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510(k) Data Aggregation
(158 days)
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
The iSlcep10 and 20 are intended for non-invasive use.
The iSleep10 and 20 shall only be used by patients with spontaneous breathing.
The CPAP function is intended to deliver continuous positive airway pressuretherapy for the treatment of obstructive sleep apnea in adults (who weigh more than 30 kg).
The iSleep10 and 20 are intended to be operated by trained users and qualified personnel.
The iSleep 10 and 20 systems are pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneous breathing patients who require longterm support by mechanical ventilation during the night.
The iSleep 10 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 10 and 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 10 and 20 housing are 6.8 x 6.8 x 8.2 inches, and the device weighs 2.8 pounds (iSleep 20 including empty humidifier 3.1 pounds).
Acceptance Criteria and Device Performance Study for Breas iSleep 10 and 20 System
This document outlines the acceptance criteria and the studies conducted to demonstrate that the Breas iSleep 10 and 20 Systems meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Non-clinical Performance | Meeting stated performance specifications | Device passed all tests. |
| Comparative Performance | Substantial equivalence in waveform, Work of Breathing, and Pressure Dynamic regulation compared to predicate device (Breas PV100, K001553). | Bench testing confirmed substantial equivalence. |
| Regulatory Compliance (General) | Compliance with November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" and July 1995 "Draft Reviewer Guidance for Ventilators" by FDA's Division of Cardiovascular, Respiratory, and Neurological Devices. | Device passed all tests for applicable requirements. |
| Electrical Safety | IEC 60601-1 | Device passed all tests. |
| Safety and Performance | ISO 17510-1 | Device passed all tests. |
| Electromagnetic Compatibility (EMC) | EMC testing | Device passed all tests. |
| Mechanical Safety | Mechanical Safety testing | Device passed all tests. |
| Environmental | Environmental testing | Device passed all tests. |
| Functional | Functional testing | Device passed all tests. |
| Particle Matter | Particle matter testing | Device passed all tests. |
| Software Validation | FDA's May 11, 2005 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices" | Device passed all tests. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not specify a "test set" in the context of human subject data. The testing mentioned is primarily bench-testing (non-clinical, comparative, and compliance testing) and software testing. Therefore, the concept of sample size and data provenance as typically applied to clinical studies with patient data does not directly apply here.
- Sample Size for Bench/Non-Clinical Testing: Not explicitly stated, but these typically involve multiple units to ensure reproducibility and robustness of results. The testing was conducted by or on behalf of the manufacturer, Breas Medical AB.
- Data Provenance: The data originates from the manufacturer's internal testing and validation processes in Sweden (Breas Medical AB, Företagsvägen 1, SE 435 33 Mölnlycke, Sweden). This is prospective testing conducted specifically for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As the primary testing was non-clinical bench testing and software validation, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologist for imaging) is not applicable.
- Experts for Bench Testing: The experts involved would be engineers, quality assurance personnel, and regulatory affairs specialists at Breas Medical AB, with expertise in medical device design, testing, and regulatory standards. Their qualifications would be relevant to these technical fields.
- Ground Truth for Non-Clinical Data: The "ground truth" for the bench tests is defined by the technical specifications of the device and the objective performance requirements of the relevant industry and regulatory standards (e.g., IEC 60601-1, ISO 17510-1, FDA guidance documents).
4. Adjudication Method for the Test Set
Given that the testing described is non-clinical and technical, an adjudication method (like 2+1 or 3+1 for clinical disagreements) is not relevant. The "adjudication" in this context would be the successful verification and validation of the device's technical specifications and adherence to standards, as determined by internal quality control processes and regulatory submissions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The submission explicitly states: "Clinical studies were not required to support a substantial equivalence determination."
Therefore, there is no effect size reported for how much human readers improve with AI vs. without AI assistance, as the device does not incorporate AI for diagnostic or interpretative assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an algorithm's performance without human interaction was not conducted. The device is a CPAP system, a hardware medical device with embedded software. Its performance is assessed as a system, not as a standalone AI algorithm that provides outputs for human interpretation. The software aspects were validated in accordance with FDA guidance for software in medical devices, but this refers to the functionality and safety of the embedded control software, not an independent interpretive algorithm.
7. Type of Ground Truth Used
The "ground truth" used for this submission is based on:
- Technical Specifications and Requirements: The manufacturer's defined performance specifications for the iSleep 10 and 20 systems.
- Industry Standards: Compliance with established international standards such as IEC 60601-1 (electrical safety) and ISO 17510-1 (safety and performance for devices used for the treatment of sleep apnea).
- Regulatory Guidance Documents: Adherence to FDA's "Reviewer Guidance for Premarket Notification Submissions," "Draft Reviewer Guidance for Ventilators," and "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
- Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Breas PV100, K001553) served as a benchmark for comparative testing to establish substantial equivalence.
8. Sample Size for the Training Set
The concept of a "training set" as it relates to machine learning or AI models is not applicable to this submission. The device is a CPAP system, a hardware device with embedded control software, not an AI/ML device that requires a training set for model development. The software was documented and tested for functionality and safety, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
Since there was no "training set" in the context of AI/ML, there is no ground truth established for such a set. The "ground truth" relevant to the device's development and validation (as described in point 7) was inherent in the engineering design specifications, international standards, and regulatory requirements.
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