(237 days)
The intended use of the HC500 is to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, when using an artificial ventilation system. This includes use with systems such as portable volume ventilation systems, pressure support ventilation and continuous positive airway pressure (CPAP) devices. These systems may bypass the patient airway (using an endotracheal tube) or use mask ventilation. Providing heat and humidification to these gases counteracts the effects of bypassing the nose, pharynx and trachea, where this function would normally be carried out by the body. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through mask ventilation is similarly beneficial to prevent drying of the patient airways.
The HC500 is enclosed in a thermoplastic case that features an aluminium heater plate mounted in the top of the unit, with a chamber clamping mechanism. The device indicators, controls and temperature display are located on the front panel. Sockets for a temperature probe and heater wire, and the power switch are on the right side, and a mounting bracket is located on the back of the device. The HC500 measures 135 x 170 x 156mm and weighs 2.8kg without a humidification chamber fitted. It contains a mains transformer and Power and Control printed circuit boards.
The HC500 Servo-Controlled Heated Respiratory Humidifier controls the addition of heat and humidity to respiratory gases delivered through a patient delivery circuit. The humidifier operates in two modes that are individually selected: (1) Non Heated Wire mode, and (2) Heated Wire mode.
The provided text is a 510(k) summary for the Fisher & Paykel HC500 Servo-Controlled Heated Respiratory Humidifier. This document focuses on demonstrating that the new device is substantially equivalent to a predicate device, rather than proving its effectiveness through a typical clinical study with acceptance criteria, sample sizes, and ground truth established by experts as one might find for a diagnostic or AI-powered medical device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a drug or a modern diagnostic device are not applicable (N/A) to this type of regulatory submission for a humidifier.
However, I can extract information related to how the device's performance was evaluated for its 510(k) submission.
Here's an attempt to answer the questions based on the provided text, heavily indicating when information is Not Applicable (N/A) due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or AI device. Instead, it discusses the device's specifications, safety features, and how its performance was compared to predicate devices to demonstrate equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Thermal overheat cut-out activation temperature. | 118°C thermal overheat cut-out on the heaterplate. |
| Back-up electronic over temperature protection circuit. | Present. |
| Connection or fault alarms for temperature probe and heater wire. | Present. |
| High temperature alarm at patient end of delivery circuit. | Set to 41°C. Alarms turn off heater element, turn on audible/visual indicators, display temp. |
| Chamber high temperature alarms. | Set at > 47°C, and 41°C for longer than 20 minutes. |
| Electrical safety parameters within international design standard. | All electrical safety parameters such as leakage current are within limits set by international design standard. |
| Performance (Equivalence to Predicate): | |
| Deliver therapeutic levels of heat and humidity. | "Performance testing demonstrates that the device functions as specified under a variety of conditions of use... Comparative testing for both heated wire and non heated wire operating modes ensure that performance is equivalent to the predicate devices in terms of delivery of absolute humidity or temperature levels within the specified flow limits of the HC500." |
| Operational ranges (e.g., temperature control). | Non Heated Wire mode: Heater plate temperature controlled from 45°C to 80°C. Patient airway temperature (displayable) in normal operation. |
| Heated Wire mode: Patient delivery temperature controlled from 32°C to 39°C. Heater plate controls temp at chamber output; +2°C rise to patient end controlled by heater wire. | |
| Capability to withstand extreme conditions (mechanical, env.). | Mechanical shock, vibration and environmental conditions testing ensures that the HC500 can withstand extreme conditions of use without loss of function or significant physical damage. |
| Correct operation of software features. | Software changes from the predicate device have been verified through functional tests, which prove correct operation of the features which have had parameters modified for the HC500. |
| Functional Equivalence: | |
| Device size, shape, material, component location similar to predicate. | Retained in HC500. |
| Significant components identical to MR730/MR410. | Includes enclosure, mounting, chamber retaining components, heater plate assembly, internal chassis, transformer, PCBs, microprocessor, power supply cord, external/internal connectors, wiring. |
| Nominal mains supply. | 115Vac 60Hz. |
| Operating manual rewritten for home-use. | Rewritten to clearly detail responsibilities of home caregiver/supervising clinician, provide expanded cleaning/maintenance, and emphasize safety precautions. |
| Device modified for home use. | Unnecessary features removed, controls simplified, less liable to inadvertent adjustment. Element power reduced to 85W, max heaterplate temp reduced to 100°C (due to reduced max flow spec). Temperature control range and lower alarm limits adjusted for home use. Power on indicator added, alarm indicators combined on front display. I/O and stand-by mode removed. Chamber temp display, chamber offset, heater wire mode switch, general temp display reduced accessibility. |
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: N/A. This was not a data-driven clinical study with a "test set" in the sense of patient data. The "testing" involved non-clinical performance, mechanical, electrical, and software verification of the device itself.
- Data Provenance: N/A for clinical data. The testing was conducted by Fisher & Paykel Electronics Limited in New Zealand.
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)
- Number of experts: N/A. "Ground truth" from medical experts, as would be used in a diagnostic study, is not relevant here. The "truth" or correctness of the device's operation was established through engineering and performance testing against specifications and predicate device equivalence.
- Qualifications of experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: N/A. This concept is not applicable to the non-clinical testing performed for this device.
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
- MRMC Study: No, this was not an MRMC study. This device is a medical humidifier, not an AI-powered diagnostic tool.
- Effect size for human readers with AI: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: N/A. This device does not involve an algorithm performing a diagnostic task. Its software controls the humidification function, and its performance was tested as part of the overall device functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: N/A in the clinical sense. For this device, "ground truth" equates to engineering specifications, regulatory standards (e.g., electrical safety), and the established performance characteristics of the predicate devices. For example, a temperature reading of 41°C from a calibrated sensor would be considered "ground truth" for whether the over-temperature alarm activated correctly.
8. The sample size for the training set
- Sample Size for Training Set: N/A. This device does not use machine learning or AI that requires a "training set" of data.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A. As there is no training set, this question is not applicable.
§ 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).