(324 days)
The indications for use of the BeneVision Central Monitoring System include:
• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).
• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.
• Printing patient data from compatible physiological monitor, and anesthesia devices.
• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.
• Transfer of patient clinical data and settings between several CentralStations.
• Provides a Resting 12 Lead interpretation of previously stored data.
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, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.
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, TM80, and TM70.
• 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/TM70 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/TM70.
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 (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.
When connected to a compatible anesthesia device, BeneVision CMS can display the parameters, waveforms and alarms of the anesthesia device. The device does not contain bi-directional capabilities for the compatible anesthesia devices.
The BeneVision CMS includes the AlarmGUARD application. AlarmGUARD supports delivering notifications of physiological and technical alarms to clinical professionals' mobile devices. AlarmGUARD is not intended for real time monitoring of patients and is not intended to act as a primary source for alarms.
It appears the provided FDA 510(k) clearance letter and summary for the BeneVision Central Monitoring System (K242728) does not contain specific acceptance criteria, test results (like sensitivity/specificity, accuracy metrics), or detailed study methodologies that directly address how the device's performance meets quantitative acceptance criteria for its intended functions.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K220058) through:
- Comparison of Indications for Use: Showing minor differences (expanded compatibility to include anesthesia systems, but not for real-time monitoring).
- Technological Comparisons: Highlighting changes in operating systems, host configurations, and the addition of features like Multi-Patient Viewer separation and AlarmGUARD support.
- Performance Data Section: This section lists the types of testing conducted but does not provide the results of those tests or specific acceptance criteria met by those results. It merely states that "Software verification and validation testing was conducted" and "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."
Therefore, based solely on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document confirms the following regarding the study:
- Study Type: Software verification and validation testing, along with specific bench testing.
- Clinical Data/Animal Testing: Not applicable/not required for this submission to establish substantial equivalence. This suggests the clearance relies on non-clinical data and comparison to the predicate.
- Ground Truth: The document implies that the ground truth for software verification and validation would be the design specifications and expected behavior of the system, rather than clinical outcomes or expert consensus on a diagnostic task. For the "Waveform Display Accuracy from compatible Anesthesia Machine," the ground truth would likely be the direct output from the anesthesia machine itself.
What is present in the document that somewhat relates to your request:
- "Bench Testing" section (Page 19): This lists specific tests performed:
- AlarmGUARD IEC 60601-2-27
- AlarmGUARD IEC 60601-1-8
- AlarmGUARD Human Factors
- Waveform Display Accuracy from compatible Anesthesia Machine
To fulfill your request as best as possible with the given information, I will have to state that many details are explicitly absent from this public 510(k) summary.
Here's a structured response based on the provided document, indicating what information is present and what is absent:
Device Acceptance Criteria and Performance Study Summary (K242728)
Based on the provided FDA 510(k) Clearance Letter and Summary, detailed quantitative acceptance criteria and specific performance metrics (like accuracy, sensitivity, specificity) for the BeneVision Central Monitoring System are not explicitly presented. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K220058) through verification and validation of software and specific bench testing.
The document states that "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance 'Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff'." It also mentions that "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Function | Acceptance Criteria (As Implied/Stated in Document) | Reported Device Performance (As Stated in Document) |
|---|---|---|
| Real-time Viewing Accuracy | Implicit: Accurate display of physiological data and alarms from compatible monitors, and non-real time data from anesthesia devices. | "Waveform Display Accuracy from compatible Anesthesia Machine" bench testing was conducted. Specific results (e.g., % accuracy, error rates) are not provided. |
| AlarmGUARD Functionality | Compliance with relevant IEC standards for alarms and human factors. | "AlarmGUARD IEC 60601-2-27," "AlarmGUARD IEC 60601-1-8," and "AlarmGUARD Human Factors" testing was conducted. Specific passing metrics or performance results are not detailed. |
| Software Functionality | Meets design specifications; performs as designed; adheres to V&V requirements. | "Software verification and validation testing was conducted" and "product works as designed" and "design and performance... checked." No specific quantitative metrics (e.g., defect rate, uptime) are provided. |
| Compatibility (Anesthesia Devices) | Successful display, storage, and transfer of non-real time data from Mindray A8, A9 anesthesia systems. | The system "supports" these devices and the ability to "display, store, print, and transfer information" from them. Specific performance on this compatibility is not quantitatively described beyond the mention of related bench testing. |
| Technological Performance Changes (e.g., Host Configurations, Max Connections) | Device operates within new specifications and maintains safety and effectiveness. | Subject device moved to Windows 11 for some components, increased minimum memory/CPU for CentralStation/WorkStation, increased max connections to 128. These are documented as "No change" for performance or as new specifications that were presumably met. Performance data specific to these upgrades (e.g., latency under max load) is not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in the provided document for any of the listed tests (AlarmGUARD, Waveform Display Accuracy, general software V&V).
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that no clinical data was used or required, the "data" would be synthetic, simulated, or derived from direct device connections during bench testing.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable / Not specified. The document does not describe the use of human experts to establish ground truth for a diagnostic task or for the performance evaluation of this central monitoring system. The focus is on software function and electro-mechanical performance validation against design specifications and international standards.
4. Adjudication Method for the Test Set
- Not applicable / Not specified. No adjudication method is mentioned as human reader input for a test set is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states that "Clinical testing is not required to establish substantial equivalence to the predicate device" and does not mention any MRMC study. This device is a central monitoring system displaying physiological data, not an AI diagnostic tool requiring MRMC studies for improved human reader performance.
6. Standalone Performance (Algorithm Only)
- The "performance data" section lists "Software Verification and Validation Testing" and "Bench Testing" (including "Waveform Display Accuracy from compatible Anesthesia Machine"). These tests conceptually represent 'standalone' performance in that they evaluate the device's technical functions directly. However, no specific quantitative standalone performance metrics (e.g., classification accuracy, sensitivity, specificity for any internal algorithms) are provided in this summary beyond the statement that v&v was conducted to ensure the product "works as designed."
7. Type of Ground Truth Used
- The ground truth for the device's performance appears to be:
- Design Specifications: For general software verification and validation.
- External Reference Standards/Simulators: For tests like "Waveform Display Accuracy" (e.g., comparing the displayed waveform to the known, true signal generated by a simulator or the anesthesia machine itself).
- International Standards: For AlarmGUARD functionality (e.g., IEC 60601-2-27, IEC 60601-1-8).
8. The Sample Size for the Training Set
- Not applicable / Not specified. This document describes a traditional medical device (patient monitoring system software) rather than a machine learning/AI device that typically requires a distinct "training set." Therefore, no training set size is mentioned.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not specified. As no training set for an AI/ML model is indicated, there is no mention of how its ground truth would be established.
FDA 510(k) Clearance Letter - BeneVision Central Monitoring System
Page 1
July 31, 2025
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Lei Li
Manager Regulatory Affairs
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen, Guangdong 518057
China
Re: K242728
Trade/Device Name: BeneVision Central Monitoring System
Regulation Number: 21 CFR 870.2300
Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm)
Regulatory Class: Class II
Product Code: MSX, DRT, DQA, DXN, DSB, MHX, DRQ
Dated: July 24, 2025
Received: July 24, 2025
Dear Lei Li:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K242728 - Lei Li Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K242728 - Lei Li Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
JENNIFER W. SHIH -S
Jennifer Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242728
Device Name: BeneVision Central Monitoring System
Indications for Use (Describe)
The indications for use of the BeneVision Central Monitoring System include:
• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).
• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.
• Printing patient data from compatible physiological monitor, and anesthesia devices.
• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.
• Transfer of patient clinical data and settings between several CentralStations.
• Provides a Resting 12 Lead interpretation of previously stored data.
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, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.
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, TM80, and TM70.
• 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/TM70 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/TM70.
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Page 5
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known): K242728
Device Name: BeneVision Central Monitoring System
Indications for Use (Describe)
The indications for use of the BeneVision Central Monitoring System include:
• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).
• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.
• Printing patient data from compatible physiological monitor, and anesthesia devices.
• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.
• Transfer of patient clinical data and settings between several CentralStations.
• Provides a Resting 12 Lead interpretation of previously stored data.
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, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.
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, TM80, and TM70.
• 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/TM70 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/TM70.
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
FORM FDA 3881 (8/23) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF
Page 6
FORM FDA 3881 (8/23) Page 2 of 2
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 7
510(k) Summary – K242728
Page 1 of 14
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mindray BeneVision Central System is provided below.
1 SUBMITTER
Applicant: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Contact: Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680
E-mail: lilei.js@mindray.com
Date Prepared: July 21, 2025
2 DEVICE
Device Trade Name: BeneVision Central Monitoring System
Device Common Name: System, network and communication, physiological monitors
Classification Name: 21 CFR 870.2300, Cardiac monitor (including cardiotachometer and rate alarm)
Regulatory Class: Class II
Primary Product Code: MSX
Table 1: Secondary Product Codes
| Regulation Number/Class | Product Code | Regulation description | Device Common Name |
|---|---|---|---|
| 21 CFR 870.2300 | DRT | Cardiac Monitor (including cardiotachometer and rate alarm) | Monitor, cardiac (incl. cardiotachometer & rate alarm) |
| 21 CFR 870.2700 | DQA | Oximeter | Oximeter |
| 21 CFR 870.1130 | DXN | Noninvasive blood pressure measurement system | System, measurement, blood-pressure, noninvasive |
| 21 CFR 870.2770 | DSB | Impedance plethysmograph | Plethysmograph, impedance |
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510(k) Summary – K242728 Page 2 of 14
| 21 CFR 870.1025 | MHX | Arrhythmia detector and alarm (including ST-segment measurement and alarm). | Monitor, physiological, patient (with arrhythmia detection or alarms) |
| 21 CFR 870.2060 | DRQ | Transducer signal amplifier and conditioner | Amplifier and signal conditioner, transducer signal |
3 PREDICATE DEVICE
Predicate Device:
• K220058 - BeneVision Central Monitoring System (SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD)
4 REFERENCE DEVICES
• K211900 - Patient Information Center iX - Philips Medizin Systeme Böblingen GmbH
• K161164 - CareEvent inclusive of the CareEvent Mobile Application accessory -PHILIPS MEDICAL SYSTEMS
5 DEVICE DESCRIPTION
The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.
When connected to a compatible anesthesia device, BeneVision CMS can display the parameters, waveforms and alarms of the anesthesia device. The device does not contain bi-directional capabilities for the compatible anesthesia devices.
The BeneVision CMS includes the AlarmGUARD application. AlarmGUARD supports delivering notifications of physiological and technical alarms to clinical professionals' mobile devices. AlarmGUARD is not intended for real time monitoring of patients and is not intended to act as a primary source for alarms.
6 INTENDED USE/INDICATIONS FOR USE
The indications for use of the BeneVision Central Monitoring System include:
• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of
Page 9
510(k) Summary – K242728 Page 3 of 14
compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).
• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.
• Printing patient data from compatible physiological monitor, and anesthesia devices.
• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.
• Transfer of patient clinical data and settings between several CentralStations.
• Provides a Resting 12 Lead interpretation of previously stored data.
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, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.
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, TM80, and TM70.
• 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/TM70 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/TM70.
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510(k) Summary – K242728 Page 4 of 14
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
7 SUBSTANTIAL EQUIVALENCE
Comparison of Indications
Both the predicate device and the subject device are patient monitoring systems intended to be used in healthcare facilities under the direction of clinical professionals The device compatibility for the subject BeneVision Central Monitoring System has been expanded to include anesthesia systems. The subject BeneVision Central Monitoring System supports data storage and viewing (but not real time monitoring) for compatible anesthesia devices.
In conclusion, the difference of the indications for use do not change the fundamental intended use of the BeneVision Central Monitoring System
Technological Comparisons
The table below provides a comparison of the technological features of system compared to the predicate system in K220058. Differences between the subject device and predicate are marked in grey. Each row applies to all modules of the system (CentraStation, WorkStation, ViewStation, CMSViewer and Multi Patient Viewer unless otherwise noted).
Table 2 Technological Comparison
| Feature | As Cleared in K220058 | Subject Device |
|---|---|---|
| Operation System | 1. CentralStation: supports Windows 10/Server 2016/Server 20192. WorkStation and ViewStation: supports Windows 103. CMS Viewer: supports Windows 104. The CentralStation supports installation on the Virtual Machine Platform when running as service such as VMWare and Hyper-V | 1. No change2. No change3. CMS Viewer, Multi Patient Viewer support Windows114. No change |
| Host configurations | 1.CentralStation is Running as an Application on a host computer, the configurations are as below: | 1.CentralStation is Running as an Application on a host computer, the configurations are as below: |
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| | 1.1 CPU: 4 cores and 2.9 GHz minimum1.2 Memory: 4GB minimum1.3 Hard disk: 500 GB minimum1.4 Network adapter: 100M (minimum), Ethernet 802.32.CentralStation is Running as a service :1) on a host computer, the configurations are as below:2.1 CPU: 4 cores and 2.4 GHz minimum2.2 Memory: 12GB minimum2.3 Hard disk: 1TB minimum2.4 Network adapter: 1000M (minimum) self-adapting, Ethernet 802.32) on virtual machine, the configurations are as below:2.1 CPU: 4 cores and 2.4 GHz minimum2.2 Memory: 12GB minimum2.3 Hard disk: 1TB minimum2.4 Network adapter: 1000M (minimum), Ethernet 802.33.The configurations of host computer where WorkStation/ViewStation is running are as below:3.1 CPU: dual cores and 2.0 GHz minimum3.2 Memory: 2GB minimum3.3 Hard disk: 100 GB minimum3.4 Network adapter: 100M (minimum) self-adapting, Ethernet 802.3 | 1.1 No change1.2 Memory: 16GB minimum1.3 No change1.4 Network adapter: 1000M (minimum), Ethernet 802.32. CentralStation is Running as a service:1) on a host computer: the configurations are as below:2.1 CPU: 8 cores and 2.4 GHz minimum2.2 Memory: 16GB minimum2.3 No change2.4 No change2) on virtual machine, the configurations are as below:2.1 CPU: 8 cores and 2.4 GHz minimum2.2 No change2.3 No change2.4 No change3.The configurations of host computer where WorkStation/ViewStation is running are as below:3.1 CPU: quad-cores and 2.4 GHz minimum3.2 Memory: 8GB minimum3.3 No change3.4 No change4. The configurations of CMS Viewer have no change5. The configurations of host computer where Multi Patient viewer is running are as below: |
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| 4.The configurations of host computer where CMSviewer is running are as below:4.1 CPU: 2 cores and 3.0 GHz minimum4.2 Memory: 2GB minimum4.3 Hard disk: 80GB minimum4.4 Network adapter: 100M, Ethernet 802.3 | 4.1 CPU: 4 cores and 2.9 GHz minimum4.2 Memory: 4GB minimum4.3 Hard disk: 100GB minimum4.4 Network adapter: 100M, Ethernet 802.3 | |
|---|---|---|
| Display (including touchscreen capability) | Resolution:1920 x 1080,1280*1024 | No change |
| AudioApplies to all except CMS viewer and Multi Patient Viewer | Built-in speakers | No change |
| RecorderApplies to all except CMS viewer and Multi Patient Viewer | Mindray thermal array module product | No change |
| Network | 100 Mbps, Ethernet 802.3 | No change |
| Max connections are supported for one CentralStationApplies to Central Station | Up to 32 WorkStation or ViewStation connections are supported for one CentralStation | Up to 128 WorkStation or ViewStation connections are supported for one CentralStation |
| Patient Monitor Numbers – | 1. Support 64 monitors running as application.2. When Running as service | No change |
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| Number Supported | Up to 128 monitors with no patient display, the display is provided by WorkStations3. CMS Viewer only supports one monitor4. Multi Patient Viewer supports 36 monitors |
|---|---|
| Telemetry Systems and monitors | Supports the following telemetry systems and monitors:− TMS-6016 (K183238)− TMS60 (K183238)− Telepack-608 (K183238)− TM80(K193391)− TM70(K193391) |
| Communication protocol (and compatible monitors) | CMS+ protocol:DPM3 (K072235）DPM4/5 (K070791)DPM6/7 (K092449)Passport 12m/17m (170876)Passport8/12 (K153448)Passport V (K091834)Accutorr 7/VS-900 (K170712)T1 (K152902)ELAN protocol:Spectrum (K062098)Spectrum OR (K062098)Passport II (K020550)V12/21 (K150352)MD2 protocol:CMS Viewer (K220058)ViewStation (K220058)WorkStation (K220058)TM80 (K193391)TM70(K193391) |
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| BeneVision N22/N19/N17/N15/N12/N1 (K199391)VS8/8A/9(K211475)ePM Series Patient Monitors (ePM 10/ePM12/ePM 15/ ePM 10M/ePM 12M/ePM 15M) (K200015) | BeneVision N22/N19/N17/N15/N12/N1 (K199391)VS8/8A/9(K211475)ePM Series Patient Monitors (ePM 10/ePM12/ePM 15/ ePM 10M/ePM 12M/ePM 15M) (K200015)Anesthesia Systems (Mindray A8, A9) (K201957) | |
|---|---|---|
| Bi-directional ConfigurationApplies to Central Station WorkStation | Patient demographics, alarm settings and parameter settingsFor TM80: patient demographics, alarm settings and parameter setup information can be set by both the CentralStation and TM80.The QRS threshold, ST point/ISO point/J point, and ST and QT template can only be set by the CentralStation. | No change |
| CalculationsApplies to Central Station WorkStation ViewStation | Supports five calculation mode:Drug CalculationHemodynamics CalculationOxygenation CalculationVentilation CalculationRenal Calculation | No change |
| View Other BedApplies to all but Multi Patient Viewer | Provides the user the ability to remotely view 32 patient's parameters, waveforms, and alarms from a patient monitor connected to another BeneVision Central Monitoring System | No change |
| HL7 OutputApplies to: CentralStation | Provide HL7 interface output | No change |
| Paging Interface | Enables transmission of configured alarm notifications to a third-party paging system | No change |
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Applies to: CentralStation
WorkStation
| Dynamic short trend | 8 hours | No change |
|---|---|---|
| Trend review | 240 hours | No change |
| Wave review | 240 hours of full-disclosure waveforms and compressed waveforms | No change |
| NIBP review | Most recent 3000 NIBP measurements | No change |
| Event review | 3000 events | No change |
| 12-lead review | 720 12-lead analysis results, 12 analysis waveforms for each analysis result | No change |
| ST review | Most recent 240 hours of ST segments | No change |
| Cardiac output review | 720 measurements | No change |
| Patient information, real-time waveform, real-time alarm, Alarm Settings, Multi-lead ECG Report, CSA Report, waveform review, Arrhythmia Statistic Result, Trend Review, C.O. measurement, events, 12-lead Review, ST review, QT View Report, drug calculations, hemodynamics calculations, oxygenation calculations, ventilation calculations, renal calculations, ICG hemodynamic parameter, CCO hemodynamic parameter, SvO2/ScvO2 oxygenation parameters | No change | |
| Records | Patient information, real-time waveform, real-time alarm, waveform review, C.O. | No change |
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| measurement, events, 12-lead Review, ST review, drug calculation, hemodynamics calculations, oxygenation calculations, ventilation calculations, renal calculations, ICG hemodynamic parameter, CCO hemodynamic parameter, SvO2/ScvO2 oxygenation parameters | |
|---|---|
| Data storage | The patient data will be saved in an encrypted file. |
| ECG Algorithm | Supports Mindray and Mortara |
| ECG Functions | 3-lead, 5-lead, 6-lead selectable, Arrhythmia detection, ST segment analysis, QT Analysis, Heart rate |
| HR | Adult:Range:15～300 bpmAccuracy：±1 bpm or ±1%, whichever is greaterPediatric:Range:15～350 bpmaccuracy：±1 bpm or ±1%, whichever is greater |
| ST | Range: -2.0~2.0mVAccuracy: ±0.02mV or ±10%, whichever is greater, in the range of -0.8mV to +0.8mV; not specified in other range |
| J Point Auto Detection | J-point Auto detection for ST algorithm. Supports automatically detecting the location of the J-point on the ST template. |
| ARR | Mindray algorithm:Asystol, V-Fib/V-Tach, V-Tach, Vent Brady, Extreme Tachy, Extreme Brady, PVCs/min, Vent Rhythm, Couplet, Bigeminy Trigeminy, R on T, Run PVCs, PVC, Tachy, Brady, Missed Beats, |
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| Pacer Not Pacing, Pacer Not Capture, Multiform PVC, Nonsus V-Tach, Pause, Irr Rhythm, Pauses/min, and A-FibMortara algorithm:Asystol, V-Fib, V-Tach, Vent Rhythm, Couplet, Run PVCs, PVCs/min, Bigeminy Trigeminy, R on T, Multiform PVC, Irr Rhythm, Tachy, Brady, Pacer Not Pacing, Pacer Not Capture, Extreme Tachy, Extreme Brady, Pause and Pauses/min | |
|---|---|
| Adjustable Leads for Arrhythmia Analysis | Adjustable Leads for Arrhythmia Analysis.Supports selectable ECG leads as primary detection lead, secondary detection lead and beat classification lead for arrhythmia analysis |
| QT Analysis | Mindray algorithm:− QT measurement range: [200, 800] ms− QT accuracy [200, 800] ms: ± 30 ms, beyond this range is not specified− QT resolution: [200, 800] ms: 4 ms, beyond this range is not specified− QTc measurement range: [200, 800] ms− QTc resolution [200, 800] ms: 1 ms, beyond this range is not specified− QT-HR measurement range: Adult: [15, 150] bpm, pediatric: [15, 180] bpmMortara algorithm: |
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| − QT measurement range: [300, 600] ms− QT accuracy [300, 600] ms: ± 30 ms, beyond this range is not specified− QT resolution: [300, 600] ms: 2 ms, beyond this range is not specified− QTc measurement range: [300, 600] ms− QTc resolution [300, 600] ms: 1 ms, beyond this range is not specified− QT-HR measurement range: Adult: [43, 130] bpm, pediatric: [43, 130] bpm | |
|---|---|
| QRS Detection Threshold | Adjustable QRS Detection threshold.QRS threshold range: 0.16-0.48mV. |
| Pace mark | Detects and marks pace pulse.Amplitude: ±2 to ±700 mVDuration: 0.1 to 2 msRise time: 10 to 100 µs |
| Pace pulse rejection | Meets the requirements of IEC60601-2-27 2011: Section 201.12.1.101.13.The following pulses without overshoot will be rejected:Amplitude: ±2 to ±700 mVDuration: 0.1 to 2 msRise time: 10 to 100 µs |
| Multi Patient ViewerApplies to: new software component | Previously part of the CMS ViewerRan as a Single Instance |
| Supports to AlarmGUARDApplies to: new software component | Not provided |
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| can send a notification to the AlarmGUARD APP of the caregiver. |
|---|
Substantial Equivalence Conclusion
In conclusion, the subject device has the same intended use, and minor difference in the technological characteristics. The differences in technology compared to the predicate BeneVision Central Monitoring System (K220058) do not raise different questions of safety and effectiveness based on the supportive testing referenced in this section and can be found substantially equivalent to the predicate device.
8 PERFORMANCE DATA
Biocompatibility Testing
Not applicable. The changes are just concerned with Software, not related to Biocompatibility Testing.
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance "Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff". Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. The changes are just concerned with Software, not related to Electrical safety and electromagnetic compatibility.
Bench Testing
The following performance testing was conducted to support the subject device:
• AlarmGUARD IEC 60601-2-27
• AlarmGUARD IEC 60601-1-8
• AlarmGUARD Human Factors
• Waveform Display Accuracy from compatible Anesthesia Machine
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Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device.
9 CONCLUSION
Based on the detailed comparison of specifications for each of the characteristics to the predicate devices, the software verification and validation testing, the BeneVision Central Monitoring System can be found substantially equivalent to the predicate devices.
§ 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).