(14 days)
The Respironics H2 Heated Humidifier is an accessory for positive pressure ventilation systems to provide moisture to the patient circuit.
It is intended for use with adult patients (> 30 kg), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation.
The H2 Heated Humidifier is a microprocessor-controlled system that has been designed to moisten and warm the air from a positive pressure ventilation device and thus help to compensate for the drying effect. The device is intended for use with the standard patient circuit that is used to connect the device to the patient interface (mask) and to the positive pressure ventilation device.
It is a Respiratory Gas Humidifier (heated Passover type) according to 21 CFR 868.5450. Heat is used to provide an evaporated water content to dry breathing gases.
The H2 Heated Humidifier has a thermoplastic enclosure with dimensions of 5.5 in. high x 6.5 in. wide x 5.25 in. deep and weighs 1.24 lbs. (without the chamber fitted), 1.63 lbs. (with the chamber fitted), and 2.5 lbs. (with the chamber fitted and filled with water). The unit is compromised of a metal heater plate that is controlled from control electronics, contained in a plastic enclosure that is directly supplied with AC power. The heater plate is positioned in the front of the unit. The humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located on the top panel.
Accessories for the H2 Heated Humidification chambers, breathing tubing and mounting arrangements.
The provided text is a 510(k) summary for the H2 Heated Humidifier. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not describe any clinical study proving the device meets acceptance criteria.
The information provided is largely focused on regulatory approval and device description, not performance testing results against specific acceptance criteria. Specifically, it mentions "design verification and validation testing" and "verification testing" regarding a baffle modification, but it does not detail:
- Acceptance criteria for performance metrics (e.g., specific humidity levels, temperature ranges, or other functional parameters).
- Any studies involving human subjects or animal models.
- The methodologies for setting ground truth, expert involvement, or sample sizes related to clinical performance.
Given this, I cannot answer most of your questions as the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific Performance Criteria (e.g., humidity output, temperature control, stability) | Not provided in the text. The text mentions "design verification and validation testing" and "verification testing" for a baffle modification, but specific numerical or qualitative acceptance criteria and corresponding performance metrics are not detailed. |
| Mitigation of water turbulence (for baffle modification) | "Verification testing has demonstrated that the addition of the baffle to the water chamber mitigated the water turbulence, which caused the water to spill into the patient circuit, observed at 30 cm H₂O under normal operating conditions and at 40 cm H2O under single fault conditions." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The text only refers to "design verification and validation testing" and "verification testing" without detailing the number of units or test conditions beyond specific pressure points for the baffle (30 cm H₂O and 40 cm H₂O).
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). This was likely internal engineering test data rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The testing described (baffle efficacy) appears to be engineering/laboratory testing, not involving expert interpretation of clinical data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically used in clinical studies for diagnostic accuracy, which is not described here.
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
- No. This type of study is irrelevant for a respiratory gas humidifier and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/algorithm-driven device in the sense of image analysis or diagnostic aid. The "software" mentioned is for device control, not for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the baffle modification, the ground truth was likely determined by physical observation (presence or absence of water splashing/spilling into the patient circuit) under controlled laboratory conditions, against engineering specifications.
8. The sample size for the training set
- Not applicable/Not provided. This device does not have a "training set" in the context of machine learning or AI models. The software is noted as "unchanged from the software provided in K012633," indicating pre-existing, validated control software.
9. How the ground truth for the training set was established
- Not applicable/Not provided. See point 8. The "ground truth" for the device's operational parameters would have been established through engineering design, specifications, and previous validation for predicate devices.
§ 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).