(162 days)
The Comfort Flo Humidification System provides a continuous flow of heated and humidified gas to spontaneously breathing patients. It is indicated for single use by neonate/infant, pediatic, and adult patients in professional healthcare environments.
The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients. The Comfort Flo Humidification System is designed to be used in conjunction with the Neptune Heated Humidifier with ConchaSmart Technology for neonate/infant, pediatric, and adult populations. The Comfort Flo Humidification System includes a Heated Wire Breathing Circuit, a ConchaSmart Column, and various Class I exempt accessories.
The document describes the acceptance criteria and performance of the Comfort Flo Humidification System, primarily focusing on its substantial equivalence to a predicate device (K131912).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Objective | Reported Device Performance |
|---|---|
| Shelf life / Useful life testing | PASS |
| - Pre- and Post-aging Visual Inspection | Met |
| - Length per ISO 5367 | Met |
| - Connection strength testing | Met |
| - Maximum Temperature / Minimum flow testing | Met |
| - ISO 8185 Section 101 (Useful life testing) | Met |
| - Rainout control | Met |
| Enthalpy related to flow variations, Resistance to Flow, Resistance to Flow with a bend, Leakage, Humidity Output, Enthalpy related to use and system errors, Warm Up Time and Temperature Tracking (as per applicable sections of ISO 8185: Section 51.103, Section 56.101.2 and 56.101.3, Section 101, Section 51.103 with faults from 3.6 bb, Section 6.8.2 a) 14) | PASS |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided document. The document mentions "The proposed Corrugated Comfort Flo Heated Wire Breathing Circuit" and "the proposed device," implying that testing was conducted on samples of the new design.
- Data Provenance: The document does not specify the country of origin of the data. The testing appears to be "bench testing" or "laboratory testing" based on the nature of the tests (ISO standards, physical and functional performance). It is prospective in the sense that the testing was performed on the new device (or samples thereof) to demonstrate its performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the described testing involves objective physical and functional performance criteria against established ISO standards, rather than subjective expert assessment or "ground truth" derived from human interpretation.
4. Adjudication method for the test set:
- This information is not applicable. The testing involves objective measurements and adherence to specified performance parameters defined by ISO standards. Therefore, an adjudication method for human interpretation is not relevant.
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD systems that assist human interpretation of medical images, which is not the nature of the Comfort Flo Humidification System.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- A standalone algorithm-only performance study was not done. This device is a medical apparatus (humidification system), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation of the Comfort Flo Humidification System is based on International Organization for Standardization (ISO) standards and specific engineering/performance requirements. This includes:
- ISO 8185:2007 - Respiratory tract humidifiers for medical use
- ISO 5356-1:2004 - Anaesthetic and respiratory equipment -- Conical connectors
- ISO 5367:2000 - Breathing tubes
- ISO 10993 series - Biological evaluation of medical devices (for biocompatibility)
- Specific functional parameters like visual inspection, length, connection strength, temperature/flow, rainout control, enthalpy, resistance to flow, leakage, humidity output, warm-up time, and temperature tracking.
8. The sample size for the training set:
- This information is not applicable. The Comfort Flo Humidification System is a physical medical device, not an AI/machine learning model that requires a training set. The term "training set" is typically used in the context of developing AI algorithms.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as #8. No training set or associated ground truth was relevant for this 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).