(113 days)
No
The document explicitly states "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors." and there are no mentions of AI, DNN, or ML.
No
The device is a monitoring system that displays, stores, and transfers patient clinical data and alarms. It does not provide any therapeutic function.
No
The device is a networked patient monitoring system that displays, stores, prints, and transfers patient clinical data and alarms from compatible physiological monitors. It explicitly states, "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors," and its purpose is remote patient monitoring, not diagnosis.
No
The device description explicitly lists hardware components (CentralStation, ViewStation, WorkStation, CMSViewer, and Telemetry Systems) as part of the BeneVision Central Monitoring System.
Based on the provided text, the BeneVision Central Monitoring System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- BeneVision System Function: The BeneVision Central Monitoring System is described as a networked patient monitoring system that displays, stores, prints, and transfers physiological data (ECG, SpO2, NIBP, Resp) received from compatible physiological monitors and telemetry systems. It does not process or analyze biological specimens.
- Intended Use: The intended use focuses on real-time viewing, storage, review, printing, and configuration of patient clinical data and alarms, all derived from physiological measurements taken directly from the patient.
Therefore, the BeneVision Central Monitoring System falls under the category of patient monitoring systems, not in vitro diagnostic devices.
N/A
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
- · Storage and Historical review of patient clinical data and alarms
- · Printing of real time and historical patient data
- · Configuration of local settings as well as synchronizing settings across the network to a remote device
- · Transfer of patient clinical data and settings between several CentralStations
The Bene Vision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthes to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The Bene Vision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.
The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, and TM80.
· The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.
· The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.
· The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
· The TM80 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80. The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
Product codes (comma separated list FDA assigned to the subject device)
MSX, DRQ, MHX, DRT, DXN, DQA, DSB
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:
-
- CentralStation
-
- ViewStation
-
- WorkStation
-
- CMSViewer
-
- Telemetry Systems (TMS 6016. Telepak-608. TMS60. TM80)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and Pediatric patients
Adult and Pediatric patients over three years old
Intended User / Care Setting
professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
To establish the substantial equivalence of the BeneVision Central Monitoring System, Mindray 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K162607 - BeneVision Central Monitoring System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K161531-Philips IntelliVue Patient Monitor MP2, K172482-Nellcor™ USB Pulse Oximetry Monitor Interface Cable, K170876- Passport 12m/17m
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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 Bene Vision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthes to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The Bene Vision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.
The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, and TM80.
· The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.
· The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.
· The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
· The TM80 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80. The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
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.
3
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4
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, physiological
monitors |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | BeneVision Central Monitoring System |
| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan
Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680 |
| Contact: | Yanhong Bai
Manager Regulatory Affairs
SHENZHEN MINDRAY BIO-MEDICAL
ELECTRONICS CO., LTD.
Mindray Building, Keji 12th Road South
High-tech Industrial Park, Nanshan 518057, P.R. China
Tel: +86 755 81888998
Fax: +86 755 26582680
E-mail: baiyanhong@mindray.com |
| Date Prepared: | November 9, 2018 |
| Classification Regulation: | 870.2300 - Cardiac Monitor (including cardiotachometer
and rate alarm)
Class II |
| | |
| Panel: | Cardiovascular |
| Product Code: | MSX –System, network and
communication, physiological monitors |
5
| Subsequent Product Codes: | DRQ- amplifier and signal conditioner,
transducer signal
MHX - monitor, physiological, patient (with
arrhythmia detection or alarms)
DRT - monitor, cardiac (incl.
cardiotachometer & rate alarm)
DXN - system, measurement, blood-
pressure, non-invasive
DQA- Oximeter
DSB- Impedance plethysmograph |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | K162607 - BeneVision Central Monitoring
System |
| Reference devices: | K161531-Philips IntelliVue Patient Monitor MP2:
provided as a reference device for the TM80
intelligent alarm function that has been added to the
subject TM80.
K172482-Nellcor™ USB Pulse Oximetry Monitor
Interface Cable: provided as a reference device for
the Nellcor module that has been added to the
subject TM80 and TMS60
K170876- Passport 12m/17m: provided as a
reference device for the beat annotation feature |
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:
-
- CentralStation
-
- ViewStation
-
- WorkStation
-
- CMSViewer
-
- Telemetry Systems (TMS 6016. Telepak-608. TMS60. TM80)
6
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 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 telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, and TM80.
- The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor . ECG and SpO2 physiological data.
- The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor . ECG and SpO2 physiological data.
- The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years . old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
- The TM80 telemetry monitor is intended for use on Adult and Pediatric patients over three . years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80.
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
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.
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 CMS
Viewer) |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation System | Microsoft Windows 7 Professional
Embedded SP1 | Added Microsoft Windows 10 and Windows
Server 2016 to CentralStation, WorkStation,
ViewStation. |
| Host | The Central Station supports 3 options for
host computers:
- HP Compaq 8380 Elite MT
- HP EliteDesk 800 G1 SFF
- Kontron KISS 2U V2 KTQ87FLEX | Added support for the following host
computers: - HP EliteDesk 800 G3 SFF
- Added HP ProDesk 600 G3 DM (Only
supports WorkStation and ViewStation) - Added HPE Proliant DL360 Gen9 (Only
supports CentralStation)
No longer supports the following host
computer: - HP EliteDesk 800 G1 SFF |
| Display (including
touchscreen capability) | 1920 x 1080 resolution, 16:9 widescreen
LCD 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-screen
mode for 1280*1024 resolution
Up to 24 monitors in the single-screen
mode for 1920 x 1080 resolution
Up 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 CMS
Viewer) |
| | 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 and
parameter settings | For 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.
For other devices: No change. |
| Calculations | Supports five calculation mode:
Drug Calculation
Hemodynamics Calculation
Oxygenation Calculation
Ventilation Calculation
Renal Calculation | No change |
| View Other Bed | Provides the user the ability to remotely
view one patient's parameters,
waveforms, and alarms from a patient | Provides the user the ability to remotely
view 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 CMS
Viewer) |
| monitor connected to another BeneVision
Central Monitoring System | to another BeneVision Central Monitoring
System. | |
| HL7 Output | Provide HL7 interface output | No change |
| Paging Interface | Enables transmission of configured alarm
notifications to a third-party paging
system | No change |
| 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 1000 NIBP measurements | No change |
| Event review | 1000 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 |
| Print | 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.
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 | No change |
| Data storage | The patient data will be saved in an
encrypted file. | No change |
| ECG Algorithm | Supports Mindray and Mortara | No change |
| ECG Functions | 3-lead, 5-lead, 6-lead selectable,
Arrhythmia detection, ST segment
analysis, QT Analysis, Heart rate | No change |
| Feature | Predicate Device - K162607
(CentralStation, WorkStation,
ViewStation, and CMS Viewer) | Subject Device (CentralStation,
WorkStation, ViewStation, and CMS
Viewer) |
| HR | Adult:
Range:15300 bpm350 bpm
Accuracy: ±1 bpm or ±1%,
whichever is greater
Pediatric:
Range:15
accuracy: ±1 bpm or ±1%,
whichever is greater | No change |
| ST | Range: -2.0~2.0mV
Accuracy: ±0.02mV or ±10%, whichever
is 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 the
location 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, Pacer
Not Pacing, Pacer Not Capture, Multif.
PVC, Nonsus.Vtac, Pause, Irr. Rhythm,
Pauses/min, and Afib
Mortara 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, Pause
and Pauses/min | Mindray algorithm:
The following name changes were made to
improve 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 to
improve 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 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 | 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 CMS
Viewer) |
| | - 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]
bpm
Mortara 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 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. | No change |
| Pace mark | Detects and marks pace pulse.
Amplitude: ±2 to ±700 mV
Duration: 0.1 to 2 ms
Rise time: 10 to 100 μs | No change |
| Pace pulse rejection | Meets the requirements of IEC60601-2-27
2011: Section 201.12.1.101.13.
The following pulses without over shoot
will be rejected:
Amplitude: ±2 to ±700 mV
Duration: 0.1 to 2 ms
Rise time: 10 to 100 μs | No change |
| Support ECG Beat
Annotation | Not provided | Provides the ability to annotate the ECG
waveform in the Events review dialog
and the Full Disclosure review dialog
with ECG beat classification
information. |
| Feature | Predicate Device - K162607
(CentralStation, WorkStation,
ViewStation, and CMS Viewer) | Subject Device (CentralStation,
WorkStation, ViewStation, and CMS
Viewer) |
| | | Although the predicate device does not
support ECG Beat Annotation, the
feature has been cleared in K170876. |
| The CMS offline technology
alarm priority is
configurable | Not provided. CMS offline alarm priority
is fixed to low. | The CMS supports configuration of the
offline technology alarm priority. The
options include High, Med and Low.
The default priority option is Low. |
| Graphical display ST Value | Not provided | The CMS ViewBed window supports an
independent window for the graphical
display of the ST value. |
| Strengthen cybersecurity
features | MD2 protocol Encryption Type: XOR | MD2 protocol Encryption Type: XOR
Two additional cybersecurity features
have been added:
- MD2 protocol encryption:
Encrypt MD2 protocol with TLS 1.2
(Transport Layer Security). - MLDAP (Mindray Lightweight
Directory Access Protocol) access
authorization control: Access
authorizations of the CMS is controlled
by MLDAP. |
| Sending configurations to
TM80 telemetry monitor via
the CMS | Not provided | When multiple TM80 telemetry
monitors are monitored by the CMS, the
CMS supports sending the configuration
of one connected TM80 telemetry
monitor to another connected TM80
telemetry monitor. The following
configuration settings can be transferred:
- parameter alarm settings: alarm switch,
alarm limit, alarm priority. - parameter setup information, such as
ECG lead type, ECG filter. |
| Ability to turn off system
alarm notifications within
the CMS | Can turn off all CMS system alarm
notifications | Can turn off alarm notifications based on
the alarm priority.
CMS can select the priority of the
system alarms whose sound will be
turned off.
When the Med&Low or Low option is
selected: - if the current highest system alarm
priority of the CMS is medium or low,
the CMS will not issue an alarm sound.
Additionally, the audio off symbol
is displayed at the top of the CMS
monitor.
Image: audio off symbol |
| Feature | Predicate Device - K162607
(CentralStation, WorkStation,
ViewStation, and CMS Viewer) | Subject Device (CentralStation,
WorkStation, ViewStation, and CMS
Viewer) |
| | | - If the highest system alarm priority of
the CMS is high, then the alarm will not
be muted.
When Disable is selected, if an alarm is
triggered, the alarm sound will not be |
| | | muted (turned off).
The default option is Disable. |
| The CMS can set whether
to allow turning off alarm
sounds for beds. | Can turn off alarm sound for all beds. | The CMS can set whether the CMS can
turn off the alarm sounds for a single
bed. |
| | | When the option is set to Disable, the
user cannot turn off an alarm sound for a
single bed. When the option is set to
Enable, the Audio tab is displayed in the
Alarm Setup menu and the user can turn
off the alarm sound for one bed without
affecting the alarm sounds of other beds. |
| | | This feature does not affect the settings
in the remote patient monitor or
telemetry monitor. |
| | | The default option is Disable. |
| Display, storage and
printing of physiological
or technical alarm | Supports display, storage and printing of
external device information | Supports display, storage and printing of
external device information |
| properties of external | | Additionally, when a patient monitor is |
| devices (connected to
monitors via Benelink) | | connected to an external device via
device integration, the user can set the |
| | | physiological or technical alarm |
| | | properties for the external devices via
the CMS. |
| | | The following alarm properties of the
external device can be set by the CMS: - whether to store and display alarms
- whether to issue alarm sounds |
| | | This feature does not affect the
settings 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 telemetry
device 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 CMS
Viewer) |
| | | active device is switched, the CMS will
automatically bind the monitoring data
coming from two devices to same
patient. |
| CentralStation can be
installed as a service on HPE
Proliant DL360 Gen9 server. | Not Provided | CentralStation can be installed as a
service mode. The CentralStation, in
conjunction with the connected
Workstation, provides the centralized
monitoring function.
In service mode, the CentralStation is
connected with the bedside monitor and
the telemetry device, and processes and
stores the patient data. The WorkStation
provides the frontend display and CMS
alarms. The WorkStation can only
review patient data and print reports.
If the CentralStation is disconnected
from the monitoring device or the
WorkStation, the WorkStation will
immediate activate the network
disconnected alarm.
When the CentralStation is installed as a
service, one CentralStation can support
up to 128 monitoring devices, and up to
32 WorkStations/ViewStations. |
Table 1: Device Comparison Table - CentralStation, WorkStation, ViewStation, and CMS Viewer
8
9
10
11
12
13
14
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 voltage
protect circuit | Battery board: Level one and Level two
over 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: The
charging circuit will shut down when the
voltage output is abnormal. |
15
| Feature | Predicate Device - K162607
(TM80) | Subject Device
(TM80) |
|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IPX | IPX7 | No change |
| Buttons | Power On/Off key
Nurse call key
Main menu key | No change |
| Device Disinfection | 70% isopropyl alcohol
10% sodium hypochloride (bleach)
solution
3% hydrogen peroxide
Virkon
Super Sani-cloth (0.5% Quaternary
ammonium chloride and 55% Isopropyl
alcohol)
50% propyl alcohol (1-propyl alcohol)
70% ethanol | Added:
Propanol
Alpet® D2 Surface Sanitizing Wipes
CIDEX® OPA Solution
Clorox Dispatch® Hospital Cleaner
Disinfectant Towels with Bleach
Clorox Healthcare® Bleach Germicidal Wipes
Clorox Healthcare® Hydrogen Peroxide
Cleaner Disinfectant Wipe
Diversey Oxivir® TB Wipes
Hydrogen peroxide
Isopropanol
Metrex CaviCide1™
Metrex CaviWipes™
PDI Sani-Cloth® AF3 Germicidal Disposable
Wipe
PDI Sani-Cloth® Bleach Germicidal
Disposable Wipe
PDI Sani-Cloth® HB Germicidal Disposable
Wipe
PDI Sani-Cloth® Plus Germicidal Disposable
Cloth
Sodium hypochlorite bleach
VIRAGUARD Hospital Surface Disinfectants
Virex® II 256
Virex® TB |
| Feature | Predicate Device - K162607
(TM80) | Subject Device
(TM80) |
| Accessory Disinfection | ECG leadset:
Ethanol 70%,
Isopropanol 70%,
Glutaraldehyde-type (2%) liquid
disinfectants. | Support additional disinfecting agents as
identified in Error! Reference source not
found. of main document, column "ECG lead
set", "NIBP cuff" and "SpO2 Sensor". |
| | SPO2 sensor:
Ethanol 70%,
Isopropanol 70%,
Glutaraldehyde-type (2%) liquid
disinfectants,
Jifro(ethanol 54%-66%, n-propanol 9%-
11%, trichloroacetic 0.04%-0.06% ),
Chlorine disinfectant 500mg/L. | |
| | NIBP cuff:
70% ethanol
70% isopropanol | |
| Cover material | Front cover material:
SabicPC3412HF
Soft plastic material:
KE-2090-60
Back cover material:
Sabic PC 945
Battery lock material:
Lubriloy D20009
Battery cover material:
Sabic PC 945
ECG lead connector material:
Sabic PC945
Label material:
PC 8010 | Front cover material:
Kalix 5950 HFFR
Soft plastic material:
3070-60
Back cover material:
Kalix 5950 HFFR
Battery lock material:
POM MP90-44
Battery cover material:
PPSU RADEL R-5800
ECG lead connector material:
Sabic 3706
Label 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-2462Mhz
5180Mhz-5240Mhz, 5745Mhz-
5825Mhz
ETSI:
2412Mhz-2472Mhz
5180Mhz-5240Mhz | No change |
| Channel spacing | IEEE 802.11b/g/n (at 2.4G): 5 MHz
IEEE802.11a/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 Mbps
IEEE 802.11a/n(at 5G): 665Mbps | No change |100 % |
| Output power
(transfer power) | 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 rpm
Pediatric:0 to 150 rpm | No change |
| Resolution | 1rpm | No change |
| Accuracy | 7 to 150 rpm: ±2 rpm or ±2%, whichever
is greater
0 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 without
motion 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 has
been cleared in K172482. | | |
| SpO2 Measurement range | Not provided | 0
| SpO2 Accuracy | Not provided | 70%100%: ±2% ABS; 70%300 bpm |100%: 069%:
not specified. |
| PR Measurement range | Not provided | 20
| PR Accuracy | Not provided | 20250 bpm ±3 bpm; 251300 bpm, not
specified |
| BP10 NIBP module | | |
| Power type | Two AA batteries
Rechargeable lithium-ion battery:
DC 3.7V, 1800mAh, 6.66Wh
Cover material: Sabic PC 945
Battery cell: SANYO supply, UF103450P-
N01EA
Battery board: Level one over voltage
protect circuit | Two AA batteries
Rechargeable lithium-ion battery:
DC 3.7V, 1800mAh, 6.66Wh
Cover material: PPSU RADEL R-5800
Battery cell: SANYO supply, UF103450P-
H01UA
Battery board: Level one and Level two
over voltage protect circuit |
| Display | 2.4", 320*240 pixels | No change |
| Feature | Predicate Device - K162607
(TM80) | Subject Device
(TM80) |
| Buttons | Power On/Off key
Nurse call key
Main 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 mmHg
Max standard deviation: 8 mmHg | No change |
| PR from NIBP Module | Measurement ranges:30-300bpm
Accuracy: $\pm$ 3bpm or $\pm$ 3%, whichever
is greater;
Resolution:1bpm | No change |
| Cover material | Cover material:
Sabic PC 945
LCD glass:
PC
Soft plastic material:
KE-2090-60
Battery lock material:
Lubriloy D20009
Battery cover material:
Sabic PC 945 | Cover material:
Kalix 5950 HFFR
LCD glass:
HWC-PC
Soft plastic material:
3070-60
Battery lock material:
POM MP90-44
Battery cover material:
PPSU RADEL R-5800 |
| Feature | Predicate Device - K162607
(TM80) | Subject Device
(TM80) |
| Arrhythmia analysis and
alarm. | Provided by the CentralStation | Added the ability to perform Arrhythmia
analysis locally using the same methods
employed by the Central station.
The types of arrhythmia have not been
changed, they are just implemented
locally within the TM80 instead of being
implemented by the CentralStation. |
| ARR | Provided by the CentralStation | Asystole, V-Fib/V-Tach, V-Tach, Vent
Brady, Extreme Tachy, Extreme Brady, R
on T, Run PVCs, Couplet, Multif.PVC,
PVC, Bigeminy, Trigeminy, Tachy,
Brady, Pacer Not Capture, Pacer Not
Pacing, 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, NIBP
physiology alarm function. |
| Intelligent arrhythmia
alarm | Not provided | Arrhythmia Alarm Chains;
Alarm Refractory Period;
Arrhythmia Alarm Timeout
Although the predicate device does not
support an intelligent arrhythmia alarm
functionality, the feature has been cleared in
K161531 |
| ST segment analysis
and display | Provided by the CentralStation | Added the ability to perform ST segment
analysis locally using the same methods
employed by the Central Station.
The specifications of ST segment analysis
are the same as in the predicate device,
only they are implemented locally instead
of by the CentralStation. |
| QT analysis and display | Provided by the CentralStation | Added the ability to perform QT analysis
locally using the same methods as the
CentralStation.
The specifications of QT analysis are the
same as in the predicate device, only they
are implemented locally instead of by the
CentralStation. |
| Mindray ECG algorithm
modifications | ARR, HR, ST, QT analysis | ARR, HR, ST, QT analysis
enhanced performance:
- Enhance premature ventricular contraction
(PVC) recognition sensitivity.
Reduced threshold for detecting baseline
wander or electromyography signals. |
| Patient management | Provided by the CentralStation | Allows users to enter or change patient
demographic information, or discharge
patients 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 of
ECG, RESP, NIBP, SpO2 in TM80. |
| Data retransmission | 10s real time data can be resent to the
CentralStation after reconnected. | More than 2 hours of ECG, SPO2, NIBP,
and RESP data generated during a
disconnection from the network can be
resent to the CentralStation after the
CentralStation is reconnected. |
| Other Change | | |
| Other changes | | Design improvement:
• WiFi firmware upgrade.
• SPO2 connector: add the pin touch length
from 0.85mm to 2mm.
• End of life material substitute: LCD, Flash. |
16
17
18
19
20
21
Table 3: Device Comparison Table – TMS60
| Feature | Predicate Device - K162607
(TMS60) | Subject Device
(TMS60) |
|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Transmitter | | |
| Power type | Two or three AA batteries
Rechargeable lithium-ion battery:
DC 3.8V, 3800mAh, 14.44Wh
Cover material: Sabic PC 945
Battery cell: SANYO supply, UF515155S-
H003A
Battery board: Level one over voltage protect
circuit | Two or three AA batteries
Rechargeable lithium-ion battery:
DC 3.8V, 3800mAh, 14.44Wh
Cover material: PPSU RADEL R-5800
Battery cell: ATL supply, GC-SDC-514752-
010L
Battery board: Level one and Level two over
voltage protect circuit |
| Display | Support touch-screen display | No change |
| Central Charger | Internal charging IC input :
15V
Voltage monitoring : Not provided | Internal charging IC input :
5.4V
Add voltage monitoring function, shut down
when voltage output abnormal. |
| IPX | IPX7 | No change |
| Buttons | Power On/Off key
Nurse call key
Main menu key | No change |
| Feature | Predicate Device - K162607
(TMS60) | Subject Device
(TMS60) |
| Cover material | Top cover material:
SabicPC3412HF
Soft plastic material:
KE-2090-60
Back cover material:
Sabic PC 945
Battery lock:
Lubriloy D20009
Battery holder cover:
Sabic PC 945
ECG lead connector material:
Sabic PC945
Label material:
PC 8010 | Top cover material:
Kalix 5950 HFFR
Soft plastic material:
3070-60
Back cover material:
Kalix 5950 HFFR
Battery lock:
POM MP90-44
Battery holder cover:
PPSU RADEL R-5800
ECG lead connector material:
Sabic 3706
Label material:
PET A4300 |
| Device Disinfection | 70% isopropyl alcohol
10% sodium hypocholride (bleach) solution
3% hydrogen peroxide
Virkon
Super Sani-cloth (0.5% Quaternary
ammonium chloride and 55% Isopropyl
alcohol)
50% propyl alcohol (1-propyl alcohol)
70% ethanol | Added:
Propanol
Alpet® D2 Surface Sanitizing Wipes
CIDEX® OPA Solution
Clorox Dispatch® Hospital Cleaner Disinfectant
Towels with Bleach
Clorox Healthcare® Bleach Germicidal Wipes
Clorox Healthcare® Hydrogen Peroxide Cleaner
Disinfectant Wipe
Diversey Oxivir® TB Wipes
Hydrogen peroxide
Isopropanol
Metrex CaviCide1™
Metrex CaviWipes™
PDI Sani-Cloth® AF3 Germicidal Disposable
Wipe
PDI Sani-Cloth® Bleach Germicidal Disposable
Wipe
PDI Sani-Cloth® HB Germicidal Disposable
Wipe
PDI Sani-Cloth® Plus Germicidal Disposable
Cloth
Sodium hypochlorite bleach
VIRAGUARD Hospital Surface Disinfectants
Virex® II 256
Virex® TB |
| Feature | Predicate Device - K162607
(TMS60) | Subject Device
(TMS60) |
| Accessory
Disinfection- | ECG leadset:
Ethanol 70%,
Isopropanol 70%,
Glutaraldehyde-type (2%) liquid
disinfectants.
SPO2 sensor:
Ethanol 70%,
Isopropanol 70%,
Glutaraldehyde-type (2%) liquid
disinfectants,
Jifro(ethanol 54%-66%, n-propanol 9%-11%,
trichloroacetic 0.04%-0.06% ),
Chlorine disinfectant 500mg/L.
NIBP cuff:
70% ethanol
70% isopropanol | Supports additional disinfecting agents |
| Receiver | | |
| Antenna connector | Quantity: 2
Connector type: TNC | No change |
| Ethernet interface | Protocol: IEEE 802.3
Speed: 10M/100M (self-adaptive) Connector
type: 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 | 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 rpm
Pediatric:0 to 150 rpm | No change |
| Resolution | 1rpm | No change |
| Accuracy | 7 to 150 rpm: ±2 rpm or ±2%, whichever is
greater
0 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 motion
in 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 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 has
been cleared in K172482. | | |
| SpO2 Measurement
range | Not provided | 0100 % |300 bpm |
| SpO2 Accuracy | Not provided | 70%100% : ±2% ABS; 069%: not specified. |
| PR Measurement
range | Not provided | 20
| PR Accuracy | Not provided | 20250 bpm ±3 bpm; 251300 bpm, not
specified |
| BP10 NIBP module | | |
| Power type | Two AA batteries
Rechargeable lithium-ion battery:
DC 3.7V, 1800mAh, 6.66Wh
Cover material: Sabic PC 945
Battery cell: SANYO supply, UF103450P-
N01EA
Battery board: Level one over voltage protect
circuit | Two AA batteries
Rechargeable lithium-ion battery:
DC 3.7V, 1800mAh, 6.66Wh
Cover material: PPSU RADEL R-5800
Battery cell: SANYO supply, UF103450P-
H01UA
Battery board: Level one and Level two over
voltage protect circuit |
| Display | 2.4", 320*240 pixels | No change |
| Buttons | Power On/Off key
Nurse call key
Main 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 mmHg
Max standard deviation: 8 mmHg | No change |
| PR from NIBP
Module | Measurement ranges:30-300bpm
Accuracy:±3bpm or ±3%, whichever is
greater;
Resolution:1bpm | No change |
| Cover material | Cover material:
Sabic PC 945
LCD glass:
PC
Soft plastic material:
KE-2090-60
Battery lock material:
Lubriloy D20009
Battery cover material:
Sabic PC 945 | Cover material:
Kalix 5950 HFFR
LCD glass:
HWC-PC
Soft plastic material:
3070-60
Battery lock material:
POM MP90-44
Battery cover material:
PPSU RADEL R-5800 |
| Other Change | | |
| Other change | / | Design improvement:
• SPO2 connector: add the pin touch
length from 0.85mm to 2mm.
• End of life material substitute: LCD,
Flash. |
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23
24
25
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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.