(43 days)
The PARI Hydrate G is designed to warm and add moisture to breathing gases for administration to infant, pediatric, and adult patients. The Hydrate G is intended for use in homes, hospitals, and sub-acute institutions.
The Hydrate G is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A nasal cannula is used to deliver the heated and humidified gas to the patient.
Here's an analysis of the provided text regarding the PARI Hydrate G and its acceptance criteria, structured as requested:
Acceptance Criteria and Device Performance for PARI Hydrate G
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance |
|---|---|---|
| Performance Comparability | Device performance should be comparable to legally marketed predicate devices, specifically "Active High Flow Gas Humidification systems" (Vapotherm 2000i and AquinOx P50000) in terms of humidification output. | The PARI Hydrate G employs "similar materials, similar air, water, and power inputs, and delivers similar outputs compared to the predicate devices." Its "Capillary Force Vaporization technology... results in comparable humidification output to the predicate devices." |
| Standard Compliance | Compliance with ISO 8185 for humidifier output. | The PARI Hydrate G "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 device is reported as "comparable to the predicates," implying compliance with the applicable parts of ISO 8185 related to humidifier output comparability. |
| Safety and Effectiveness | The device should meet performance requirements and raise no new issues of safety or effectiveness when compared to the predicate devices. | "PARI Hydrate G meets performance requirements and raises no new issues of safety or effectiveness." This is a conclusive statement from the submission. The FDA's substantial equivalence determination further corroborates that the device does not raise new safety or effectiveness concerns compared to existing legally marketed devices. |
Study Details:
The provided submission, K070107 for the PARI Hydrate G, describes a non-clinical test summary rather than clinical studies.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified. The submission mentions a "gravimetric test standard for humidifier output across the range of flows" but does not give specific numbers of test samples (e.g., number of devices tested, number of readings taken).
- Data Provenance: Not specified. The testing was reported by PARI Innovative Manufacturers, Inc., based in Midlothian, VA, suggesting it was likely conducted in the US, but this is not explicitly stated. It was a non-clinical, in-vitro comparison rather than data from patients. The nature of the testing (comparing output) implies it was prospective for the specific purpose of the 510(k) submission.
-
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):
- Not applicable. This was an engineering/performance comparison against existing devices and an international standard (ISO 8185), not a clinical assessment requiring expert-established ground truth. The "ground truth" here would be the measured physical properties (humidification output) of the device and predicate devices, as well as the ISO standard specifications.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies for human interpretation or assessment, which was not performed here. The performance was measured directly.
-
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:
- No MRMC study was done. This device is a medical device (humidifier) and not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an algorithm-only device. Performance testing was done on the physical device itself in a standalone manner (without patient interaction for this specific regulatory requirement). The "standalone" performance here refers to the device's ability to produce comparable humidification output in laboratory conditions.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the non-clinical testing was based on:
- Measured humidification output of the predicate devices.
- Specifications/requirements of ISO 8185 for humidifier output.
- The principle that "Active High Flow Gas Humidification systems" should produce comparable humidification output, regardless of the specific technology.
- The "ground truth" for the non-clinical testing was based on:
-
The sample size for the training set:
- Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."
-
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).