(228 days)
The Luna® G3 BPAP 25A is a 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. If is to be used on patients >66lbs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.
The Luna® G3 BPAP 25A is a microprocessor controlled, blower-based system that generates bi-level positive airway pressure (IPAP/EPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 25 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway.
This document, primarily a 510(k) Pre-market Notification to the FDA, describes a medical device called the Luna® G3 BPAP 25A, a Bi-level Positive Airway Pressure (BPAP) device for treating Obstructive Sleep Apnea (OSA). The document outlines its intended use, technological characteristics, and compares it to predicate devices to prove substantial equivalence.
Acceptance Criteria and Device Performance:
The acceptance criteria for the Luna® G3 BPAP 25A are not explicitly stated as quantitative performance metrics (e.g., accuracy, sensitivity, specificity) but are derived from comparing its technological characteristics and performance against legally marketed predicate and reference devices, as well as adherence to recognized regulatory standards. The "reported device performance" refers to the demonstrated compliance with these standards and the equivalence of its characteristics to established devices.
Here's a table summarizing the implicit acceptance criteria (based on predicate device characteristics and regulatory standards) and the reported performance of the subject device:
| Acceptance Criteria (Derived / Implicit) | Reported Device Performance (Luna® G3 BPAP 25A) |
|---|---|
| Clinical Performance: | |
| Treatment of adult Obstructive Sleep Apnea (OSA) | Indicated for the treatment of adult OSA. |
| Ability to deliver Bi-level therapy or Auto Bi-level therapy | Delivers S, Auto S, CPAP, AutoCPAP therapies. |
| Pressure Range (CPAP/AutoCPAP: 4-20 cmH2O; Auto S/S: 4-25 cmH2O) | Meets this range (CPAP/AutoCPAP: 4.0–20.0 cmH2O; Auto S/S: 4.0-25.0 cmH2O). |
| Pressure Regulation (± 0.5 cmH2O) | Meets this (± 0.5 cmH2O). |
| Expiratory Pressure Relief (e.g., Reslex® function Level 1-3) | Has Reslex® function Level 1-3. |
| Humidity Output (e.g., ≥10 mg/L as per ISO8185 or ≥15 mg/L as per ISO80601-2-74) | ≥15 mg/L, as required by ISO80601-2-74 (more rigorous than predicate's ≥10 mg/L). |
| Humidifier Settings (range of temperatures) | 1-5 (95 to 154.4°F/35 to 68°C), similar to predicate (104 to 149°F/40 to 65°C). |
| Safety and Performance Standards: | |
| Biocompatibility (ISO 10993 series, ISO 18562 series) | Complies with ISO 10993-1, -5, -10; ISO 18562-1, -2, -3, -4. Test results confirm biocompatibility. |
| Electrical Safety (AAMI ANSI ES 60601-1, IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-74) | Complies with AAMI ANSI ES 60601-1:2005/(R)2012, IEC 60601-1-11:2015, ISO 80601-2-70:2015, ISO 80601-2-74:2017. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Complies with IEC 60601-1-2:2014. Wireless coexistence of cellular module tested. |
| Usability (IEC 60601-1-6) | Complies with IEC 60601-1-6:2013. |
| Software Verification and Validation (FDA Guidance) | Software V&V conducted; documentation provided per FDA guidance. |
| Cybersecurity (FDA Guidance) | Cybersecurity of cellular module software tested and assessed. |
| Mechanical Robustness (Shock, Vibration, Drop, Damp Heat, Dielectric, Leakage tests) | Mechanical tests performed; results indicate no new safety/effectiveness questions. |
| Sound Pressure Level ( |
§ 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).