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The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.

The operating flow range is 5 to 120L/min depending on the patient interface.

The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.

The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.

The HC550 System consists of the following components:

• . HC550 Respiratory Humidifier
• . Accessories:
  • a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432)
  • b) Humidification Chamber (as cleared in K9341401 and K913368)
  • c) Heaterwire Adaptor (as cleared in K073706)
  • d) Temperature/Flow Probe (as cleared in K983112)
  • RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e)

The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber.

A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.

The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier.

The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb.

If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit.

Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.

HC550 System Acceptance Criteria and Study Details

This document describes the acceptance criteria and corresponding study results for the HC550 System, a respiratory gas humidifier. The information is extracted from the provided 510(k) Notification K132017.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HC550 System are based on compliance with the ISO 8185:2007 standard for humidification systems. The device's performance is compared to these requirements.

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state a specific sample size for a "test set" in the context of clinical studies. The performance evaluation was conducted through bench testing to demonstrate compliance with ISO 8185:2007.

• Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated through bench testing.
• Data Provenance: Bench testing results, derived from laboratory experiments, not patient data. No country of origin for specific data is stated, but the submission is from Auckland, New Zealand.
• Retrospective/Prospective: Not applicable, as no clinical study with patient data was performed.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. Ground truth was established by international standards (ISO 8185:2007) for device performance, not expert consensus on an annotated dataset.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable, as no clinical study requiring adjudication of expert opinions was conducted. Performance was judged against predefined engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
• Effect Size of AI vs. without AI assistance: Not applicable, as this is a medical device and not an AI-assisted diagnostic or treatment system.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance study was done in the form of bench testing. The algorithm (or device in this case) was tested against established international standards (ISO 8185) to assess its functional performance independently. The results are presented in the table above, demonstrating the device's ability to meet the humidity and enthalpy requirements specified by the standard.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was international standard compliance (ISO 8185:2007). This standard sets quantifiable performance requirements for respiratory gas humidifiers.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not utilize machine learning or AI models that require a "training set." Its design and performance are based on engineering principles and compliance with established standards.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as no training set was used.

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