(157 days)
Simon™ is a multichannel recording system designed to record and store physiological signals acquired from adult and pediatric patients during sleep. The portable design of the device facilitates its use in any clinical setting or in the home environment.
Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder. Additionally, a modem may be used to connect to the Host PC during acquisition, to interface with a Respironics CPAP or BiPAP device for titration or to download the data post acquisition. Once downloaded, the recorded data can be scored for physiological events using the associated Simon™ HOST Software.
The clinician can review, validate, edit and print scored data. The software allows the user to configure / customize all reports to best meet individual needs.
Simon™ is a multichannel recording system, which may be used for adult or pediatric patients in a variety of settings. The system is comprised of the Simon Recorder, Host Software, auxiliary CPAP / BiPAP devices (as applicable), computer equipment (CPU and monitor) and various accessories (modem, etc.). The recorder is small, lightweight and may be worn while the patient sleeps. The recorder collects physiologic signals from sensors attached to the patient. This eight-channel system records Nasal Flow or Pressure, Body Position, Snoring Sounds, Oximetry, Respiration via Chest Effort, Respiration via Abdominal Effort, Actigraphy, Pressure and Flow from auxiliary Respironics CPAP / BiPAP devices.
The Simon™ Host Software is a Windows-based application, which facilitates remote titration of CPAP / BiPAP settings via modem, as well as download of recorded data onto a personal computer. Once downloaded, the Host software scores the recorded data for physiological events per user-defined parameters.
The software allows user validation/editing of all events, and provides reporting capabilities that are fully user-configurable.
This 510(k) summary describes the Simon™ Multichannel Recording System (Model 5500), manufactured by Respironics, Inc. The device is a portable system designed to record and store physiological signals from adult and pediatric patients during sleep, for use in clinical or home settings. It collects data from eight channels, including Nasal Flow or Pressure, Body Position, Snoring Sounds, Oximetry, Respiration via Chest Effort, Respiration via Abdominal Effort, Actigraphy, and Pressure/Flow from auxiliary CPAP/BiPAP devices. The associated Host Software facilitates data download, scoring of physiological events, and allows clinicians to review, validate, edit, and print scored data.
Acceptance Criteria and Study for Simon™ Multichannel Recording System
Based on the provided 510(k) summary, the acceptance criteria and study that prove the device meets these criteria are detailed below. It's important to note that this submission did not include clinical testing. The evaluation was based on non-clinical testing to demonstrate functionality, safety, and effectiveness, and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| System Functionality | - Operational Testing (System level) | The cumulative test results demonstrated the functionality of the Simon™ Multichannel Recording System. |
| Device Performance | - Performance Testing (System level) | The cumulative test results demonstrated the effectiveness of the Simon™ Multichannel Recording System. |
| Safety | - Environmental Testing | The cumulative test results demonstrated the safety of the Simon™ Multichannel Recording System. |
| Electromagnetic Compatibility (EMC) | - EMC Testing | The cumulative test results demonstrated compliance with EMC requirements. |
| Hardware Requirements | - Hardware Test Plan (System level, module/integration level) | The Hardware Test Plan verified all defined hardware requirements. |
| Software Requirements | - Software Test Plan (System level, module/integration level) | The Software Test Plan verified all defined software requirements. |
| Substantial Equivalence | - Comparison to predicate device: Healthdyne Technologies' Alice 4 System (K971867) regarding technology (software engine, signal recording manner), intended use (recording physiological signals during sleep), settings (clinical/home), and features (data download, scoring, review, editing, printing). | The cumulative test results demonstrated the substantial equivalence of the Simon™ Multichannel Recording System to the predicate device. Simon™ utilizes the same software "engine" and records signals in a similar manner to the Alice 4 System. Differences noted (e.g., number of channels) were not deemed to alter the fundamental equivalence for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: "Bench testing utilized simulated data." No specific number of simulated cases or data points is mentioned.
- Data Provenance: The data used for testing was entirely simulated data. There is no mention of data provenance in terms of country of origin or whether it was retrospective or prospective, as it was not real patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. The testing utilized simulated data and no clinical experts were involved in establishing ground truth for a test set based on real patient data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. As no clinical testing was performed and simulated data was used, there was no adjudication method involving human interpretation of real patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No. The document explicitly states, "No Clinical testing was performed." Therefore, no MRMC study, with or without AI assistance, was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: The testing described ("Operational and Performance testing," "Hardware Test Plan," "Software Test Plan") would largely constitute standalone performance assessment of the device's components and system functionality against its defined requirements using simulated data. However, it is not presented as a formal "standalone performance study" in terms of diagnostic accuracy with real patient data compared to a clinical ground truth. The device includes software that scores physiological events, but the validation of this scoring against clinical outcomes or expert consensus on real data was not part of this 510(k) submission. The intended use states the clinician reviews, validates, and edits scored data, indicating a human-in-the-loop workflow.
7. The Type of Ground Truth Used:
- Ground Truth Type: For the non-clinical testing performed, the "ground truth" was based on defined hardware and software requirements and expected outputs from simulated data. There was no clinical ground truth (e.g., expert consensus, pathology, or outcomes data) established from real patient cases.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This document describes a medical device, not an AI/ML algorithm that undergoes a training phase using a specific training dataset in the typical sense. The "software engine" is mentioned as being the same as the predicate device, suggesting a previously developed and established system, rather than a newly trained model requiring a distinct training set for this specific submission.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As it is not an AI/ML algorithm requiring a training set with established ground truth, this information is not relevant to this submission. The software's event scoring parameters are described as "user-defined parameters," implying configurability rather than a fixed algorithm established through a training process with ground truth data.
§ 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).