· 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 BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

Device Description

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:

1. CentralStation
1. ViewStation
1. WorkStation
1. CMSViewer
1. Telemetry Systems (TMS 6016. Telepak-608. TMS60. TM80)

AI/ML Overview

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.

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.
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.
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.
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.
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.
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."
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.
How the ground truth for the training set was established:
- This section is not applicable, as no training set is mentioned.

Summary

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March 13, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shenzhen Mindray Bio-medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, 518057 CN

Re: K183238

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, DRQ, MHX, DRT, DXN, DQA, DSB Dated: February 7, 2019 Received: February 8, 2019

Dear Yanhong Bai:

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 (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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Arielle Drummond -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183238

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
· 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 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 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the BeneVision Central Monitoring System is provided below.

Device Common Name:	System, network and communication, physiologicalmonitors
Device Trade Name:	BeneVision Central Monitoring System
Applicant:	SHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, NanshanShenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680
Contact:	Yanhong BaiManager Regulatory AffairsSHENZHEN MINDRAY BIO-MEDICALELECTRONICS CO., LTD.Mindray Building, Keji 12th Road SouthHigh-tech Industrial Park, Nanshan 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared:	November 9, 2018
Classification Regulation:	870.2300 - Cardiac Monitor (including cardiotachometerand rate alarm)Class II

Panel:	Cardiovascular
Product Code:	MSX –System, network andcommunication, physiological monitors

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Subsequent Product Codes:	DRQ- amplifier and signal conditioner,transducer signalMHX - monitor, physiological, patient (witharrhythmia detection or alarms)DRT - monitor, cardiac (incl.cardiotachometer & rate alarm)DXN - system, measurement, blood-pressure, non-invasiveDQA- OximeterDSB- Impedance plethysmograph
Predicate Device:	K162607 - BeneVision Central MonitoringSystem
Reference devices:	K161531-Philips IntelliVue Patient Monitor MP2:provided as a reference device for the TM80intelligent alarm function that has been added to thesubject TM80.K172482-Nellcor™ USB Pulse Oximetry MonitorInterface Cable: provided as a reference device forthe Nellcor module that has been added to thesubject TM80 and TMS60K170876- Passport 12m/17m: provided as areference device for the beat annotation feature

Subsequent Product Codes:

DRQ- amplifier and signal conditioner,transducer signalMHX - monitor, physiological, patient (witharrhythmia detection or alarms)DRT - monitor, cardiac (incl.cardiotachometer & rate alarm)DXN - system, measurement, blood-pressure, non-invasiveDQA- OximeterDSB- Impedance plethysmograph

Predicate Device:

K162607 - BeneVision Central MonitoringSystem

Reference devices:

K161531-Philips IntelliVue Patient Monitor MP2:provided as a reference device for the TM80intelligent alarm function that has been added to thesubject TM80.K172482-Nellcor™ USB Pulse Oximetry MonitorInterface Cable: provided as a reference device forthe Nellcor module that has been added to thesubject TM80 and TMS60K170876- Passport 12m/17m: provided as areference device for the beat annotation feature

Device Description:

The BeneVision Central Monitoring System consists of the following components:

1. CentralStation
1. ViewStation
1. WorkStation
1. CMSViewer
1. Telemetry Systems (TMS 6016. Telepak-608. TMS60. TM80)

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The TMS 6016, Telepak-608, TMS60 telemetry monitoring systems operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.

The TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for processing, display, and alarm.

Indication for Use:

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 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.

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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.

TM80 local monitoring function has been added to the indications for use of the subject TM80 device, including local ECG, SpO2, RESP, NIBP physiology alarm, arrhythmia analysis, ST segment analysis and display, and QT analysis and display. The local functions were previously performed for the predicate TM80 (K162607) via the CentralStation and thus the modifications do not constitute a new intended use for a patient monitoring system.

Comparison of Technological Characteristics:

The technological characteristics of the subject device are compared to the predicate device in the table below.

Feature	Predicate Device - K162607(CentralStation, WorkStation,ViewStation, and CMS Viewer)	Subject Device (CentralStation,WorkStation, ViewStation, and CMSViewer)
Operation System	Microsoft Windows 7 ProfessionalEmbedded SP1	Added Microsoft Windows 10 and WindowsServer 2016 to CentralStation, WorkStation,ViewStation.
Host	The Central Station supports 3 options forhost computers:- HP Compaq 8380 Elite MT- HP EliteDesk 800 G1 SFF- Kontron KISS 2U V2 KTQ87FLEX	Added support for the following hostcomputers:- HP EliteDesk 800 G3 SFF- Added HP ProDesk 600 G3 DM (Onlysupports WorkStation and ViewStation)- Added HPE Proliant DL360 Gen9 (Onlysupports CentralStation)No longer supports the following hostcomputer:- HP EliteDesk 800 G1 SFF
Display (includingtouchscreen capability)	1920 x 1080 resolution, 16:9 widescreenLCD display 19", 21.5" and 23"	No change
Audio	Built-in speakers	No change
Recorder	Mindray thermal array module product	No change
Network	100 Mbps, Ethernet 802.3	No change
Patient Monitor Numbers -Number Supported	Up to 16 monitors in the single-screenmode for 1280*1024 resolutionUp to 24 monitors in the single-screenmode for 1920 x 1080 resolutionUp to 32 monitors in multi-screen mode	No change
Feature	Predicate Device - K162607(CentralStation, WorkStation,ViewStation, and CMS Viewer)	Subject Device (CentralStation,WorkStation, ViewStation, and CMSViewer)
	Supports up to four local displays
Telemetry System	Supports the following telemetry systems:— TMS-6016 (K162607)— TMS60 (K162607)— Telepack-608 (K162607)— TM80(K162607)	No change
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:CMSViewer (K162607)ViewStation (K162607)WorkStation (K162607)TM80 (K162607)	No change
Bi-directional Configuration	Patient demographics, alarm settings andparameter settings	For TM80: patient demographics, alarmsettings and parameter setup information canbe set by both the CentralStation and TM80.The QRS threshold, ST point/ISO point/Jpoint, and ST and QT template can only beset by the CentralStation.For other devices: No change.
Calculations	Supports five calculation mode:Drug CalculationHemodynamics CalculationOxygenation CalculationVentilation CalculationRenal Calculation	No change
View Other Bed	Provides the user the ability to remotelyview one patient's parameters,waveforms, and alarms from a patient	Provides the user the ability to remotelyview 32 patients' parameters, waveforms,and alarms from a patient monitor connected
Feature	Predicate Device - K162607(CentralStation, WorkStation,ViewStation, and CMS Viewer)	Subject Device (CentralStation,WorkStation, ViewStation, and CMSViewer)
monitor connected to another BeneVisionCentral Monitoring System	to another BeneVision Central MonitoringSystem.
HL7 Output	Provide HL7 interface output	No change
Paging Interface	Enables transmission of configured alarmnotifications to a third-party pagingsystem	No change
Dynamic short trend	8 hours	No change
Trend review	240 hours	No change
Wave review	240 hours of full-disclosure waveformsand compressed waveforms	No change
NIBP review	Most recent 1000 NIBP measurements	No change
Event review	1000 events	No change
12-lead review	720 12-lead analysis results, 12 analysiswaveforms for each analysis result	No change
ST review	Most recent 240 hours of ST segments	No change
Cardiac output review	720 measurements	No change
Print	Patient information, real-time waveform,real-time alarm, Alarm Settings, Multi-lead ECG Report, CSA Report, waveformreview, Arrhythmia Statistic Result,Trend Review, C.O. measurement, events,12-lead Review, ST review, QT ViewReport, drug calculations, hemodynamicscalculations, oxygenation calculations,ventilation calculations, renalcalculations, ICG hemodynamicparameter, CCO hemodynamic parameter,SvO2/ScvO2 oxygenation parameters	No change
Records	Patient information, real-time waveform,real-time alarm, waveform review, C.O.measurement, events, 12-lead Review, STreview, drug calculation, hemodynamicscalculations, oxygenation calculations,ventilation calculations, renalcalculations, ICG hemodynamicparameter, CCO hemodynamic parameter,SvO2/ScvO2 oxygenation parameters	No change
Data storage	The patient data will be saved in anencrypted file.	No change
ECG Algorithm	Supports Mindray and Mortara	No change
ECG Functions	3-lead, 5-lead, 6-lead selectable,Arrhythmia detection, ST segmentanalysis, QT Analysis, Heart rate	No change
Feature	Predicate Device - K162607(CentralStation, WorkStation,ViewStation, and CMS Viewer)	Subject Device (CentralStation,WorkStation, ViewStation, and CMSViewer)
HR	Adult:Range:15~~300 bpmAccuracy: ±1 bpm or ±1%,whichever is greaterPediatric:Range:15~~350 bpmaccuracy: ±1 bpm or ±1%,whichever is greater	No change
ST	Range: -2.0~2.0mVAccuracy: ±0.02mV or ±10%, whicheveris greater, in the range of -0.8mV to+0.8mV; not specified in other range	No change
J Point Auto Detection	J-point Auto detection for ST algorithm.Supports automatically detecting thelocation of the J-point on the ST template.	No change
ARR	Mindray algorithm:Asystol, Vfib/Vtac, Vtac, Vent. Brady,Extreme Tachy, Extreme Brady,PVCs/min, Vent. Rhythm, Couplet,Bigeminy Trigeminy, R on T, Run PVCs,PVC, Tachy, Brady, Missed Beats, PacerNot Pacing, Pacer Not Capture, Multif.PVC, Nonsus.Vtac, Pause, Irr. Rhythm,Pauses/min, and AfibMortara algorithm:Asystol, Vfib, Vtac, Vent.Rhythm,Couplet, Run PVCs, PVCs/min,Bigeminy Trigeminy, R on T,Multif.PVC, Irr.Rhythm, Tachy, Brady,Pacer Not Pacing, Pacer Not Capture,Extreme Tachy, Extreme Brady, Pauseand Pauses/min	Mindray algorithm:The following name changes were made toimprove clarity:- 'VFib/Vtac' to 'V-Fib/V-Tach'- 'Vtac' to 'V-Tach'- 'Vent.Brady' to 'Vent Brady',- 'Nonsus.Vtac' to 'Nonsus V-Tach'- 'Vent.Rhythm' to 'Vent Rhythm'- 'Afib' to 'A-Fib'- 'Multif.PVC' to 'Multiform PVC'- 'Irr. Rhythm' to 'Irr Rhythm'Mortara algorithm:The following name changes were made toimprove clarity:- 'VFIB' to 'V-Fib'- 'VTAC' to 'V-Tach'- 'Vent.Rhythm' to 'Vent Rhythm'- 'Multif.PVC' to 'Multiform PVC'- 'Irr. Rhythm' to 'Irr Rhythm'
Adjustable Leads forArrhythmia Analysis	Adjustable Leads for ArrhythmiaAnalysis.Supports selectable ECG leads as primarydetection lead, secondary detection leadand beat classification lead for arrhythmiaanalysis	No change
QT Analysis	Mindray algorithm:QT measurement range: [200, 800] ms	No change
Feature	Predicate Device - K162607(CentralStation, WorkStation,ViewStation, and CMS Viewer)	Subject Device (CentralStation,WorkStation, ViewStation, and CMSViewer)
	- 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 notspecified- QT-HR measurement range: Adult:[15, 150] bpm, pediatric: [15, 180]bpmMortara algorithm:
	- 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 notspecified
	- 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.	No change
Pace mark	Detects and marks pace pulse.Amplitude: ±2 to ±700 mVDuration: 0.1 to 2 msRise time: 10 to 100 μs	No change
Pace pulse rejection	Meets the requirements of IEC60601-2-272011: Section 201.12.1.101.13.The following pulses without over shootwill be rejected:Amplitude: ±2 to ±700 mVDuration: 0.1 to 2 msRise time: 10 to 100 μs	No change
Support ECG BeatAnnotation	Not provided	Provides the ability to annotate the ECGwaveform in the Events review dialogand the Full Disclosure review dialogwith ECG beat classificationinformation.
Feature	Predicate Device - K162607(CentralStation, WorkStation,ViewStation, and CMS Viewer)	Subject Device (CentralStation,WorkStation, ViewStation, and CMSViewer)
		Although the predicate device does notsupport ECG Beat Annotation, thefeature has been cleared in K170876.
The CMS offline technologyalarm priority isconfigurable	Not provided. CMS offline alarm priorityis fixed to low.	The CMS supports configuration of theoffline technology alarm priority. Theoptions include High, Med and Low.The default priority option is Low.
Graphical display ST Value	Not provided	The CMS ViewBed window supports anindependent window for the graphicaldisplay of the ST value.
Strengthen cybersecurityfeatures	MD2 protocol Encryption Type: XOR	MD2 protocol Encryption Type: XORTwo additional cybersecurity featureshave been added:1. MD2 protocol encryption:Encrypt MD2 protocol with TLS 1.2(Transport Layer Security).2. MLDAP (Mindray LightweightDirectory Access Protocol) accessauthorization control: Accessauthorizations of the CMS is controlledby MLDAP.
Sending configurations toTM80 telemetry monitor viathe CMS	Not provided	When multiple TM80 telemetrymonitors are monitored by the CMS, theCMS supports sending the configurationof one connected TM80 telemetrymonitor to another connected TM80telemetry monitor. The followingconfiguration settings can be transferred:- parameter alarm settings: alarm switch,alarm limit, alarm priority.- parameter setup information, such asECG lead type, ECG filter.
Ability to turn off systemalarm notifications withinthe CMS	Can turn off all CMS system alarmnotifications	Can turn off alarm notifications based onthe alarm priority.CMS can select the priority of thesystem alarms whose sound will beturned off.When the Med&Low or Low option isselected:- if the current highest system alarmpriority of the CMS is medium or low,the CMS will not issue an alarm sound.Additionally, the audio off symbolis displayed at the top of the CMSmonitor.Image: audio off symbol
Feature	Predicate Device - K162607(CentralStation, WorkStation,ViewStation, and CMS Viewer)	Subject Device (CentralStation,WorkStation, ViewStation, and CMSViewer)
		- If the highest system alarm priority ofthe CMS is high, then the alarm will notbe muted.When Disable is selected, if an alarm istriggered, the alarm sound will not be
		muted (turned off).The default option is Disable.
The CMS can set whetherto allow turning off alarmsounds for beds.	Can turn off alarm sound for all beds.	The CMS can set whether the CMS canturn off the alarm sounds for a singlebed.
		When the option is set to Disable, theuser cannot turn off an alarm sound for asingle bed. When the option is set toEnable, the Audio tab is displayed in theAlarm Setup menu and the user can turnoff the alarm sound for one bed withoutaffecting the alarm sounds of other beds.
		This feature does not affect the settingsin the remote patient monitor ortelemetry monitor.
		The default option is Disable.
Display, storage andprinting of physiologicalor technical alarm	Supports display, storage and printing ofexternal device information	Supports display, storage and printing ofexternal device information
properties of external		Additionally, when a patient monitor is
devices (connected tomonitors via Benelink)		connected to an external device viadevice integration, the user can set the
		physiological or technical alarm
		properties for the external devices viathe CMS.
		The following alarm properties of theexternal device can be set by the CMS:- whether to store and display alarms- whether to issue alarm sounds
		This feature does not affect thesettings of the remote patient monitor.
The CMS can bind bedside	CMS can bind an external device or a	CMS can bind one bedside monitor and
monitor and/or telemetrydevice to one sector.	monitor to a CMS sector.	one telemetry device to one sector,however only one device can be active
		in the CMS at a time. The user
		determines the active device. If the
Feature	Predicate Device - K162607(CentralStation, WorkStation,ViewStation, and CMS Viewer)	Subject Device (CentralStation,WorkStation, ViewStation, and CMSViewer)
		active device is switched, the CMS willautomatically bind the monitoring datacoming from two devices to samepatient.
CentralStation can beinstalled as a service on HPEProliant DL360 Gen9 server.	Not Provided	CentralStation can be installed as aservice mode. The CentralStation, inconjunction with the connectedWorkstation, provides the centralizedmonitoring function.In service mode, the CentralStation isconnected with the bedside monitor andthe telemetry device, and processes andstores the patient data. The WorkStationprovides the frontend display and CMSalarms. The WorkStation can onlyreview patient data and print reports.If the CentralStation is disconnectedfrom the monitoring device or theWorkStation, the WorkStation willimmediate activate the networkdisconnected alarm.When the CentralStation is installed as aservice, one CentralStation can supportup to 128 monitoring devices, and up to32 WorkStations/ViewStations.

Table 1: Device Comparison Table - CentralStation, WorkStation, ViewStation, and CMS Viewer

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Table 2: Device Comparison Table – TM80

Feature	Predicate Device - K162607(TM80)	Subject Device(TM80)
Power type	Two or three AA batteries	Two or three AA batteries
	Rechargeable lithium-ion battery:	Rechargeable lithium-ion battery:
	DC 3.8V, 3800mAh, 14.44Wh	DC 3.8V, 3800mAh, 14.44Wh
	Cover material: Sabic PC 945	Cover material: PPSU RADEL R-5800
	Battery cell: SANYO supply, UF515155S-H003A	Battery cell: ATL supply, GC-SDC-514752-010L
	Battery board: Level one over voltageprotect circuit	Battery board: Level one and Level twoover voltage protect circuit
Display	Support touch-screen display	No change
Central Charger	Internal charging IC input :15V	Internal charging IC input :5.4V
	Voltage monitoring : Not provided	Add voltage monitoring function: Thecharging circuit will shut down when thevoltage output is abnormal.

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Feature	Predicate Device - K162607(TM80)	Subject Device(TM80)
IPX	IPX7	No change
Buttons	Power On/Off keyNurse call keyMain menu key	No change
Device Disinfection	70% isopropyl alcohol10% sodium hypochloride (bleach)solution3% hydrogen peroxideVirkonSuper Sani-cloth (0.5% Quaternaryammonium chloride and 55% Isopropylalcohol)50% propyl alcohol (1-propyl alcohol)70% ethanol	Added:PropanolAlpet® D2 Surface Sanitizing WipesCIDEX® OPA SolutionClorox Dispatch® Hospital CleanerDisinfectant Towels with BleachClorox Healthcare® Bleach Germicidal WipesClorox Healthcare® Hydrogen PeroxideCleaner Disinfectant WipeDiversey Oxivir® TB WipesHydrogen peroxideIsopropanolMetrex CaviCide1™Metrex CaviWipes™PDI Sani-Cloth® AF3 Germicidal DisposableWipePDI Sani-Cloth® Bleach GermicidalDisposable WipePDI Sani-Cloth® HB Germicidal DisposableWipePDI Sani-Cloth® Plus Germicidal DisposableClothSodium hypochlorite bleachVIRAGUARD Hospital Surface DisinfectantsVirex® II 256Virex® TB
Feature	Predicate Device - K162607(TM80)	Subject Device(TM80)
Accessory Disinfection	ECG leadset:Ethanol 70%,Isopropanol 70%,Glutaraldehyde-type (2%) liquiddisinfectants.	Support additional disinfecting agents asidentified in Error! Reference source notfound. of main document, column "ECG leadset", "NIBP cuff" and "SpO2 Sensor".
	SPO2 sensor:Ethanol 70%,Isopropanol 70%,Glutaraldehyde-type (2%) liquiddisinfectants,Jifro(ethanol 54%-66%, n-propanol 9%-11%, trichloroacetic 0.04%-0.06% ),Chlorine disinfectant 500mg/L.
	NIBP cuff:70% ethanol70% isopropanol
Cover material	Front cover material:SabicPC3412HFSoft plastic material:KE-2090-60Back cover material:Sabic PC 945Battery lock material:Lubriloy D20009Battery cover material:Sabic PC 945ECG lead connector material:Sabic PC945Label material:PC 8010	Front cover material:Kalix 5950 HFFRSoft plastic material:3070-60Back cover material:Kalix 5950 HFFRBattery lock material:POM MP90-44Battery cover material:PPSU RADEL R-5800ECG lead connector material:Sabic 3706Label material:PET A4300
WIFI specification
WIFI Protocol	IEEE 802.11a/b/g/n	No change
Modulation mode	DSSS and OFDM	No change
Operating frequency	FCC:2412Mhz-2462Mhz5180Mhz-5240Mhz, 5745Mhz-5825MhzETSI:2412Mhz-2472Mhz5180Mhz-5240Mhz	No change
Channel spacing	IEEE 802.11b/g/n (at 2.4G): 5 MHzIEEE802.11a/n (at 5G): 20MHz	No change
Feature	Predicate Device - K162607(TM80)	Subject Device(TM80)
Wireless baud rate(data rate)	IEEE 802.11b/g/n (at 2.4G): 1-65 MbpsIEEE 802.11a/n(at 5G): 6~65Mbps	No change
Output power(transfer power)	< 20 dBm (CE requirement: detectionmode - RMS);< 30 dBm (FCC requirement: detectionmode - peak power).	No change
Operating mode	Infrastructure	No change
Data security	Standard:WPA-PSK and WPA2-PSKWPA-Enterprise, WPA2-EnterpriseEAP method:PEAP-GTC, PEAP- MSCHAPv2,EAP-TLSEncryption: TKIP and AES	No change
Qos	Qos setting supported	No change
Communication protocol	MD2 protocol	No change
Bluetooth specification
Bluetooth	Bluetooth low energy 4.0	No change
Modulation mode	GFSK	No change
Operating frequency	2402 ~ 2480MHz	No change
Channel spacing	2 MHz	No change
Wireless baud rate(data rate)	1 Mbps	No change
Output power(transfer power)	≤2.5mW	No change
Data security	Private protocol	No change
Bluetooth function	Configuration transferConnect to BP10 NIBP module	No change
ECG Specifications
Lead type	3-lead: I, II, III5-lead: I, II, III, aVR, aVL, aVF, V6-lead: II, III, aV, aVL, aVF, Va, VbAutomatic lead recognition	No change
Maximum Input	$ \pm $ 8 mV (Peak to Peak Value)	No change
Frequency Response	ST mode: 0.05-40 HzMonitoring mode: 0.5-40 Hz	No change
CMRR	> 105dB	No change
Noise	≤ 30 $ \mu $ V (p-v RTI)	No change
Defibrillation Proof	Meets IEC 60601-2-27	No change
Feature	Predicate Device - K162607(TM80)	Subject Device(TM80)
Measurement range	Adult: 0 to 120 rpmPediatric:0 to 150 rpm	No change
Resolution	1rpm	No change
Accuracy	7 to 150 rpm: ±2 rpm or ±2%, whicheveris greater0 to 6 rpm: Not specified	No change
SpO2 Specifications
Nonin SpO2 Module
SpO2 range	0% to 100%	No change
SpO2 accuracy	70-100%: ± 3 % (digital);0-69%: Not specified	No change
PR range	20 bpm to 300 pm	No change
PR accuracy	±3 bpm	No change
Masimo SpO2 Module
SpO2 Measurement range	1% to 100%	No change
SpO2 Accuracy	70 to 100%: ±2% (measured withoutmotion in adult/pediatric mode)70 to 100%: ±3% (measured with motion)1% to 69%: Not specified.	No change
PR Measurement range	25 bpm to 240 bpm	No change
PR Accuracy	± 3 bpm (without motion)± 5 bpm (with motion)	No change
Nellcor SpO2 Module (Added): Although the predicate device does not support Nellcor SpO2 module, the feature hasbeen cleared in K172482.
SpO2 Measurement range	Not provided	0~100 %
SpO2 Accuracy	Not provided	70%~100%: ±2% ABS; 70%~~100%: 0~~69%:not specified.
PR Measurement range	Not provided	20~300 bpm
PR Accuracy	Not provided	20~~250 bpm ±3 bpm; 251~~300 bpm, notspecified
BP10 NIBP module
Power type	Two AA batteriesRechargeable lithium-ion battery:DC 3.7V, 1800mAh, 6.66WhCover material: Sabic PC 945Battery cell: SANYO supply, UF103450P-N01EABattery board: Level one over voltageprotect circuit	Two AA batteriesRechargeable lithium-ion battery:DC 3.7V, 1800mAh, 6.66WhCover material: PPSU RADEL R-5800Battery cell: SANYO supply, UF103450P-H01UABattery board: Level one and Level twoover voltage protect circuit
Display	2.4", 320*240 pixels	No change
Feature	Predicate Device - K162607(TM80)	Subject Device(TM80)
Buttons	Power On/Off keyNurse call keyMain menu key	No change
Protocol	Bluetooth low energy 4.0	No change
Modulation mode	GFSK	No change
Operating frequency	2402 ~ 2480MHz	No change
Channel spacing	2 MHz	No change
Wireless baud rate(data rate)	1 Mbps	No change
Output power(transfer power)	$ \le 2.5mW $	No change
Data security	Private protocol	No change
Bluetooth function	Connect to TMS60/TM80 transmitter	No change
Measurement ranges(mmHg)	Adult :Systolic: 25-290mmHg ;Diastolic: 10-250mmHg ;Mean: 15-260mmHg;Pediatric :Systolic: 25-240mmHg ;Diastolic: 10-200mmHg ;Mean: 15-215mmHg	No change
Accuracy	Max mean error: $\pm$ 5 mmHgMax standard deviation: 8 mmHg	No change
PR from NIBP Module	Measurement ranges:30-300bpmAccuracy: $\pm$ 3bpm or $\pm$ 3%, whicheveris greater;Resolution:1bpm	No change
Cover material	Cover material:Sabic PC 945LCD glass:PCSoft plastic material:KE-2090-60Battery lock material:Lubriloy D20009Battery cover material:Sabic PC 945	Cover material:Kalix 5950 HFFRLCD glass:HWC-PCSoft plastic material:3070-60Battery lock material:POM MP90-44Battery cover material:PPSU RADEL R-5800
Feature	Predicate Device - K162607(TM80)	Subject Device(TM80)
Arrhythmia analysis andalarm.	Provided by the CentralStation	Added the ability to perform Arrhythmiaanalysis locally using the same methodsemployed by the Central station.The types of arrhythmia have not beenchanged, they are just implementedlocally within the TM80 instead of beingimplemented by the CentralStation.
ARR	Provided by the CentralStation	Asystole, V-Fib/V-Tach, V-Tach, VentBrady, Extreme Tachy, Extreme Brady, Ron T, Run PVCs, Couplet, Multif.PVC,PVC, Bigeminy, Trigeminy, Tachy,Brady, Pacer Not Capture, Pacer NotPacing, Missed Beats, Nonsus V-Tach,Vent Rhythm, Pause, Irr Rhythm, A-Fib,PVCs/min, Pauses/min
ECG, SpO2, RESP,NIBP physiology alarm	Provided by the CentralStation	Added Local SpO2, RESP, NIBPphysiology alarm function.
Intelligent arrhythmiaalarm	Not provided	Arrhythmia Alarm Chains;Alarm Refractory Period;Arrhythmia Alarm TimeoutAlthough the predicate device does notsupport an intelligent arrhythmia alarmfunctionality, the feature has been cleared inK161531
ST segment analysisand display	Provided by the CentralStation	Added the ability to perform ST segmentanalysis locally using the same methodsemployed by the Central Station.The specifications of ST segment analysisare the same as in the predicate device,only they are implemented locally insteadof by the CentralStation.
QT analysis and display	Provided by the CentralStation	Added the ability to perform QT analysislocally using the same methods as theCentralStation.The specifications of QT analysis are thesame as in the predicate device, only theyare implemented locally instead of by theCentralStation.
Mindray ECG algorithmmodifications	ARR, HR, ST, QT analysis	ARR, HR, ST, QT analysisenhanced performance:- Enhance premature ventricular contraction(PVC) recognition sensitivity.Reduced threshold for detecting baselinewander or electromyography signals.
Patient management	Provided by the CentralStation	Allows users to enter or change patientdemographic information, or dischargepatients via TM80.
Feature	Predicate Device - K162607(TM80)	Subject Device(TM80)
Data storage	Provided by the CentralStation	Allows users to store ECG, RESP, NIBP,SpO2 data in TM80.
Local History review	Provided by the CentralStation	Allows users to review history data ofECG, RESP, NIBP, SpO2 in TM80.
Data retransmission	10s real time data can be resent to theCentralStation after reconnected.	More than 2 hours of ECG, SPO2, NIBP,and RESP data generated during adisconnection from the network can beresent to the CentralStation after theCentralStation is reconnected.
Other Change
Other changes		Design improvement:• WiFi firmware upgrade.• SPO2 connector: add the pin touch lengthfrom 0.85mm to 2mm.• End of life material substitute: LCD, Flash.

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Table 3: Device Comparison Table – TMS60

Feature	Predicate Device - K162607(TMS60)	Subject Device(TMS60)
Transmitter
Power type	Two or three AA batteriesRechargeable lithium-ion battery:DC 3.8V, 3800mAh, 14.44WhCover material: Sabic PC 945Battery cell: SANYO supply, UF515155S-H003ABattery board: Level one over voltage protectcircuit	Two or three AA batteriesRechargeable lithium-ion battery:DC 3.8V, 3800mAh, 14.44WhCover material: PPSU RADEL R-5800Battery cell: ATL supply, GC-SDC-514752-010LBattery board: Level one and Level two overvoltage protect circuit
Display	Support touch-screen display	No change
Central Charger	Internal charging IC input :15VVoltage monitoring : Not provided	Internal charging IC input :5.4VAdd voltage monitoring function, shut downwhen voltage output abnormal.
IPX	IPX7	No change
Buttons	Power On/Off keyNurse call keyMain menu key	No change
Feature	Predicate Device - K162607(TMS60)	Subject Device(TMS60)
Cover material	Top cover material:SabicPC3412HFSoft plastic material:KE-2090-60Back cover material:Sabic PC 945Battery lock:Lubriloy D20009Battery holder cover:Sabic PC 945ECG lead connector material:Sabic PC945Label material:PC 8010	Top cover material:Kalix 5950 HFFRSoft plastic material:3070-60Back cover material:Kalix 5950 HFFRBattery lock:POM MP90-44Battery holder cover:PPSU RADEL R-5800ECG lead connector material:Sabic 3706Label material:PET A4300
Device Disinfection	70% isopropyl alcohol10% sodium hypocholride (bleach) solution3% hydrogen peroxideVirkonSuper Sani-cloth (0.5% Quaternaryammonium chloride and 55% Isopropylalcohol)50% propyl alcohol (1-propyl alcohol)70% ethanol	Added:PropanolAlpet® D2 Surface Sanitizing WipesCIDEX® OPA SolutionClorox Dispatch® Hospital Cleaner DisinfectantTowels with BleachClorox Healthcare® Bleach Germicidal WipesClorox Healthcare® Hydrogen Peroxide CleanerDisinfectant WipeDiversey Oxivir® TB WipesHydrogen peroxideIsopropanolMetrex CaviCide1™Metrex CaviWipes™PDI Sani-Cloth® AF3 Germicidal DisposableWipePDI Sani-Cloth® Bleach Germicidal DisposableWipePDI Sani-Cloth® HB Germicidal DisposableWipePDI Sani-Cloth® Plus Germicidal DisposableClothSodium hypochlorite bleachVIRAGUARD Hospital Surface DisinfectantsVirex® II 256Virex® TB
Feature	Predicate Device - K162607(TMS60)	Subject Device(TMS60)
AccessoryDisinfection-	ECG leadset:Ethanol 70%,Isopropanol 70%,Glutaraldehyde-type (2%) liquiddisinfectants.SPO2 sensor:Ethanol 70%,Isopropanol 70%,Glutaraldehyde-type (2%) liquiddisinfectants,Jifro(ethanol 54%-66%, n-propanol 9%-11%,trichloroacetic 0.04%-0.06% ),Chlorine disinfectant 500mg/L.NIBP cuff:70% ethanol70% isopropanol	Supports additional disinfecting agents
Receiver
Antenna connector	Quantity: 2Connector type: TNC	No change
Ethernet interface	Protocol: IEEE 802.3Speed: 10M/100M (self-adaptive) Connectortype: RJ45	No change
WMTS specification
frequency range	608 to 614MHz (WMTS band)	No change
Modulation mode	GFSK	No change
Channel spacing	25KHz	No change
Wireless baud rate	8 kbps±3%	No change
Transmit power	<10mW	No change
Receiver sensitivity	≤-110dBm (Bit error rate ≤1%)	No change
Data security	Private protocol	No change
Bluetooth specification
Protocol	Bluetooth low energy 4.0	No change
Modulation mode	GFSK	No change
Operating frequency	2402 ~ 2480MHz	No change
Channel spacing	2 MHz	No change
Wireless baud rate(data rate)	1 Mbps	No change
Feature	Predicate Device - K162607(TMS60)	Subject Device(TMS60)
Output power(transfer power)	<2.5mW	No change
Data security	Private protocol	No change
Wireless function	Configuration transferConnect to BP10 NIBP module	No change
ECG Specifications
Lead type	3-lead: I, II, III5-lead: I, II, III, aVR, aVL, aVF, VAutomatic 3/5 lead recognition	No change
Maximum Input	±8 mV(Peak to Peak Value)	No change
Frequency Response	ST mode: 0.05-40 HzMonitoring mode: 0.5-40 Hz	No change
CMRR	> 105dB	No change
Noise	≤ 30 μV (p-v RTI)	No change
Defibrillation Proof	Meets IEC 60601-2-27	No change
Resp Specifications
Measurement range	Adult: 0 to 120 rpmPediatric:0 to 150 rpm	No change
Resolution	1rpm	No change
Accuracy	7 to 150 rpm: ±2 rpm or ±2%, whichever isgreater0 to 6 rpm: Not specified	No change
Supported external devices
Nonin SpO2 Module (K150632)
SpO2 range	0% to 100%	No change
SpO2 accuracy	70-100%: ± 3 % (digital);0-69%: Not specified	No change
PR range	20 bpm to 300 bpm	No change
PR accuracy	±3 bpm	No change
Masimo SpO2 Module (K150632)
SpO2 Measurement range	1% to 100%	No change
SpO2 Accuracy	70 to 100%: ±2% (measured without motionin adult/pediatric mode)70 to 100%: ±3% (measured with motion)1% to 69%: Not specified.	No change
Feature	Predicate Device - K162607(TMS60)	Subject Device(TMS60)
PR Measurementrange	25 bpm to 240 bpm	No change
PR Accuracy	± 3 bpm (without motion)± 5 bpm (with motion)	No change
Nellcor SpO2 Module (Added): Although the predicate device does not support Nellcor SpO2 module, the feature hasbeen cleared in K172482.
SpO2 Measurementrange	Not provided	0~100 %
SpO2 Accuracy	Not provided	70%~~100% : ±2% ABS; 0~~69%: not specified.
PR Measurementrange	Not provided	20~300 bpm
PR Accuracy	Not provided	20~~250 bpm ±3 bpm; 251~~300 bpm, notspecified
BP10 NIBP module
Power type	Two AA batteriesRechargeable lithium-ion battery:DC 3.7V, 1800mAh, 6.66WhCover material: Sabic PC 945Battery cell: SANYO supply, UF103450P-N01EABattery board: Level one over voltage protectcircuit	Two AA batteriesRechargeable lithium-ion battery:DC 3.7V, 1800mAh, 6.66WhCover material: PPSU RADEL R-5800Battery cell: SANYO supply, UF103450P-H01UABattery board: Level one and Level two overvoltage protect circuit
Display	2.4", 320*240 pixels	No change
Buttons	Power On/Off keyNurse call keyMain menu key	No change
Protocol	Bluetooth low energy 4.0	No change
Modulation mode	GFSK	No change
Operating frequency	2402 ~ 2480MHz	No change
Channel spacing	2 MHz	No change
Wireless baud rate(data rate)	1 Mbps	No change
Output power(transfer power)	≤2.5mW	No change
Data security	Private protocol	No change
Bluetooth function	Connect to TMS60/TM80 transmitter	No change
Feature	Predicate Device - K162607(TMS60)	Subject Device(TMS60)
Measurement ranges(mmHg)	Adult :Systolic: 25-290mmHg ;Diastolic: 10-250mmHg ;Mean: 15-260mmHg。Pediatric :Systolic: 25-240mmHg ;Diastolic: 10-200mmHg ;Mean: 15-215mmH	No change
Accuracy	Max mean error: ±5 mmHgMax standard deviation: 8 mmHg	No change
PR from NIBPModule	Measurement ranges:30-300bpmAccuracy:±3bpm or ±3%, whichever isgreater;Resolution:1bpm	No change
Cover material	Cover material:Sabic PC 945LCD glass:PCSoft plastic material:KE-2090-60Battery lock material:Lubriloy D20009Battery cover material:Sabic PC 945	Cover material:Kalix 5950 HFFRLCD glass:HWC-PCSoft plastic material:3070-60Battery lock material:POM MP90-44Battery cover material:PPSU RADEL R-5800
Other Change
Other change	/	Design improvement:• SPO2 connector: add the pin touchlength from 0.85mm to 2mm.• End of life material substitute: LCD,Flash.

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In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.

Performance Data:

Biocompatibility Testing

The CentralStation, ViewStation and CMS viewer are software only devices, therefore biocompatibility is not applicable. There have been no changes to the patient contacting materials of the telemetry systems.

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Software Verification and Validation Testing

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the BeneVision Central Monitoring System was conducted to ensure that the device works as designed. Validation was conducted to check the design and performance of the device.

Electromagnetic Compatibility and Electrical Safety

The BeneVision Central Monitoring System were assessed for conformity with the relevant requirements of the following standards and found to comply:

ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
IEC 62133:2012 (Second Edition) Secondary cell and batteries containing alkaline or other non-● acid electrolytes

Bench Testing

To establish the substantial equivalence of the BeneVision Central Monitoring System, Mindrav conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.

In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.

IEC 60601-1-8:2006 + Am1:2012 Medical electrical equipment part 1-8: general requirements ● for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment IEC80601-2-30 Edition 1.1 2013-07
IEC 60601-2-49:2011 Medical electrical equipment -Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-61: 2011 Medical electrical equipment part 2-61: particular requirements for basic ● safety and essential performance of pulse oximeter equipment

Conclusion:

Based on the detailed comparison between the predicate devices and the subject devices, the performance testing and conformance with applicable standards, the Bene Vision Central Monitoring System can be found substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).