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510(k) Data Aggregation
(86 days)
BREATHEX OMEGA CPAP DEVICE, MODEL 322
The BreatheX Omega continuous positive airway pressure (CPAP) device is intended for use in the treatment of obstructive sleep apnea (OSA).
The BreatheX Omega CPAP is used while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) at a specified pressure level in order to prevent airway obstruction.
The BreatheX Omega CPAP is for use on adult patients weighing at least 30 kg, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic.
The BreatheX Omega is not intended for life support.
The BreatheX Omega CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg.
The BreatheX Omega CPAP device provides continuous positive airway pressure.
Caution: Federal law restricts this device to sale by or on the order of a physician.
The BreatheX provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The device is battery operated.
The BreatheX Omega 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 BreatheX Omega CPAP device consists of the following main components:
- CPAP blower .
- Battery/Battery charger .
- Therapy Tubing .
The patient interface (CPAP mask) is a commercially available accessory provided separately. The patient interface is not covered in this submission.
The provided document is a 510(k) summary for the BreatheX™ Omega™ CPAP Device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical performance study using human subjects or AI algorithms. Instead, it describes non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical tests rather than specific clinical acceptance criteria or performance metrics directly comparable to a predicate device in a tabulated format. The acceptance criteria were implicit in "meeting specified requirements" and being "comparable to the applicable specifications of the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with medical electrical safety standards | Device passed all applicable standards for medical electrical safety. |
| Compliance with electromagnetic compatibility standards | Device passed all applicable standards for electromagnetic compatibility. |
| Compliance with shock and vibration standards | Device passed all applicable standards for shock and vibration. |
| Compliance with environmental temperature and humidity standards | Device passed all applicable standards for environmental temperature and humidity. |
| Static and dynamic pressure performance | Device met specified requirements and was comparable to the applicable specifications of the predicate device (Fisher & Paykel HC200). |
| Software verification to requirements | Embedded software was verified to requirements. |
| Software validation to meet intended use | Embedded software was validated to meet intended use by software and system level performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable to this 510(k) submission. The non-clinical tests described were laboratory-based, focusing on engineering and software validation. There is no mention of a "test set" of patient data in the context of an AI/medical device study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for the non-clinical tests would be the accepted engineering standards and the specifications of the predicate device. Expert human review of data for diagnostic accuracy, as would be relevant for AI, is not mentioned.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states "Clinical Tests Submitted: None."
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The device described is a physical CPAP device, not an AI algorithm. The software mentioned is embedded control software for the device's function, not a diagnostic or interpretive algorithm.
7. Type of Ground Truth Used
The ground truth used for the non-clinical tests was based on:
- Applicable engineering and medical device standards (e.g., for safety, EMC).
- The specifications and performance of the predicate device (Fisher & Paykel HC200) for static and dynamic pressure testing.
- Software requirements and intended use for software validation.
8. Sample Size for the Training Set
Not applicable. The document describes a physical CPAP device and its embedded control software, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there was no AI model or training set, there was no establishment of ground truth for a training set.
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