Heat™ Heated Humidifier include the humidification (water) chambers, temperature probes, interface cables and brackets.
Heated Wire Ventilator Breathing Circuits: A heated Wire Ventilator Breathing Circuit is a disposable device compromised of 22mm corrugated plastic tubing, 22 mm plastic tube connectors, and an electrical heater-wire harness subassembly. After the gas is warmed and humidification chamber it is delivered through the inspiratory limb of the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by the heated humidifier. The heated wire breathing circuits may be comprised of a dual limb or single limb circuit. The purpose of the heated wire ventilator breathing circuits is to maintain or raise the gas temperature to or above the dew point reducing or eliminating water condensation and/or pooling of water in the breathing circuit. Other accessories such as exhalation valves, water traps, etc. can be added in to the overall assembly creating different product variations.
The provided text describes a 510(k) premarket notification for the "Thera-Heat™ Heated Humidifier and Heated Wire Ventilator Breathing Circuits." The focus of this submission is on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment, which are typical for studies validating AI/ML medical devices, is not explicitly detailed or applicable in this context.
Here's an analysis based on the available information:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of quantitative acceptance criteria for device performance. Instead, it states that the device "complies with the performance and safety standards ASTM F1690 (USA) and ISO 8185 for active humidification" with two noted exceptions. The reported "performance" is primarily compliance with these standards.
Acceptance Criteria (Standards Compliance) Reported Device Performance IEC60601-1 (Safety) Complies UL60601-1 (Safety) Complies CAN/CSA 22.2 No.60601.1 (Safety) Complies IEC60601-1-2 (Electromagnetic Compliance) Complies IEC60601-1-4 (Software Compliance) Complies (to the acceptance of Underwriters Laboratories) ASTM F1690 (USA) (Active Humidification) Complies with exceptions:
- Clause 51.6.2: Generates a high priority alarm if airway temperature is $\ge$ 41°C.
- Clause 51.8 part C: Cannot reduce airway temperature sufficiently when airflow is instantaneously increased from minimum to maximum rated flow in a non-heated circuit, allowing airway temperature to exceed 43°C for 30 seconds. An alarm is generated, and heating stops. A warning label and operational manual notice are provided. |
| ISO 8185 (Active Humidification) | Complies with exceptions: - Clause 51.6.2: Generates a high priority alarm if airway temperature is $\ge$ 41°C.
- Clause 51.8 part C: Cannot reduce airway temperature sufficiently when airflow is instantaneously increased from minimum to maximum rated flow in a non-heated circuit, allowing airway temperature to exceed 43°C for 30 seconds. An alarm is generated, and heating stops. A warning label and operational manual notice are provided. (As per ASTM F1690, which likely references similar performance metrics). |
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Sample Size and Data Provenance (for test set):
The document does not detail specific "test sets" in the context of clinical or performance data for an AI/ML device. The testing conducted was "non-clinical testing...covering mechanical, electrical, and software for functional performance and temperature accuracy under environmental conditions and tests standards." This implies laboratory or bench testing, not patient data. -
Number of Experts and Qualifications (for ground truth):
Not applicable. The ground truth for this device is based on compliance with established engineering and medical device safety standards (IEC, UL, CSA, ASTM, ISO), not expert consensus on diagnostic or clinical outcomes from a test set of data. -
Adjudication Method:
Not applicable. No expert adjudication method is mentioned as this is not a study involving human interpretation of data for medical diagnosis. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states "Clinical Data: Not required." This indicates that no human-in-the-loop clinical study comparing human performance with and without AI assistance was conducted or deemed necessary for this 510(k) submission. -
Standalone (Algorithm Only) Performance:
"Standalone performance" in the context of an AI/ML algorithm is not applicable here. The device is a physical medical device (humidifier and breathing circuits). Its performance was assessed through non-clinical laboratory testing against engineering and safety standards. -
Type of Ground Truth Used:
The "ground truth" for this submission is compliance with international and national safety and performance standards for respiratory gas humidifiers and breathing circuits (e.g., IEC60601-1, UL60601-1, CAN/CSA 22.2 No.60601.1, IEC60601-1-2, IEC60601-1-4, ASTM F1690, ISO 8185). -
Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The device is a hardware system. -
How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in that manner. The "ground truth" for its design and manufacturing is adherence to established engineering principles and regulatory standards.
§ 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).