(117 days)
o two CPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients in the hospital environment and emergency medical service applications to treat patients in respiratory distress.
The o two CPAP device provides a constant positive airway pressure to the lungs of patients in respiratory distress from Pulmonary Emphysema, Congestive Heart Failure and a number of other obstructive airway conditions. This open system has no moving parts and uses a "vectored flow valve" to create a wall of resistance to expiration and an additive flow to inspiration. By varying the oxygen flow through the valve the baseline pressure can be raised or lowered to maintain a positive airway pressure. The rise in baseline pressure keeps alveoli from collapsing, forces fluid in the lungs back intro the interstitium and improves medication delivery.
The provided text describes a 510(k) premarket notification for the "o_two CPAP System". This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might find for a novel AI/software medical device.
Therefore, the requested information elements related to AI/software performance studies, such as sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and training set details, are not applicable to this 510(k) submission.
The "study" in this context is the comparison against predicate devices to establish substantial equivalence based on design, materials, indications for use, performance, and function.
Here's the information that can be extracted and a clear indication of what is not present given the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for novel performance. Instead, it demonstrates that the o_two CPAP System is comparable to its predicate devices in various characteristics. The "performance" is implied by its similarity to the predicate devices and its stated functional principles.
| Characteristic | Predicate Devices (Implied Acceptance Criteria: Similar Performance) | O_two CPAP System (Reported Device Performance) |
|---|---|---|
| Intended Use | Boussignac CPAP Device: Intended to provide CPAP to spontaneously breathing patients. | |
| CAREvent Handheld CPAP System: Provide constant positive airway pressure for spontaneous breathing respiratory support. | o_two CPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients. | |
| Environments of Use | Boussignac CPAP Device: Hospital and pre-hospital environment. | |
| CAREvent Handheld CPAP System: Hospital, pre-hospital (EMS) environments. | Hospital, pre-hospital (EMS) environments. | |
| Patient Population | Boussignac CPAP Device: Spontaneous breathing adult and pediatric patients. | |
| CAREvent Handheld CPAP System: Spontaneous breathing adult and pediatric patients. | Spontaneous breathing adult and pediatric patients. | |
| Operating Principles | Boussignac CPAP Device: Open system with no moving parts using a "virtual valve" to create resistance to expiration and additive flow to inspiration; varying oxygen flow adjusts baseline pressure to maintain positive airway pressure, keeping alveoli from collapsing, forcing fluid back into interstitium, and improving medication delivery. | |
| CAREvent Handheld CPAP System: Pneumatic, demand flow system. | An open system with no moving parts and uses a "vectored flow valve" to create a wall of resistance to expiration and an additive flow to inspiration. By varying the oxygen flow through the valve, the baseline pressure can be raised or lowered to maintain a positive airway pressure. The rise in baseline pressure keeps alveoli from collapsing, forces fluid in the lungs back into the interstitium and improves medication delivery. | |
| Input Range | Boussignac CPAP Device: 0-25 L/min variable flow source. | |
| CAREvent Handheld CPAP System: 45 to 87 PSI. | 0-25 L/min variable flow source. | |
| Patient Connection | Boussignac CPAP Device: Face Mask. | |
| CAREvent Handheld CPAP System: Tubing with external expiratory valve, manometer and mask. | Face Mask. | |
| Displays | Boussignac CPAP Device: Manometer (optional). | |
| CAREvent Handheld CPAP System: Manometer. | Manometer (optional). | |
| Safety Features | Boussignac CPAP Device: Open system design but exhaust port could be unintentionally blocked causing a dangerous rise in patient airway pressure. | |
| CAREvent Handheld CPAP System: Internal high-pressure release (at 40 cmH2O), anti-suffocation valve on patient valve port. | Open system and main body design which limits airway pressure rise above 30 cm H2O in case of unintentional exhaust port blockage. | |
| Patient Support Modes | Boussignac CPAP Device: CPAP. | |
| CAREvent Handheld CPAP System: CPAP. | CPAP. | |
| Peak Flow on Demand | Boussignac CPAP Device: Unlimited (open system). | |
| CAREvent Handheld CPAP System: 120. | Unlimited (open system). | |
| CPAP Levels (cmH2O) | Boussignac CPAP Device: 0-10. | |
| CAREvent Handheld CPAP System: 0-20. | 0-20. | |
| Materials in Gas Pathway | Boussignac CPAP Device: Polycarbonate, PVC. | |
| CAREvent Handheld CPAP System: Polycarbonate, PC, Brass, Aluminum & stainless steel. | Polycarbonate, PVC and brass. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is a substantial equivalence claim, not a clinical trial or performance study on a test set in the context of an AI/software device. The comparison is based on the technical specifications and intended use of the device against legally marketed predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. See point 2.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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 a hardware medical device (CPAP system), not an AI/software device intended to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices as determined by their prior clearance by the FDA. The o_two CPAP System is deemed substantially equivalent based on its design and performance characteristics matching or exceeding those of the predicates.
8. The sample size for the training set:
- Not applicable. This is a hardware medical device, not an AI/software device trained on data.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).