(44 days)
The HC238 CPAP Humidifier 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, which may arise from use of a CPAP system. The HC238 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.
The HC238 CPAP Humidifier is a non-invasive Continuous Positive Airway Pressure flow generator, incorporating a Heated Respiratory Humidifier. The HC238 is comprised of two functional units. One is a motorised fan assembly that provides positive air pressure. The fan speed is directly related to air pressure, and is open at a humidification chamber at the front of the device. The second functional unit of the HC238 is a heated passover humidifier. The water is contained in the humidifying chamber and is heated on a heaterplate at the front of the unit. Humidified air is delivered from the blower assembly via a port at the back of the chamber. The chamber connects directly to the breathing tube.
Here's an analysis of the provided 510(k) summary regarding the HC238 CPAP Humidifier, focusing on acceptance criteria and supporting studies:
This 510(k) submission (K050904) for the Fisher & Paykel Healthcare Ltd HC238 CPAP Humidifier does not contain information about clinical acceptance criteria or studies with human subjects that prove the device meets specific performance thresholds related to its clinical efficacy in a statistical manner. This is explicitly stated in the document: "(b)(2) Discussion of the Clinical Tests: Clinical verification studies on the HC238 CPAP Humidifier were not required in order to demonstrate the safety, effectiveness, and performance of the device."
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (HC234 CPAP Humidifier, K040941) through non-clinical testing and shared technological characteristics.
Therefore, for your specific request, I can only provide information based on the non-clinical testing described and the regulatory pathway taken.
1. A table of acceptance criteria and the reported device performance
Since no specific clinical acceptance criteria with quantitative thresholds are provided, and no clinical performance data from human studies are reported, the table below reflects the non-clinical compliance and performance goals based on applicable standards.
| Acceptance Criterion (Non-Clinical) | Reported Device Performance |
|---|---|
| Mechanical safety compliance | Complies with relevant requirements (implied by submission) |
| Electrical safety compliance | Complies with IEC 60601-1 |
| Thermal safety compliance | Complies with relevant requirements (implied by submission) |
| Environmental conditions compliance | Complies with relevant requirements (implied by submission) |
| Electromagnetic compatibility (EMC) compliance | Complies with IEC 60601-1-2 |
| Functional verification | Meets design and performance functional requirements |
| Performance (general) | Meets design and performance functional requirements |
| Performance & Safety (CPAP Devices) | Complies with ISO 17510-1 |
| Humidification Systems Performance & Safety | Complies with "key international - and - 607 requirements from particular standards for humidification systems" (specific standard numbers are partially obscured but generally referencing relevant standards for humidifiers) |
| Delivered pressure maintenance (software feedback) | Implemented to maintain delivered pressure for instances of mouth or resource feedback, ambient air density, and dynamic changes in flow. |
| Delivered pressure measurement & display | Functional measurement and display (implied as a modification to predicate) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No human test subjects were used for clinical verification studies. The "test set" for non-clinical studies would typically refer to the specific units of the device tested in a laboratory setting. The number of devices tested is not specified, but it's standard practice to test multiple units to ensure reproducibility and compliance.
- Data Provenance: Not applicable. No human data was collected. Non-clinical testing data would originate from laboratory experiments conducted by Fisher & Paykel Healthcare Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical ground truth was established through expert consensus as no clinical studies were performed. Ground truth for non-clinical testing is typically defined by engineering specifications, regulatory standards, and accepted measurement techniques.
4. Adjudication method for the test set
- Not applicable. No human expert adjudication was performed for clinical outcomes. Compliance with standards and functional requirements in non-clinical testing is determined by engineers and quality assurance professionals against pre-defined specifications and test protocols.
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 device is a CPAP humidifier, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical/electronic medical device, not an algorithm. Therefore, no standalone algorithm performance study was done.
7. The type of ground truth used
- For the non-clinical tests, the "ground truth" was based on:
- Regulatory Standards: Specific requirements outlined in standards like IEC 60601-1, IEC 60601-1-2, and ISO 17510-1.
- Engineering Specifications: Internal design and performance specifications for the device.
- Predicate Device Performance: The HC238 was compared to the predicate HC234 CPAP Humidifier (K040941) to demonstrate substantial equivalence in intended use, fundamental technological characteristics, and manufacturing process.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning product; therefore, there is no "training set" in that context. If "training set" refers to the data used to design and refine the device, it would involve extensive engineering development, component testing, and prototype evaluation. The specific "sample size" of developmental units or data is not provided.
9. How the ground truth for the training set was established
- Not applicable in the context of AI/ML. For traditional medical device development, the "ground truth" during the design and development ("training") phase is established through:
- User Needs Analysis: Understanding the requirements of patients and healthcare providers.
- Regulatory Requirements: Adhering to applicable standards and regulations from the outset.
- Benchmarking: Evaluating existing similar products (like the predicate device) to understand performance expectations.
- Engineering Principles: Applying established principles of fluid dynamics, heat transfer, electrical engineering, etc., to design components and systems.
- Iterative Testing: Repeated testing of components and prototypes against design specifications to ensure they meet intended performance and safety metrics.
§ 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).