(118 days)
The DeVilbiss IntelliPAP/SleepCube Model DV56 ST Series Bilevel is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.
The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea. Positive airway pressure is applied to the oropharynx to act as a pneumatic splint to prevent the collapse of the pharyngeal muscle, which occludes the patient airway during sleep. Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult. The DeVilbiss Bilevel ST product will replace the 9055D in the sleep product line as well as provide a new product offering where time backup rate is necessary. The product will have a reduced manufactured cost, primarily derived from reduced material costs and improved engineering design associated with the existing IntelliPAP/SleepCube product platform. The market has dictated a need for lower cost and smaller sized bilevel units as well as improved functionality such as timed backup rate and manually adjustable inhale/exhale triggering sensitivity. The triggering sensitivity overall must be increased as much as possible to be competitive with other bilevel ST devices currently available. Automatic and manual inhale/exhale trigger sensitivity is to be provided to allow the clinician to customize trigger parameters for specific operating conditions. The DeVilbiss IntelliPAP/SleepCube Bilevel ST product is not intended to meet the needs for the "ventilator" market, which necessitates features such as alarms, higher operating pressures and other ventilator specific functions
This 510(k) submission describes the DeVilbiss IntelliPAP/SleepCube Bilevel ST device, intended for treating Obstructive Sleep Apnea (OSA). The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, or specificity) or detailed reported device performance in a quantitative way for the DeVilbiss IntelliPAP/SleepCube Bilevel ST device.
Instead, the submission states that:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with appropriate ISO, ASTM, and IEC standards and other applicable requirements. | "This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols." |
| Adherence to FDA's Draft Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices. | "The DeVilbiss DV56 ST Series Bilevel CPAP was designed and tested according to guidance outlined in: 1. FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993)... As suggested by FDA's November 1993 publication... the DeVilbiss Bilevel S/ST was tested in accordance with the applicable voluntary standards. The DeVilbiss Bilevel S/ST met the required performance criteria and functioned as intended." |
| Adherence to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | "The DeVilbiss DV56 ST Series Bilevel CPAP was designed and tested according to guidance outlined in: ...2. FDA 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." (Implied compliance by testing according to guidance). |
| Substantial equivalence to predicate devices in terms of meeting performance criteria and functioning as intended. | "Analysis of comparison of design, function and features of the DeVilbiss Bilevel ST to the Resmed VPAP ST (K080131), DeVilbiss 9055 Bilevel (K032056) and DeVilbiss Intellipap (K071689), together with the results of testing demonstrates the device to be substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended." The submission also notes the device "met the required performance criteria and functioned as intended." and "does not raise any new issues of safety and effectiveness." The device's technological characteristics are similar (same intended use, operating principle, basic Bilevel modes, and materials). The market dictates a need for "increased" triggering sensitivity "to be competitive". |
| To provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea effectively. | "The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea." (Functionality is implicitly met through testing and substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set (e.g., number of patients or clinical cases). The testing described is "Non-Clinical Testing" and refers to compliance with standards and guidance documents. There is no mention of data provenance (e.g., country of origin, retrospective or prospective) as it pertains to patient data, because this was not a clinical study involving patients for direct performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided text. The device underwent non-clinical standard testing and comparison to predicate devices, not evaluation against expert-established ground truth in a clinical setting.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this submission. The submission focuses on demonstrating substantial equivalence through engineering and standards compliance, not on comparing human reader performance with or without AI assistance. The device is a medical device (CPAP machine), not an AI-powered diagnostic tool for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable in the context of this device. The DeVilbiss IntelliPAP/SleepCube Bilevel ST is a therapeutic device that delivers positive airway pressure, not an algorithm, and it always operates with a "human-in-the-loop" (the patient and prescribing clinician). The testing focused on the device's mechanical and software performance against established engineering standards and specifications.
7. Type of Ground Truth Used
The ground truth used for this submission's non-clinical testing was based on engineering specifications, regulatory guidance, and performance criteria outlined in applicable ISO, ASTM, and IEC standards. The device's functionality was evaluated against these predefined technical benchmarks and its ability to act as a therapeutic device for OSA, consistent with the intended use. It was also compared to the performance and characteristics of predicate devices. There is no mention of pathology, expert consensus (in a clinical interpretation sense), or patient outcomes data from a study for establishing ground truth.
8. Sample Size for the Training Set
This information is not applicable. The Device is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there was no training set for an AI/ML algorithm.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).