(295 days)
The 3B Luna CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital / institutional environment on adult patients.
The Luna CPAP and Auto CPAP System is a microprocessor-controlled, blower-based system that generates positive airway pressure from 4 to 20 cm H20. The device is intended for use with a patient interface (mask). The device has been modified to include a color LCD, menu driven user interface, and a redesigned enclosure. The electrical circuit was redesigned to incorporate the color LCD. The basic functionality and performance characteristics of the Luna CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K132967).
This document is a 510(k) premarket notification for the 3B™ Luna CPAP and Auto-CPAP System, which includes an integrated heated humidifier. It compares the proposed device to a predicate device, the RESmart® CPAP and Auto-CPAP Systems (K132967). The main purpose of the notification is to demonstrate substantial equivalence to the predicate device, not necessarily to independently prove the device meets specific performance criteria beyond those of the predicate.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of a new technology proving its efficacy against established benchmarks. Instead, it aims to demonstrate that the proposed device is substantially equivalent to a predicate device. Therefore, the "acceptance criteria" can be inferred as matching or performing similarly to the predicate device based on various technical specifications and non-clinical testing.
| Feature/Function/Test | Predicate Device (K132967) Performance | Proposed Device (K141770) Performance | Acceptance Criteria (Inferred from Substantial Equivalence) | Outcome |
|---|---|---|---|---|
| Therapy Delivered | CPAP, Auto CPAP | CPAP, Auto CPAP | Same | Meets |
| Operation Temperature | 5 to 30° C (41 to 86°F) | 5 to 35° C (41 to 95°F) | Comparable (Proposed has wider range) | Meets |
| Storage/Transport Temperature | -20 to 55° C | -25 to 70° C | Comparable (Proposed has wider range) | Meets |
| Humidity | ≤ 80% Non-condensing | 15% to 93% Non-condensing | Comparable (Proposed has wider range) | Meets |
| Atmospheric Pressure | 86 to 106 kPa | 76 to 106 kPa | Comparable (Proposed has wider range) | Meets |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, ISO 8185 | IEC 60601-1, IEC60601-1-11, IEC 60601-1-2 | Complies with relevant safety and performance standards | Meets |
| Mode of Operation | Continuous | Continuous | Same | Meets |
| AC Power Consumption | 100-240VAC, 50/60Hz, 1.0A max | 100-240VAC, 50/60Hz, 2.0A max | Comparable (Proposed has higher current draw) | Meets |
| Software | Microprocessor controlled | Microprocessor controlled | Same | Meets |
| System Contents | Air blower, pressure-flow monitoring, pressure controlling, user interface, heated humidifier, power cord, carrying case, user manual. | Air blower, pressure-flow monitoring, pressure controlling, user interface, heated humidifier, power cord, carrying case, user manual. | Same | Meets |
| Type of Protection Against Electric Shock | Class II Equipment | Class II Equipment | Same | Meets |
| Degree of Protection Against Electric Shock | Type BF Vertical Applied Part | Type BF Vertical Applied Part | Same | Meets |
| Degree of Protection Against Ingress of Water | IPX1-Drip-Proof, Vertical | IP22 | Comparable (Both provide protection, with IP22 generally indicating protection against solid objects >12.5mm and direct sprays of water up to 15 degrees from the vertical, while IPX1 protects against vertically falling drops of water). | Meets |
| Pressure Range | 4-20 cmH2O (in 0.5 cmH2O increments) | 4-20 cmH2O (in 0.5 cmH2O increments) | Same | Meets |
| Sound Pressure Level | 350 ml | 350 ml at recommended water level | Similar | Meets |
| Heater Settings (Humidifier) | 1 to 5 (104 to 149 °F) | 1 to 5 (95 to 167 °F) | Comparable (Proposed has wider range) | Meets |
| Pressure Drop with Humidifier | 10mg/L | Comparable (Proposed specified as >10mg/L, implies it's within or exceeds the lower bound of predicate) | Assumed Met | |
| Static and dynamic pressure accuracies | 4 to 20 cmH2O (± 1 cmH2O) | 4 to 20 cmH2O (± 1 cmH2O) | Same | Meets |
| Biocompatibility | Tested and passed in K132967 | No new testing, relies on predicate | Materials are identical, so previous testing is sufficient | Meets |
| Particulate matter and volatiles | Demonstrated compliance in K132967 | No new testing, relies on predicate | Assumed to be identical to predicate | Meets |
Device Performance Evidence Summary: The study essentially asserts that the proposed device performs equivalently to the predicate device. The performance data presented is a side-by-side comparison of specifications for both devices, highlighting that the proposed device shares the same intended use, operating principle, technology, materials, and manufacturing process as the predicate, or has comparable or slightly improved characteristics.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a premarket notification (510(k)) that relies heavily on bench testing and comparison to a predicate device, not clinical trials with human subjects.
- Test Set: No independent human subject test set is described. The "test set" consists of bench performance tests comparing the proposed device to the predicate.
- Sample Size: Not applicable in the context of human data. The sample size for non-clinical testing (e.g., number of devices tested for pressure accuracy) is not specified, but it's implied that sufficient units were tested to demonstrate performance.
- Data Provenance: The document does not provide information about the country of origin for any human data (as there isn't any mentioned). The testing itself is non-clinical, likely conducted by the manufacturer (BMC Medical CO., LTD, CHINA). The study is retrospective in the sense that it refers to the performance and testing of the predicate device (K132967) for many aspects, and current bench testing for the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission.
- Ground Truth: The "ground truth" for this submission is established through engineering and performance specifications and compliance with international standards (e.g., ISO, IEC), rather than expert consensus on medical outcomes or pathology.
- Experts: The document does not describe the involvement of medical experts to establish a "ground truth" for a test set. Engineering and regulatory specialists would be involved in designing and evaluating the bench tests.
4. Adjudication Method for the Test Set
This is not applicable. There is no "test set" in the sense of a set of cases requiring adjudication by multiple experts. The evaluation is based on objective measurements from bench testing against predefined engineering 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
No, an MRMC comparative effectiveness study was not done. This device is a CPAP/Auto-CPAP system for delivering positive pressure, not an AI-assisted diagnostic or interpretative tool that would involve human "readers" or AI assistance in a clinical setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm that functions in a standalone diagnostic capacity. It is a medical device for therapeutic delivery of positive pressure.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this submission is based on:
- Engineering Specifications and Performance Standards: Defined by international standards (ISO 17510-1:2007, IEC 60601 series) and the specifications of the predicate device.
- Performance Bench Testing: Objective measurements conducted in a laboratory setting to verify that the device meets its design specifications (e.g., pressure accuracy, sound level, humidification, electrical safety).
- Biocompatibility Testing: Conducted in the predicate device against ISO 10993 standards, and carried over due to identical materials.
8. The Sample Size for the Training Set
This is not applicable. The device is not based on machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
§ 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).