(322 days)
The Fisher & Paykel Healthcare HC200 CPAP Humidifier is a combined Continuous Positive Airway Pressure Blower and Heated Respiratory Humidifier (as per 73 BZD, 21 CFR §868.5905 and 73 BTT, 21 CFR §868.5450).
The HC200 is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction.
The addition of heated respiratory humidification to the device (normally included as an accessory to CPAP therapy) relieves the drying and irritating effects on the patient airways which may arise from use of a CPAP system.
The HC200 is for use on adult, spontaneously breathing (non ventilator-dependent) patients and is a prescription-use device.
The Fisher & Paykel Healthcare HC200 CPAP Humidifier is a Continuous Positive Airway Pressure flow generator, as per 73 BZD, 21 CFR §868.5905. It includes a Heated Respiratory Humidifier, as per 73 BTT, 21 CFR §868.5450.
The HC200 is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition of heated respiratory humidification relieves the drying and irritating effects on patient airways which may arise from use of a CPAP system. The HC200 is for use on adult, spontaneously breathing (non ventilator-dependent) patients and is a prescription-use device.
A motorized fan assembly provides positive air pressure, which can be adjusted as prescribed by a physician. The fan speed is directly related to air pressure, and is controlled by software. An air filter is located at the back of the device leading to the input of the fan assembly. Warmth and moisture are added to the air as it passes over a heated body of water in a humidification chamber, which slides into place on a heaterplate at the front of the unit. The chamber connects directly to the CPAP generator section via a port at the back of the chamber. The temperature of the heaterplate can be adjusted by the user. Temperature is controlled by software, with the level of humidification delivered dependent on heaterplate temperature, rate of air flow, and ambient conditions of temperature and humidity.
Safety features for the device consist of software monitoring of CPAP generator. humidifier and power supply parameters, electronic monitoring of the microprocessor and a thermal cut-out on the heaterplate.
Controls include a pressure set potentiometer and mains power switch, on the right side of the device, with the mains power cord. A heaterplate adjustment potentiometer, mask test mode button and display LED are located on the front control panel.
The case enclosure components are a polycarbonate thermoplastic, and the heaterplate is cast aluminum. The humidification chamber is a clear thermoplastic top with an aluminum base. Accessories for the HC200 consist of a delivery tube and replacement humidification chambers.
The provided document is a 510(k) summary for the Fisher & Paykel HC200 CPAP Humidifier and does not contain detailed acceptance criteria or a study with the specific information requested in your prompt regarding device performance metrics like AUC, sensitivity, specificity, or detailed experimental setups with sample sizes, expert involvement, and ground truth methodologies usually associated with AI/ML device evaluations.
This document describes a traditional medical device (CPAP Humidifier) clearance based on substantial equivalence to predicate devices, not an AI/ML powered device. Therefore, many of the requested fields are not applicable or cannot be extracted from this document.
However, I can extract the information related to the device's functional equivalence testing.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance:
Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be the performance characteristics of the predicate devices. The "reported device performance" indicates that the HC200 met these equivalent characteristics.
| Performance Characteristic | Acceptance Criteria (Implied from Predicate Devices) | Reported Device Performance (HC200) |
|---|---|---|
| CPAP Operating Pressure | Same range as predicate devices | Operates in the same CPAP operating pressure range |
| Heaterplate Temperature | Same range as predicate devices | Operates in the same heaterplate temperature range |
| Pressure Drop vs. Flowrate | Equivalent to predicate CPAP systems | Has equivalent pressure drop vs. flowrate characteristics to predicate CPAP systems |
| Dynamic Pressure Variation | Equivalent to predicate CPAP systems | Has equivalent dynamic pressure variation characteristics to predicate CPAP systems |
| Temperature Delivery | Same levels as the predicate humidifier | Provides the same levels of temperature over varying flowrates as the predicate humidifier, at the same heaterplate temperatures |
| Humidity Delivery | Same levels as the predicate humidifier | Provides the same levels of humidity over varying flowrates as the predicate humidifier, at the same heaterplate temperatures |
| Safety Features | Equivalent to predicate devices (software monitoring, electronic monitoring, thermal cut-out, compliance with IEC 601-1) | Has similar safety features (software monitoring, electronic monitoring, thermal cut-out) and complies with IEC 601-1 |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "Testing carried out on the HC200 demonstrates that the device has equivalent performance..." but does not provide a sample size (e.g., number of units tested, duration of testing, specific conditions).
- Data provenance: Not specified. This would typically be laboratory testing conducted by the manufacturer, Fisher & Paykel Healthcare, in New Zealand, as indicated by their address. It's a prospective test of newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing described is for a physical device's performance characteristics (pressure, temperature, humidity) against engineering specifications and predicate device performance, not for an AI/ML algorithm requiring expert interpretation of medical data.
4. Adjudication method for the test set:
Not applicable. There is no mention of expert adjudication for physical device performance testing.
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:
Not applicable. This is not an AI/ML device where human readers are involved in interpreting outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a traditional medical device, not an AI/ML algorithm.
7. The type of ground truth used:
The ground truth for this type of device performance testing would be:
- Engineering specifications/measurements: The established physical and electrical parameters for CPAP pressure, flow, temperature, and humidity.
- Predicate device performance data: The documented performance characteristics of previously cleared CPAP systems and humidifiers (Respironics Inc, Solo™ CPAP System, K961626; ResCare Ltd, Sullivan® III Nasal CPAP System, K930656; Fisher & Paykel, HC100 Respiratory Humidifier, K915460). The HC200's performance was compared directly to these.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).