(67 days)
The Breas iSleep 20+ System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).
The iSleep20+ is intended for non-invasive use.
The iSleep20+ shall only be used by patients with spontancous breathing.
The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea in adults (who weigh more than 30 kg).
The iSleep 20+ is intended to be operated by trained users and qualified personnel.
The iSleep 20+ system is pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneous breathing patients who require long-term support by mechanical ventilation during the night.
In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application.
The iSleep 20+ system can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician.
It is not intended for life support applications or for transport of critical care patients.
The therapy delivered by the Breas iSleep 20+ System is Constant Positive Airway Pressure (CPAP)
The iSleep 20+ airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended.
The iSleep 20+ systems have an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available.
The outer dimensions of the iSleep 20+ housing is 6.8 x 6.8 x 8.2 inches, and the device weighs 3.1 pounds including empty humidifier.
The provided text describes a 510(k) Premarket Notification for the Breas iSleep 20+ System, a CPAP device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, much of the information typically found in acceptance criteria and detailed study designs for new medical device performance validation is not present or not applicable in this context.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission are generally derived from recognized standards and the performance of the predicate device. The text does not explicitly list quantitative acceptance criteria in a table format with corresponding reported values. Instead, it states that the device passed various tests designed to demonstrate safety, performance, and substantial equivalence to the predicate device.
Table 1: Implied Acceptance Criteria and Reported Device Performance
| Acceptance Criterion Category | Source of Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance Specifications | Stated performance specifications of the Breas iSleep 20+ System | "The Breas 20+ System is capable of meeting its stated performance specifications" (Passed) |
| Risk Analysis Issues | Addressed risk analysis issues | "Jul Risk Analysis issues have been appropriately addressed" (Passed) |
| Wave-form performance | Performance of predicate device (Breas PV10i) | "substantial equivalent with regards to Wave-form performance" (Passed) |
| Work of Breathing | Performance of predicate device (Breas PV10i) | "substantial equivalent with regards to... Work of Breathing" (Passed) |
| Pressure Dynamic regulation | Performance of predicate device (Breas PV10i) | "substantial equivalent with regards to... Pressure Dynamic regulation" (Passed) |
| Electrical Safety | IEC 60601-1 standard | "Passed all applicable tests." (Compliant) |
| Safety and Performance | ISO 17510-1 standard | "Passed all applicable tests." (Compliant) |
| Electromagnetic Compatibility (EMC) | EMC testing standards | "Passed all applicable tests." (Compliant) |
| Mechanical Safety | Relevant mechanical safety standards | "Passed all applicable tests." (Compliant) |
| Environmental Performance | Relevant environmental testing standards | "Passed all applicable tests." (Compliant) |
| Functional Performance | Functional requirements of the device | "Passed all applicable tests." (Compliant) |
| Particle Matter | Relevant particle matter testing standards | "The device passed all tests." (Compliant) |
| Software Documentation & Testing | FDA's May 11, 2005 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices" | "The device passed all tests." (Compliant) |
Here's a breakdown of the other requested information based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The submission refers to "non-clinical testing" and "bench-testing" rather than human subject testing with a "test set" in the context of AI/diagnostic device validation. The "test set" here refers to the device itself and its components undergoing engineering and performance evaluations.
- Data Provenance: Not applicable. The testing described is laboratory/bench testing of the device and its components. No human data (e.g., patient records, images) is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The ground truth for device performance in this 510(k) context is established by engineering standards, specifications, and comparison to the predicate device's measured performance on a test bench, not by expert human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for clinical studies where human interpretation or outcomes need to be adjudicated. The testing here is against objective engineering and performance standards.
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. A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical studies were not required to support a substantial equivalence determination." The device is a CPAP system, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a CPAP system, not an algorithm, and its performance is assessed as a standalone electromechanical device against specified engineering and safety standards, and in comparison to a predicate device's physical output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance is established by engineering specifications, recognized international standards (e.g., IEC 60601-1, ISO 17510-1), and the measured performance of the legally marketed predicate device (Breas PV10i). This is a technical, objective ground truth based on physical measurements and compliance, not clinical or interpretative "ground truth" as might be used for diagnostic algorithms.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The "training" here would refer to the device's design and manufacturing processes meeting the required specifications.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set in the context of an AI/machine learning 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).