(57 days)
The VIASYS Sleep Systems Mini CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg. The VIASYS Sleep Systems Mini CPAP device provides continuous positive airway pressure. The Humidifier accessory provides humidification of the air delivered to the patient.
The Mini CPAP and Humidifier Accessory provide a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The Mini CPAP device can be operated from mains supply or an optional battery. The Mini CPAP is comprised of a motorized blower assembly that provides positive air pressure. The blower speed is directly related to air pressure, and is controlled by software. The Mini CPAP and Humidifier Accessory consist of the following main components: CPAP blower, Humidifier, Power Supply, Therapy Tubing, Optional Battery and Charger. The Humidifier accessory is designed for operation only with the Mini CPAP device and utilizes a temperature controlled heated water tray and a manifold to provide humidified air to the patient. The humidification level is user adjustable. Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements. The patient interface (CPAP mask) is a commercially available accessory provided separately.
The provided document describes the safety and effectiveness of the VIASYS Sleep Systems Mini CPAP and Humidifier Accessory, primarily through demonstrating substantial equivalence to predicate devices, rather than through a traditional clinical study with pre-defined acceptance criteria based on diagnostic performance metrics.
Therefore, the requested information components (#1 through #9) related to diagnostic performance and clinical study details (e.g., sample size, ground truth, expert qualifications, MRMC studies) are not applicable in this context because:
- No clinical tests were submitted. The document explicitly states: "Clinical Tests Submitted: None".
- The evaluation focused on non-clinical performance and technological equivalence. The primary method of demonstrating safety and effectiveness was through "Laboratory, software, and standards compliance tests" and comparison to predicate devices, not through a study involving patient outcomes or diagnostic accuracy.
Here's the breakdown of what can be extracted from the provided text regarding acceptance criteria and testing:
Description of Acceptance Criteria and the Study that Proves the Device Meets Acceptance Criteria
The VIASYS Sleep Systems Mini CPAP and Humidifier Accessory demonstrated its safety and effectiveness primarily through non-clinical tests and a comparison of its technological characteristics and performance to predicate devices. The acceptance criteria were implicitly met by demonstrating compliance with applicable standards and comparable performance to established devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with applicable medical device electrical safety standards. | "The device was tested in accordance with applicable standards for medical device Electrical Safety... The Mini CPAP and Humidifier Accessory passed all of the tests." |
| Electromagnetic Compatibility | Compliance with applicable medical device electromagnetic compatibility standards. | "The device was tested in accordance with applicable standards for medical device... Electromagnetic Compatibility... The Mini CPAP and Humidifier Accessory passed all of the tests." |
| Shock and Vibration | Compliance with applicable medical device shock and vibration standards. | "The device was tested in accordance with applicable standards for medical device... Shock and Vibration... The Mini CPAP and Humidifier Accessory passed all of the tests." |
| Environmental Performance | Compliance with applicable standards for environmental temperature and humidity. | "The device was tested in accordance with applicable standards for medical device... Environmental Temperature and Humidity. The Mini CPAP and Humidifier Accessory passed all of the tests." |
| Static and Dynamic Pressure | Performance comparable to predicate devices in static and dynamic pressure characteristics. | "Static and dynamic pressure testing... was performed in comparison with the predicate devices. The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Humidifier Performance | Performance comparable to predicate devices for humidification. | "Humidifier testing was performed in comparison with the predicate devices. The device met specified requirements and was comparable to the applicable specifications of the predicate devices." |
| Software Verification/Validation | Embedded software verified to requirements and validated to meet intended use. | "Embedded software in the device was verified to requirements and validated to meet intended use by software and system level performance testing." |
| Biocompatibility | Moisture-contacting materials in the humidifier and therapy tube meet biocompatibility requirements. (This is stated in Device Description) | "Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements." (Implicitly met, no direct testing results reported in the "Non-Clinical Tests Submitted" section for this specific point, but stated as a characteristic, likely confirmed through material qualification). |
| Substantial Equivalence | Demonstrate technological similarity and comparable performance to predicate devices. | "The function of the Mini CPAP and Humidifier Accessory device is substantially equivalent to the predicate devices... all of the testing demonstrates that the VIASYS Sleep Systems LLC Mini CPAP and Humidifer Accessory is as safe and effective and performs in a manner equivalent to the predicate devices..." |
2. Sample size used for the test set and the data provenance
- Not Applicable. No human subjects or biological samples were used as part of a formal "test set" in the context of diagnostic performance. The testing involved medical device performance metrics against standards and predicate devices (e.g., pressure output, air flow, temperature control, electrical safety).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of diagnostic accuracy or clinical outcomes was not established as there were no clinical studies. The "ground truth" for performance testing was defined by industry standards and the specifications of predicate devices.
4. Adjudication method for the test set
- Not Applicable. No adjudication of clinical outcomes or diagnostic accuracy was performed. Mechanical and electrical performance was assessed against predefined benchmarks and predicate device specifications.
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. No MRMC study was conducted. This device is a CPAP machine, not an AI-powered diagnostic tool, and the submission explicitly states "Clinical Tests Submitted: None."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-only or AI-driven device. Its performance is entirely standalone in its function as a CPAP device; however, the question implies diagnostic algorithm performance without human intervention, which is not relevant here.
7. The type of ground truth used
- The "ground truth" was based on engineering specifications, recognized industry standards (e.g., electrical safety, EMC), and the established performance characteristics of legally marketed predicate devices. For example, pressure output was compared against the predicate device's expected pressure range.
8. The sample size for the training set
- Not Applicable. The device is not a machine learning or AI-driven system that requires a "training set" for model development.
9. How the ground truth for the training set was established
- Not Applicable. As there was no training set, this question is not relevant.
§ 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).