(59 days)
The COMFORT FLO™ Humidification System is intended to provide a continuous flow of heated and humidified gases to spontaneously breathing patients.
Indications For Use:
To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.
The COMFORT FLO™ Humidification System is a gas delivery system.This system is designed to deliver heated and humidified respiratory gases to spontaneously breathing adult, pediatric, infant, and/or neonatal patients. This delivery system will be used in conjunction with the ConchaTherm Heated Humidifier product line. The COMFORT FLO™ Humidification System consists of a heated circuit, a Concha® Column, and a nasal cannula patient interface. All components of the COMFORT FLO™ Humidification System are non-sterile with the exception of the gamma-sterilized Concha® Column.
The provided text describes the COMFORT FLO™ Humidification System and its 510(k) submission, including a summary of testing conducted to demonstrate its performance. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Target performance) | Reported Device Performance |
|---|---|
| All components operate at or near 100% Relative Humidity. | "all components can operate at or near 100% Relative Humidity" |
| All components operate at 37°C. | "all components can operate at... 37°C" |
| All components operate at a rate of 1 to 40 LPM. | "all components can operate at... a rate of 1 to 40 LPM" |
| Maintain functional integrity for up to 14 days. | "all components can operate... for up to 14 days without loss of functional integrity." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact number of units or test runs used for the evaluation. It mentions "The COMFORT FLO™ Humidification System was evaluated and tested under simulated and extended use hospital conditions."
- Data Provenance (Country of Origin): Not explicitly stated, but the applicant (Teleflex Medical) is located in Bannockburn, IL, USA, and the FDA's address is Rockville, MD, USA. This suggests the testing was likely conducted in the USA or supervised by US entities.
- Retrospective or Prospective: The testing described is prospective, as it was conducted specifically to demonstrate the device's performance for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the study did not involve human interpretation or subjective assessment of data requiring expert consensus or ground truth in the way medical imaging or diagnostic algorithms would. The study focused on the functional performance of a medical device against objective physical parameters (humidity, temperature, flow rate, duration).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. The testing involved objective measurements of physical parameters, not subjective assessments requiring adjudication.
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
This section is not applicable. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems with human readers. This submission is for a medical device (humidification system) with no AI component or human interpretative task.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as there is no algorithm or AI component mentioned in the device description or testing summary. The device's performance was evaluated as a standalone physical system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the specified physical parameters/performance requirements for the device: 100% Relative Humidity, 37°C, 1 to 40 LPM flow rate, and maintenance of functional integrity for 14 days. Compliance was assessed against these objective, measurable conditions.
8. The sample size for the training set
This section is not applicable. The device is a physical medical system, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set mentioned or implied 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).