(113 days)
The indications for use of the BeneVision Central Monitoring System include:
- · Real time viewing of patient clinical data and alarms
- · Storage and Historical review of patient clinical data and alarms
- · Printing of real time and historical patient data
- · Configuration of local settings as well as synchronizing settings across the network to a remote device
- · Transfer of patient clinical data and settings between several CentralStations
The Bene Vision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthes to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The Bene Vision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.
The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, and TM80.
· The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.
· The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.
· The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
· The TM80 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80.
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.
The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.
The BeneVision Central Monitoring System consists of the following components:
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- CentralStation
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- ViewStation
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- WorkStation
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- CMSViewer
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- Telemetry Systems (TMS 6016. Telepak-608. TMS60. TM80)
Here's an analysis of the acceptance criteria and study information provided, structured as requested.
Acceptance Criteria and Device Performance
The provided document describes modifications to an existing device (BeneVision Central Monitoring System) and aims to demonstrate substantial equivalence to a predicate device (K162607). The document presents a comparison of technological characteristics as the primary proof of meeting acceptance criteria, rather than explicit quantitative acceptance metrics for performance. The "Performance Data" section details types of testing conducted to ensure the device performs as designed and meets relevant standards.
Table of Acceptance Criteria and Reported Device Performance
Since explicit quantitative acceptance criteria with specific threshold values for "device performance" in terms of accuracy, sensitivity, specificity, etc., are not directly stated in the tables for the subject device (as would be common for diagnostic AI), the "Acceptance Criteria" column will reflect the stated functionalities or characteristics of the subject device, and "Reported Device Performance" will indicate if the device meets these in comparison to the predicate. The overall "acceptance criterion" is essentially demonstrating that the changes do not raise new questions of safety and effectiveness and that the device continues to meet relevant standards.
| Acceptance Criteria (based on stated features and standards conformance) | Reported Device Performance (as described for Subject Device) |
|---|---|
| CentralStation, WorkStation, ViewStation, CMS Viewer | |
| Support for Microsoft Windows 10 and Windows Server 2016 | Added support for Microsoft Windows 10 and Windows Server 2016 for CentralStation, WorkStation, ViewStation. |
| Support for new host computers (HP EliteDesk 800 G3 SFF, HP ProDesk 600 G3 DM, HPE Proliant DL360 Gen9) | Added support for these new host computers. |
| Bi-directional configuration for TM80 (patient demographics, alarm settings, parameter settings) | Bi-directional configuration supported for TM80; specific settings detailed. |
| Ability to remotely view 32 patients' parameters, waveforms, and alarms | Provides the ability to remotely view 32 patients' parameters, waveforms, and alarms from a patient monitor connected to another BeneVision Central Monitoring System. |
| Support for ECG Beat Annotation | Provides the ability to annotate ECG waveform in Events and Full Disclosure review dialogs. Feature cleared in K170876 was leveraged. |
| Configurable CMS offline technology alarm priority (High, Med, Low) | CMS supports configuration of the offline technology alarm priority with options High, Med and Low. Default is Low. |
| Graphical display of ST Value in CMS ViewBed window | CMS ViewBed window supports an independent window for the graphical display of the ST value. |
| Enhanced cybersecurity features (TLS 1.2, MLDAP) | MD2 protocol encryption with TLS 1.2 and MLDAP access authorization control added. |
| Sending configurations to multiple TM80 devices via CMS | CMS supports sending configurations (alarm settings, parameter setup) from one connected TM80 to another. |
| Ability to turn off specific system alarm notifications based on priority | CMS can select the priority of system alarms whose sound will be turned off. Default is Disable. |
| Ability to allow/disallow turning off alarm sounds for single beds | CMS can set whether the CMS can turn off alarm sounds for a single bed. Default is Disable. |
| Support for external device physiological/technical alarm properties configuration via CMS | Supports display, storage, and printing of external device information, and configuration of their physiological or technical alarm properties (store/display alarms, issue alarm sounds). |
| Ability to bind one bedside monitor and one telemetry device to one sector | CMS can bind one bedside monitor and one telemetry device to one sector, with active device determination by user. |
| CentralStation installation as a service on HPE Proliant DL360 Gen9 server (supporting more devices) | CentralStation can be installed as a service mode, supporting up to 128 monitoring devices and 32 WorkStations/ViewStations. |
| TM80 | |
| New cover material (PPSU RADEL R-5800) and battery cell (ATL supply) | New materials used for cover and battery cell. |
| New battery board with Level one and Level two over voltage protect circuit | New battery board includes additional over voltage protection. |
| Central Charger internal charging IC input voltage of 5.4V and voltage monitoring | Central Charger has input of 5.4V and includes voltage monitoring to shut down on abnormal output. |
| Added disinfectants for device disinfection | New disinfectants added to the approved list. |
| Added accessories for disinfection | Additional disinfecting agents identified for accessories. |
| Local Arrhythmia analysis and alarm functions | Added ability to perform Arrhythmia analysis locally, using same methods as CentralStation. |
| Local ECG, SpO2, RESP, NIBP physiology alarm function | Added local physiological alarm function for these parameters. |
| Intelligent arrhythmia alarm (Arrhythmia Alarm Chains, Refractory Period, Timeout) | Intelligent arrhythmia alarm features added, leveraging K161531. |
| Local ST segment analysis and display | Added ability to perform ST segment analysis locally, using same methods as CentralStation. |
| Local QT analysis and display | Added ability to perform QT analysis locally, using same methods as CentralStation. |
| Enhanced Mindray ECG algorithm performance (PVC recognition sensitivity, baseline wander threshold) | Enhanced PVC recognition sensitivity and reduced threshold for baseline wander. |
| Patient management functions (enter/change demographic info, discharge) via TM80 | Allows users to manage patient demographic information and discharge patients via TM80. |
| Data storage for ECG, RESP, NIBP, SpO2 data on TM80 | Allows users to store these data types locally on TM80. |
| Local history review of ECG, RESP, NIBP, SpO2 data on TM80 | Allows users to review history data locally on TM80. |
| Data retransmission (more than 2 hours of data) | More than 2 hours of data can be resent to CentralStation after re-connection. |
| Design improvements (WiFi firmware, SPO2 connector, EOL material substitution) | Implemented specific design improvements. |
| TMS60 | |
| New cover material (PPSU RADEL R-5800) and battery cell (ATL supply) | New materials used for cover and battery cell. |
| New battery board with Level one and Level two over voltage protect circuit | New battery board includes additional over voltage protection. |
| Central Charger internal charging IC input voltage of 5.4V and voltage monitoring | Central Charger has input of 5.4V and includes voltage monitoring to shut down on abnormal output. |
| Added disinfectants for device disinfection and accessories | New disinfectants added to the approved list for device and accessories. |
| Support for Nellcor SpO2 Module (with specified ranges and accuracy) | Nellcor SpO2 module support added, with specified measurement ranges and accuracies previously cleared in K172482. |
| Design improvements (SPO2 connector, EOL material substitution) | Implemented specific design improvements. |
| Conformance with ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 62133, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-49, ISO 80601-2-61 | The device was assessed for conformity with these standards and found to comply. |
Study Information
The document describes software verification and validation, electromagnetic compatibility, electrical safety, and bench testing to demonstrate substantial equivalence. It is important to note that this is a 510(k) Premarket Notification for a modified device, not a de novo submission or a claim of new clinical efficacy. Therefore, the "studies" outlined are primarily focused on engineering and performance verification of the changes.
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for test sets in terms of patient data or clinical cases. The testing appears to be focused on functional and system-level verification, as well as conformance to technical standards.
- Data provenance (e.g., country of origin, retrospective/prospective) is not provided as the focus is on engineering verification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable or provided. The document focuses on demonstrating substantial equivalence through technical comparisons and compliance with relevant standards, rather than establishing a clinical "ground truth" derived from expert interpretation of medical images or patient data in a comparative clinical study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving multiple readers and ground truth evaluation, which is not the focus of this 510(k) summary.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done or reported. The device (BeneVision Central Monitoring System) is a patient monitoring system which, based on the description, primarily displays, stores, prints, and transfers physiological data and alarms. While it performs some analysis (e.g., arrhythmia, ST segment), it's not described as an AI-powered diagnostic tool requiring a human-in-the-loop performance study in the way an AI-CADx system would. The changes described are enhancements to the monitoring system's capabilities and compliance with updated standards.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that elements like the "Mindray ECG algorithm modifications" and "Intelligent arrhythmia alarm" have undergone verification to ensure they perform according to specifications (e.g., "enhanced performance," "same methods employed by the Central Station"). However, a formal "standalone performance study" with typical metrics like sensitivity, specificity, and F1 score against a reference standard on a clinical dataset is not explicitly detailed or quantified in the provided text. The verification likely involved testing against known waveforms and simulated conditions to confirm algorithm accuracy according to engineering specifications.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given the nature of the device (a core patient monitoring system), the "ground truth" for its functional performance would typically involve:
- Reference signals/simulators: For verifying ECG, SpO2, NIBP, RESP parameters against known inputs.
- Standardized test conditions: For EMC, electrical safety, and alarm system performance.
- Software testing (unit, integration, system): Using expected outputs for given inputs to verify logic and calculations.
- Predicate device comparison: The predicate device itself acts as a reference for expected performance in many aspects of substantial equivalence.
- Specific details about ground truth for individual algorithms (e.g., how the "enhanced performance" of the ECG algorithm was measured against a reference standard) are not provided beyond the general statement of "functional and system level testing."
- Given the nature of the device (a core patient monitoring system), the "ground truth" for its functional performance would typically involve:
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The sample size for the training set:
- The document does not mention a training set, as these are engineering changes and updates to a non-AI patient monitoring system, not a de novo AI/ML algorithm requiring a distinct training phase.
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How the ground truth for the training set was established:
- This section is not applicable, as no training set is mentioned.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).