(29 days)
The Respironics BiPAP Pro 2 Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only. For use in the home or hospital/institutional environment on adult patients.
The Respironics BiPAP Pro 2 Bi-level System is a microprocessor controlled blower based bi-level positive pressure system that delivers two different positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. The BiPAP Pro 2 Bi-level System also includes the flex therapy feature cleared in K032834 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. This clearance is seeking to extend the Bi-Flex range from 20 to 25 cmH2O maximum, to provide remote control of the device in a clinical setting and to allow viewing of compliance data by a physician/clinician. Like its predicates, the BiPAP Pro 2 Bi-level System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.
This document is a 510(k) premarket notification for a modified medical device, the Respironics BiPAP Pro 2 Bi-level System with Bi-Flex. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or comprehensive performance studies.
Therefore, much of the requested information regarding detailed acceptance criteria, study sizes, expert qualifications, and the specifics of a comparative effectiveness study is not provided in this regulatory submission.
Here's the information that can be extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Design verification tests were performed on the Respironics BiPAP Pro 2 Bi-level System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
However, no specific acceptance criteria or the reported device performance for those criteria are detailed in the provided text. The submission focuses on the argument of substantial equivalence based on sameness with predicate devices and compliance with general standards.
2. Sample Size for the Test Set and Data Provenance
Not applicable/Not provided. The submission refers to "design verification tests" but does not describe the methodology, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for these tests. The focus is on verifying engineering requirements rather than a clinical trial-like test set.
3. Number of Experts and Qualifications for Ground Truth of the Test Set
Not applicable/Not provided. Clinical trials with expert-established ground truth for a test set are not described in this regulatory submission.
4. Adjudication Method for the Test Set
Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described. The submission is a 510(k) for a modified device, focusing on substantial equivalence, not a comparative effectiveness study showing improvement with AI assistance. The device also does not appear to incorporate AI.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No. This device is a hardware-based positive airway pressure system; it does not have a standalone "algorithm-only" performance that would typically be evaluated in such a study for software-as-a-medical-device (SaMD). The "design verification tests" would assess the integrated system's performance.
7. The Type of Ground Truth Used
The "ground truth" in the context of this submission refers to the engineering and performance specifications that the device was designed to meet, as verified by "design verification tests." The document states: "All tests were verified to meet the required acceptance criteria."
- For the "Intended Use" and "Features": The ground truth is established by the functional requirements of the device (e.g., delivering positive airway pressure, bi-level pressure, Bi-Flex feature up to 25 cmH2O, remote control, viewing compliance data). Compliance with these features is assessed through engineering tests.
- For "Safety and Effectiveness": The ground truth is compliance with applicable standards (e.g., 21 CFR 868.5905, Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 1998) and demonstration of substantial equivalence to predicate devices, implying similar safety and effectiveness profiles.
8. Sample Size for the Training Set
Not applicable/Not provided. This device is not described as using machine learning or AI that would require a "training set" in the conventional sense. The "design verification tests" are for validating the product's engineering and performance against requirements.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided, as there is no mention of a training set for an AI/ML algorithm. The "ground truth" for the device's design and testing would be based on engineering specifications and regulatory standards.
§ 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).