(211 days)
Intended Use:
The Stardust is a respiratory disorder diagnostic device that is intended to measure and record five parameters. These parameters are percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort, and body position (i.e., supine or non-supine). It can also be connected to a Respironics Virtuoso Smart CPAP System to record and display continuous positive airway pressure (CPAP) and ainway index level.
The Stardust can be used as a stand-alone unit for recording data. It also interfaces with a commercially available IEC 950 compliant computer, which enables you to view data real-lime in a recording mode. The Stardust does not have any audible alarms and, therefore, should not be used for continuous monitoring of oxygen saturation or as a replacement for pulse oximeter monitors.
Indications for Use: The Stardust is indicated for use in the diagnosis of respiratory disorders, such as sleep apnea.
A low-power, diagnostic, recording device that interfaces with predefined sensors, and processes and records physiologic patient data.
The Stardust is a respiratory disorder diagnostic device that is intended to be used to measure and record five parameters. These parameters are:
- D percent SpO, (functional)
- 0 pulse rate
- oral/nasal airflow
- 0 respiratory effort
- body position (i.e., supine or non-supine) o
It can also be connected to a Respironics Virtuoso Smart CPAP System to record and display continuous positive airway pressure (CPAP) and airway index level. The Stardust can be used as a stand alone unit for recording data. It also interfaces with a commercially available IEC 950 compliant computer and can be used to view data real-time in a recording mode. The Stardust does not have any audible alarms and, therefore, should not be used for continuous monitoring.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. Instead, it describes the Stardust device, its intended use, software capabilities, and general safety and effectiveness testing to demonstrate substantial equivalence to predicate devices (HMS 4000 and HMS 5000).
The document mentions:
- "Testing was performed to demonstrate that the performance of the Stardust in its intended environment is as safe and effective as that of the legally marketed predicate devices."
- "The safety and effectiveness of Stardust were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing."
- "The Stardust was tested and found compliant with the standards referenced in the 'Draft FDA Reviewer Guidance for Premarket Notifications,' November 1993."
However, it does not provide:
- A table of specific numerical acceptance criteria (e.g., accuracy thresholds, sensitivity, specificity values).
- Reported device performance against such criteria.
- Details about a clinical study involving a test set, ground truth establishment, sample sizes, expert qualifications, or adjudication methods for diagnostic accuracy.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study.
- Sample sizes or methods for establishing ground truth for training data.
The software section describes "manual scoring" and "automatic scoring" rules for identifying apneas and hypopneas based on parameters like minimum event duration and peak inspiratory value percentages. While these are rules for the algorithm's operation, they are not presented as acceptance criteria for the device's diagnostic performance against a clinical ground truth.
Therefore, requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in the provided text.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).