Search Results

The 3B and BMC RESmart 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 device. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The BMC RESmart™ CPAP System (Private labeled in the USA as the "3B CPAP System") and the BMC RESmart" Auto CPAP System (Private labeled in the USA as the "3B Auto CPAP System") are microprocessor controlled, blower-based systems that generate positive airway pressures from 4-20 cm H2O. The devices are intended for use with a patient circuit that is used to connect the device to the patient interface, i.e., the mask.

The CPAP and Auto CPAP devices consist of a blower, pressure/flow monitoring, pressure controlling, user interface and optional heated humidifier. The air blower consists of a DC brushless motor, turbofan, and shell, Fresh air is sucked in via an inlet due to the vacuum created by the air blower. The inlet foam filters dust and other floating particles. The filtered air is compressed to a certain pressure and blown out via an outlet. The outlet pressure is determined by the motor rate speed, which is controlled by the pressure control system.

The device has a real time pressure/flow monitoring system. Sensors monitor the outlet air pressure/flow, providing feedback, which is used to control the rate of speed of DC brushless motor, which regulates outlet air pressure in real time. The leakage of the mask and tubing will lead to a decrease of the outlet air pressure. This can be detected by the monitoring system and feedback allows the pressure controlling system to modify the rate speed of motor. In this way, the lost pressure caused by leakage will be compensated. When system is in standby, the pressure/flow change caused by respiratory via mask will also be detected by monitoring system and the automatically turning on of the function will be achieved. Pressure/flow changes caused by removal of the mask and/or tubing will also be detected, triggering the device alert and stopping the pressure output of the device.

Device control, setting and system status are displayed and achieved by user interface including buttons and LCD. The backlit LCD can display the system status and parameters. The buttons consist of start/stop, humidifier, ramp and +/- user buttons. User and medical equipment vendor service personnel can control and set the device via these buttons.

The two models bundled into this 510(k) submission (RESmart© CPAP and Auto CPAP) are mechanically identical. The difference in functionality is determined by the software. In the standard CPAP model, the automated pressure regulation module of the software is disabled. The CPAP System provides only one level of pressure. In contrast the Auto CPAP provides varying levels of pressure that automatically adjusts, based on the patient's needs. The pressure required to overcome obstruction may vary, based upon body position, sleep stage, weight, neck size, congestion, or other factors. The Auto CPAP System will adjust the pressures throughout the night as the patient's pressure requirements change. The Auto CPAP System will maintain an optimal pressure, which, in most cases, will be lower that the pressure provided by the CPAP System.

No mask is included with the device, and the mask must be purchased separately. The integrated humidifier is optional. It also is packaged and sold separately. This humidifier moistens the air delivered by the CPAP and Auto CPAP Systems. It is used only on a single patient and must not be re-used on another person in order to avoid the risk of cross-infection.

The heated humidifier is used to increase the outlet air temperature and humidity. The humidifier is an optional component packaged and sold separately, but when added, is integrated by simple snap in place mechanism to the CPAP device. The humidifier consists of a heated platform and water chamber. The water is heated, which raises the temperature and humidity of the air in contact. The humidifier is controlled via infrared port and powered by the main device. The temperature sensors ensure the desired temperature and safety.

The RESmart CPAP and Auto CPAP devices are mechanically identical. The two devices operate on the same principles; utilize the exact same components and circuit, design, and manufacturing approach. The only difference consists of the software algorithm driving the fan controller board. A summary of the software algorithm is attached to the Appendix. The output treatment pressure of the CPAP device is set by the physician and fixed. By contrast, the pressure delivered in an Auto CPAP device is adjusted automatically in real time by the Auto CPAP system by tracking patient's respiration and airflow.

The RESmart CPAP and Auto CPAP, and integrated humidifier, complies with IEC 60601-1 and EN ISO 17510-1

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

Clinical Testing (5.8 SUMMARY OF CLINICAL TESTING)

1. Sample size used for the test set and the data provenance:

   • Sample Size: 30 patients.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that the device's performance is being compared to an existing predicate. It's unclear if the data collected for the 30 patients was prospective for this study or if existing patient data was re-evaluated. "Clinical testing was conducted on 30 patients" suggests prospective data collection for this study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: "an expert" (singular)
   • Qualifications: "masked to the performance of the device" is mentioned, implying objectivity, but no specific medical qualifications (e.g., "radiologist with 10 years of experience") are provided.

3. Adjudication method for the test set:

   • "manual scoring by an expert masked to the performance of the device" - This indicates a single expert was responsible for scoring, effectively making the adjudication method "None" in the sense of consensus or multiple reader review.

4. 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. The study was focused on the device's substantial equivalence to a predicate device, not on how human readers' performance might improve with the device's assistance.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the clinical testing seems to evaluate the device (algorithm and hardware) in a standalone capacity by comparing its output (respiratory event detection, sensitivity, therapy delivery pressure) against a predicate device and manual scoring by an expert. It's evaluating the device's inherent performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • "manual scoring by an expert" - This indicates expert scoring/evaluation, which serves as the ground truth.

7. The sample size for the training set:

   • The document does not provide any information about a training set or its sample size. This submission focuses on the performance and equivalence of the already developed device.

8. How the ground truth for the training set was established:

   • Since no information about a training set is provided, how its ground truth was established is also not available in this document.

Ask a specific question about this device