(203 days)
The Cloud 1 Humidification System is intended to warm and humidify gas before it is delivered to the airway of a patient requiring mechanical ventilation or ventilatory assistance.
The Cloud 1 Humidification System is used to deliver heat energy and humidity to a patient's proximal airway in those instances where the patient's natural mechanisms of heat retention and humidification are bypassed by intubation. The system consists of a humidifier that creates water vapor at an elevated temperature and mixes the vapor with air from a ventilator and a specialized breathing circuit including a heating element in either the inspiratory limb or both the inspiratory and expiratory limbs. The water content of the air exiting the humidifier is close to saturation at a desired proximal airway temperature. The breathing circuit heater adds heat energy to the air/vapor mixture as it travels from from the humidifier to the patient's proximal airway and, optionally, from the patient's airway to the ventilator expiratory valve. By reducing the temperature loss in the breathing tube, condensation of water vapor (rainout) is minimized resulting in safer operation and reduced clinical maintenance of the system.
The proposed system is a dual microprocessor controlled system with multiple redundant alarm and system check features. The humidification system uses the Vapor Phase transfer chamber concept that provides a physical separation between the water compartment and the vapor compartment by means of a hydrophobic membrane. This separation assures that a large bolus of liquid water cannot enter the patient's breathing circuit due to tipping of the humidifier. The construction of the chamber's membrane and the relatively high operating temperature allows the use of low cost distilled water instead of sterile water as is more commonly used in humidifiers.
The proposed system uses a breathing circuit heater assembly that supports heater elements in the center of the inspiratory air flow with a polymer web. The heater elements are placed such that they cannot touch the wall of the breathing circuit tube, reducing the chance for the heater melting through the tube wall and creating a circuit leak. Locating the heater elements at the center of the tube optimizes heat transfer to the airflow, reducing the operating temperature of the heater elements, further reducing chance of melting the breathing tube. The heater element employs straight wires instead of the more conventional spiral wound wires to reduce the risk of hot spot formation due to uneven spiral pitch winding and subsequent melting of the heater assembly and/or breathing circuit tube.
The support web serves as a structure to connect and support temperature sensors (thermistors), two extending to the proximal end of the heater assembly and another at the distal end of the heater assembly. The proximally located sensors measure proximal airway temperature (PAT) while the distally located sensor measures the chamber output temperature (COT). Additional conductive wires are extruded in the assembly support ribbon to electrically connect the PAT sensors to a cable assembly molded in the distal end. The cable assembly plugs into the humidifie/heated wire controller.
The provided text describes a medical device, the "CLOUD 1 Humidification System," and its 510(k) submission for market clearance. However, the document does not contain detailed acceptance criteria, a specific study protocol, or quantitative data demonstrating how the device meets acceptance criteria. It primarily focuses on comparing the device's performance characteristics and safety features to predicate devices in a qualitative manner.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with numerical targets. Instead, it describes performance in comparative terms to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Humidity Delivery | "In most flow/setpoint conditions, the RSP system delivered humidity closer to saturation than either of the competitors' systems." |
| Safety Features | "The RSP system provides greater safety by using a dual PAT sensor and tracking error detection, redundant latching high and low PAT alarms, redundant power switches for both the heater platen and the circuit heater, redundant latching platen overtemperature sensing and alarming, and tertiary safety with a platen thermal fuse in addition to the safety benefits of the transfer chamber and improved circuit heater constructions." |
| Physical Separation (preventing water bolus) | "The humidification system uses the Vapor Phase transfer chamber concept that provides a physical separation between the water compartment and the vapor compartment by means of a hydrophobic membrane. This separation assures that a large bolus of liquid water cannot enter the patient's breathing circuit due to tipping of the humidifier." |
| Breathing Circuit Heater Safety | "The heater elements are placed such that they cannot touch the wall of the breathing circuit tube, reducing the chance for the heater melting through the tube wall... The heater element employs straight wires instead of the more conventional spiral wound wires to reduce the risk of hot spot formation..." |
| Water Type Usage | "The construction of the chamber's membrane and the relatively high operating temperature allows the use of low cost distilled water instead of sterile water as is more commonly used in humidifiers." |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "the performance of the system was tested and compared," but no details on the testing methodology or data generation are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes "non-clinical data" and comparisons to predicate devices, not studies involving expert-established ground truth for a test set.
4. Adjudication method for the test set
Not applicable, as no test set with expert ground truth or adjudication is described.
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
Not applicable. This device is a humidification system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device, not an algorithm, and the concept of "standalone performance" in this context refers to the device's functional operation. The text indicates the device's functional performance was tested ("performance of the system was tested"), but it's not "algorithm only."
7. The type of ground truth used
For the "Non-Clinical Data" described, the "ground truth" seems to be derived from instrumental measurements of humidity output, temperature control, and safety feature functionality, compared against the performance of predicate devices. It is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).