(37 days)
The PARI Hydrate V is intended to warm and add moisture to breathing gases to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases for administration to infant, pediatric, and adult patients. The Hydrate V is intended for use in homes, hospitals, and sub-acute institutions.
The Hvdrate V is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A breathing circuit is used to deliver the heated and humidified gas to the patient.
The provided 510(k) summary for the PARI Hydrate V describes a non-clinical study to demonstrate substantial equivalence to predicate devices, rather than a study against explicit acceptance criteria with reported device performance in the format typically used for AI/ML-based device evaluations. The summary focuses on comparing the device's technical characteristics and performance to existing, legally marketed humidifiers.
Therefore, the following analysis is based on interpreting the provided information in the context of a 510(k) submission for a non-AI/ML medical device, where the "acceptance criteria" are implied by performance equivalence to predicate devices and adherence to relevant standards.
Acceptance Criteria and Study Details
The PARI Hydrate V is a respiratory gas humidifier. For such a device, the primary performance characteristic is its ability to warm and add moisture to breathing gases effectively and safely. The acceptance criteria are implicitly defined by the performance of the predicate devices and adherence to international standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a non-AI/ML device, the "acceptance criteria" are based on equivalence to predicate devices and relevant industry standards (ISO 8185). The reported device performance is stated as being "comparable to the predicates."
| Acceptance Criteria (Implied) | Reported Device Performance (PARI Hydrate V) |
|---|---|
| Humidifier Output: Gravimetric output across various flow rates, equivalent to predicate devices (PARI Hydrate G, Fisher & Paykel MR 850) and meeting ISO 8185 standards. | "PARI Hydrate V was tested to compare performance to the predicate devices and ISO 8185, using a gravimetric test standard for humidifier output across the range of flows. The subject device is comparable to the predicates." |
| Safety and Effectiveness: Meets performance requirements without raising new concerns regarding safety or effectiveness. | "PARI Hydrate V meets performance requirements and raises [no] safety or effectiveness [concerns]." (Presumed typo in original: "raises of safety or effectiveness" likely means "raises no new concerns of safety or effectiveness.") |
2. Sample Size Used for the Test Set and Data Provenance
The summary describes "non-clinical testing" which typically involves bench testing rather than patient data.
- Sample Size: Not explicitly stated but refers to "a gravimetric test standard for humidifier output across the range of flows." This implies multiple measurements were taken at different flow rates to demonstrate consistent performance. The "sample" in this context would likely be the device itself and a series of test conditions.
- Data Provenance: Bench test data. Not applicable in terms of country of origin or retrospective/prospective as it doesn't involve patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For a non-clinical bench test of a humidifier, the "ground truth" is typically established by objective physical measurements (e.g., gravimetric analysis for humidity output) using calibrated laboratory equipment, not by human expert assessment. The testing would have been conducted by engineers or technicians in a laboratory setting.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Performance is determined by objective measurements against a standard.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often in conjunction with AI assistance. The PARI Hydrate V is a therapeutic device, and its performance is assessed via engineering and physical tests.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device does not incorporate an AI algorithm. Its performance is inherent to its physical design and operation.
7. Type of Ground Truth Used
- Objective Measurements: The ground truth for the device's performance (humidification output) was established through objective gravimetric measurements according to a "test standard for humidifier output," likely following the procedures outlined in ISO 8185. This involves precisely measuring the mass of water added to a gas stream over time.
- Predicate Device Performance: The ground truth for comparative purposes was the established performance of the legally marketed predicate devices (PARI Hydrate G and Fisher & Paykel MR 850), as well as the requirements of ISO 8185.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML device and therefore does not have a "training set" in the computational sense. Its design and development would have involved engineering principles and prototype testing, but not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above.
§ 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).