(248 days)
The Luna® G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/ institutional environment on adult patients. It is to be used on patients > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.
The Luna® G3 BPAP system is a microprocessor controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. Its hardware design is identical to the previously cleared Luna® G3 BPAP 25A (K201620). The subject device includes two models, with different pressure ranges. They both have four therapy modes, which are CPAP, Spontaneous (S), Timed (T) and Spontaneous/Timed (S/T).
This 510(k) summary (K212263) describes a device modification to an existing Bi-level PAP system (Luna G3 BPAP System). The core of the submission revolves around demonstrating substantive equivalence to a predicate device (Luna G3 BPAP 25A, K201620) and referencing a device (Juno VPAP ST-A, K153061) for new functionalities.
It is crucial to understand that this document describes a device intended for treatment of Obstructive Sleep Apnea (OSA), providing positive airway pressure. It is not an AI/ML powered diagnostic device that would typically involve a multi-reader multi-case (MRMC) study or complex ground truth establishment from expert consensus or pathology, as might be seen for an imaging AI.
Therefore, many of the typical "acceptance criteria" and "study types" for AI/ML-powered devices, such as those related to standalone performance (e.g., sensitivity, specificity, AUC), MRMC studies, and expert ground truth establishment for a diagnostic output, are not applicable to this type of medical device submission.
Instead, the acceptance criteria and supporting studies are focused on engineering and performance characteristics of the medical device itself, ensuring it functions safely and effectively as intended and is equivalent to previously cleared devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a single aggregated table of "acceptance criteria" versus "reported performance" for a diagnostic output as would be seen for AI/ML diagnostic tools. Instead, it details specific performance tests and standards met, comparing the subject device's characteristics to its predicate and reference devices. The "acceptance criteria" are implied by adherence to recognized standards and demonstrated equivalence to the cleared predicate.
Here's an interpretation of relevant performance characteristics that serve as de facto acceptance criteria and their reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Adherence to ISO 10993 and ISO 18562 standards for breathing gas pathways. | Leveraged testing from predicate (K201620) for no material/manufacturing/hardware changes. Additional accelerated aging tests performed for particulate matter and VOC emissions (ISO 18562-2, -3). |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | EMC Testing conducted and in accordance with IEC 60601-1-2:2014. |
| Device Performance (Therapy Modes): Functionality of CPAP, S, T, and S/T modes. | CPAP and S modes identical to predicate. T and S/T modes identical to reference device. Functional performance testing conducted. |
| Device Performance (Static/Dynamic Pressure): (Implicit measurement accuracy and stability) | Testing conducted for Static pressure and Dynamic pressure. (Specific numerical results not provided in summary, but indicated as passed). |
| Device Performance (Maximum Flow Rate): (Implicit measurement accuracy) | Testing conducted for Maximum flow rate. (Specific numerical results not provided in summary, but indicated as passed). |
| Device Performance (Rise Time): (Implicit measurement accuracy) | Testing conducted for Rise time. (Specific numerical results not provided in summary, but indicated as passed). |
| Pressure Display Accuracy: Within specified limits. | Subject Device: ±(0.8cmH2O+4%). (Identical to predicate). |
| Pressure Range: Correct implementation for models. | LG3800-25VT: CPAP 4-20 cmH2O; S, T, S/T 4-25 cmH2O. |
| LG3800-30VT: CPAP 4-20 cmH2O; S, T, S/T 4-30 cmH2O. | |
| Sound Pressure Level: Below specified maximum. |
§ 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).